0A4F4F9BD490A749D5437F821CF06DF1
Regulation for the Health Control of Products
https://honduras.eregulations.org/media/Acuerdo-06-2005-REGLAMENTO-PARA-EL-CONTROL-SANITARIO.pdf
http://leaux.net/URLS/ConvertAPI Text Files/2CF9FB008EE14C62087A5D9FCF5EF958.en.txt
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This file was generated: 2020-07-15 06:06:13
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator illegal:
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p.(None): acquittal in favor of the alleged offender, which must be notified.
p.(None): Article 230.- If the pniebas were insufficient and the defendant denied the charges, the health authority ex officio or
p.(None): at the request of the party, it will order the opening of evidence, granting a term of ten (10) business days to propose them and
p.(None): evacuate them; throughout
p.(None): In this case, the competent health authority may, at any time, have the practice of any evidence it deems
p.(None): pertinent for the best decision of the matter.
p.(None): Article 231.- After the probationary term and the proceedings of the case, the health authority
p.(None): will issue the resolution following the administrative procedure.
p.(None): StttİÓil A ÀtlltFd0S and ltïts
p.(None): M l PmØiJ'ZiIFP MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Article 232.- The resolution must contain:
p.(None): a) Name of the issuing authority.
p.(None): b) Summary relationship of the facts.
p.(None): c) Statement of relevant considerations.
p.(None): d) Resolve categorically, clearly and precisely; citing the legal instruments, regulations or provisions
p.(None): sanitary in which it is based.
p.(None): e) Place and date of issue.
p.(None): f) Signature and seal of the competent health authority.
p.(None): Article 233.- In the event that the resolution is sanctioning, it will also provide:
p.(None): a) Imposition of the sanction.
p.(None): b) Prohibition of continuing illegal acts or violations of sanitary provisions.
p.(None): c) Warning at the offender that in case of recidivism or disobedience to the resolution, the
p.(None): more drastic sanctions provided for in this Regulation.
p.(None): d) The term to make effective the economic sanction imposed, which will be within ten (10) business days,
p.(None): counted from the day following the notification.
p.(None): e) The remedies that legally proceed against the resolution.
p.(None): f) The competent body before whom to lodge the resources and the term that has for it.
p.(None): Article 234.- Resolutions will be notified personally within a maximum period of five (5) business days from
p.(None): from the date of issuance and will be practiced by delivering the full copy of the resolution.
p.(None): Article 235. - Not having been able to personally notify the resolution within five (5) days, it will be made.
p.(None): fixing the operative part of the resolution in the table of notices of the office of the sanitary authority.
p.(None): Article 236.- Personal notification or by table will be recorded in the corresponding file.
p.(None): Article 237.- Against the resolutions issued by the health authority and that impose sanctions the appeals proceed
p.(None): of replacement and appeal.- These appeals will be substantiated in accordance with the Law of Procedure
p.(None): Adininistrative.
p.(None): THIRD SECTION
p.(None): OFFENCES AND PENALTIES
p.(None): Article 238.- Violations of the provisions of the Health Code and these Regulations will be sanctioned without
p.(None): penalty of the penalties to which the offender becomes creditor for the configuration
p.(None): of crimes against public health, in which case the Ministry of Health will put the background in knowledge
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Political / criminal
Searching for indicator criminal:
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p.(None): following:
p.(None): a) They are promoted only with the information and arguments approved by the competent health authority.
p.(None): b) Do not suggest that the use of these medications can delay or avoid using a doctor.
p.(None): c) Do not suggest its use permanently, limiting the term of authorized administration.
p.(None): d) Do not use phrases or words that exaggerate the benefits of the product in the text.
p.(None): e) They are expressed in colloquial language, without using medical or technical terms that confuse the consumer.
p.(None): f} Do not use testimonial arguments of notorious persons or entities in teaching, research or
p.(None): Health sciences, which can induce consumption.
p.(None): CHAPTER IX
p.(None): OF BREACHES, SANCTIONS AND PROCEDURES
p.(None): SECTION ONE GENERAL PROVISIONS
p.(None): Article 203.- Any infraction by intentional act or omission or negligence that contravenes the
p.(None): provisions of the Health Code, these Regulations, the Technical Standards or the provisions issued by the Secretariat in
p.(None): the exercise of its functions and competences, committed by the owner
p.(None): representative of the establishment and the workers who are at the service of the same, which harms or
p.(None): may harm the legal good protected from life and the health of the population will be repressed with one or more of
p.(None): the sanctions referred to in Article 206 of this Regulation, taking into account their significance
p.(None): to the detriment of the health of the population and its recidivism, by reasoned administrative act without prejudice to the
p.(None): civil and criminal liability incurred.
p.(None): Article 204.- For the purpose of applying the sanctions contained in this Regulation, the infractions are
p.(None): classified as follows:
p.(None): a) Slight lack
p.(None): b) Less serious offense; Y,
p.(None): c) Serious foul.
p.(None): Article 205.- The application of sanctions for violation of this Regulation shall be carried out in accordance with
p.(None): the procedure established and guaranteeing at all times the right of defense to the accused; the penalties will be
p.(None): applied after resolution issued by the Director General or Departmental Regional Chiefs, based on the
p.(None): mandatory and optional reports and opinions of the corresponding technical and legal units.
p.(None): Article 206.- The sanctions that the sanitary authorities must impose for the inquiries to the dispositions
p.(None): contained in these Regulations are the following:
p.(None): a) Written warning
p.(None): b) Single or successive fines, depending on the case, ranging between twenty lempiras (L. 20.00) and fifty thousand lempiras
p.(None): (L. 50,000.00).
p.(None): c) Confiscation of products, substances or artifacts.
p.(None): d) Suspension or cancellation of health records or licenses.
p.(None): e) Temporary or definitive closure of buildings and establishments.
p.(None): Article 207.- For the application of the sanctions referred to in the previous Article, the health authority shall have
p.(None): Discretionary account of the following:
p.(None): a) The importance of the infraction to the detriment of the health of the population.
p.(None): b) The recidivism in the infraction or omission of the sanitary dispositions.
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C .; NOVEMBER 4, 2005 N ‘. 30,841
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p.(None): proceeding to place seals or seals that guarantee their conservation and permanence in the establishment
p.(None): inspected.- In case of not wanting or being able to sign the witnesses and / or the interested party, it will be recorded in the minutes,
p.(None): which does not invalidate it.
p.(None): Article 215.- In order to comply with the provisions of the Health Code and this Regulation, the authority
p.(None): When required, it will request the support of the Public Prosecutor's Office, the Municipal Offices, the Police
p.(None): National, the Attorney General's Office, the Secretary of Natural Resources and Environment and the Secretariat of
p.(None): Agriculture and Livestock.
p.(None): In all the proceedings that are carried out, only the aforementioned authorities will participate, avoiding notoriety
p.(None): public, unnecessary inconvenience or damage to the establishment.
p.(None): Article 216.- In those cases that from the violation of the legal and regulatory provisions risks and
p.(None): serious damage to people's health or the environment, the health authority will immediately notify the
p.(None): General Directorate of Health Regulation. This, when the case merits it will make public the fact and
p.(None): notify the respective authority, to prevent major risks or damages.
p.(None): Article 217.- The application of the administrative sanctions of which the Health Code deals with and this
p.(None): Regulations, do not exempt the offender from civil or criminal liability to have place for the act sanctioned.
p.(None): or tapes in visible places in the entrances and in the machines, Article 218.- In the cases that
p.(None): of the violation of
p.(None): equipment, locks and others, with the legend: “Closed legal and regulatory provisions result
p.(None): Responsibility Temporarily or Closed Definitely by the Criminal Authority, the health authority
p.(None): communicate immediately to the Sanitary ”, with the purpose of preventing the continuation of the General Directorate of
p.(None): Sanitary Regulation, so that this activity, entry or use, as appropriate.
p.(None): file the respective complaint with the corresponding authority.
p.(None): Ç MPUBLICA DE HONDURAS - TEGUCIGALPA, IYI. D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84.
p.(None): Article 219.- For the purposes of the sanctions established by this regulation, the persons shall be liable
p.(None): natural or legal that sell products or provide health services.
p.(None): Article 220.- To verify the facts and determine the
p.(None): Article 225.- t.a citation will be made to the owner of the establishment or legal representative of the company by
p.(None): ID card that will be delivered to you personally; if you are not in the establishment, delivery will be made to
p.(None): any of your
p.(None): family members or employees who are in it or in their
p.(None): Violations of the legal provisions health authority may make use of the
p.(None): a) Inspections
p.(None): b) Witness Statement
p.(None): c) Sampling
p.(None): d) Laboratory analysis or tests
p.(None): Regulatory, the first steps:
p.(None): residence.- Delivery of the identity card, the owner or legal representative shall be deemed legally cited.
p.(None): Article 226.- The citation card must contain:
p.(None): a) Name of the health authority issuing it
p.(None): b) The name and surname of the person to whom the citation is made
p.(None): SECOND SECTION
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Political / political affiliation
Searching for indicator party:
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p.(None): Health Recovery, Title I of Pharmaceutical Products and Medical Equipment, Title II of
p.(None): Health Institutions, Book IV, Title 11 Measures and Administrative Acts, Title III Procedure in the
p.(None): Actions of the Health Authorities of the Health Code.
p.(None): Article 2.- The following are fundamental principles of this Regulation:
p.(None): a) Protect the Health and life of users and consumers in relation to products, services and
p.(None): Health Interest establishments.
p.(None): b) Regulate the conditions of safety, efficacy and safety of the products, services and establishments of
p.(None): Health interest.
p.(None): CHAPTER II GENERAL PROVISIONS
p.(None): Article 3.- This Regulation regulates the products, services and establishments of health interest and the
p.(None): personnel linked to them, and for the purposes of their application the following terms or concepts are defined:
p.(None): Abandonment: Declaration of early termination of a procedure, which is not concluded by not responding to
p.(None): time the requirements made to complete the process.
p.(None): Sample record: Document containing the proof of sampling.
p.(None): Citation Act: Document by means of which, the inspector quotes the regent, legal representative or the owner
p.(None): of the establishment to appear before the corresponding dependency of the Ministry of Health.
p.(None): Inspection Act: Document that reflects the result of the inspection carried out by the health authority (s)
p.(None): competent duly subscribed by them and the interested party.
p.(None): Customs: Official competent body that regulates the import and export of merchandise from the country.
p.(None): Food for Medical Use: The one that has been subjected to processes that modify the relative concentration
p.(None): of the various nutrients, of their constitution or their quality, or by incorporation of substances
p.(None): outside its composition, they acquire therapeutic properties.
p.(None): Written reprimand: Action to reprimand someone, by writing motivated by omission, execution of a
p.(None): activity or conduct contrary to legal or regulatory provisions.
p.(None): Hearing: Citation that is made to the public employee in order to render discharges on actions that are
p.(None): imputed or attributed.
p.(None): Outpatient Care: Actions aimed at patient care for diagnosis and treatment, when
p.(None): Check that it does not require hospitalization.
p.(None): Hospital Care: Actions aimed at the care of patients who, due to their state of health, need to be
p.(None): integrated for more than 24 hours for diagnosis or medical or surgical treatment.
p.(None): s REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and
p.(None): health rehabilitation.
p.(None): Preventive Care: A set of general promotion and specific protection actions provided to the
p.(None): individual and the general population with the purpose of reducing morbidity.
p.(None): Rehabilitation Care: Actions aimed at correcting physical or mental disability.
p.(None): Health Care: Promotional, preventive, curative and rehabilitation actions provided by a
p.(None): multidisciplinary team in the health area.
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p.(None): Distributors and A i: etites, of Ü tupresas Naci ona le • s and E.xti ünjer ‹i.s. .3 of his Reformed Regret
p.(None): iuedi ‹urte ho. Agreement 749-8. ,) 'fi, ric its Regulations iiiodiíicado by Agreement No. 1 80-00, of October 31
p.(None): the 2000,
p.(None): RESINLVE:
p.(None): PRIA4ERt3: l9eclarar WITH 1.IIGAR, the Application for LICENt'IA Dfiî l9ISTRIBL'IIJf3R filed pt ›r e1 Advocate JOIIEL
p.(None): ANTONIO Z.ELAYA AI .. $ ’'AREZ, Legal Representative of Mr. JESSY JAME NIASSO hlASSIJ, constituted corn‹ ›€“ oniei‘ciante
p.(None): Individual through Instrument No. 31.6
p.(None): from 30 d * i * = * dcl 2005, authorized ¡i ‹x‘ el .4bogado and h otario l ° úbIico lklüt “. € “. NUÑEZ VEI..ASQLIEZ., Who
p.(None): The development of its useful activities is rare, with ilenonaination and JAMES INVESTING, having its
p.(None): domicile in l ‹i ciu‹ lad me 4’egucigalpa, municipality of the Central District, for complying with the requirements
p.(None): Establishments in the Law of Representatives, Distributors and Agents, of National and Foreign Companies
p.(None): and its Regulation.
p.(None): SEGI.iNDO: Conceive Mr. IESSY JAME AIN $ .SO íYlASStl, who
p.(None): ] I ‹iru the desaiTOllo of its activities uses the JEíSS deniiuiución .IAMES IN ¥ 'ERSIONkS, who has his domicile
p.(None): in the city of ’Tegucigalpa, municipality of the Centiu1 District, the LICE. to,
p.(None): for a definite time until July 14, 2006, with jin isdiccióH in the territory of the Republic of Honduras, for
p.(None): distribute the pt‘oduct ‹› s of the CEGAL brand, pet4eneciente to the granting company A.P.C.-2000, INC., with donation
p.(None): in Nevada, United States. of Anléricii.
p.(None): THIRD: Publish this Resolution in the Official Gazette, on behalf of the interested party and the
p.(None): presentation of the copy in which the publication is recorded, register in the respective Registry that for such
p.(None): the effect is the Dú’eccióti € íeneial of Productive Sectors. NOJJFIQtIESFí. IRVING ELIAS GUERRERO, Secretary of State
p.(None): in the l3espachos de Industria y Comercio, RAFAEI .. AN "I" ONIO ’I’REJO, Secretary € íeneraI.
p.(None): For the purposes that interest Gorivenha, the present is extended, in the city of ’fesucigalpa, municipality of
p.(None): Central District, on the nineteenth day of September of two thousand and five.
p.(None): RENE RODRIGUEZ.OCHOA
p.(None): Head of the General Secretariat
p.(None): 4 N. 2005
p.(None): The undersigned, Secretary General of the Secretary of State in the Offices of Industry and Commerce,
p.(None): J'RANSCRIBE: the Resolution that literally says: RESfilLIJCION N °. 715-i005, SECRE R. ANIA STATE IN THE
p.(None): OFFICES HE INDUSTRY AND COMMERCE.- TEGUCIGALPA, MUNICIPALITY OF THE CENTRAL DISTRICT, October 24, 2005.
p.(None): ¥ 'ISTA: To resolve application No. 614-2005, filed with this
p.(None): .Secretary of State on the eleventh date of October two thousand five, by Mr. ROLANDO ARTURO TOME MOLINA,
p.(None): I urge the Bar Association of Honduras under No. 07109, as Legal Representative of the Appointed
p.(None): “EhIPRESA DE SERVICIOS MtTl.TIPLkS IVA CANEÑ A”, domiciled in the municipality of Cane, department of I.a Paz,
p.(None): contracted to request that the granting of the Legal Personality be granted to its representative. approval of
p.(None): Statutes and Registration.
p.(None): WHEREAS: That through Agreement ho. 254-97 dated December 14, 1997, the Office of Development of the
p.(None): Social Sector
p.(None): Ía Economía (O.D.S.), having among other attributions, the qualification of documents of £? Onstitution and Registration
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p.(None): will use the following control mechanisms: Sanitary License, Sanitary Registry, Sanitary Inspection,
p.(None): Audits, Accreditation and Certification.
p.(None): Article 123.- If, in order to comply with the previous article, the use of other public laboratories or
p.(None): private, the Ministry of Health may use its services, ensuring that they are duly accredited by
p.(None): National or international institution recognized.
p.(None): Article 124.- The Ministry of Health may contract professional services for sanitary inspection,
p.(None): audits, accreditation and certification, if necessary.
p.(None): Article 125.- The Ministry of Health shall formulate the technical norms for hiring professional services.
p.(None): in the specific areas of health regulation.
p.(None): SECOND SECTION
p.(None): OF THE HEALTH LICENSE
p.(None): Article 126.- For the purpose of applying this Regulation, the establishments of health interest are classified as
p.(None): the following classes:
p.(None): Complexity I (Low Risk), complexity II (Medium Risk) and complexity III (High Risk).
p.(None): The Ministry of Health through the General Directorate of Health Regulation will issue the establishment list of
p.(None): according to this classification.
p.(None): Article 127.- Any establishment of health interest of complexity I, II and III, prior to its operation in the
p.(None): country requires an extended license by the competent health authority.
p.(None): Article 128.- The sanitary license for establishments of sanitary interest, at the option of the interested party, shall have
p.(None): validity of two (2), four (4) and six (6) years, from the date of its granting.- Except for
p.(None): the infractions to the sanitary laws or their regulations, the suspension or cancellation of the same is necessary.
p.(None): UNIT I
p.(None): OF THE REQUIREMENTS TO OBTAIN THE HEALTH LICENSE
p.(None): Article 129.-To obtain the sanitary license it is required:
p.(None): 1. Submit an application with the Sum indicating: HEALTH LICENSE IS REQUESTED, with the following information:
p.(None): a) Body to which it is addressed: General Directorate of Health Regulation or Departmental Regional Headquarters, according to
p.(None): correspond.
p.(None): b) Name and generals of the owner or legal representative of the establishment and the legal representative.
p.(None): ) Corporate name or company name
p.(None): d) Name of the establishment.
p.(None): e) Exact address of the establishment, including telephone, fax, email.
p.(None): Activity or activities to be dedicated. Place and date of the request
p.(None): Fimia of the applicant.
p.(None): 2.- Power granted to the legal professional.
p.(None): 3.- Photocopy of the deed of incorporation of the company or individual merchant, duly registered in the
p.(None): Registration of Real Estate and Commercial Property.
p.(None): 4.- Photocopy of the card of the professional who will act as Regent, or Medical Director, when appropriate.
p.(None): 5.- Payment receipt for health license services.
p.(None): 6.- Presentation of the plans of the physical, electrical, drinking water and wastewater facilities of the
p.(None): Establishment approved by the corresponding City Hall.
p.(None): TO.
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Vehicles and means of transpoi’te of food products and health services (ambulances, services
...
p.(None): Document proving the commercial relationship between the owner and the manufacturer of the products, when they are
p.(None): different.
p.(None): m) Stability study, in accordance with established norm.
p.(None): n) Mandatory insert or your project in over-the-counter products, when the required information is not found in
p.(None): the primary or secondary packaging according to current labeling standard.
p.(None): Free Sale Certificate in the country of origin or certificate of WHO pharmaceutical product.
p.(None): p) Certificate of Good Manufacturing Practices (in case it is not attached to the free sale certificate,
p.(None): export or equivalent document) where it is established that the laboratory is subject to periodic inspections by the
p.(None): corresponding regulatory entity.
p.(None): III.- Biological products, in addition to what is required
p.(None): previous:
p.(None): a) Technical product information.
p.(None): b) Preclinical information
p.(None): ) Clinical information
p.(None): d) Document issued by the regulatory authority of the country of origin, related to the cold chain.
p.(None): e) Certificate of lot release issued by the competent authority of the country of origin.
p.(None): Due to their complexity, the different pniebas to request these products will be based on what is established in the series of
p.(None): WHO technical reports, Volume XII.
p.(None): g) Document proving that the product must be prequalified by WHO or by the regulatory authority of a
p.(None): country recognized by WHO.
p.(None): Article 147.- To market the vaccines after obtaining the sanitary registration, the interested party must obtain
p.(None): batch release approval submitting documents
p.(None): a) Batch release certificate, issued by the competent authority of the country of origin.
p.(None): b) Summary protocol of production of the reference lot.
p.(None): c) Summary protocol of the quality control of the last three lots.
p.(None): d) Others determined by the National Technical Standard.
p.(None): Article 148.- To market the blood products, the following must be accredited:
p.(None): a) Origin of plasma
p.(None): b) Type of donors
p.(None): c) Controls to donors
p.(None): d) Evidence of commercialization
p.(None): e) Viral inactivation methods
p.(None): í) Others contemplated by national legislation or international standards
p.(None): Article 149.- For cosmetic products in addition to the general requirements established in Article 146,
p.(None): You must comply with the following:
p.(None): a) Free Sale Certificate, export or equivalent document of the authenticated country of origin.
p.(None): b) Specifications of the finished product.
p.(None): c) Qualitative formula of the product stating the quantities of restricted or controlled substances
p.(None): when applicable
p.(None): Article 150.- For hygienic products and chemical products, in addition to the general requirements established in
p.(None): Article 146 must comply with the following:
p.(None): a) Certificate of Free Sale, export or equivalent document, authenticated.
p.(None): b) Product Safety Sheet in accordance with international standard when applicable.
p.(None): c) Original document containing the qualitative formula, signed and stamped by the responsible technical professional.
p.(None): d) Method and standards (with its certificate of purity) for laboratory analysis, (in the case of pesticides for use
...
p.(None): Products, route of administration, country of origin of the manufacturer, must be processed with a new sanitary registration.
p.(None): Article 158.- In the case of food products, beverages, and related products, which undergo modification of the principle
p.(None): active, chemical formula, concentration of active principle, excipients that modify the nature of the products, via
p.(None): of administration, country of origin of the manufacturer, must be processed with a new sanitary registration.
p.(None): UNIT V
p.(None): REGISTRATION NOMENCLATURE
p.(None): SANITARY.
p.(None): Article 159.- The sanitary registry shall have the following nomenclature:
p.(None): a) Capital letters RS: What does the Sanitary Registry mean?
p.(None): b) The number corresponding to the Departmental Health Region, where applicable.
p.(None): The letter and number that identify the class and type of product.
p.(None): d) Four digits corresponding to the month and year in which the Sanitary Registry is granted.
p.(None): e) Six (6) digit correlative numbering, with which the product is identified in the records, starting
p.(None): with the number 000001.
p.(None): UNIT VI
p.(None): OF THE PROCESS OF THE LICENSE AND REGISTRATION
p.(None): SANITARY
p.(None): Article 160.-Once the application is submitted, it will be verified if it contains the requirements established in the chapter
p.(None): above and if not met, the petitioner will be required so that within the corresponding term established in
p.(None): the Administrative Procedure Law proceed to complete it with the warning that if it does not do so,
p.(None): will file the proceedings without further processing. If requested, the documentation will be returned to the interested party.
p.(None): Article 161.-The competent health authority shall issue a ruling taking the application as admitted and ordering
p.(None): send the proceedings to the corresponding instance, with the object that within twenty (20) days
p.(None): Skills carry out the inspection of the establishment or the analysis of. respective laboratory.
p.(None): REPUBLICA DE HONDunAs - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): The competent authority shall provide whether laboratory tests are performed or not, as well as which tests and tests
p.(None): perform. The original samples, technical product information, the original samples will be sent to the respective laboratory
p.(None): standards of active ingredients, with the order of analysis.
p.(None): The following products will not require analysis for sanitary registration purposes: chemical elements not
p.(None): controlled, uncontrolled chemicals, hygienic products, cosmetics, topical products,
p.(None): uncontrolled chemicals, dietary supplements, laboratory reagents, raw materials, food
p.(None): risk b and c.
p.(None): In any case, they will pay the respective rights for health surveillance and control.
p.(None): Article 162.- The authority that has carried out the inspection must deliver within three (3)
p.(None): working days the minutes drawn up with the corresponding technical information by sending it to your immediate superior manager.
p.(None): Article 163.- Received the minutes and technical report referred to in the preceding article, the General Directorate of
p.(None): Sanitary Regulation or the Departmental Regional Headquarters, will transfer the administrative file to the Legal Unit
p.(None): so that within three (3) business days issue the corresponding opinion; This Unit will return said file to the
p.(None): General Directorate of Health Regulation or the Departmental Regional Headquarters, so that within five (5) days
p.(None): next business issues the reasoned resolution granting or denying the requested license.
p.(None): Article 164.- The instance that has practiced laboratory analyzes, in the case of food products,
p.(None): you must deliver within the term of fifteen (15) business days the corresponding technical report by sending it
p.(None): to your immediate superior boss for your respective opinion. In the case of food products, beverages,
p.(None): medicines and related products and natural products, the results of laboratory quality control
p.(None): official or other designated by the Ministry of Health, will be delivered in a term up to twenty (20) days
p.(None): Skilled to the Delegated Department, who will prepare the corresponding technical report. In both cases you must be
p.(None): Deliver a copy of the laboratory analysis to the interested party at no cost.
p.(None): Article 165.- Once the technical report indicated in the previous article has been completed, the competent Delegated Department
p.(None): will proceed to the legal analysis of the file so that within the term of three
p.(None): (3) business days, the analysis is completed for the issuance of the corresponding decision. Once the analysis is finished
p.(None): corresponding queorigió the application for the license or sanitary registration, the file is sent to the Directorate
p.(None): General of Sanitary Regulation or
p.(None): the Regional Department of Health, so that within a term of five (5) business days issue resolution
p.(None): motivated, granting or denying the sanitary registration.
p.(None): UNIT VII
p.(None): ON THE RENEWAL OF THE LICENSE AND HEALTH REGISTRATION
p.(None): Article 166.- For the renewal of the Sanitary license of the Establishments and sanitary registration of the
p.(None): products, must be requested before the competent General Directorate or Head of Departmental Health Region, to
p.(None): through the legal representative or legal representative, within three (3) months for the health license of the
p.(None): establishments and five (5) months for sanitary registration of products, prior to the expiration date. May
p.(None): have extemporaneous renewal up to six (6) months after the expiration date of the license or registration
p.(None): health, paying the rights to registration, in addition to a fine, whose value should not be less than the cost of registration
p.(None): sanitary. In any case, you must submit a certified affidavit stating that
p.(None): maintains the original conditions under which it was granted.
p.(None): Otherwise, you must carry out the procedure, indicated in Articles 130 and 146, as the case may be.
p.(None): In any case, be it renewal or new procedure, it will keep the original license number or sanitary registration.
p.(None): Article 167.- The period of validity expired without having requested the renewal of the license and registration
p.(None): health, will proceed according to the sanction regime.
p.(None): Article 168.- The payment of the rights by license and sanitary registration, as by the services of surveillance and
p.(None): Health control will be assumed by the interested party and canceled in the place determined by the health authority
p.(None): competent.
p.(None): FOURTH SECTION
p.(None): OF THE HEALTH INSPECTIONS
p.(None): Article 169.- The inspectors of the Ministry of Health, duly certified and accredited in the exercise of their
p.(None): functions, within their working hours and overtime when designated by their superior, will have
p.(None): free access to establishments, premises or sites of health interest, prior to the inspection order issued
p.(None): by the Competent Health Authority, in order to verify compliance with related sanitary standards
p.(None): with:
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): 1. Production, processing, handling, packaging, storage, conservation, transportation, distribution,
p.(None): dispensing, import, export of products of health interest.
p.(None): 2. Provision of health services.
p.(None): 3. Advertising and propaganda of health products, services and establishments of health interest.
p.(None): 4. Waste management generated by the establishments.
p.(None): 5. Occupational safety and industrial safety.
p.(None): 6. Hygienic conditions of the establishments.
p.(None): 7. Products.
p.(None): 8. Good Manufacturing Practices, in force in the Industry.
p.(None): Article 170.-The General Directorate of Health Regulation shall define and establish the technical procedures and
p.(None): operational for the verification of the requirements in health interest establishments.
p.(None): Article 171.- The owners, representatives or managers of the establishments, premises or sites, remain
p.(None): obliged at any time to allow the entry of certified inspectors of the Ministry of Health.
...
p.(None): j) Date of arrival of the shipment
p.(None): k) Route through which you will enter and name of the Customs.
p.(None): l) Identification of the means of transport.
p.(None): m) Pro-Forma Invoice that identifies the type, type and quantity of product or raw material.
p.(None): The request must be accompanied by the payment receipt for services.
p.(None): I.- For Export Certificates of Controlled Products, you must also comply with:
p.(None): a) Import Certificate issued by the competent Authority of the importing country.
p.(None): b) Name and address of the exporter and importer and the consignee.
p.(None): ) Product name.
p.(None): d) Quantity of the product to be exported.
p.(None): e) Customs office of entry and exit.
p.(None): Shipping date
p.(None): g) Document proving the Regent Pharmaceutical Chemist responsible for the custody of the product.
p.(None): Article 184.- The Certificate of Free Sale will be valid for two (2) years from the date of its
p.(None): Issue.- In the case of the sanitary registration that expires before this period, the validity of the certificate will be the
p.(None): same of the sanitary registry.
p.(None): The Certificate of Good Manufacturing Practices will be valid for one (1) year from the date of issue
p.(None): and its procedure will be done in accordance with the procedure established in section V of this Regulation and the norm
p.(None): established.
p.(None): The Export Certificate of controlled products will be valid for ninety (90) days and will be necessary
p.(None): Request one for each shipment.
p.(None): The Import Certificate of controlled products will be valid for one hundred and fifty (150) days and will be
p.(None): necessary to request one for each shipment, it will be valid only once
p.(None): Article 185.- The interested party in obtaining the Official Import Certificate for psychotropic substances and
p.(None): narcotics must submit to the General Directorate of Health Regulation the request relating the
p.(None): Following data:
p.(None): a) Name of the Regent or company manager.
p.(None): b) Name and address of the importer and exporter.
p.(None): c) Name of the pharmaceutical establishment that represents
p.(None): d) Provider Name
p.(None): e) Quantity
p.(None): í) Concentration if it is the case of finished product
p.(None): g) Product name
p.(None): h) Date of admission
p.(None): i) Customs office of entry
p.(None): j) Origin of shipment
p.(None): k) Bell of Lps. 5.00 (five lempiras) for each request.
p.(None): Article 186.- Narcotic drugs, psychotropic and controlled chemical substances may only be exported by
p.(None): laboratories and drug stores to establishments legally authorized for this purpose in the importing country.
p.(None): UNIT II
p.(None): THE PROCESS OF CERTIFICATES
p.(None): Article 187.- Once the application has been submitted, it will be registered in the corresponding book of entries, after which
p.(None): will verify if it contains the requirements established in the preceding articles.- If it does not meet them, it will be required to
p.(None): petitioner so that within ten (10) business days he may complete it, with the warning that
p.(None): Do it, the proceedings will be filed without further processing. If requested by the interested party, the
p.(None): documentation to the interested party.
p.(None): Article 188.- Admitted the request, within five (5) business days following the delegated health authority,
p.(None): will issue a reasoned resolution granting or denying the requested certificate.
p.(None): RH REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ’. 30.84
p.(None): UNIT III
p.(None): OF PRODUCT INCOME AND RAW MATERIALS
p.(None): Article 189.- For the importation of controlled chemical products and substances, official authorization is required.
p.(None): extended by the competent health authority.
p.(None): Article 190.- Food and beverages that are imported by anyone who is not the natural or legal person who
p.(None): registered and that does not have an exclusive distributor, must be registered, subjecting it to laboratory analysis by batch
p.(None): when the competent health authority deems it necessary, and the respective rights must be paid.-
p.(None): Imported products must comply with the labeling standard in force in the country.
p.(None): Article 191.- Prior to the clearance of all controlled products, the Executive Directorate of Revenue through the
p.(None): customs, will require the importer the Official Import Authorization extended by the General Directorate of
p.(None): Sanitary Regulation For this purpose, coordination mechanisms will be established at their different levels.
p.(None): In addition to the Official Import Authorization, pharmaceutical products and controlled quínucas substances
p.(None): they will be inspected and authorized by the competent health authority, who will sign and seal the document of
p.(None): import, prior to its clearance.
p.(None): Article 192.- In case the importer does not comply with the requirement of the Official Import Certificate, for
p.(None): psychotropic and narcotic substances and controlled chemical substances should be re-exported to your country
p.(None): of origin and the importer
p.(None): shall assume the conditions caused by the surveillance and contingency actions, exercised by the health authority without
p.(None): damage of the respective legalization process and of the sanctions that are imposed by
p.(None): violation of the provisions of this Regulation.
p.(None): Article 193.- In the case of rejection of imported products and raw material that is carried out in accordance with
p.(None): established in the Health Code and these Regulations, the General Directorate of Sanitary Regulation shall notify
p.(None): to the health authorities of the country of origin, so that the relevant measures in health protection of
p.(None): the consumers.
p.(None): UNIT IV
p.(None): OF THE PROCESS OF THE APPLICATION
p.(None): Article 194.- Once the application has been submitted, it will proceed to be registered in the corresponding book of entries then
p.(None): will verify if
p.(None): It contains the requirements established in the preceding articles.- If it does not meet them, the petitioner will be required
p.(None): so that within ten (10) business days proceed to complete it, with the warning that if not,
p.(None): the proceedings will be carried out without further processing. If requested, the documentation will be returned to the interested party.
p.(None): Article 195.- Admitted the request, within five (5) business days following the health authority
p.(None): competent, will issue a reasoned resolution granting or denying the requested authorization.
p.(None): Article 196.- Prior to the authorization of the clearance of controlled chemical products and substances, the Authority
p.(None): Sanitary competent in coordination with the General Directorate of Customs must check the contents of the shipment
p.(None): Checking it with the Official Import Authorization.- If they do not conform to the established sanitary norms,
p.(None): order its re-export to the place of origin, after a reasoned resolution of the competent health authority.
p.(None): CHAPTER VIII
p.(None): OF THE BROADCASTING OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF INTEREST
p.(None): SANITARY
p.(None): Article 197.- The Ministry of Health shall establish the criteria for the Advertising of Sale Medicines without
p.(None): Medical Prescription or Prescription Without Prescription (OTC).
p.(None): Article 198.- The advertising of products, services and establishments of health interest must conform to the
p.(None): truth and therefore the benefits that its use or use may offer cannot be overstated,
p.(None): control corresponds to the competent health authority.
p.(None): Article 199.- The health authority shall prohibit the advertising of products, services and establishments of interest.
p.(None): health in the following cases:
p.(None): a) When it contravenes the general rules applicable to health, nutrition or therapeutic education.
...
p.(None): d) Committing the infraction with the purpose of hiding another '.
p.(None): e) Shun the responsibility or attribute it to another or others.
p.(None): Article 208.- The imposition of any of the sanctions indicated in this chapter shall be made without prejudice to requiring
p.(None): to the offender responsible for compliance with the measures determined by the health authority, for the purpose that
p.(None): the effects of the infraction are repaired or minimized as the case may be, for which the term shall be indicated
p.(None): correspondent.
p.(None): Article 209.- The fines that are imposed must be made effective in compliance with the Recovered Funds Regulations.
p.(None): of the Ministry of Health, within the term of ten (10) business days from the date on which
p.(None): notify the offender of the resolution; The amount of the financial penalty may not be reduced or waived.
p.(None): Article 210.- Failure to comply with the resolutions emanating from the health authority shall be sufficient grounds for
p.(None): execute them by means of the forced fulfillment contemplated in Articles 109 and 110 of the Law of Procedure
p.(None): Administrative, for which the Health Authority will request the support of the National Police or the Municipal Authority
p.(None): correspondent.
p.(None): Article 211.- The temporary closure of an establishment entails the suspension of the Sanitary License and may
p.(None): be issued for up to thirty (30) calendar days
p.(None): If the causes that gave rise to the sanction disappeared, the interested party's request has been filed, the authority
p.(None): corresponding sanitary, prior to its * erification will resolve its reopening and restitution of the sanitary license
p.(None): Article 21 2.- The definitive closure of an establishment entails the cancellation of the Sanitary License.
p.(None): Article 213.- To proceed to the temporary or definitive closure of an establishment that violates provisions
p.(None): legal and regulatory, the competent health authority will place posters
p.(None): In the case of temporary closure, access to the establishment will be allowed to maintain the equipment or
p.(None): machinery that by its nature require special care.
p.(None): In the case of definitive closure the offender will have access to the establishment to remove the machinery, equipment,
p.(None): furniture and other prior authorization of the competent authority.
p.(None): Article 214.- To retain or deposit products, goods, raw materials, substances and others, you must
p.(None): the respective inventory and official certificate signed by the interested party, two witnesses and the health authority be taken up;
p.(None): proceeding to place seals or seals that guarantee their conservation and permanence in the establishment
p.(None): inspected.- In case of not wanting or being able to sign the witnesses and / or the interested party, it will be recorded in the minutes,
p.(None): which does not invalidate it.
p.(None): Article 215.- In order to comply with the provisions of the Health Code and this Regulation, the authority
p.(None): When required, it will request the support of the Public Prosecutor's Office, the Municipal Offices, the Police
p.(None): National, the Attorney General's Office, the Secretary of Natural Resources and Environment and the Secretariat of
p.(None): Agriculture and Livestock.
p.(None): In all the proceedings that are carried out, only the aforementioned authorities will participate, avoiding notoriety
p.(None): public, unnecessary inconvenience or damage to the establishment.
p.(None): Article 216.- In those cases that from the violation of the legal and regulatory provisions risks and
p.(None): serious damage to people's health or the environment, the health authority will immediately notify the
p.(None): General Directorate of Health Regulation. This, when the case merits it will make public the fact and
p.(None): notify the respective authority, to prevent major risks or damages.
p.(None): Article 217.- The application of the administrative sanctions of which the Health Code deals with and this
p.(None): Regulations, do not exempt the offender from civil or criminal liability to have place for the act sanctioned.
p.(None): or tapes in visible places in the entrances and in the machines, Article 218.- In the cases that
p.(None): of the violation of
p.(None): equipment, locks and others, with the legend: “Closed legal and regulatory provisions result
...
p.(None): how to be:
p.(None): a) Order or carry out the measures of disinfection, disinfection and deratization
p.(None): b) Order the suspension of work and services,
p.(None): c) Retain or deposit products, raw materials, substances, equipment, utensils and objects.
p.(None): d) All conducive to health prevention.
p.(None): and the character with which he is quoted.
p.(None): c) The causes or reasons why the citation is made.
p.(None): d) Place, date and time to appear.
p.(None): e) The prevention that the non-appearance will cause the damages to which there was place in law.
p.(None): f} Place and date on which the card is issued.
p.(None): g) Signature of the competent health authority.
p.(None): Article 227.- If the aforementioned does not appear by means of a legal representative duly accredited to the place, date and time
p.(None): referred to in the citation, it will be taken for granted by declaring in absentia and will proceed to issue the resolution that
p.(None): in appropriate law.
p.(None): Article 228.- If the evidence in the appearance were sufficient or the defendant admits the charges made, the
p.(None): Health authority will issue the corresponding resolution.
p.(None): Article 229.- When the charges are distorted in the appearance, the health authority shall issue a resolution
p.(None): acquittal in favor of the alleged offender, which must be notified.
p.(None): Article 230.- If the pniebas were insufficient and the defendant denied the charges, the health authority ex officio or
p.(None): at the request of the party, it will order the opening of evidence, granting a term of ten (10) business days to propose them and
p.(None): evacuate them; throughout
p.(None): In this case, the competent health authority may, at any time, have the practice of any evidence it deems
p.(None): pertinent for the best decision of the matter.
p.(None): Article 231.- After the probationary term and the proceedings of the case, the health authority
p.(None): will issue the resolution following the administrative procedure.
p.(None): StttİÓil A ÀtlltFd0S and ltïts
p.(None): M l PmØiJ'ZiIFP MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Article 232.- The resolution must contain:
p.(None): a) Name of the issuing authority.
p.(None): b) Summary relationship of the facts.
p.(None): c) Statement of relevant considerations.
p.(None): d) Resolve categorically, clearly and precisely; citing the legal instruments, regulations or provisions
p.(None): sanitary in which it is based.
p.(None): e) Place and date of issue.
p.(None): f) Signature and seal of the competent health authority.
p.(None): Article 233.- In the event that the resolution is sanctioning, it will also provide:
p.(None): a) Imposition of the sanction.
p.(None): b) Prohibition of continuing illegal acts or violations of sanitary provisions.
p.(None): c) Warning at the offender that in case of recidivism or disobedience to the resolution, the
p.(None): more drastic sanctions provided for in this Regulation.
p.(None): d) The term to make effective the economic sanction imposed, which will be within ten (10) business days,
p.(None): counted from the day following the notification.
...
Health / Drug Dependence
Searching for indicator dependence:
(return to top)
p.(None): requirements described by the Health Code and its Regulations.
p.(None): Complexity: It is the criterion used to identify an establishment taking into account the magnitude of the risk
p.(None): sanitary, the technology it uses and the man hours necessary for its sanitary inspection.
p.(None): Quality Control: Planned system of activities whose purpose is to ensure a top quality product.
p.(None): Smuggling: Consists of the importation or entry into the country of goods that do not meet the requirements
p.(None): legal established for this purpose.
p.(None): Sanitary Control: It is the action of checking, supervising, inspecting, intervening, registering, monitoring, regulating
p.(None): sanitary hygienic conditions of the establishments, of the personnel where goods are produced or provided and
p.(None): services of health interest, in order to protect the health of the population.
p.(None): Technical Control: It is the action carried out by the Ministry of Health of Honduras, in pharmaceutical establishments.
p.(None): Basic Medication Chart: It is the official list, prepared for this purpose by the State Health Institutions.
p.(None): Guilt: Modality of violating leyporimperice, negligence or unpredictability.
p.(None): M M1'UBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): DCI: International Common Denomination: Common name for medicines, recommended by the World Organization of
p.(None): Health, in order to achieve its international identification.
p.(None): Confiscation: Confiscation or seizure of substances, artifacts or products to prevent further elaboration
p.(None): articles or products that reach the public without complying with the legal or regulatory provisions.
p.(None): Dependence on a medication: Condition in which the user of a medication feels compelling desire to continue
p.(None): the use of it. The use of the expressions drug addiction and habituation is currently recommended
p.(None): medicated; Drug dependence is used as a synonym for drug dependence.
p.(None): Cross dependence: The ability of a drug to suppress manifestations of physical dependence induced by
p.(None): another medicine and replace it in the maintenance of a state of physical dependence.
p.(None): Physical dependence: Elevated or adapted physiological state that occurs in an individual through administration
p.(None): Repeated medication. Physical dependence induced by prolonged use of a medication is only revealed
p.(None): when it is abruptly discontinued or when its shares are diminished by the administration of a
p.(None): specific antagonist
p.(None): Psychological dependence: Condition characterized by strong emotional or mental desire to continue using a
p.(None): medicine.
p.(None): Dental Deposits: Establishments dedicated to importation, sale, marketing, manufacturing,
p.(None): storage and distribution of bio materials, dental equipment and instruments for care or ‹lontology, as well
p.(None): as materials, equipment and instruments for the use of dental laboratories.
p.(None): Customs clearance: It is the process for the nationalization of merchandise that legally enters the country.
p.(None): Withdrawal: Act by which the petitioner's request is accepted not to continue with the process giving rise to
p.(None): file of the file containing the proceedings.
p.(None): Dispensing: It consists in the delivery of medications to the user patient usually as a result of a
p.(None): medical prescription.
p.(None): Availability: Relationship between the volume of demand and type of existing resource to meet the needs
p.(None): of offer attention. It is a dimension of supply risk.
p.(None): Device and Equipment for Medical Use: Instrument, apparatus, implement, machine, implant or other similar item or
p.(None): related that by itself or in combination with any accessory or program for its proper operation is
p.(None): used in prevention, healing, rehabilitation and health research.
p.(None): Dolo: Modality of breaking the Law with full knowledge of the cause.
p.(None): Therapeutic dose: Amount of active ingredient that produces the desired therapeutic effects in a given period
p.(None): of time.
p.(None): Drug / drug substance / medicine: In legal and technical use, these terms have 2 meanings:
...
p.(None): Health Establishments: Are those public or private establishments, in which directed care is provided
p.(None): fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals,
p.(None): Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics
p.(None): Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories
p.(None): dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of
p.(None): body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories
p.(None): analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
p.(None): Slight failure: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions and not
p.(None): It constitutes a risk that harms or may harm the health of the population.
p.(None): Less serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions, which are
p.(None): It constitutes a moderate risk to affect the health of the population, intervening the voluntary action or omission.
p.(None): Serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
...
p.(None): Fine: Pecuniary penalty that is imposed for the execution or omission of a conduct, contrary to the provisions
p.(None): sanitary
p.(None): Generic Name: It is the name of the active substance that generally corresponds to the common denomination
p.(None): International (D.C.I.) recommended by WHO.
p.(None): Chemical Name: It is the name used intemacionahnente for a chemical substance, following the rules of
p.(None): Nomenclature of the I.U.P.A.C., which unequivocally denotes the composition and structure of the substance.
p.(None): Honduran Standard: It is one that has been adopted or adapted from an international standard or formulated and
p.(None): approved in the country and that is related to products, services or establishments of health interest.
p.(None): Sanitary Notification: Document sent by the manufacturer that certifies any change of a scientific nature and
p.(None): duly justified and documented.
p.(None): Lot Code Number: The designation (in numbers or letters) or coding of the product that identifies the lot to
p.(None): That this one belongs.
p.(None): Organoleptic: Evaluation of any product of health interest made through the senses (sight, smell,
p.(None): touch, taste, yoido).
p.(None): Perishable: Product that is easily altered or decomposed in a short period of time.
p.(None): Precursor or precursor substance: It is the substance or substances from which it can be synthesized,
p.(None): manufacture, process and obtain products that can produce physical or psychological dependence.
p.(None): Pharmaceutical or Commercial Presentation: It is the quantity expressed in units of pharmaceutical form, volume, weight or
p.(None): number of doses in case of aerosols, pharmaceutical or cosmetic product.
p.(None): Forecast: Amount planned for the consumption of controlled medicines for the period of one year.
p.(None): as a new molecule and therefore demonstrate the documentation Active ingredient: Substance or mixture of
p.(None): Related substances related to efficacy, safety and quality. endowed with a
p.(None): specific pharmacological effect
p.(None): Sertión A Atueriłos y leycs
p.(None): K REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘. 30,841
p.(None): Product: Thing produced, resulting from the work done on a raw material.
p.(None): Altered Product: When replaced, totally or partially added or replaced constituent elements
p.(None): that are part of the officially registered composition or when substances that may have been added
p.(None): modify its effects or its physicochemical or organoleptic characteristics.
p.(None): Cosmetic Product: It is any substance or formula of local application to be used on different surfaces
p.(None): external of the human body and its annexes including mucosa, buccal and teeth in order to clean, perfume,
p.(None): improve its appearance and protect or maintain it.
p.(None): Alines Products: They are natural products, cosmetics, hygienic products, laboratory reagents, material and
p.(None): Dental and health laboratory equipment, devices, equipment and surgical medical equipment.
p.(None): Bulk Product: It is any processed substitution found in its final form and which has been uncle
p.(None): packed in final distribution packages.
...
p.(None): laboratory, as well as requests made to the competent health authority must be endorsed by the
p.(None): Regent.
p.(None): Article 56.- Only narcotics, șicotropics, products and products may be imported into the national territory.
p.(None): Chemical substances controlled by the customs of Pueno Cortes, Toncontín, La Mesa and others that in the future authorize the
p.(None): competent health authority.
p.(None): Article 57.- Drugstores may sell controlled products to duly authorized doctors who provide
p.(None): its services in the rural area, where there are no pharmacies, for this purpose, the medical professional must
p.(None): submit the corresponding card issued by the competent health authority, which will be valid for a
p.(None): (1) Aryan.
p.(None): K MPUBLICA DE HON DIJRAS - TEGUCIGALPA, M. lß. C., NOVEMBER 4, 2005 N ".
p.(None): 30,841
p.(None): At ticle 58.- For the sale of narcotic patients that are carried out between pharmaceutical establishments,
p.(None): will require authorization issued by the competent health authority; the cornprav ent of psychotropics that
p.(None): It is rea1 i ce, Between pharmacist establishments will be sent through notification; the sale of substances
p.(None): 9UC controlled chemicals will be performed between companies will require authorization issued by the health authority
p.(None): competent.
p.(None): Article I 59.- Controlled products must be identified with a red “C” and the law of Jdil C {ue
p.(None): say "Product susceptible to dependence"
p.(None): ›Title 60.- The products of strict control cny‹ i sale requires a cspccial mćJica prescription, they will be subject to
p.(None): Dispositions of Title I, Articles 150 at 154 of the SKİ Code and may only be dispensed prior to
p.(None): presentation of the i specti goes written prescription with tetra cl ‹ira y n (legible, signed and
p.(None): sealed and must be dispensed by customer according to the regulations established for paia ta1 fi’i.
p.(None): Article 61.- The special recipe books for products of strict cont1’o1 will be provided
p.(None): pei‘sonalnsente in the Ministry of Health by the cornpctcnte authority to the isiédicos collegiate.
p.(None): Article 62.- In order to obtain the book of special documents, the doctor must:
p.(None): a) Submit the application personally, finalized and scllad ‹i.
p.(None): b) Presentai ’came of association.
p.(None): c) Make the corresponding payment.
p.(None): d) For the request of a new checkbook you must submit the previous one.
p.(None): e) Present record of the Medical Colcgio cynic is entitled to exercise.
p.(None): Article 63.-. The doctors, dentists and vetci’i l) íll’İOS ț3Od1’ÜJ keep in their briefcase up to two vials tie
p.(None): Birth of strict control conditioning its use to the character of cirergencia.
p.(None): Article 64.- The quantities that may be prescribed for products of strict control shall be determined by the CIC.
p.(None): according to the corresponding national and intentional protocols and technical standards.
p.(None): Article 65.- For the tixitainiento of chronic or terminal enfcrnaedades, the Co-competent Health Authority
p.(None): based on the medical diagnosis, it will authorize in writing to the pharmacological establishment Dispense ‘the products
...
p.(None): License SíìlJiÍí‘‘il.- For the analysis, periodification and transfer of the establishments of interest:
p.(None): sarliÎílrio is authorized by the Secret ‹1l’Íil UC Salud.
p.(None): Article: No. 71.- 3 “oc cos cstablccirnientos dc interest saniliu i‹ ›: health institutions according to article 157
p.(None): del Códi, po ‹lc Salud, de.:ilirncntos y I ebidas, of natural products, laboi‹ it ‹› i u ›s for the analysis of calitlad
p.(None): of pl products of intcrćs sanit.ii’ii ›, distributors of insulins and laboratory equipment, distritloi cs of
p.(None): raw materials of products of health interest, irl distl ibui ‹ioi cs of chemical substances, distributors of
p.(None): insilmos y equi¡ao ‹lc laboratories, tlisti ibudores de irlsrnros and rnérlico quiiiii’i: it. or, distributors
p.(None): of inputs and otlontological equipment, cstarán siljcl ‹› s
p.(None): g2 MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): to this regulation for which they must meet the minimum essential requirements related to structure
p.(None): physics and facilities, equipment, human resources, waste management, organization and operation
p.(None): established in the technical standard.
p.(None): Article 72.- The sanitary control of the establishments of sanitary interest will be exercised by the Ministry of Health for
p.(None): through the General Directorate of Sanitary Regulation, Department of Sanitary Control of Products, Services and
p.(None): Establishments or Delegated Department and the Departmental Regions and municipal authorities.
p.(None): Article 73.- The sale of drugstores and laboratories is strictly prohibited.
p.(None): narcotic drugs, psychotropic and other controlled drugs that may cause dependence or habit, to the positions of
p.(None): sale of medicines and in general to non-pharmaceutical establishments; such products will be subject to
p.(None): provisions established in Articles 150, 151, 152,153 and 154 of the Health Code.
p.(None): Article 74.- Drugstores may only sell products in the medical emergency kits.
p.(None): amounts established in the list approved by the competent health authority.
p.(None): Article 75.- The establishments will occupy independent premises according to the activity or service that
p.(None): lend and separate from any other commercial, residential establishment complying with the technical standard of
p.(None): minimum essential requirements.
p.(None): Article 76.- Establishments of Health Interest Complexity I and II may be installed in commercial centers,
p.(None): supermarkets, department stores and other similar establishments, in individual locations that
p.(None): guarantee the safety and hygiene of the services provided.
p.(None): Article 77.- All pharmaceutical establishments according to their category must comply with good manufacturing practices
p.(None): or product handling.
p.(None): Article 78.- The pharmaceutical shift is mandatory for all pharmacies where it is so established by the
p.(None): competent health authority, however, in times of epidemic or any other public need the Secretariat
p.(None): Health by resolution may order that all pharmacies provide such services continuously to the public,
p.(None): as long as the cause that originates persists.- The Ministry of Health will coordinate with the Ministry of Security
p.(None): protection to the establishment in turn.
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p.(None): CHAPTER X: FEES FOR RECOVERY FOR RIGHTS AND SERVICES.
p.(None): CAPI TU LO XI: DIS POS I CI ONES FIN ALES AND TRANSITORIAS.
p.(None): CHAPTER I RINES AND PRINCIPLES
p.(None): Article 1.- The present P.eglainento has as a purpose, to develop and monitor compliance with the provisions of
p.(None): Book II of the Promotion and Protection d ‹: Health, Title II of Food and Beverage, Book III of the
p.(None): Health Recovery, Title I of Pharmaceutical Products and Medical Equipment, Title II of
p.(None): Health Institutions, Book IV, Title 11 Measures and Administrative Acts, Title III Procedure in the
p.(None): Actions of the Health Authorities of the Health Code.
p.(None): Article 2.- The following are fundamental principles of this Regulation:
p.(None): a) Protect the Health and life of users and consumers in relation to products, services and
p.(None): Health Interest establishments.
p.(None): b) Regulate the conditions of safety, efficacy and safety of the products, services and establishments of
p.(None): Health interest.
p.(None): CHAPTER II GENERAL PROVISIONS
p.(None): Article 3.- This Regulation regulates the products, services and establishments of health interest and the
p.(None): personnel linked to them, and for the purposes of their application the following terms or concepts are defined:
p.(None): Abandonment: Declaration of early termination of a procedure, which is not concluded by not responding to
p.(None): time the requirements made to complete the process.
p.(None): Sample record: Document containing the proof of sampling.
p.(None): Citation Act: Document by means of which, the inspector quotes the regent, legal representative or the owner
p.(None): of the establishment to appear before the corresponding dependency of the Ministry of Health.
p.(None): Inspection Act: Document that reflects the result of the inspection carried out by the health authority (s)
p.(None): competent duly subscribed by them and the interested party.
p.(None): Customs: Official competent body that regulates the import and export of merchandise from the country.
p.(None): Food for Medical Use: The one that has been subjected to processes that modify the relative concentration
p.(None): of the various nutrients, of their constitution or their quality, or by incorporation of substances
p.(None): outside its composition, they acquire therapeutic properties.
p.(None): Written reprimand: Action to reprimand someone, by writing motivated by omission, execution of a
p.(None): activity or conduct contrary to legal or regulatory provisions.
p.(None): Hearing: Citation that is made to the public employee in order to render discharges on actions that are
p.(None): imputed or attributed.
p.(None): Outpatient Care: Actions aimed at patient care for diagnosis and treatment, when
p.(None): Check that it does not require hospitalization.
p.(None): Hospital Care: Actions aimed at the care of patients who, due to their state of health, need to be
p.(None): integrated for more than 24 hours for diagnosis or medical or surgical treatment.
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p.(None): 30.84
p.(None): At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and
p.(None): health rehabilitation.
p.(None): Preventive Care: A set of general promotion and specific protection actions provided to the
p.(None): individual and the general population with the purpose of reducing morbidity.
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Health / Drug Usage
Searching for indicator drug:
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p.(None): sanitary, the technology it uses and the man hours necessary for its sanitary inspection.
p.(None): Quality Control: Planned system of activities whose purpose is to ensure a top quality product.
p.(None): Smuggling: Consists of the importation or entry into the country of goods that do not meet the requirements
p.(None): legal established for this purpose.
p.(None): Sanitary Control: It is the action of checking, supervising, inspecting, intervening, registering, monitoring, regulating
p.(None): sanitary hygienic conditions of the establishments, of the personnel where goods are produced or provided and
p.(None): services of health interest, in order to protect the health of the population.
p.(None): Technical Control: It is the action carried out by the Ministry of Health of Honduras, in pharmaceutical establishments.
p.(None): Basic Medication Chart: It is the official list, prepared for this purpose by the State Health Institutions.
p.(None): Guilt: Modality of violating leyporimperice, negligence or unpredictability.
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p.(None): 30.84
p.(None): DCI: International Common Denomination: Common name for medicines, recommended by the World Organization of
p.(None): Health, in order to achieve its international identification.
p.(None): Confiscation: Confiscation or seizure of substances, artifacts or products to prevent further elaboration
p.(None): articles or products that reach the public without complying with the legal or regulatory provisions.
p.(None): Dependence on a medication: Condition in which the user of a medication feels compelling desire to continue
p.(None): the use of it. The use of the expressions drug addiction and habituation is currently recommended
p.(None): medicated; Drug dependence is used as a synonym for drug dependence.
p.(None): Cross dependence: The ability of a drug to suppress manifestations of physical dependence induced by
p.(None): another medicine and replace it in the maintenance of a state of physical dependence.
p.(None): Physical dependence: Elevated or adapted physiological state that occurs in an individual through administration
p.(None): Repeated medication. Physical dependence induced by prolonged use of a medication is only revealed
p.(None): when it is abruptly discontinued or when its shares are diminished by the administration of a
p.(None): specific antagonist
p.(None): Psychological dependence: Condition characterized by strong emotional or mental desire to continue using a
p.(None): medicine.
p.(None): Dental Deposits: Establishments dedicated to importation, sale, marketing, manufacturing,
p.(None): storage and distribution of bio materials, dental equipment and instruments for care or ‹lontology, as well
p.(None): as materials, equipment and instruments for the use of dental laboratories.
p.(None): Customs clearance: It is the process for the nationalization of merchandise that legally enters the country.
p.(None): Withdrawal: Act by which the petitioner's request is accepted not to continue with the process giving rise to
p.(None): file of the file containing the proceedings.
p.(None): Dispensing: It consists in the delivery of medications to the user patient usually as a result of a
p.(None): medical prescription.
p.(None): Availability: Relationship between the volume of demand and type of existing resource to meet the needs
p.(None): of offer attention. It is a dimension of supply risk.
p.(None): Device and Equipment for Medical Use: Instrument, apparatus, implement, machine, implant or other similar item or
p.(None): related that by itself or in combination with any accessory or program for its proper operation is
p.(None): used in prevention, healing, rehabilitation and health research.
p.(None): Dolo: Modality of breaking the Law with full knowledge of the cause.
p.(None): Therapeutic dose: Amount of active ingredient that produces the desired therapeutic effects in a given period
p.(None): of time.
p.(None): Drug / drug substance / medicine: In legal and technical use, these terms have 2 meanings:
p.(None): 1. In the first, the term drug or medication is used to describe the active substance or drug that for its
p.(None): Administration must be fomiulated.
p.(None): 2. In the second one, medication or drug is understood as any pharmaceutical product used for the
p.(None): prevention, diagnosis and treatment of a disease or pathological state or to modify systems
p.(None): physiological benefits for the person to whom it was administered.
p.(None): Drugstore: Establishment dedicated to the importation, storage, distribution and sale of medicines in bulk and
p.(None): minor, where direct supply to the public is prohibited except in cases authorized by the Ministry of Health,
p.(None): under the responsibility of a duly registered pharmaceutical professional.
p.(None): Packaging and Packaging: All material used to protect a product for its conservation, handling and transport.
p.(None): Packaging: Any container intended to contain products
p.(None): SdRÍtdfÍOS.
p.(None): Primary Container: It is one that is in direct contact with the product.
p.(None): Secondary Container: It is one that is in direct contact with the primary container.
p.(None): Pharmaceutical Equivalence: Two medications are considered to have pharmaceutical equivalence when they contain
p.(None): equal amounts of the same active ingredient (s) in identical doses and dosage forms to be administered
p.(None): by the same route and that meet the same specifications.
p.(None): Pharmaceutical Specialty: Is that medicine produced by a manufacturer under a brand name or generic of
p.(None): a way that is characteristic.
p.(None): II E'Z MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Sputum: Nasopharyngeal secretion that spits.
p.(None): Establishment of health interest: Entity that produces, manipulates, stores, transports, distributes, sells and
p.(None): dispenses products of health interest, as well as provides health services in a formally organized manner,
p.(None): classified according to the degree of complexity in Category I low complexity, Category II medium complexity and
p.(None): Category III high complexity.
p.(None): Food Establishments: Factories, stores, places where food is manufactured, handled, dispensed and served
p.(None): and drinks, vehicles that transport food and food stalls on public roads.
p.(None): Health Establishments: Are those public or private establishments, in which directed care is provided
p.(None): fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals,
p.(None): Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics
p.(None): Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories
p.(None): dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of
p.(None): body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories
p.(None): analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
...
p.(None): respective operation.
p.(None): Waterproof: Impenetrable to water or other fluids.
p.(None): Challenge: Legal action through which the disagreement of an administrative act is manifested in the first instance
p.(None): requesting its renewal or modification.
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p.(None): Control report: It consists of the report as a result of an inspection visit.
p.(None): Violation: Violation of the legal norm. , '
p.(None): Disabling of professional practice: Temporary or permanent suspension in professional practice by the
p.(None): respective school.
p.(None): Insert: Document addressed to the medical or patient body where in a summary form it explains the main indications,
p.(None): contraindications, warnings, adverse reactions, doses, toxicological record and commercial presentations.
p.(None): Inspection: Act of reviewing or verifying the operating status of a health interest establishment
p.(None): and the management of uncontrolled, controlled and precursor products for compliance with the provisions of
p.(None): these regulations issued by the Ministry of Health.
p.(None): Eye inspection: Judicial test method by conducting a visuiil inspection route.
p.(None): Sanitary inspector: Sanitary Authority that acts in an official capacity with powers to inspect and inspect
p.(None): supervisions, and corrective action.
p.(None): Inventory or stoclt: Physical quantity in stock of a product.
p.(None): JIFfi: International Narcotics Control Board: Supervisory body that has to assume the functions that
p.(None): He is assigned the different International Drug Control Conx'enios, one of whose functions consists of
p.(None): monitor licit drug trade subject to international control
p.(None): Dental Laboratories: Establishments dedicated to the support of dental professionals in manufacturing
p.(None): of devices be they acrylic, metallic, porcelain or others that contribute to the rehabilitation of health
p.(None): oral.
p.(None): Narcotics control book: Special format book that records entries, exits and balances
p.(None): of narcotics.
p.(None): Book of control of psychotropics: Book of special format where the registry of entrances, exits and
p.(None): Psychotropic balances.
p.(None): Raw material control book: Special format book where the record of entries, exits and balances is kept
p.(None): raw material.
p.(None): Book of finished product and transfers: Book of special format where the register of entrances and exits of
p.(None): Controlled product, as well as transfers.
p.(None): Licensing: Mandatory administrative technical procedure aimed at verifying compliance with
p.(None): minimum requirements in force.
p.(None): Sanitary License: It is the authorization for an establishment to manufacture, import, export,
p.(None): transport, distribute, handle, store, pack, sell and dispense products of sanitary interest; as well as
p.(None): Provide health services, once all technical and legal requirements are met.
p.(None): Batch: Quantity of a product that is produced in a single manufacturing cycle.
p.(None): Manipulator —Seller: Person who performs his work of handling or selling food.
p.(None): Manual of Pharmacological Standards: Properly classified organization of recognized Pharmacological Standards
p.(None): and officialized by the Ministry of Health.
p.(None): IY Raw material: Any active or inactive substance ‹jut: is used to manufacture products of interest
p.(None): sanitary ›regulated in this regulation whether it is unaltered, modified or eliminated in the course of
p.(None): production process.
p.(None): Medication: Any active substance or mixture of the misrrios with or without the addition of excipients, prepared to be
p.(None): Presented as a pharmaceutical form.
p.(None): Controlled medication:
p.(None): a) Any psychotropic medication and hypertension under the control regimen according to the Conventions on
p.(None): narcotic and psychotropic substances respectively, Ul contrc 1 on this type of substances is exercised by the
p.(None): Junt ‹i National Drug Control.
p.(None): b) A substance that can be incorporated into pharmaceutical post-linguistic forms only within the limits
p.(None): Specific deRrminated by studies.
p.(None): c) A substance approved by the Ministry of Health but subject to restrictions that exclude its use in a
p.(None): considerable proportion of the potential population of patients to whom it would be destined.
p.(None): Drug of strict control: They are pharmaceutical preparations based on narcotic drugs which requires a
p.(None): special recipe booklet for your prescription.
p.(None): Orphan Drug: It is said of the potential active ingredients in which there is no interest on the part of
p.(None): producing laboratories for its development as medicines,
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): since such development does not present an economic incentive, although they can meet health needs.
p.(None): Over-the-counter medication: It is the one that due to its composition and the pharmacological action of its active substances can
p.(None): used by the public without a prescription.
p.(None): Essential Medication: It is the one considered most important, indispensable and necessary to satisfy the
p.(None): health needs of most of the population.
p.(None): Multifuente Medication: It is one that must meet the same standards of quality, safety and efficacy applicable
p.(None): to the innovative medicine.
p.(None): Innovative Medicine: It is the original that demonstrated safety and efficacy with preclinical, clinical and post studies
p.(None): marketing and established quality standards, which will be used as a reference medicine.
p.(None): New Medication: Any Medication that has not been registered or released to the market for medical purposes including new
p.(None): salts or esters of an active substance, new fixed combinations of substances that are already on the market, or
p.(None): any medication previously registered or offered on the market, provided that its indications for use
p.(None): mode of administration or formulation have been changed.
p.(None): Official Medication: It is the one recorded in the respective monograph of the Normative Code that can bear the name of
p.(None): its active ingredients; Official Generic; or that of your patent registration; Official Patented
p.(None): Reference Medicine: Is the innovator or defined by the health authority.
p.(None): Similar Drug: It is the one that contains the same or same active ingredients, has the same concentration, form
p.(None): pharmaceutical, route of administration, dosage and therapeutic indication of the reference medicine, registered by
p.(None): the regulatory authority responsible, being able to differ only in characteristics related to the size and shape of the
p.(None): product, expiration date, packaging, label, excipients and vehicles must always be identified by
p.(None): trade or brand name
p.(None): New Molecule: Active substance that is not contained in any type of pharmaceutical product previously
p.(None): Registered by the health authority. A new salt, be or derived from an approved active substance, must
p.(None): be considered
p.(None): Medical sample: Representative units or small amounts of a drug that is provided free of charge
p.(None): For your promotion.
p.(None): Sampling: Taking units of a product that are representative of their total.
p.(None): Fine: Pecuniary penalty that is imposed for the execution or omission of a conduct, contrary to the provisions
p.(None): sanitary
p.(None): Generic Name: It is the name of the active substance that generally corresponds to the common denomination
p.(None): International (D.C.I.) recommended by WHO.
p.(None): Chemical Name: It is the name used intemacionahnente for a chemical substance, following the rules of
p.(None): Nomenclature of the I.U.P.A.C., which unequivocally denotes the composition and structure of the substance.
p.(None): Honduran Standard: It is one that has been adopted or adapted from an international standard or formulated and
p.(None): approved in the country and that is related to products, services or establishments of health interest.
p.(None): Sanitary Notification: Document sent by the manufacturer that certifies any change of a scientific nature and
p.(None): duly justified and documented.
p.(None): Lot Code Number: The designation (in numbers or letters) or coding of the product that identifies the lot to
p.(None): That this one belongs.
p.(None): Organoleptic: Evaluation of any product of health interest made through the senses (sight, smell,
p.(None): touch, taste, yoido).
p.(None): Perishable: Product that is easily altered or decomposed in a short period of time.
...
p.(None): b) Take samples of products of health interest.
p.(None): c) Retain products, substances and artifacts that are considered hazardous to health.
p.(None): d) Execute the confiscation, denaturation and destruction of products of health interest, prior resolution.
p.(None): e) Execute or notify the actions and penalties contemplated in this Regulation according to the resolution issued
p.(None): by competent authority.
p.(None): c) Make the request of the representative or owner of the establishment to appear before the
p.(None): competent authority to solve the problems or deficiencies found.
p.(None): d) Other delegates.
p.(None): CHAPTER IV
p.(None): SANITARY RULES APPLICABLE TO PRODUCTS, SERVICES AND
p.(None): ESTABLISHMENTS OF HEALTH INTEREST.
p.(None): Article 8.- For the application of this Regulation, the Secretary of State in the Department of Health, through
p.(None): the competent bodies adopt the mandatory national regulations in force and those that are approved in the
p.(None): future, as well as international standards on products, services and establishments of health interest
p.(None): contained in international conventions and treaties ratified by Honduras.
p.(None): If REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): Article 9.- In the case of food, food additives, packaging and labeling, they will be applied in the order of
p.(None): following priority: a) This Regulation, b) Central American Customs Regulations, c) Technical Standards
p.(None): Hondurbñas,
p.(None): d) Nonnas of the Codex Alimentarius, e) Regulations of the Federal Code of Regulations of the Office of Administration of
p.(None): Food and Drug Administration (FDA) of the United States of America and f) Pan-American Sanitary Standards of the Organization
p.(None): Pan American Health (PAHO).
p.(None): Article 10.-In the case of establishments where they are produced, handled, stored, distributed and sold
p.(None): food, this Regulation provides as mandatory: a) Customs Union Regulations
p.(None): Central American and, b) Honduran Technical Standards for Aliinentos Establishments.
p.(None): Article 11.-In the case of Medical Devices and Devices, in the application of these Regulations they are considered
p.(None): Mandatory provisions established in the Honduran Technical Standard and the Norms and / or Regulations of the Union
p.(None): Central American Customs.
p.(None): Article 12.-The physical-chemical, microbiological and biological evaluation of famiaceutical products must comply
p.(None): according to order of priority with the following standards: Honduran Technical Standard, the specifications established in the
p.(None): USP Pharmacopoeias of the United States of America, British, European, International, Japanese, French, Argentina,
p.(None): German, Helvetic Mexican, Spanish, Mexican Homeopathic Pharmacopoeia, Codex Frances, Code of Regulations
p.(None): Federal and in the case of new products not included in the previous pharmacopoeias the methodology will be accepted
p.(None): duly validated and specifications developed by the manufacturer. In either case, you must comply
p.(None): with the Risk Criteria.
p.(None): For the medical evacuation of mcdicarrientos the Central American Farcuacological Standard is considered and
p.(None): of Dominican Republic.
p.(None): Article 13.-The health establishments, included in these Regulations must carry out a priority order
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p.(None): of Honduras.- This regulation will be implemented gradually, according to the technical standards of Good Practices
p.(None): Manufar: Tura (BPM) of the Pan American Health Organization (PAHO) to the validity of this regulation.
p.(None): Article 33.- The Ministry of Health will prepare special regulations for medicines destined for the market
p.(None): of generics
p.(None): Article 34.- Over-the-counter medicines authorized by the competent health authority may be marketed
p.(None): also in non-pharmaceutical establishments such as supermarkets, warehouses and grocery stores complying with the
p.(None): Good storage practices.
p.(None): Article 35.- The quality control of products of sanitary interest shall be carried out in laboratories that establish
p.(None): national legislation or others that are recognized and certified by the sanitary authority.- For those
p.(None): products that are subject to mutual recognition between countries, through international agreements, their control is
p.(None): will perform once they are in the national territory. '
p.(None): Article 36.- The regulation of drugs classified as controlled shall be in accordance with the provisions.
p.(None): in these Regulations and the provisions of the United Nations Conventions: Single Convention of 1 961
p.(None): on Narcotic Drugs issued by the 1972 Protocol, Convention on Psychotropic Substances of 1971,
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988,
p.(None): International Narcotics Control Board, National Narcotics and Other Drug Control Board
p.(None): Dangerous and other agreements that the country be signatory and ratify.
p.(None): Article 37.- Three (3) regimes are established: Prohibition, Strict Control and Control.
p.(None): I. a) It is prohibited, for medical or scientific purposes, the cultivation, production, manufacture,
p.(None): distribution and use of the following narcotic drugs:
p.(None): Cannabis and its resins
p.(None): Ketobemidone (4-meta-hydroxyphenyl2-methyl-4propioni1pi-
p.(None): peridine) Desomorphine (Dihydiodeoxymorphine) Heroin (Diacetylmorphine)
p.(None): The preparation, distribution, trade and use of Lysergic Acid Dietilamide (LSD), of the
p.(None): Psilocybin, mezcalin and other similar substances.
p.(None): II. The narcotic substances mentioned in List I, List 11 and are subject to strict control
p.(None): List III of the Single Convention of 1961.
p.(None): III. The psychotropic substances mentioned in List I, List II, List III and List IV remain under control
p.(None): of the Single Convention of 1971.
p.(None): Article 38.- In accordance with the provisions of Articles 150, 151, 152 and 154 of the Health Code, the regulation and
p.(None): the control of narcotic drugs, psychotropic products and chemicals, like other dangerous drugs that
p.(None): they can create dependencies or habits, regarding their import, export, production, storage,
p.(None): distribution, prescription and dispensation will be done through the Ministry of Health applying the rules and
p.(None): regulations established in international agreements.
p.(None): Article 39.- The dispensation of psychotropic products, narcotics and preparations containing them, may only
p.(None): be made by the pharmaceutical regent, upon presentation of the corresponding special prescription, which will contain
p.(None): the following requirements:
p.(None): a) Letterhead, stamp and signature of the prescribing physician.
p.(None): b) Date of issue.
p.(None): c) Name and age of the patient.
p.(None): d) Patient address.
p.(None): e) Commercial and generic name readable of the prescribing drug.
p.(None): f) Dose and quantity prescribed in letters and number.
p.(None): Article 40.- Psychotropic drugs, narcotics and other controlled drugs may only be marketed by
p.(None): Pharmaceutical laboratories, drug stores and pharmacies nationwide.
p.(None): Article 41.- For the management of psychotropic and other controlled drugs, veterinarians and dentists shall be governed by
p.(None): Ready for medical professionals.
p.(None): Ę REPUBLICA DE HONDURAS - "1" EGIJCIGALPA, M.D. C., NOVEMBER 4, 2005
p.(None): No. 30,841
p.(None): Article 42.- The validity of psychotropic prescriptions will be fifteen days and three days for narcotics,
p.(None): counted from the date of issue. When circumstances of force majeure arise
p.(None): competent health authority may authorize prescriptions that have expired said terms.
p.(None): Article 43.-These are duties and obligations of the pharmaceutical regents regarding the handling of narcotic drugs,
p.(None): Psychotropic and controlled products the following:
p.(None): a) To personally dispense the recipes of these products.
p.(None): b) Dispense such products only to persons of legal age
p.(None): c) Keep the products controlled in a special section, under have and instead not accessible to the public.
p.(None): d) Seal the prescriptions dispatched with the seal of the pharmacy and the pharmaceutical regent.
p.(None): e) Reject prescriptions that have amendments or deletions or without the seal of the doctor who extends it.
p.(None): Ę Bring the control books to 1 day.
p.(None): g) Authorize cpn your signature for orders, reports or requests that refer to these products.
p.(None): h) Inform the competent health authority about the anonymity that is known regarding
p.(None): these products.
p.(None): Article 44.- The General Directorate of Health Regulation through the competent health authority shall remain
p.(None): updated list of psychotropic drugs and other controlled products, as well as substances
p.(None): Chemicals subject to control and inspection.
p.(None): Article 45.- Every importer of psychotropic drugs, narcotics and controlled chemical substances must send
p.(None): a monthly report to the competent health authority, indicating the movements of entry, exit and balances, as well
p.(None): as specifying the people or establishments to which the product was sold, being verified, audited and
p.(None): inspected when the health authority deems it convenient.
p.(None): Article 46.- Narcotic drugs, psychotropic drugs may only be exported by laboratories and drug stores to
p.(None): establishments legally authorized for this purpose in the importing country.
p.(None): Article 47.- The amounts of psychotropics, narcotic drugs and controlled chemical substances that are required with
p.(None): Medical, scientific or production purposes must be reported before April 10 of each year to the authorities
p.(None): competent by the interested parties, indicating if they will be imported or acquired localinente.
p.(None): Article 48.- The competent health authority, in accordance with the previous article, shall approve the quota
p.(None): within the annual forecasts established according to the needs of the country, to each authorized establishment
p.(None): to import or manufacture
p.(None): Psychotropic, narcotic, and controlled or prepared chemical substances containing them.
p.(None): Article 49.- The competent health authority shall keep a record of the forecasts and of the fees set.
p.(None): for each establishment.- If at the end of the year the quantities authorized to manufacture have not been used in
p.(None): in its entirety, the surplus will be deducted from the amount authorized for the following year.
p.(None): Article 50.- The pharmaceutical laboratory that manufactures controlled chemical products and substances must have
p.(None): with two control books, one for the movement of raw material and another for the transfer of finished product.
p.(None): Article 51.- The control books of the producing, importing, distributing and dispensing establishments of
p.(None): controlled chemical products and substances must be labeled, folded and sealed by the authority
p.(None): competent sanitary registering the corresponding information.
...
p.(None): Dispositions of Title I, Articles 150 at 154 of the SKİ Code and may only be dispensed prior to
p.(None): presentation of the i specti goes written prescription with tetra cl ‹ira y n (legible, signed and
p.(None): sealed and must be dispensed by customer according to the regulations established for paia ta1 fi’i.
p.(None): Article 61.- The special recipe books for products of strict cont1’o1 will be provided
p.(None): pei‘sonalnsente in the Ministry of Health by the cornpctcnte authority to the isiédicos collegiate.
p.(None): Article 62.- In order to obtain the book of special documents, the doctor must:
p.(None): a) Submit the application personally, finalized and scllad ‹i.
p.(None): b) Presentai ’came of association.
p.(None): c) Make the corresponding payment.
p.(None): d) For the request of a new checkbook you must submit the previous one.
p.(None): e) Present record of the Medical Colcgio cynic is entitled to exercise.
p.(None): Article 63.-. The doctors, dentists and vetci’i l) íll’İOS ț3Od1’ÜJ keep in their briefcase up to two vials tie
p.(None): Birth of strict control conditioning its use to the character of cirergencia.
p.(None): Article 64.- The quantities that may be prescribed for products of strict control shall be determined by the CIC.
p.(None): according to the corresponding national and intentional protocols and technical standards.
p.(None): Article 65.- For the tixitainiento of chronic or terminal enfcrnaedades, the Co-competent Health Authority
p.(None): based on the medical diagnosis, it will authorize in writing to the pharmacological establishment Dispense ‘the products
p.(None): controlled indicating drug, daily dose and days of tralarniento.
p.(None): Article 66.-In the case of national or international health organizations or bripadas duly authorized quc
p.(None): do
p.(None): Floor or manejcn cstrlpcfacient and psychotropic adeirás deíaci.ili request ‹iritorización ¡For t‹ il fin ‹i la
p.(None): Authority Sani till Ìil competeiite, acornJsananclo the following information:
p.(None): a.- Garlic tl plan that includes place, beginning and duration ‹1c l‹ i activity,
p.(None): b.- List of pi odnctos, including noisilare genéi’ic ‹i and commercial, present‹ 1 Phyloraceuticals,
p.(None): concentration, quantity ‹l (‹ ›n numbers; / letters) and expiration date.
p.(None): Article: ulo 67.- Controlled pi'od ucts and not counted oItIt IS that is known only to be justified and t] ue
p.(None): seam aptOS .ll’il USE. the Dii’cccióú Gcneral de Salud coiiipctente You can dot iai to public hospitals
p.(None): similar entities that need cll ‹is, from which the minutes will be taken and the respective resolution will be issued.
p.(None): Artíi: iılo 68. The Regent and the owner are rcsponsablcs ‹le that do not exist for sale Pharmaceutical products
p.(None): expired cm cl establishment. The pharmacological laboratory fabricantc cs responsal: ale by means of the regelite
p.(None): de ladrogueríó COn csponclici ite de retirur tlel nacl cado los rnedicarnentos lio aptos print cl consume ›,
p.(None): c) If they are damaged or expired. The regent ‹lc the fanvaci‹ i is responsible for the expired product being broken £ Î Î
p.(None): ütm ›and separated cJe unredited licenses.
p.(None): SECTION IS PTI MA
p.(None): Dłlś LOS ESJ’ABLECI M IE NTOS OF I NTERI £ S
p.(None): SANITARY
p.(None): Artíi:! N'6'9.- Sc consider the establishment of public health interest İCOS O) 3l’iVíldOS, COn or without ends
...
p.(None): Article 184.- The Certificate of Free Sale will be valid for two (2) years from the date of its
p.(None): Issue.- In the case of the sanitary registration that expires before this period, the validity of the certificate will be the
p.(None): same of the sanitary registry.
p.(None): The Certificate of Good Manufacturing Practices will be valid for one (1) year from the date of issue
p.(None): and its procedure will be done in accordance with the procedure established in section V of this Regulation and the norm
p.(None): established.
p.(None): The Export Certificate of controlled products will be valid for ninety (90) days and will be necessary
p.(None): Request one for each shipment.
p.(None): The Import Certificate of controlled products will be valid for one hundred and fifty (150) days and will be
p.(None): necessary to request one for each shipment, it will be valid only once
p.(None): Article 185.- The interested party in obtaining the Official Import Certificate for psychotropic substances and
p.(None): narcotics must submit to the General Directorate of Health Regulation the request relating the
p.(None): Following data:
p.(None): a) Name of the Regent or company manager.
p.(None): b) Name and address of the importer and exporter.
p.(None): c) Name of the pharmaceutical establishment that represents
p.(None): d) Provider Name
p.(None): e) Quantity
p.(None): í) Concentration if it is the case of finished product
p.(None): g) Product name
p.(None): h) Date of admission
p.(None): i) Customs office of entry
p.(None): j) Origin of shipment
p.(None): k) Bell of Lps. 5.00 (five lempiras) for each request.
p.(None): Article 186.- Narcotic drugs, psychotropic and controlled chemical substances may only be exported by
p.(None): laboratories and drug stores to establishments legally authorized for this purpose in the importing country.
p.(None): UNIT II
p.(None): THE PROCESS OF CERTIFICATES
p.(None): Article 187.- Once the application has been submitted, it will be registered in the corresponding book of entries, after which
p.(None): will verify if it contains the requirements established in the preceding articles.- If it does not meet them, it will be required to
p.(None): petitioner so that within ten (10) business days he may complete it, with the warning that
p.(None): Do it, the proceedings will be filed without further processing. If requested by the interested party, the
p.(None): documentation to the interested party.
p.(None): Article 188.- Admitted the request, within five (5) business days following the delegated health authority,
p.(None): will issue a reasoned resolution granting or denying the requested certificate.
p.(None): RH REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ’. 30.84
p.(None): UNIT III
p.(None): OF PRODUCT INCOME AND RAW MATERIALS
p.(None): Article 189.- For the importation of controlled chemical products and substances, official authorization is required.
p.(None): extended by the competent health authority.
p.(None): Article 190.- Food and beverages that are imported by anyone who is not the natural or legal person who
p.(None): registered and that does not have an exclusive distributor, must be registered, subjecting it to laboratory analysis by batch
p.(None): when the competent health authority deems it necessary, and the respective rights must be paid.-
...
Searching for indicator substance:
(return to top)
p.(None): medicine.
p.(None): Dental Deposits: Establishments dedicated to importation, sale, marketing, manufacturing,
p.(None): storage and distribution of bio materials, dental equipment and instruments for care or ‹lontology, as well
p.(None): as materials, equipment and instruments for the use of dental laboratories.
p.(None): Customs clearance: It is the process for the nationalization of merchandise that legally enters the country.
p.(None): Withdrawal: Act by which the petitioner's request is accepted not to continue with the process giving rise to
p.(None): file of the file containing the proceedings.
p.(None): Dispensing: It consists in the delivery of medications to the user patient usually as a result of a
p.(None): medical prescription.
p.(None): Availability: Relationship between the volume of demand and type of existing resource to meet the needs
p.(None): of offer attention. It is a dimension of supply risk.
p.(None): Device and Equipment for Medical Use: Instrument, apparatus, implement, machine, implant or other similar item or
p.(None): related that by itself or in combination with any accessory or program for its proper operation is
p.(None): used in prevention, healing, rehabilitation and health research.
p.(None): Dolo: Modality of breaking the Law with full knowledge of the cause.
p.(None): Therapeutic dose: Amount of active ingredient that produces the desired therapeutic effects in a given period
p.(None): of time.
p.(None): Drug / drug substance / medicine: In legal and technical use, these terms have 2 meanings:
p.(None): 1. In the first, the term drug or medication is used to describe the active substance or drug that for its
p.(None): Administration must be fomiulated.
p.(None): 2. In the second one, medication or drug is understood as any pharmaceutical product used for the
p.(None): prevention, diagnosis and treatment of a disease or pathological state or to modify systems
p.(None): physiological benefits for the person to whom it was administered.
p.(None): Drugstore: Establishment dedicated to the importation, storage, distribution and sale of medicines in bulk and
p.(None): minor, where direct supply to the public is prohibited except in cases authorized by the Ministry of Health,
p.(None): under the responsibility of a duly registered pharmaceutical professional.
p.(None): Packaging and Packaging: All material used to protect a product for its conservation, handling and transport.
p.(None): Packaging: Any container intended to contain products
p.(None): SdRÍtdfÍOS.
p.(None): Primary Container: It is one that is in direct contact with the product.
p.(None): Secondary Container: It is one that is in direct contact with the primary container.
p.(None): Pharmaceutical Equivalence: Two medications are considered to have pharmaceutical equivalence when they contain
p.(None): equal amounts of the same active ingredient (s) in identical doses and dosage forms to be administered
p.(None): by the same route and that meet the same specifications.
p.(None): Pharmaceutical Specialty: Is that medicine produced by a manufacturer under a brand name or generic of
p.(None): a way that is characteristic.
p.(None): II E'Z MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
...
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
p.(None): Slight failure: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions and not
p.(None): It constitutes a risk that harms or may harm the health of the population.
p.(None): Less serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions, which are
p.(None): It constitutes a moderate risk to affect the health of the population, intervening the voluntary action or omission.
p.(None): Serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and also DIS] 3O5itions issued by the Ministry of Health, in the exercise of its functions, which are
p.(None): constitutes a gi’ave risk or has caused or damage to the health of the population and that mediates negligence or
p.(None): malicious intent.
p.(None): ., Fqrmacia; It is the establishment that is dedicated to the preparation of recipes, dispensing and supply
p.(None): of medicines and related products directly to the public.
p.(None): Germs: Microbes or microorganisms.
p.(None): Systematization Sheet: Document in which the data of the application for registration, renewal or
p.(None): modification
p.(None): Hermetic: Complete and impenetrable closure.
...
p.(None): Dental Laboratories: Establishments dedicated to the support of dental professionals in manufacturing
p.(None): of devices be they acrylic, metallic, porcelain or others that contribute to the rehabilitation of health
p.(None): oral.
p.(None): Narcotics control book: Special format book that records entries, exits and balances
p.(None): of narcotics.
p.(None): Book of control of psychotropics: Book of special format where the registry of entrances, exits and
p.(None): Psychotropic balances.
p.(None): Raw material control book: Special format book where the record of entries, exits and balances is kept
p.(None): raw material.
p.(None): Book of finished product and transfers: Book of special format where the register of entrances and exits of
p.(None): Controlled product, as well as transfers.
p.(None): Licensing: Mandatory administrative technical procedure aimed at verifying compliance with
p.(None): minimum requirements in force.
p.(None): Sanitary License: It is the authorization for an establishment to manufacture, import, export,
p.(None): transport, distribute, handle, store, pack, sell and dispense products of sanitary interest; as well as
p.(None): Provide health services, once all technical and legal requirements are met.
p.(None): Batch: Quantity of a product that is produced in a single manufacturing cycle.
p.(None): Manipulator —Seller: Person who performs his work of handling or selling food.
p.(None): Manual of Pharmacological Standards: Properly classified organization of recognized Pharmacological Standards
p.(None): and officialized by the Ministry of Health.
p.(None): IY Raw material: Any active or inactive substance ‹jut: is used to manufacture products of interest
p.(None): sanitary ›regulated in this regulation whether it is unaltered, modified or eliminated in the course of
p.(None): production process.
p.(None): Medication: Any active substance or mixture of the misrrios with or without the addition of excipients, prepared to be
p.(None): Presented as a pharmaceutical form.
p.(None): Controlled medication:
p.(None): a) Any psychotropic medication and hypertension under the control regimen according to the Conventions on
p.(None): narcotic and psychotropic substances respectively, Ul contrc 1 on this type of substances is exercised by the
p.(None): Junt ‹i National Drug Control.
p.(None): b) A substance that can be incorporated into pharmaceutical post-linguistic forms only within the limits
p.(None): Specific deRrminated by studies.
p.(None): c) A substance approved by the Ministry of Health but subject to restrictions that exclude its use in a
p.(None): considerable proportion of the potential population of patients to whom it would be destined.
p.(None): Drug of strict control: They are pharmaceutical preparations based on narcotic drugs which requires a
p.(None): special recipe booklet for your prescription.
p.(None): Orphan Drug: It is said of the potential active ingredients in which there is no interest on the part of
p.(None): producing laboratories for its development as medicines,
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): since such development does not present an economic incentive, although they can meet health needs.
p.(None): Over-the-counter medication: It is the one that due to its composition and the pharmacological action of its active substances can
p.(None): used by the public without a prescription.
p.(None): Essential Medication: It is the one considered most important, indispensable and necessary to satisfy the
p.(None): health needs of most of the population.
p.(None): Multifuente Medication: It is one that must meet the same standards of quality, safety and efficacy applicable
p.(None): to the innovative medicine.
p.(None): Innovative Medicine: It is the original that demonstrated safety and efficacy with preclinical, clinical and post studies
p.(None): marketing and established quality standards, which will be used as a reference medicine.
p.(None): New Medication: Any Medication that has not been registered or released to the market for medical purposes including new
p.(None): salts or esters of an active substance, new fixed combinations of substances that are already on the market, or
p.(None): any medication previously registered or offered on the market, provided that its indications for use
p.(None): mode of administration or formulation have been changed.
p.(None): Official Medication: It is the one recorded in the respective monograph of the Normative Code that can bear the name of
p.(None): its active ingredients; Official Generic; or that of your patent registration; Official Patented
p.(None): Reference Medicine: Is the innovator or defined by the health authority.
p.(None): Similar Drug: It is the one that contains the same or same active ingredients, has the same concentration, form
p.(None): pharmaceutical, route of administration, dosage and therapeutic indication of the reference medicine, registered by
p.(None): the regulatory authority responsible, being able to differ only in characteristics related to the size and shape of the
p.(None): product, expiration date, packaging, label, excipients and vehicles must always be identified by
p.(None): trade or brand name
p.(None): New Molecule: Active substance that is not contained in any type of pharmaceutical product previously
p.(None): Registered by the health authority. A new salt, be or derived from an approved active substance, must
p.(None): be considered
p.(None): Medical sample: Representative units or small amounts of a drug that is provided free of charge
p.(None): For your promotion.
p.(None): Sampling: Taking units of a product that are representative of their total.
p.(None): Fine: Pecuniary penalty that is imposed for the execution or omission of a conduct, contrary to the provisions
p.(None): sanitary
p.(None): Generic Name: It is the name of the active substance that generally corresponds to the common denomination
p.(None): International (D.C.I.) recommended by WHO.
p.(None): Chemical Name: It is the name used intemacionahnente for a chemical substance, following the rules of
p.(None): Nomenclature of the I.U.P.A.C., which unequivocally denotes the composition and structure of the substance.
p.(None): Honduran Standard: It is one that has been adopted or adapted from an international standard or formulated and
p.(None): approved in the country and that is related to products, services or establishments of health interest.
p.(None): Sanitary Notification: Document sent by the manufacturer that certifies any change of a scientific nature and
p.(None): duly justified and documented.
p.(None): Lot Code Number: The designation (in numbers or letters) or coding of the product that identifies the lot to
p.(None): That this one belongs.
p.(None): Organoleptic: Evaluation of any product of health interest made through the senses (sight, smell,
p.(None): touch, taste, yoido).
p.(None): Perishable: Product that is easily altered or decomposed in a short period of time.
p.(None): Precursor or precursor substance: It is the substance or substances from which it can be synthesized,
p.(None): manufacture, process and obtain products that can produce physical or psychological dependence.
p.(None): Pharmaceutical or Commercial Presentation: It is the quantity expressed in units of pharmaceutical form, volume, weight or
p.(None): number of doses in case of aerosols, pharmaceutical or cosmetic product.
p.(None): Forecast: Amount planned for the consumption of controlled medicines for the period of one year.
p.(None): as a new molecule and therefore demonstrate the documentation Active ingredient: Substance or mixture of
p.(None): Related substances related to efficacy, safety and quality. endowed with a
p.(None): specific pharmacological effect
p.(None): Sertión A Atueriłos y leycs
p.(None): K REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘. 30,841
p.(None): Product: Thing produced, resulting from the work done on a raw material.
p.(None): Altered Product: When replaced, totally or partially added or replaced constituent elements
p.(None): that are part of the officially registered composition or when substances that may have been added
p.(None): modify its effects or its physicochemical or organoleptic characteristics.
p.(None): Cosmetic Product: It is any substance or formula of local application to be used on different surfaces
p.(None): external of the human body and its annexes including mucosa, buccal and teeth in order to clean, perfume,
p.(None): improve its appearance and protect or maintain it.
p.(None): Alines Products: They are natural products, cosmetics, hygienic products, laboratory reagents, material and
p.(None): Dental and health laboratory equipment, devices, equipment and surgical medical equipment.
p.(None): Bulk Product: It is any processed substitution found in its final form and which has been uncle
p.(None): packed in final distribution packages.
p.(None): Products of interest s “year: They are food and beverages, medicines, biologicals, cosmetics,
p.(None): hygienic products, hazardous substances, medical devices and equipment, natural products, reagents
p.(None): laboratory and others that in their time are considered by the sanitary authority; those that are classified zsí:
p.(None): Risk "A" or high risk Risk "B" or medium risk Risk "C" or low risk
p.(None): Finished Pharmaceutical Product: A preparation containing é1 or the active ingredients and excipients; formulated in a
p.(None): famiaceutical form.
p.(None): Natural Product: Processed, industrialized and labeled product are attributed medicinal qualities,
p.(None): Qite contains in its formulation ingredients obtained from plants, animals, minerals or mixtures thereof.
p.(None): Products that, being inezclas, have a chemical active ingredient included, are not considered natural products.
p.(None): Seini-elaborated product: It is any substance or mixture of substances that is still in the manufacturing process.
p.(None): Expired Product: The one that has fulfilled its expiration or expiration date.
p.(None): Finished Product: Prepared ready for dispensing.
p.(None): Products (ligienicos: Are those products intended to be applied in homes, buildings and facilities
p.(None): public and
p.(None): private, industries and other places, as well as objects and utensils that are in contact with people, used with
p.(None): In order to clean dewatering, deodorizing yaromatize.
p.(None): Prospectus: Document addressed to the medical body or patients where in a summary form it explains the indications, main
p.(None): contraindications, warnings, adverse reactions, doses, toxicologist record and commercial presentations.
p.(None): Stall of Sale: Local, site, furniture, food and non-alcoholic beverage sales in public premises
p.(None): legally authorized.
p.(None): Position of Sale of Medicines: Establishments destined in restricted form, only the dispensing of
p.(None): medicines authorized by the competent authority, and in which the preparation of prescriptions and handling of
p.(None): Controlled medications.
p.(None): Recipe: Any written and eligible prescription extended by a competent professional duly registered to the
p.(None): specific person and that contains the addresses for its correct use, of a simple or compound medicine, in
p.(None): Any pharmaceutical form intended for therapeutic purposes.
p.(None): Special Recipe: It is the prescription on safety paper provided by the Doctor for psychotropic products or
p.(None): controlled.
p.(None): Regent or Technical Director: The university professional, in full exercise of his rights and duties assumed by the
...
p.(None): regulate health services and actions.
p.(None): Article 95.- The owners or legal representatives of the Establishments must inform the Secretariat of
p.(None): Health, in a term not exceeding thirty days, when they decide to stop providing temporary temporary services or
p.(None): definitive
p.(None): EIGHTH SECTION
p.(None): OF DEVICES AND USE EQUIPMENT
p.(None): SURGICAL DOCTOR
p.(None): Article 96.-The Ministry of Health corresponds through the General Directorate of Health Regulation, the
p.(None): sanitary regulation of importation, manufacturing, marketing, transportation, storage, handling and use of
p.(None): Devices and equipment for surgical medical use.
p.(None): Article 98.-The devices and equipment for surgical medical use Risk A includes the following:
p.(None): a) Those destined to administer energy to the human body in a potentially dangerous way.
p.(None): b) Non-invasive ones that come into contact with the injured skin, in wounds with rupture of the dermis and that only
p.(None): Heal by second intention.
p.(None): c) Invasive surgical type for short-term use, if they are intended to diagnose, monitor or correct a
p.(None): cardiac, central circulatory system and respiratory system alteration.
p.(None): d) The invasives. Surgical-type surgical, long-term use that is used in direct contact with
p.(None): the heart, the central circulatory system or the central nervous system.
p.(None): e) Non-invasive used to modify the biological or chemical composition of blood or other liquids or
p.(None): body fluids, with the purpose of being introduced to the human body by infusion or other route of administration,
p.(None): whose characteristics mean that during the modification process a strange substance can be introduced into a
p.(None): potentially dangerous concentration.
p.(None): Article 99.- The Ministry of Health through the General Directorate of Health Regulation will prepare and approve
p.(None): by agreement the lists of devices and equipment for surgical medical use according to risk classification,
p.(None): same that must be updated periodically.
p.(None): Article 100.-The devices and equipment of surgical medical use Risk B, are those that can be indirectly
p.(None): invasive, which induce or store substances that at some time can be surgically implanted in the body
p.(None): human.
p.(None): Article 101.- Devices and equipment for surgical medical use Risk C, considered non-invasive or invasive that
p.(None): they present the lowest potential risk of harm to the patient and are devices that do not come into contact with the patient or
p.(None): They only do it superficially with the skin.
p.(None): Article 102.-Any device and equipment for surgical medical use that is intended to be donated must be subject to
p.(None): the provisions established in the External Cooperation Standards in force in the Ministry of Health.
p.(None): Article 103.-The competent Health Authority shall carry out inspection visits to the establishments and their
p.(None): devices and equipment for surgical medical use, in order to guide, educate and apply the measures
p.(None): corrective and corresponding health security.
p.(None): Article 97.-The devices and equipment for medical use Article 104.- All devices and equipment of
...
p.(None): of analysis.
p.(None): Specific requirements:
p.(None): I. For food products and beverages must present:
p.(None): a) Qualitative and quantitative product formula.
p.(None): b) Certificate of Free Sale for imported products.
p.(None): c) In the case of imported products that cannot be credited
p.(None): Article 145.- The health authority in qualified cases requirements a and b, must present
p.(None): document that may dictate the retention of food products, beverages, declare the formula
p.(None): qualitative, table of factors medicines and related products and others that the health authority
p.(None): Nutrition and affidavit of the importer of
p.(None): SJ REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84i.
p.(None): product where responsibility for the quality and safety of it is assumed.
p.(None): II.- Pharmaceutical products also require the following technical information:
p.(None): a) Qualitative and Quantitative Formula complete, signed and stamped by the responsible Pharmaceutical Chemist.
p.(None): (Original).
p.(None): b) Commercial presentation (s).
p.(None): ) General method of elaboration
p.(None): d) Product monograph.
p.(None): f) Phase III clinical studies of the product (for new molecules in the market)
p.(None): g) Technical specifications of the product.
p.(None): h) Justification of the commercial presentation and of the pharmaceutical form, based on the dose and duration of the
p.(None): treatment. International standards or standards.
p.(None): j) Analytical method validated by the manufacturing laboratory when the product is not pharmacopeic.
p.(None): k) Quality control certificate of the active substance and finished product.
p.(None): Document proving the commercial relationship between the owner and the manufacturer of the products, when they are
p.(None): different.
p.(None): m) Stability study, in accordance with established norm.
p.(None): n) Mandatory insert or your project in over-the-counter products, when the required information is not found in
p.(None): the primary or secondary packaging according to current labeling standard.
p.(None): Free Sale Certificate in the country of origin or certificate of WHO pharmaceutical product.
p.(None): p) Certificate of Good Manufacturing Practices (in case it is not attached to the free sale certificate,
p.(None): export or equivalent document) where it is established that the laboratory is subject to periodic inspections by the
p.(None): corresponding regulatory entity.
p.(None): III.- Biological products, in addition to what is required
p.(None): previous:
p.(None): a) Technical product information.
p.(None): b) Preclinical information
p.(None): ) Clinical information
p.(None): d) Document issued by the regulatory authority of the country of origin, related to the cold chain.
p.(None): e) Certificate of lot release issued by the competent authority of the country of origin.
p.(None): Due to their complexity, the different pniebas to request these products will be based on what is established in the series of
p.(None): WHO technical reports, Volume XII.
p.(None): g) Document proving that the product must be prequalified by WHO or by the regulatory authority of a
p.(None): country recognized by WHO.
p.(None): Article 147.- To market the vaccines after obtaining the sanitary registration, the interested party must obtain
...
p.(None): related, will be regulated in accordance with international conventions or treaties ratified by Honduras.
p.(None): Article 154.- It is the obligation of the holder of the recognized sanitary registry to issue the instructions to the distributor to
p.(None): in order to facilitate inspectors the necessary sampling of products.- Samples will be taken in
p.(None): Any establishment of the marketing or service chain.- The number of samples will be in accordance with
p.(None): the Technical Standard; The results of the analyzes will be delivered to the regulatory authority and to the holder of the registry
p.(None): sanitary or to the distributor, in a maximum period of thirty (30) days.
p.(None): UNIT IV
p.(None): REGISTRATION MODIFICATION
p.(None): SANITARY
p.(None): Article 155.-Every holder of the sanitary registry must request from the competent sanitary authority, modification of the
p.(None): sanitary registration, when changes of any existing condition occur at the time of being initially granted, such as
p.(None): be: name of the manufacturer or distributor of the product, name of the registered product, of the business name, of the container,
p.(None): of the label and packaging, of the commercial presentation, of the excipients of the product that do not change the nature
p.(None): of the product.- The application will be processed expeditiously.
p.(None): Article 156.- The competent sanitary authority shall authorize the modification of the sanitary registry, keeping the
p.(None): same nomenclature and validity of the registry initially granted.
p.(None): Article 157.- Pharmaceutical and natural products that undergo modification of the active substance, form
p.(None): pharmaceutical, chemical formula, concentration of active substance, excipients that modify the nature of the
p.(None): Products, route of administration, country of origin of the manufacturer, must be processed with a new sanitary registration.
p.(None): Article 158.- In the case of food products, beverages, and related products, which undergo modification of the principle
p.(None): active, chemical formula, concentration of active principle, excipients that modify the nature of the products, via
p.(None): of administration, country of origin of the manufacturer, must be processed with a new sanitary registration.
p.(None): UNIT V
p.(None): REGISTRATION NOMENCLATURE
p.(None): SANITARY.
p.(None): Article 159.- The sanitary registry shall have the following nomenclature:
p.(None): a) Capital letters RS: What does the Sanitary Registry mean?
p.(None): b) The number corresponding to the Departmental Health Region, where applicable.
p.(None): The letter and number that identify the class and type of product.
p.(None): d) Four digits corresponding to the month and year in which the Sanitary Registry is granted.
p.(None): e) Six (6) digit correlative numbering, with which the product is identified in the records, starting
p.(None): with the number 000001.
p.(None): UNIT VI
p.(None): OF THE PROCESS OF THE LICENSE AND REGISTRATION
p.(None): SANITARY
p.(None): Article 160.-Once the application is submitted, it will be verified if it contains the requirements established in the chapter
p.(None): above and if not met, the petitioner will be required so that within the corresponding term established in
p.(None): the Administrative Procedure Law proceed to complete it with the warning that if it does not do so,
p.(None): will file the proceedings without further processing. If requested, the documentation will be returned to the interested party.
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): competent duly subscribed by them and the interested party.
p.(None): Customs: Official competent body that regulates the import and export of merchandise from the country.
p.(None): Food for Medical Use: The one that has been subjected to processes that modify the relative concentration
p.(None): of the various nutrients, of their constitution or their quality, or by incorporation of substances
p.(None): outside its composition, they acquire therapeutic properties.
p.(None): Written reprimand: Action to reprimand someone, by writing motivated by omission, execution of a
p.(None): activity or conduct contrary to legal or regulatory provisions.
p.(None): Hearing: Citation that is made to the public employee in order to render discharges on actions that are
p.(None): imputed or attributed.
p.(None): Outpatient Care: Actions aimed at patient care for diagnosis and treatment, when
p.(None): Check that it does not require hospitalization.
p.(None): Hospital Care: Actions aimed at the care of patients who, due to their state of health, need to be
p.(None): integrated for more than 24 hours for diagnosis or medical or surgical treatment.
p.(None): s REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and
p.(None): health rehabilitation.
p.(None): Preventive Care: A set of general promotion and specific protection actions provided to the
p.(None): individual and the general population with the purpose of reducing morbidity.
p.(None): Rehabilitation Care: Actions aimed at correcting physical or mental disability.
p.(None): Health Care: Promotional, preventive, curative and rehabilitation actions provided by a
p.(None): multidisciplinary team in the health area.
p.(None): Health Authority: Instance, Organ or Public Official that by Law or by delegation has the power to ensure
p.(None): for compliance with nonnas, policies, criteria, systems and procedures of a technical nature that must govern
p.(None): the administrative and executing units of health services.
p.(None): Goods: Any of the things that can satisfy human needs.
p.(None): Bioavailability: Measurement of the amount of medication contained in a pharmaceutical form that reaches the formation
p.(None): systemic and the speed at which this process occurs.
p.(None): Bioeq uivalen cia: Condition that exists between two medications that are pharmaceutical equivalents and that show
p.(None): the same or sinúlar bioavailability according to criteria established in the technical nonna.
p.(None): Medical Emergency Kit: Establishments approved by the General Directorate of Health Regulation a
p.(None): request of a registered doctor and with your rights, so that you have pharmaceutical products for
p.(None): emergent use
p.(None): Cancellation of the Sanitary Registry: Definitive deprivation of the authorization that had been conferred, for having incurred
p.(None): in facts or conduct contrary to sanitary provisions.
p.(None): Cancellation of health license: Deprivation of the authorization granted for the operation of a
p.(None): Establishment
p.(None): Free Sale Certificate (C. L. V.): Document issued by the regulatory authority in which it is certified
...
Health / Terminally Ill
Searching for indicator terminal:
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p.(None): competent.
p.(None): Article I 59.- Controlled products must be identified with a red “C” and the law of Jdil C {ue
p.(None): say "Product susceptible to dependence"
p.(None): ›Title 60.- The products of strict control cny‹ i sale requires a cspccial mćJica prescription, they will be subject to
p.(None): Dispositions of Title I, Articles 150 at 154 of the SKİ Code and may only be dispensed prior to
p.(None): presentation of the i specti goes written prescription with tetra cl ‹ira y n (legible, signed and
p.(None): sealed and must be dispensed by customer according to the regulations established for paia ta1 fi’i.
p.(None): Article 61.- The special recipe books for products of strict cont1’o1 will be provided
p.(None): pei‘sonalnsente in the Ministry of Health by the cornpctcnte authority to the isiédicos collegiate.
p.(None): Article 62.- In order to obtain the book of special documents, the doctor must:
p.(None): a) Submit the application personally, finalized and scllad ‹i.
p.(None): b) Presentai ’came of association.
p.(None): c) Make the corresponding payment.
p.(None): d) For the request of a new checkbook you must submit the previous one.
p.(None): e) Present record of the Medical Colcgio cynic is entitled to exercise.
p.(None): Article 63.-. The doctors, dentists and vetci’i l) íll’İOS ț3Od1’ÜJ keep in their briefcase up to two vials tie
p.(None): Birth of strict control conditioning its use to the character of cirergencia.
p.(None): Article 64.- The quantities that may be prescribed for products of strict control shall be determined by the CIC.
p.(None): according to the corresponding national and intentional protocols and technical standards.
p.(None): Article 65.- For the tixitainiento of chronic or terminal enfcrnaedades, the Co-competent Health Authority
p.(None): based on the medical diagnosis, it will authorize in writing to the pharmacological establishment Dispense ‘the products
p.(None): controlled indicating drug, daily dose and days of tralarniento.
p.(None): Article 66.-In the case of national or international health organizations or bripadas duly authorized quc
p.(None): do
p.(None): Floor or manejcn cstrlpcfacient and psychotropic adeirás deíaci.ili request ‹iritorización ¡For t‹ il fin ‹i la
p.(None): Authority Sani till Ìil competeiite, acornJsananclo the following information:
p.(None): a.- Garlic tl plan that includes place, beginning and duration ‹1c l‹ i activity,
p.(None): b.- List of pi odnctos, including noisilare genéi’ic ‹i and commercial, present‹ 1 Phyloraceuticals,
p.(None): concentration, quantity ‹l (‹ ›n numbers; / letters) and expiration date.
p.(None): Article: ulo 67.- Controlled pi'od ucts and not counted oItIt IS that is known only to be justified and t] ue
p.(None): seam aptOS .ll’il USE. the Dii’cccióú Gcneral de Salud coiiipctente You can dot iai to public hospitals
p.(None): similar entities that need cll ‹is, from which the minutes will be taken and the respective resolution will be issued.
p.(None): Artíi: iılo 68. The Regent and the owner are rcsponsablcs ‹le that do not exist for sale Pharmaceutical products
p.(None): expired cm cl establishment. The pharmacological laboratory fabricantc cs responsal: ale by means of the regelite
p.(None): de ladrogueríó COn csponclici ite de retirur tlel nacl cado los rnedicarnentos lio aptos print cl consume ›,
p.(None): c) If they are damaged or expired. The regent ‹lc the fanvaci‹ i is responsible for the expired product being broken £ Î Î
...
Health / alcoholism
Searching for indicator alcoholic:
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p.(None): Risk "A" or high risk Risk "B" or medium risk Risk "C" or low risk
p.(None): Finished Pharmaceutical Product: A preparation containing é1 or the active ingredients and excipients; formulated in a
p.(None): famiaceutical form.
p.(None): Natural Product: Processed, industrialized and labeled product are attributed medicinal qualities,
p.(None): Qite contains in its formulation ingredients obtained from plants, animals, minerals or mixtures thereof.
p.(None): Products that, being inezclas, have a chemical active ingredient included, are not considered natural products.
p.(None): Seini-elaborated product: It is any substance or mixture of substances that is still in the manufacturing process.
p.(None): Expired Product: The one that has fulfilled its expiration or expiration date.
p.(None): Finished Product: Prepared ready for dispensing.
p.(None): Products (ligienicos: Are those products intended to be applied in homes, buildings and facilities
p.(None): public and
p.(None): private, industries and other places, as well as objects and utensils that are in contact with people, used with
p.(None): In order to clean dewatering, deodorizing yaromatize.
p.(None): Prospectus: Document addressed to the medical body or patients where in a summary form it explains the indications, main
p.(None): contraindications, warnings, adverse reactions, doses, toxicologist record and commercial presentations.
p.(None): Stall of Sale: Local, site, furniture, food and non-alcoholic beverage sales in public premises
p.(None): legally authorized.
p.(None): Position of Sale of Medicines: Establishments destined in restricted form, only the dispensing of
p.(None): medicines authorized by the competent authority, and in which the preparation of prescriptions and handling of
p.(None): Controlled medications.
p.(None): Recipe: Any written and eligible prescription extended by a competent professional duly registered to the
p.(None): specific person and that contains the addresses for its correct use, of a simple or compound medicine, in
p.(None): Any pharmaceutical form intended for therapeutic purposes.
p.(None): Special Recipe: It is the prescription on safety paper provided by the Doctor for psychotropic products or
p.(None): controlled.
p.(None): Regent or Technical Director: The university professional, in full exercise of his rights and duties assumed by the
p.(None): technical, scientific direction and professional responsibility of a health establishment.
p.(None): Sanitary Registry: This authorization so that a product of sanitary interest can be manufactured, imported,
p.(None): packaged or expended once all technical and legal requirements are met.
p.(None): Resolution denied: Administrative act by which a request, renewal or change on a Registry is rejected
p.(None): for not meeting the requirements of the Regulation.
p.(None): Sanction: Administrative provision imposed on the holder of the sanitary registration of a product or license
p.(None): health of an establishment that by action or omission violates health regulations.
p.(None): Services: Function or benefit performed by an organization and its staff.
p.(None): Health Care Services: The set of resources that systematically intervene for prevention and cure
...
Health / ill
Searching for indicator ill:
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p.(None): Recinc. ritlu ‹l
p.(None): First of all Sanita-Cod / Sani- I.?od/ Sani-
p.(None): Cod / Sani- € “od / Sani-
p.(None): Situational provisions Sancióli riu Sai) c. I would! ’ianc.
p.(None): Tai’ia Salte. taria Sanc. liuiii
p.(None): l.- Chapter V, Section III: l- a) I.-IV l .- b) and c) I-III '. .- b)
p.(None): 1.- III 1.- d) and e) 1.-III 1.- f) and g) 1.-1 (Art. 19 and 20)
p.(None): 2.- Capíkilo V, Section IV:
p.(None): (Art. 21, 22, 23, 24, 25, 25 2.- a)
p.(None): 27 and 28)
p.(None): 2.-lV 2.- b) 2.-III i! .- b) 2.- 1 II 2.- d) and e) 2.-III 2.- t) and
p.(None): g) 2.-1
p.(None): 3.- C? Chapter V, Section V: 3.- a) 3.- l V 3.- d) and e) 3.- III 3. 13 and g) 3.-
p.(None): l (An. 29, 30; and, 31)
p.(None): 4.- Chapter V, Section Vl: 4.- a) 4.- I l 4.- b) 4, .- II -1.- b)
p.(None): 4.- II 4.- d) and e) 4.- III 4.- l) and g) 4.- 1
p.(None): (Art. 32, 33, 36, 37, 38, 39;
p.(None): and, 41)
p.(None): 5.- Chapter V, Section VI1: 5.- a) 5.- 11 5.- b) 5.- Il 5. d) and e) 5.- III
p.(None): 5.- fj and g) 5.- I
p.(None): (Art. 79, 80, 81, 87, 88, S9,
p.(None): 90, 91, 92, 93, 94, 96, 97,
p.(None): '98, 99, 100, 102, 103, 104,
p.(None): [05, 10, 107, 109; and, 110)
p.(None): fi, - Chapter Vl, Section I: G.- a) (›.- l V 6.- b) and c) G.- III i› .- b)
p.(None): 6.- l l I G, - cJ) and e) 6.- III 6.- l) and g) fi.- 1 (Art. 121, 122, 1 23, 124,
p.(None): 125, 126, 127, 125, 129,
p.(None): 130, 131; and, 132)
p.(None): 7.- Chapter VI, Section II: 7.- a) 7.- l V 7.- b) and c) 7.- III ".- b) 7.- l
p.(None): II 7.- d) and e) 7.- III 7, - f) and g) 7.- l (Art. 133, 134, 135, 136,
p.(None): 137; and 135
p.(None): S.- Chapter VII, Section 8.- a) 8.- l V S.- b) 8.- III li.- b)
p.(None): 8.- III 8.- e) S.- III S.- f) 8.- 1
p.(None): III; (An. 1 or 9)
p.(None): * J.- Chapter VII: (Ar t. 212, 9.- a) 9.- l V 9.- b) and c) 9.- III 'L- b)
p.(None): '7.- Ill 9.- d) and e) 9.- III 9.- l) and g) 9.- l
p.(None): 213, 214; and, 217)
p.(None): 1.- Chapter IV: (Ai‘t. 8, 9, 1- c) 1.-111 1 .- b) and c) l-III 1. b) and c) 1.-
p.(None): 1 II 1.- d) and e) l.-Ill 1.- t) and g) 1.-1
p.(None): 10, 11, 1 2, 13; and, 14)
p.(None): 2.- Chapter V, Section 11: 2.- a) 2.-IV 2.- b) 2.-111 í! .- b) 2.-
p.(None): III 2.- d) and e) 2.-111 2.- f) and ¡i) l -1
p.(None): (Ai‘t. 17 and 18)
p.(None): 3.- Chapter V, Section VI: 3.- a) and c) 3.- [l 3.- b) and c) 3.- II 3. c) and cl) 3.- l II
p.(None): 3.- f) and g) 3.- I (Art. 42, 47, 51, 52, 53, 55,
p.(None): REPUBLI CA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 2005 N °.
p.(None): 30,841
p.(None): 59, II, 62, 65, 66, 68, 70, 73,
p.(None): 74, 75, 76, 77; and, 78)
p.(None): 4.- Chapter V, Section VIII: (Art. 111, 117, 118 and 120)
p.(None): 5.- Chapter VII, Section II (Art. 144 and 145)
p.(None): 6.- Chapter VII, Section II: (Art. 147 and 148)
p.(None): 4.- a)
p.(None): 5.- a) and b)
p.(None): 6.- a) and b)
p.(None): 4.- 11
p.(None): 5.- III
p.(None): 6.-111
p.(None): 4.- b)
p.(None): 5.- b)
p.(None): . 6.- b)
p.(None): 4.- II
p.(None): 5.- III
p.(None): 6.- III
p.(None): 4.- b) and c)
p.(None): 5.- e)
p.(None): 6.-e)
p.(None): 4.- II
p.(None): 5.- III
p.(None): 6.- III
p.(None): 4.- d) and e)
p.(None): 5.- g)
p.(None): 6, - d) and e)
p.(None): 4.- III
p.(None): 5.- I
p.(None): 6.- III
p.(None): 4.- fl and g)
p.(None): 6.- f) and g)
p.(None): 4.- I
p.(None): fi.- I
p.(None): 7.- Chapter VII, Section III: 7.- a) and b) (Art. 153, 154, 155, 156 and
p.(None): 159)
p.(None): 7.-III
p.(None): 7.- b)
p.(None): 7.- III
p.(None): 7.- b) and c)
p.(None): 7.- III
p.(None): 7.- d) and e)
p.(None): 7.- III
p.(None): 7.- f) and g)
p.(None): 7.- I
p.(None): Serious
p.(None): l.- Chapter V, Section VI: (Art. 48, 50, 54, 56, 57, 63,
p.(None): 67, 69 and 71)
p.(None): 2.- Chapter VJI, Section
p.(None): IV: (Art. 184, 186, 187,
p.(None): 1 58; and 189)
p.(None): 1.- b) and c)
p.(None): 2.- b)
p.(None): 1.- II
p.(None): 2.- lIl
p.(None): 1.- c), d);
p.(None): and, e)
p.(None): 2.- c), d);
...
Health / injured
Searching for indicator injured:
(return to top)
p.(None): Article 92- Within any health facility, the certificate that will
p.(None): accredit as regent.
p.(None): Article 93.- In accordance with Article 160 of the Health Code, it corresponds to the Ministry of Health regular and
p.(None): promote the installation of registration and information systems for adequate technical, epidemiological and
p.(None): care of all public and private health institutions.- To comply with this provision, the
p.(None): General Directorate of Health Regulation in coordination with the corresponding bodies, will establish the rules and
p.(None): minimum procedures that all health facility operators must observe.
p.(None): Article 94.- The health establishments regulated in this Regulation are obliged to exhibit
p.(None): request of the General Directorate of Health Regulation, all those provisions and internal regulations that
p.(None): regulate health services and actions.
p.(None): Article 95.- The owners or legal representatives of the Establishments must inform the Secretariat of
p.(None): Health, in a term not exceeding thirty days, when they decide to stop providing temporary temporary services or
p.(None): definitive
p.(None): EIGHTH SECTION
p.(None): OF DEVICES AND USE EQUIPMENT
p.(None): SURGICAL DOCTOR
p.(None): Article 96.-The Ministry of Health corresponds through the General Directorate of Health Regulation, the
p.(None): sanitary regulation of importation, manufacturing, marketing, transportation, storage, handling and use of
p.(None): Devices and equipment for surgical medical use.
p.(None): Article 98.-The devices and equipment for surgical medical use Risk A includes the following:
p.(None): a) Those destined to administer energy to the human body in a potentially dangerous way.
p.(None): b) Non-invasive ones that come into contact with the injured skin, in wounds with rupture of the dermis and that only
p.(None): Heal by second intention.
p.(None): c) Invasive surgical type for short-term use, if they are intended to diagnose, monitor or correct a
p.(None): cardiac, central circulatory system and respiratory system alteration.
p.(None): d) The invasives. Surgical-type surgical, long-term use that is used in direct contact with
p.(None): the heart, the central circulatory system or the central nervous system.
p.(None): e) Non-invasive used to modify the biological or chemical composition of blood or other liquids or
p.(None): body fluids, with the purpose of being introduced to the human body by infusion or other route of administration,
p.(None): whose characteristics mean that during the modification process a strange substance can be introduced into a
p.(None): potentially dangerous concentration.
p.(None): Article 99.- The Ministry of Health through the General Directorate of Health Regulation will prepare and approve
p.(None): by agreement the lists of devices and equipment for surgical medical use according to risk classification,
p.(None): same that must be updated periodically.
p.(None): Article 100.-The devices and equipment of surgical medical use Risk B, are those that can be indirectly
p.(None): invasive, which induce or store substances that at some time can be surgically implanted in the body
p.(None): human.
p.(None): Article 101.- Devices and equipment for surgical medical use Risk C, considered non-invasive or invasive that
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): Article 139.- The validity of the sanitary registry shall be five
p.(None): (5) years from the date of its granting, except for violations of health regulations and laws or
p.(None): By regulation, the competent authority resolves its cancellation.
p.(None): Article 140.-It is not allowed to manufacture, import, store, transport, distribute, package, market wholesale
p.(None): or in detail, dispense or advertise any product indicated in the preceding Article 138 that does not have
p.(None): sanitary registration, notwithstanding the provisions of Article 144 of these Regulations.
p.(None): Article 141.-Foods not subjected to any processing or packaging process, as well as raw materials
p.(None): of the
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Other products of health interest do not require sanitary registration, but they will be subject to surveillance and
p.(None): control exercised by the health authority.
p.(None): Article 142.-Food products, beverages, medicines and related products, and others produced in
p.(None): Central America and other countries where equal treatment is granted to those produced in our country, will be
p.(None): subject to treaties or agreements signed by the State of Honduras.
p.(None): Article 143.-The General Directorate of Health Regulation may exceptionally authorize the importation of products
p.(None): food, beverages, medicines, biologicals and related products, without having obtained the sanitary registration, which
p.(None): they will be subject to control and without paying the fees for analysis and registration services established by this Regulation,
p.(None): in the following cases:
p.(None): a) When circumstances of disasters and emergencies arise, qualified by decree of the Power
p.(None): Executive.
p.(None): b) In the case of samples in the necessary quantities required by the competent General Directorate for
p.(None): Health registration process.
p.(None): c) In the case of donations to state or charitable institutions, prior resolution of the Directorate
p.(None): General of competent Health.
p.(None): d) In the case of orphan drugs.
p.(None): Article 144.-The Executive Directorate of Revenue through its dependencies will only allow entry into the country of
p.(None): food products, natural, biological, cosmetics, pharmaceuticals, products subject to control
p.(None): national and international and others that the health authority determines, if it proves to have a health record or
p.(None): current authorization issued by the competent health authority of the Ministry of Health.
p.(None): In the case of controlled products prior to entering the country, you must accredit Certificate of Authorization
p.(None): Import Officer extended by the competent authority.
p.(None): Any official or public employee who allows the entry of the aforementioned products without complying with the
p.(None): requirement established in this article will be denounced before the Public Ministry to be deducted
p.(None): case responsibilities.
p.(None): determine, in the facilities of the importer or distributor and there they will remain until you obtain the registration
p.(None): respectively, the necessary controls will be established for this purpose, without prejudice to the corresponding sanctions.
p.(None): UNIT II
p.(None): OF THE REQUIREMENTS TO OBTAIN THE SANITARY RECORD
...
p.(None): functions, within their working hours and overtime when designated by their superior, will have
p.(None): free access to establishments, premises or sites of health interest, prior to the inspection order issued
p.(None): by the Competent Health Authority, in order to verify compliance with related sanitary standards
p.(None): with:
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): 1. Production, processing, handling, packaging, storage, conservation, transportation, distribution,
p.(None): dispensing, import, export of products of health interest.
p.(None): 2. Provision of health services.
p.(None): 3. Advertising and propaganda of health products, services and establishments of health interest.
p.(None): 4. Waste management generated by the establishments.
p.(None): 5. Occupational safety and industrial safety.
p.(None): 6. Hygienic conditions of the establishments.
p.(None): 7. Products.
p.(None): 8. Good Manufacturing Practices, in force in the Industry.
p.(None): Article 170.-The General Directorate of Health Regulation shall define and establish the technical procedures and
p.(None): operational for the verification of the requirements in health interest establishments.
p.(None): Article 171.- The owners, representatives or managers of the establishments, premises or sites, remain
p.(None): obliged at any time to allow the entry of certified inspectors of the Ministry of Health.
p.(None): Article 172.- Inspections may be ordinary, carried out during the normal working day of the
p.(None): Health Authority and extraordinary, when carried out at any other time, due to sanitary surveillance,
p.(None): attention to complaints or emergencies for presumption of health risk.
p.(None): Article 173.- The Health Authority will have free access to all premises and facilities dependencies.
p.(None): of sanitary interest, being obliged the owner, representative or responsible to give all kinds of
p.(None): facilities and provide the reports of health interest that are required.
p.(None): Article 174.- The refusal of the owner, representative or responsible for the establishment of health interest, for
p.(None): to punish the access of the Sanitary Authority, will be sufficient reason to resort to the police authority, with the
p.(None): object that obliges it to allow inspection, without prejudice to the corresponding sanctions.
p.(None): Article 175.- The sanitary inspection must be oriented to verify compliance with the minimum requirements
p.(None): essentials established according to the activity to which it is based on the guides of current good practices that
p.(None): apply
p.(None): Article 176.- The inspection shall not be limited only to the punitive aspects, but also to those related to
p.(None): guidance in health education and motivation in compliance with legal and regulatory provisions.
p.(None): Article 177.- The sanitary authority, when performing the inspection in any establishment of sanitary interest,
p.(None): will take official minutes of the proceedings.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): products, must be requested before the competent General Directorate or Head of Departmental Health Region, to
p.(None): through the legal representative or legal representative, within three (3) months for the health license of the
p.(None): establishments and five (5) months for sanitary registration of products, prior to the expiration date. May
p.(None): have extemporaneous renewal up to six (6) months after the expiration date of the license or registration
p.(None): health, paying the rights to registration, in addition to a fine, whose value should not be less than the cost of registration
p.(None): sanitary. In any case, you must submit a certified affidavit stating that
p.(None): maintains the original conditions under which it was granted.
p.(None): Otherwise, you must carry out the procedure, indicated in Articles 130 and 146, as the case may be.
p.(None): In any case, be it renewal or new procedure, it will keep the original license number or sanitary registration.
p.(None): Article 167.- The period of validity expired without having requested the renewal of the license and registration
p.(None): health, will proceed according to the sanction regime.
p.(None): Article 168.- The payment of the rights by license and sanitary registration, as by the services of surveillance and
p.(None): Health control will be assumed by the interested party and canceled in the place determined by the health authority
p.(None): competent.
p.(None): FOURTH SECTION
p.(None): OF THE HEALTH INSPECTIONS
p.(None): Article 169.- The inspectors of the Ministry of Health, duly certified and accredited in the exercise of their
p.(None): functions, within their working hours and overtime when designated by their superior, will have
p.(None): free access to establishments, premises or sites of health interest, prior to the inspection order issued
p.(None): by the Competent Health Authority, in order to verify compliance with related sanitary standards
p.(None): with:
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): 1. Production, processing, handling, packaging, storage, conservation, transportation, distribution,
p.(None): dispensing, import, export of products of health interest.
p.(None): 2. Provision of health services.
p.(None): 3. Advertising and propaganda of health products, services and establishments of health interest.
p.(None): 4. Waste management generated by the establishments.
p.(None): 5. Occupational safety and industrial safety.
p.(None): 6. Hygienic conditions of the establishments.
p.(None): 7. Products.
p.(None): 8. Good Manufacturing Practices, in force in the Industry.
p.(None): Article 170.-The General Directorate of Health Regulation shall define and establish the technical procedures and
p.(None): operational for the verification of the requirements in health interest establishments.
p.(None): Article 171.- The owners, representatives or managers of the establishments, premises or sites, remain
p.(None): obliged at any time to allow the entry of certified inspectors of the Ministry of Health.
p.(None): Article 172.- Inspections may be ordinary, carried out during the normal working day of the
p.(None): Health Authority and extraordinary, when carried out at any other time, due to sanitary surveillance,
p.(None): attention to complaints or emergencies for presumption of health risk.
p.(None): Article 173.- The Health Authority will have free access to all premises and facilities dependencies.
p.(None): of sanitary interest, being obliged the owner, representative or responsible to give all kinds of
p.(None): facilities and provide the reports of health interest that are required.
p.(None): Article 174.- The refusal of the owner, representative or responsible for the establishment of health interest, for
p.(None): to punish the access of the Sanitary Authority, will be sufficient reason to resort to the police authority, with the
p.(None): object that obliges it to allow inspection, without prejudice to the corresponding sanctions.
p.(None): Article 175.- The sanitary inspection must be oriented to verify compliance with the minimum requirements
p.(None): essentials established according to the activity to which it is based on the guides of current good practices that
p.(None): apply
p.(None): Article 176.- The inspection shall not be limited only to the punitive aspects, but also to those related to
p.(None): guidance in health education and motivation in compliance with legal and regulatory provisions.
p.(None): Article 177.- The sanitary authority, when performing the inspection in any establishment of sanitary interest,
p.(None): will take official minutes of the proceedings.
p.(None): At the end of the inspection, the person responsible for the establishment will be given the opportunity to state what is in his right
p.(None): agrees, recording it in the minutes to be drawn up, and the latter must also sign said minutes.- In case of refusing to
p.(None): sign will be entered in it, being the actaválida.
p.(None): At the end of the inspection, a copy of the minutes must be delivered to the person in charge of the establishment, stating
p.(None): this made in the original
p.(None): Article 178.- The sanitary conditions found shall be recorded in the inspection record and the
p.(None): Correction to the identified problem.- The testimonies of other persons present and of
...
p.(None): of the Ministry of Health, within the term of ten (10) business days from the date on which
p.(None): notify the offender of the resolution; The amount of the financial penalty may not be reduced or waived.
p.(None): Article 210.- Failure to comply with the resolutions emanating from the health authority shall be sufficient grounds for
p.(None): execute them by means of the forced fulfillment contemplated in Articles 109 and 110 of the Law of Procedure
p.(None): Administrative, for which the Health Authority will request the support of the National Police or the Municipal Authority
p.(None): correspondent.
p.(None): Article 211.- The temporary closure of an establishment entails the suspension of the Sanitary License and may
p.(None): be issued for up to thirty (30) calendar days
p.(None): If the causes that gave rise to the sanction disappeared, the interested party's request has been filed, the authority
p.(None): corresponding sanitary, prior to its * erification will resolve its reopening and restitution of the sanitary license
p.(None): Article 21 2.- The definitive closure of an establishment entails the cancellation of the Sanitary License.
p.(None): Article 213.- To proceed to the temporary or definitive closure of an establishment that violates provisions
p.(None): legal and regulatory, the competent health authority will place posters
p.(None): In the case of temporary closure, access to the establishment will be allowed to maintain the equipment or
p.(None): machinery that by its nature require special care.
p.(None): In the case of definitive closure the offender will have access to the establishment to remove the machinery, equipment,
p.(None): furniture and other prior authorization of the competent authority.
p.(None): Article 214.- To retain or deposit products, goods, raw materials, substances and others, you must
p.(None): the respective inventory and official certificate signed by the interested party, two witnesses and the health authority be taken up;
p.(None): proceeding to place seals or seals that guarantee their conservation and permanence in the establishment
p.(None): inspected.- In case of not wanting or being able to sign the witnesses and / or the interested party, it will be recorded in the minutes,
p.(None): which does not invalidate it.
p.(None): Article 215.- In order to comply with the provisions of the Health Code and this Regulation, the authority
p.(None): When required, it will request the support of the Public Prosecutor's Office, the Municipal Offices, the Police
p.(None): National, the Attorney General's Office, the Secretary of Natural Resources and Environment and the Secretariat of
p.(None): Agriculture and Livestock.
p.(None): In all the proceedings that are carried out, only the aforementioned authorities will participate, avoiding notoriety
p.(None): public, unnecessary inconvenience or damage to the establishment.
p.(None): Article 216.- In those cases that from the violation of the legal and regulatory provisions risks and
p.(None): serious damage to people's health or the environment, the health authority will immediately notify the
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Social / Age
Searching for indicator age:
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p.(None): I. a) It is prohibited, for medical or scientific purposes, the cultivation, production, manufacture,
p.(None): distribution and use of the following narcotic drugs:
p.(None): Cannabis and its resins
p.(None): Ketobemidone (4-meta-hydroxyphenyl2-methyl-4propioni1pi-
p.(None): peridine) Desomorphine (Dihydiodeoxymorphine) Heroin (Diacetylmorphine)
p.(None): The preparation, distribution, trade and use of Lysergic Acid Dietilamide (LSD), of the
p.(None): Psilocybin, mezcalin and other similar substances.
p.(None): II. The narcotic substances mentioned in List I, List 11 and are subject to strict control
p.(None): List III of the Single Convention of 1961.
p.(None): III. The psychotropic substances mentioned in List I, List II, List III and List IV remain under control
p.(None): of the Single Convention of 1971.
p.(None): Article 38.- In accordance with the provisions of Articles 150, 151, 152 and 154 of the Health Code, the regulation and
p.(None): the control of narcotic drugs, psychotropic products and chemicals, like other dangerous drugs that
p.(None): they can create dependencies or habits, regarding their import, export, production, storage,
p.(None): distribution, prescription and dispensation will be done through the Ministry of Health applying the rules and
p.(None): regulations established in international agreements.
p.(None): Article 39.- The dispensation of psychotropic products, narcotics and preparations containing them, may only
p.(None): be made by the pharmaceutical regent, upon presentation of the corresponding special prescription, which will contain
p.(None): the following requirements:
p.(None): a) Letterhead, stamp and signature of the prescribing physician.
p.(None): b) Date of issue.
p.(None): c) Name and age of the patient.
p.(None): d) Patient address.
p.(None): e) Commercial and generic name readable of the prescribing drug.
p.(None): f) Dose and quantity prescribed in letters and number.
p.(None): Article 40.- Psychotropic drugs, narcotics and other controlled drugs may only be marketed by
p.(None): Pharmaceutical laboratories, drug stores and pharmacies nationwide.
p.(None): Article 41.- For the management of psychotropic and other controlled drugs, veterinarians and dentists shall be governed by
p.(None): Ready for medical professionals.
p.(None): Ę REPUBLICA DE HONDURAS - "1" EGIJCIGALPA, M.D. C., NOVEMBER 4, 2005
p.(None): No. 30,841
p.(None): Article 42.- The validity of psychotropic prescriptions will be fifteen days and three days for narcotics,
p.(None): counted from the date of issue. When circumstances of force majeure arise
p.(None): competent health authority may authorize prescriptions that have expired said terms.
p.(None): Article 43.-These are duties and obligations of the pharmaceutical regents regarding the handling of narcotic drugs,
p.(None): Psychotropic and controlled products the following:
p.(None): a) To personally dispense the recipes of these products.
p.(None): b) Dispense such products only to persons of legal age
p.(None): c) Keep the products controlled in a special section, under have and instead not accessible to the public.
p.(None): d) Seal the prescriptions dispatched with the seal of the pharmacy and the pharmaceutical regent.
p.(None): e) Reject prescriptions that have amendments or deletions or without the seal of the doctor who extends it.
p.(None): Ę Bring the control books to 1 day.
p.(None): g) Authorize cpn your signature for orders, reports or requests that refer to these products.
p.(None): h) Inform the competent health authority about the anonymity that is known regarding
p.(None): these products.
p.(None): Article 44.- The General Directorate of Health Regulation through the competent health authority shall remain
p.(None): updated list of psychotropic drugs and other controlled products, as well as substances
p.(None): Chemicals subject to control and inspection.
p.(None): Article 45.- Every importer of psychotropic drugs, narcotics and controlled chemical substances must send
p.(None): a monthly report to the competent health authority, indicating the movements of entry, exit and balances, as well
p.(None): as specifying the people or establishments to which the product was sold, being verified, audited and
p.(None): inspected when the health authority deems it convenient.
p.(None): Article 46.- Narcotic drugs, psychotropic drugs may only be exported by laboratories and drug stores to
p.(None): establishments legally authorized for this purpose in the importing country.
p.(None): Article 47.- The amounts of psychotropics, narcotic drugs and controlled chemical substances that are required with
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Social / Incarcerated
Searching for indicator restricted:
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p.(None): Finished Pharmaceutical Product: A preparation containing é1 or the active ingredients and excipients; formulated in a
p.(None): famiaceutical form.
p.(None): Natural Product: Processed, industrialized and labeled product are attributed medicinal qualities,
p.(None): Qite contains in its formulation ingredients obtained from plants, animals, minerals or mixtures thereof.
p.(None): Products that, being inezclas, have a chemical active ingredient included, are not considered natural products.
p.(None): Seini-elaborated product: It is any substance or mixture of substances that is still in the manufacturing process.
p.(None): Expired Product: The one that has fulfilled its expiration or expiration date.
p.(None): Finished Product: Prepared ready for dispensing.
p.(None): Products (ligienicos: Are those products intended to be applied in homes, buildings and facilities
p.(None): public and
p.(None): private, industries and other places, as well as objects and utensils that are in contact with people, used with
p.(None): In order to clean dewatering, deodorizing yaromatize.
p.(None): Prospectus: Document addressed to the medical body or patients where in a summary form it explains the indications, main
p.(None): contraindications, warnings, adverse reactions, doses, toxicologist record and commercial presentations.
p.(None): Stall of Sale: Local, site, furniture, food and non-alcoholic beverage sales in public premises
p.(None): legally authorized.
p.(None): Position of Sale of Medicines: Establishments destined in restricted form, only the dispensing of
p.(None): medicines authorized by the competent authority, and in which the preparation of prescriptions and handling of
p.(None): Controlled medications.
p.(None): Recipe: Any written and eligible prescription extended by a competent professional duly registered to the
p.(None): specific person and that contains the addresses for its correct use, of a simple or compound medicine, in
p.(None): Any pharmaceutical form intended for therapeutic purposes.
p.(None): Special Recipe: It is the prescription on safety paper provided by the Doctor for psychotropic products or
p.(None): controlled.
p.(None): Regent or Technical Director: The university professional, in full exercise of his rights and duties assumed by the
p.(None): technical, scientific direction and professional responsibility of a health establishment.
p.(None): Sanitary Registry: This authorization so that a product of sanitary interest can be manufactured, imported,
p.(None): packaged or expended once all technical and legal requirements are met.
p.(None): Resolution denied: Administrative act by which a request, renewal or change on a Registry is rejected
p.(None): for not meeting the requirements of the Regulation.
p.(None): Sanction: Administrative provision imposed on the holder of the sanitary registration of a product or license
p.(None): health of an establishment that by action or omission violates health regulations.
p.(None): Services: Function or benefit performed by an organization and its staff.
p.(None): Health Care Services: The set of resources that systematically intervene for prevention and cure
p.(None): of diseases that affect individuals, as well as their rehabilitation.
p.(None): JtEPIJBLI €: 'A 13E Hf3NDI! RAS - TEGU CIGALPA, KJ. II. C., NOVEMBER 4, 2005 N “. 30,841
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p.(None): e) Certificate of lot release issued by the competent authority of the country of origin.
p.(None): Due to their complexity, the different pniebas to request these products will be based on what is established in the series of
p.(None): WHO technical reports, Volume XII.
p.(None): g) Document proving that the product must be prequalified by WHO or by the regulatory authority of a
p.(None): country recognized by WHO.
p.(None): Article 147.- To market the vaccines after obtaining the sanitary registration, the interested party must obtain
p.(None): batch release approval submitting documents
p.(None): a) Batch release certificate, issued by the competent authority of the country of origin.
p.(None): b) Summary protocol of production of the reference lot.
p.(None): c) Summary protocol of the quality control of the last three lots.
p.(None): d) Others determined by the National Technical Standard.
p.(None): Article 148.- To market the blood products, the following must be accredited:
p.(None): a) Origin of plasma
p.(None): b) Type of donors
p.(None): c) Controls to donors
p.(None): d) Evidence of commercialization
p.(None): e) Viral inactivation methods
p.(None): í) Others contemplated by national legislation or international standards
p.(None): Article 149.- For cosmetic products in addition to the general requirements established in Article 146,
p.(None): You must comply with the following:
p.(None): a) Free Sale Certificate, export or equivalent document of the authenticated country of origin.
p.(None): b) Specifications of the finished product.
p.(None): c) Qualitative formula of the product stating the quantities of restricted or controlled substances
p.(None): when applicable
p.(None): Article 150.- For hygienic products and chemical products, in addition to the general requirements established in
p.(None): Article 146 must comply with the following:
p.(None): a) Certificate of Free Sale, export or equivalent document, authenticated.
p.(None): b) Product Safety Sheet in accordance with international standard when applicable.
p.(None): c) Original document containing the qualitative formula, signed and stamped by the responsible technical professional.
p.(None): d) Method and standards (with its certificate of purity) for laboratory analysis, (in the case of pesticides for use
p.(None): domestic, industrial and public health).
p.(None): Ñ REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘.
p.(None): 30.84 ..
p.(None): Article 151.- For natural products, in addition to the general requirements established in Article 146 must
p.(None): comply with the following:
p.(None): a) Methodology of physicochemical and microbiological analysis.
p.(None): b) Specifications of the finished product.
p.(None): Article 152.- For surgical and dental medical devices and supplies, you must present:
p.(None): a) Free Sale Certificate for imported products.
p.(None): b) In case you cannot prove requirement a), you must submit an affidavit from the importer of the product
p.(None): where responsibility for the quality and safety of it is assumed.
p.(None): UNIT III
p.(None): REGISTRATION RECOGNITION
p.(None): SANITARY
p.(None): Article 153.- To obtain the Health Registry Recognition of food, beverages, medicines and products
p.(None): related, will be regulated in accordance with international conventions or treaties ratified by Honduras.
p.(None): Article 154.- It is the obligation of the holder of the recognized sanitary registry to issue the instructions to the distributor to
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Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): §J REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D.C. NOVEMBER 4, 2005 N °. 30.84
p.(None): CHAPTER VI
p.(None): OF PRODUCT LABELS AND CONTAINERS
p.(None): FIRST SECTION OF LABELS
p.(None): Article 105.- The labels of the products that are elaborated or commercialized in the national territory must
p.(None): contain the requirements that are determined in this Chapter, in the Customs Union Labeling Standard, and according to
p.(None): current regulations.
p.(None): Article 106.- On the label of domestic and foreign products, the following information must appear:
p.(None): a) Name of the product that must indicate its true nature, being normally specific or generic,
p.(None): that does not mislead or mislead the buyer or consumer.
p.(None): b) Name or business name of the owner, manufacturer or distributor of the product as applicable.
p.(None): c) Place of origin of the product, name of the country.
p.(None): d) List of ingredients or qualitative and quantitative formula as applicable.
p.(None): e) Lot number.
p.(None): f) Expiration date.
p.(None): g) Net content, declared in units of the International System, as applicable.
p.(None): h) Health registration number.
p.(None): i) The labels must be written in Spanish. Otherwise translate it to Spanish endorsed by
p.(None): External relationships.
p.(None): Article 107.- The labels may be made of paper or any other material that may be attached to the
p.(None): packaging or permanent printing on them.
p.(None): Article 108.- The inscriptions on the labels must not disappear under normal use conditions, be easily
p.(None): Visible to the naked eye and written in Spanish, except for those registered products that are
p.(None): exclusively for export.
p.(None): Article 109.- The labels of the products written in a foreign language that are marketed in the country, must
p.(None): have the corresponding translation into the Spanish language, with equal character
p.(None): Article 110.- The labels that adhere to the package may have descriptions on the back of them, provided
p.(None): that are clearly visible through the package with its contents as long as it is not the mandatory information.
p.(None): Article 111.- When the product needs special storage conditions, it must be clearly indicated in the
p.(None): label.
p.(None): Article 112.- Any product that has been treated with radiation / ionizing energy must carry the label very close
p.(None): of the name of the product, an indication of such treatment. When an irradiated product is used as an ingredient
p.(None): in another product, this circumstance must be declared in the list of ingredients.
p.(None): Article 113.- Packaged products must not be described or presented with a label containing phrases,
p.(None): words, denominations, symbols, figures or drawings, geographical names, indications that lead to interpretations
p.(None): false or error, deceit or confusion, as to its origin, origin, nature, composition and quality with another
p.(None): product.
p.(None): Article 114.- The label will not be allowed on the inner side of the container or wrap when in contact with the
p.(None): product.
p.(None): Articles 115.- It will not be allowed to write the mandatory data of the label in seals, caps, caps or
p.(None): another part that is used when opening the container, unless authorized by the General Directorate of Health Regulation.
p.(None): SECOND SECTION OF PACKAGING
p.(None): Article 116.- Product packaging can be made of plastic, metallic, paper, glass, cardboard and other material.
p.(None): authorized by the General Directorate of Sanitary Regulation through the Department of Sanitary Control of
p.(None): Products, Services and Establishments.
p.(None): Article 117.- The materials destined to be in contact with the products must be manufactured with materials
...
p.(None): c) When you impute, defame or make pejorative comparisons
p.(None): for other products and establishments of health interest and services.
p.(None): M REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): d) When the message is contrary to the law or good customs.
p.(None): e) When the products are authorized for sale with a prescription or retained prescription.
p.(None): , '
p.(None): f) When it is incompatible with the professional condition or discipline of the people who promote them.
p.(None): Article 200.- The Ministry of Health is obliged to permanently inform the general public and the
p.(None): Health professionals lists generic interchangeable drugs from laboratories that meet the
p.(None): rule.
p.(None): Article 201.- The General Directorate of Health Regulation will issue the corresponding regulations to regulate the
p.(None): advertising and promotion of products, services and establishments of health interest.
p.(None): Article 202.- The health authority, as the governing body for the registration and control of medicines in its
p.(None): different processes, you must control the advertising of over-the-counter medicines, complying with the criteria
p.(None): following:
p.(None): a) They are promoted only with the information and arguments approved by the competent health authority.
p.(None): b) Do not suggest that the use of these medications can delay or avoid using a doctor.
p.(None): c) Do not suggest its use permanently, limiting the term of authorized administration.
p.(None): d) Do not use phrases or words that exaggerate the benefits of the product in the text.
p.(None): e) They are expressed in colloquial language, without using medical or technical terms that confuse the consumer.
p.(None): f} Do not use testimonial arguments of notorious persons or entities in teaching, research or
p.(None): Health sciences, which can induce consumption.
p.(None): CHAPTER IX
p.(None): OF BREACHES, SANCTIONS AND PROCEDURES
p.(None): SECTION ONE GENERAL PROVISIONS
p.(None): Article 203.- Any infraction by intentional act or omission or negligence that contravenes the
p.(None): provisions of the Health Code, these Regulations, the Technical Standards or the provisions issued by the Secretariat in
p.(None): the exercise of its functions and competences, committed by the owner
p.(None): representative of the establishment and the workers who are at the service of the same, which harms or
p.(None): may harm the legal good protected from life and the health of the population will be repressed with one or more of
p.(None): the sanctions referred to in Article 206 of this Regulation, taking into account their significance
p.(None): to the detriment of the health of the population and its recidivism, by reasoned administrative act without prejudice to the
p.(None): civil and criminal liability incurred.
p.(None): Article 204.- For the purpose of applying the sanctions contained in this Regulation, the infractions are
p.(None): classified as follows:
p.(None): a) Slight lack
p.(None): b) Less serious offense; Y,
p.(None): c) Serious foul.
p.(None): Article 205.- The application of sanctions for violation of this Regulation shall be carried out in accordance with
p.(None): the procedure established and guaranteeing at all times the right of defense to the accused; the penalties will be
p.(None): applied after resolution issued by the Director General or Departmental Regional Chiefs, based on the
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Searching for indicator linguistic:
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p.(None): minimum requirements in force.
p.(None): Sanitary License: It is the authorization for an establishment to manufacture, import, export,
p.(None): transport, distribute, handle, store, pack, sell and dispense products of sanitary interest; as well as
p.(None): Provide health services, once all technical and legal requirements are met.
p.(None): Batch: Quantity of a product that is produced in a single manufacturing cycle.
p.(None): Manipulator —Seller: Person who performs his work of handling or selling food.
p.(None): Manual of Pharmacological Standards: Properly classified organization of recognized Pharmacological Standards
p.(None): and officialized by the Ministry of Health.
p.(None): IY Raw material: Any active or inactive substance ‹jut: is used to manufacture products of interest
p.(None): sanitary ›regulated in this regulation whether it is unaltered, modified or eliminated in the course of
p.(None): production process.
p.(None): Medication: Any active substance or mixture of the misrrios with or without the addition of excipients, prepared to be
p.(None): Presented as a pharmaceutical form.
p.(None): Controlled medication:
p.(None): a) Any psychotropic medication and hypertension under the control regimen according to the Conventions on
p.(None): narcotic and psychotropic substances respectively, Ul contrc 1 on this type of substances is exercised by the
p.(None): Junt ‹i National Drug Control.
p.(None): b) A substance that can be incorporated into pharmaceutical post-linguistic forms only within the limits
p.(None): Specific deRrminated by studies.
p.(None): c) A substance approved by the Ministry of Health but subject to restrictions that exclude its use in a
p.(None): considerable proportion of the potential population of patients to whom it would be destined.
p.(None): Drug of strict control: They are pharmaceutical preparations based on narcotic drugs which requires a
p.(None): special recipe booklet for your prescription.
p.(None): Orphan Drug: It is said of the potential active ingredients in which there is no interest on the part of
p.(None): producing laboratories for its development as medicines,
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): since such development does not present an economic incentive, although they can meet health needs.
p.(None): Over-the-counter medication: It is the one that due to its composition and the pharmacological action of its active substances can
p.(None): used by the public without a prescription.
p.(None): Essential Medication: It is the one considered most important, indispensable and necessary to satisfy the
p.(None): health needs of most of the population.
p.(None): Multifuente Medication: It is one that must meet the same standards of quality, safety and efficacy applicable
p.(None): to the innovative medicine.
p.(None): Innovative Medicine: It is the original that demonstrated safety and efficacy with preclinical, clinical and post studies
p.(None): marketing and established quality standards, which will be used as a reference medicine.
p.(None): New Medication: Any Medication that has not been registered or released to the market for medical purposes including new
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Social / Marital Status
Searching for indicator single:
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p.(None): Category III high complexity.
p.(None): Food Establishments: Factories, stores, places where food is manufactured, handled, dispensed and served
p.(None): and drinks, vehicles that transport food and food stalls on public roads.
p.(None): Health Establishments: Are those public or private establishments, in which directed care is provided
p.(None): fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals,
p.(None): Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics
p.(None): Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories
p.(None): dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of
p.(None): body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories
p.(None): analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
p.(None): Slight failure: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions and not
p.(None): It constitutes a risk that harms or may harm the health of the population.
p.(None): Less serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions, which are
...
p.(None): supervisions, and corrective action.
p.(None): Inventory or stoclt: Physical quantity in stock of a product.
p.(None): JIFfi: International Narcotics Control Board: Supervisory body that has to assume the functions that
p.(None): He is assigned the different International Drug Control Conx'enios, one of whose functions consists of
p.(None): monitor licit drug trade subject to international control
p.(None): Dental Laboratories: Establishments dedicated to the support of dental professionals in manufacturing
p.(None): of devices be they acrylic, metallic, porcelain or others that contribute to the rehabilitation of health
p.(None): oral.
p.(None): Narcotics control book: Special format book that records entries, exits and balances
p.(None): of narcotics.
p.(None): Book of control of psychotropics: Book of special format where the registry of entrances, exits and
p.(None): Psychotropic balances.
p.(None): Raw material control book: Special format book where the record of entries, exits and balances is kept
p.(None): raw material.
p.(None): Book of finished product and transfers: Book of special format where the register of entrances and exits of
p.(None): Controlled product, as well as transfers.
p.(None): Licensing: Mandatory administrative technical procedure aimed at verifying compliance with
p.(None): minimum requirements in force.
p.(None): Sanitary License: It is the authorization for an establishment to manufacture, import, export,
p.(None): transport, distribute, handle, store, pack, sell and dispense products of sanitary interest; as well as
p.(None): Provide health services, once all technical and legal requirements are met.
p.(None): Batch: Quantity of a product that is produced in a single manufacturing cycle.
p.(None): Manipulator —Seller: Person who performs his work of handling or selling food.
p.(None): Manual of Pharmacological Standards: Properly classified organization of recognized Pharmacological Standards
p.(None): and officialized by the Ministry of Health.
p.(None): IY Raw material: Any active or inactive substance ‹jut: is used to manufacture products of interest
p.(None): sanitary ›regulated in this regulation whether it is unaltered, modified or eliminated in the course of
p.(None): production process.
p.(None): Medication: Any active substance or mixture of the misrrios with or without the addition of excipients, prepared to be
p.(None): Presented as a pharmaceutical form.
p.(None): Controlled medication:
p.(None): a) Any psychotropic medication and hypertension under the control regimen according to the Conventions on
p.(None): narcotic and psychotropic substances respectively, Ul contrc 1 on this type of substances is exercised by the
p.(None): Junt ‹i National Drug Control.
p.(None): b) A substance that can be incorporated into pharmaceutical post-linguistic forms only within the limits
p.(None): Specific deRrminated by studies.
p.(None): c) A substance approved by the Ministry of Health but subject to restrictions that exclude its use in a
p.(None): considerable proportion of the potential population of patients to whom it would be destined.
p.(None): Drug of strict control: They are pharmaceutical preparations based on narcotic drugs which requires a
...
p.(None): technical, scientific direction and professional responsibility of a health establishment.
p.(None): Sanitary Registry: This authorization so that a product of sanitary interest can be manufactured, imported,
p.(None): packaged or expended once all technical and legal requirements are met.
p.(None): Resolution denied: Administrative act by which a request, renewal or change on a Registry is rejected
p.(None): for not meeting the requirements of the Regulation.
p.(None): Sanction: Administrative provision imposed on the holder of the sanitary registration of a product or license
p.(None): health of an establishment that by action or omission violates health regulations.
p.(None): Services: Function or benefit performed by an organization and its staff.
p.(None): Health Care Services: The set of resources that systematically intervene for prevention and cure
p.(None): of diseases that affect individuals, as well as their rehabilitation.
p.(None): JtEPIJBLI €: 'A 13E Hf3NDI! RAS - TEGU CIGALPA, KJ. II. C., NOVEMBER 4, 2005 N “. 30,841
p.(None): LU iriti ‹iscritti, Secretary tacne ra1 de lu Sec i elaria dc Industrie y Co me rc io. ’L“ I1 AN SCItI13 I- .:
p.(None): 1.a li c so luc iÔ ri q Ile l ite ra lnde rite dic e: REStJLUC’If3N No. 61 2-2005. SECRI? J’ARIA DE EST'.FDO IN
p.(None): THE OFFICES € “Hf1S UE INDIJS" FRIA Y COMEItCI O, TEGU €? 1GALPA, NlUNIf01'IODEL CENTRAL DISFRITO, AT NULL DAYS DELMES
p.(None): nr sErrirunnr nrL YEAR TWO THOUSAND FIVE.
p.(None): VIEW: Pai a i esol see the sofie itud contained in the administrative file Nri. 519-2005, content of
p.(None): the application submitted by Ab ‹i¡ja‹ 1st JOiIl? L YNTONIf9 ZiiLAYA AL1'AMZq enrolled in the College of A bogatlos de
p.(None): Hontlrnas under the Nt ›. 10344, Legal Representative of the Lord
p.(None): , WSSh'.IAíYfl 'MASSfl IYIASStJ, constituted as a single merchant naediantc Instrument lo. 31 G of 30
p.(None): June 200fi, authorized by the Lawyer and N ‹itario I • public JOSE C. NUEZ VELASQUEZ, who for the development of
p.(None): Its activities use 1 ‹i JENY JAMES IN VÜRSIfJNES, having its domicile in the city
p.(None): from Tegucigalpa, municipality of the Central District, contracted to request LICEN £? DISA’RTBUIDOR, of the
p.(None): Granting Company A.ILC.-2000, INC., domiciled ‹n Nevada, Fluid States of America.
p.(None): CONSII1I'H ANDO: That the Directorate of Servic ius Le¡ia1es after va1 ‹› i'ai the c4ocuireiitación acr ›mpañatla a la
p.(None): request, and considering the report of the General Directorate of Productive Sectors dictated that the applicant
p.(None): Complies with the requirements set forth in the National Representatives, Distributors and Agents Law
p.(None): and Foreigners and their Regulations, being pr Western to grant the requested License.
p.(None): I * OR TAN "£ O: t. A sr cim raiiía DE ESTÉTO IN THE DESI • EU INDIAN ISSUES" FItIA AND C’ObJERC! IO
p.(None): application of the Ai‘tícu1os: 1, 7, 1. € 1 and I 2fJ, etc. In Federal Law etc. the Public Administration; 1, 1.9. 2. 3,
p.(None): 6 (J litei al b), G4 and 72 etc. the I.cv tle Procetlinaienfo Ar4ministrativo; 1, 2, 4 and 5, the I..eye of liepresentantes
p.(None): Distributors and A i: etites, of Ü tupresas Naci ona le • s and E.xti ünjer ‹i.s. .3 of his Reformed Regret
p.(None): iuedi ‹urte ho. Agreement 749-8. ,) 'fi, ric its Regulations iiiodiíicado by Agreement No. 1 80-00, of October 31
p.(None): the 2000,
p.(None): RESINLVE:
p.(None): PRIA4ERt3: l9eclarar WITH 1.IIGAR, the Application for LICENt'IA Dfiî l9ISTRIBL'IIJf3R filed pt ›r e1 Advocate JOIIEL
p.(None): ANTONIO Z.ELAYA AI .. $ ’'AREZ, Legal Representative of Mr. JESSY JAME NIASSO hlASSIJ, constituted corn‹ ›€“ oniei‘ciante
p.(None): Individual through Instrument No. 31.6
...
p.(None): b) Store and transport altered, contaminated, adulterated or counterfeit food along with others that are
p.(None): Suitable for human consumption.
p.(None): SECTION SIX
p.(None): OF PHARMACEUTICAL PRODUCTS
p.(None): Article 32.- The regulation of pharmaceutical products in the national territory shall be done in accordance with the
p.(None): established in the Health Code, its Regulations and international conventions and treaties adopted by the State
p.(None): of Honduras.- This regulation will be implemented gradually, according to the technical standards of Good Practices
p.(None): Manufar: Tura (BPM) of the Pan American Health Organization (PAHO) to the validity of this regulation.
p.(None): Article 33.- The Ministry of Health will prepare special regulations for medicines destined for the market
p.(None): of generics
p.(None): Article 34.- Over-the-counter medicines authorized by the competent health authority may be marketed
p.(None): also in non-pharmaceutical establishments such as supermarkets, warehouses and grocery stores complying with the
p.(None): Good storage practices.
p.(None): Article 35.- The quality control of products of sanitary interest shall be carried out in laboratories that establish
p.(None): national legislation or others that are recognized and certified by the sanitary authority.- For those
p.(None): products that are subject to mutual recognition between countries, through international agreements, their control is
p.(None): will perform once they are in the national territory. '
p.(None): Article 36.- The regulation of drugs classified as controlled shall be in accordance with the provisions.
p.(None): in these Regulations and the provisions of the United Nations Conventions: Single Convention of 1 961
p.(None): on Narcotic Drugs issued by the 1972 Protocol, Convention on Psychotropic Substances of 1971,
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988,
p.(None): International Narcotics Control Board, National Narcotics and Other Drug Control Board
p.(None): Dangerous and other agreements that the country be signatory and ratify.
p.(None): Article 37.- Three (3) regimes are established: Prohibition, Strict Control and Control.
p.(None): I. a) It is prohibited, for medical or scientific purposes, the cultivation, production, manufacture,
p.(None): distribution and use of the following narcotic drugs:
p.(None): Cannabis and its resins
p.(None): Ketobemidone (4-meta-hydroxyphenyl2-methyl-4propioni1pi-
p.(None): peridine) Desomorphine (Dihydiodeoxymorphine) Heroin (Diacetylmorphine)
p.(None): The preparation, distribution, trade and use of Lysergic Acid Dietilamide (LSD), of the
p.(None): Psilocybin, mezcalin and other similar substances.
p.(None): II. The narcotic substances mentioned in List I, List 11 and are subject to strict control
p.(None): List III of the Single Convention of 1961.
p.(None): III. The psychotropic substances mentioned in List I, List II, List III and List IV remain under control
p.(None): of the Single Convention of 1971.
p.(None): Article 38.- In accordance with the provisions of Articles 150, 151, 152 and 154 of the Health Code, the regulation and
p.(None): the control of narcotic drugs, psychotropic products and chemicals, like other dangerous drugs that
p.(None): they can create dependencies or habits, regarding their import, export, production, storage,
p.(None): distribution, prescription and dispensation will be done through the Ministry of Health applying the rules and
p.(None): regulations established in international agreements.
p.(None): Article 39.- The dispensation of psychotropic products, narcotics and preparations containing them, may only
p.(None): be made by the pharmaceutical regent, upon presentation of the corresponding special prescription, which will contain
p.(None): the following requirements:
p.(None): a) Letterhead, stamp and signature of the prescribing physician.
p.(None): b) Date of issue.
p.(None): c) Name and age of the patient.
p.(None): d) Patient address.
p.(None): e) Commercial and generic name readable of the prescribing drug.
p.(None): f) Dose and quantity prescribed in letters and number.
p.(None): Article 40.- Psychotropic drugs, narcotics and other controlled drugs may only be marketed by
p.(None): Pharmaceutical laboratories, drug stores and pharmacies nationwide.
p.(None): Article 41.- For the management of psychotropic and other controlled drugs, veterinarians and dentists shall be governed by
p.(None): Ready for medical professionals.
p.(None): Ę REPUBLICA DE HONDURAS - "1" EGIJCIGALPA, M.D. C., NOVEMBER 4, 2005
p.(None): No. 30,841
p.(None): Article 42.- The validity of psychotropic prescriptions will be fifteen days and three days for narcotics,
...
p.(None): Article 203.- Any infraction by intentional act or omission or negligence that contravenes the
p.(None): provisions of the Health Code, these Regulations, the Technical Standards or the provisions issued by the Secretariat in
p.(None): the exercise of its functions and competences, committed by the owner
p.(None): representative of the establishment and the workers who are at the service of the same, which harms or
p.(None): may harm the legal good protected from life and the health of the population will be repressed with one or more of
p.(None): the sanctions referred to in Article 206 of this Regulation, taking into account their significance
p.(None): to the detriment of the health of the population and its recidivism, by reasoned administrative act without prejudice to the
p.(None): civil and criminal liability incurred.
p.(None): Article 204.- For the purpose of applying the sanctions contained in this Regulation, the infractions are
p.(None): classified as follows:
p.(None): a) Slight lack
p.(None): b) Less serious offense; Y,
p.(None): c) Serious foul.
p.(None): Article 205.- The application of sanctions for violation of this Regulation shall be carried out in accordance with
p.(None): the procedure established and guaranteeing at all times the right of defense to the accused; the penalties will be
p.(None): applied after resolution issued by the Director General or Departmental Regional Chiefs, based on the
p.(None): mandatory and optional reports and opinions of the corresponding technical and legal units.
p.(None): Article 206.- The sanctions that the sanitary authorities must impose for the inquiries to the dispositions
p.(None): contained in these Regulations are the following:
p.(None): a) Written warning
p.(None): b) Single or successive fines, depending on the case, ranging between twenty lempiras (L. 20.00) and fifty thousand lempiras
p.(None): (L. 50,000.00).
p.(None): c) Confiscation of products, substances or artifacts.
p.(None): d) Suspension or cancellation of health records or licenses.
p.(None): e) Temporary or definitive closure of buildings and establishments.
p.(None): Article 207.- For the application of the sanctions referred to in the previous Article, the health authority shall have
p.(None): Discretionary account of the following:
p.(None): a) The importance of the infraction to the detriment of the health of the population.
p.(None): b) The recidivism in the infraction or omission of the sanitary dispositions.
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C .; NOVEMBER 4, 2005 N ‘. 30,841
p.(None): c) To incur the infraction with full knowledge of its harmful and harmful effects on the health of the
p.(None): population either as author or accomplice.
p.(None): d) Committing the infraction with the purpose of hiding another '.
p.(None): e) Shun the responsibility or attribute it to another or others.
p.(None): Article 208.- The imposition of any of the sanctions indicated in this chapter shall be made without prejudice to requiring
p.(None): to the offender responsible for compliance with the measures determined by the health authority, for the purpose that
p.(None): the effects of the infraction are repaired or minimized as the case may be, for which the term shall be indicated
p.(None): correspondent.
p.(None): Article 209.- The fines that are imposed must be made effective in compliance with the Recovered Funds Regulations.
p.(None): of the Ministry of Health, within the term of ten (10) business days from the date on which
...
p.(None): of replacement and appeal.- These appeals will be substantiated in accordance with the Law of Procedure
p.(None): Adininistrative.
p.(None): THIRD SECTION
p.(None): OFFENCES AND PENALTIES
p.(None): Article 238.- Violations of the provisions of the Health Code and these Regulations will be sanctioned without
p.(None): penalty of the penalties to which the offender becomes creditor for the configuration
p.(None): of crimes against public health, in which case the Ministry of Health will put the background in knowledge
p.(None): of the Public Ministry, to proceed before the competent courts.
p.(None): Article 239.- For the purposes of the health authority, of the infractions and sanctions provided in Article 245
p.(None): of this Regulation, the following badges are established:
p.(None): 1.- The competent authority to apply the sanctions shall have the following:
p.(None): The General Directorate of Competent Health will be identified with numeral I.
p.(None): The Department of Sanitary Control of Products, Services and Facilities of Health Interest or Department
p.(None): Delegate will be identified with the numeral ß.
p.(None): The Departmental Health Region will be identified with numeral III.
p.(None): The Coordination of the Departmental Unit of Sanitary Regulation will be identified with numeral IV.
p.(None): 2.- The infractions are classified as: minor, serious and serious. 3.- To identify the sanctions will be used
p.(None): the following codes: The written reprimand will be identified with the literal a).
p.(None): The single or successive fines will be identified with the bite.
p.(None): The confiscation of products, substances or artifacts will be identified with the literal c).
p.(None): The suspension of registration or sanitary license will be identified with the district d).
p.(None): The temporary closure of buildings and establishments will be identified with the literal e).
p.(None): The cancellation of the sanitary registration or sanitary license will be identified with the site f).
p.(None): The final closure of buildings and establishments will be identified with the literal g).
p.(None): Article 240.- The application of sanctions for violation of the provisions of the Health Code and of the present
p.(None): Regulation, will be carried out by the health authority, in accordance with the descriptive table below:
p.(None): RE PUBLI CA DE HON DURA S - TEGUCIGALPA, M. D. C., 4 Dfi NOVIfiiM IIUE DEL 2005 N “. 30,841
p.(None): INFi ACTIONS
p.(None): Mild
p.(None): Aiito- Ira. Self-2nd. 3rd. Auto- 4 ".
p.(None): Aiub ›Ridatl code Realty li: einc. Iity ‘Reinc. rity
p.(None): Recinc. ritlu ‹l
p.(None): First of all Sanita-Cod / Sani- I.?od/ Sani-
p.(None): Cod / Sani- € “od / Sani-
p.(None): Situational provisions Sancióli riu Sai) c. I would! ’ianc.
p.(None): Tai’ia Salte. taria Sanc. liuiii
p.(None): l.- Chapter V, Section III: l- a) I.-IV l .- b) and c) I-III '. .- b)
p.(None): 1.- III 1.- d) and e) 1.-III 1.- f) and g) 1.-1 (Art. 19 and 20)
p.(None): 2.- Capíkilo V, Section IV:
p.(None): (Art. 21, 22, 23, 24, 25, 25 2.- a)
p.(None): 27 and 28)
p.(None): 2.-lV 2.- b) 2.-III i! .- b) 2.- 1 II 2.- d) and e) 2.-III 2.- t) and
p.(None): g) 2.-1
p.(None): 3.- C? Chapter V, Section V: 3.- a) 3.- l V 3.- d) and e) 3.- III 3. 13 and g) 3.-
p.(None): l (An. 29, 30; and, 31)
p.(None): 4.- Chapter V, Section Vl: 4.- a) 4.- I l 4.- b) 4, .- II -1.- b)
...
Social / Police Officer
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p.(None): subject to treaties or agreements signed by the State of Honduras.
p.(None): Article 143.-The General Directorate of Health Regulation may exceptionally authorize the importation of products
p.(None): food, beverages, medicines, biologicals and related products, without having obtained the sanitary registration, which
p.(None): they will be subject to control and without paying the fees for analysis and registration services established by this Regulation,
p.(None): in the following cases:
p.(None): a) When circumstances of disasters and emergencies arise, qualified by decree of the Power
p.(None): Executive.
p.(None): b) In the case of samples in the necessary quantities required by the competent General Directorate for
p.(None): Health registration process.
p.(None): c) In the case of donations to state or charitable institutions, prior resolution of the Directorate
p.(None): General of competent Health.
p.(None): d) In the case of orphan drugs.
p.(None): Article 144.-The Executive Directorate of Revenue through its dependencies will only allow entry into the country of
p.(None): food products, natural, biological, cosmetics, pharmaceuticals, products subject to control
p.(None): national and international and others that the health authority determines, if it proves to have a health record or
p.(None): current authorization issued by the competent health authority of the Ministry of Health.
p.(None): In the case of controlled products prior to entering the country, you must accredit Certificate of Authorization
p.(None): Import Officer extended by the competent authority.
p.(None): Any official or public employee who allows the entry of the aforementioned products without complying with the
p.(None): requirement established in this article will be denounced before the Public Ministry to be deducted
p.(None): case responsibilities.
p.(None): determine, in the facilities of the importer or distributor and there they will remain until you obtain the registration
p.(None): respectively, the necessary controls will be established for this purpose, without prejudice to the corresponding sanctions.
p.(None): UNIT II
p.(None): OF THE REQUIREMENTS TO OBTAIN THE SANITARY RECORD
p.(None): Article 146.-To obtain the sanitary registration, you must comply with the following general requirements:
p.(None): 1) Submit an application with the Sum indicating: SANITARY REGISTRATION IS REQUESTED, with the following information:
p.(None): a) Body to which it is addressed: General Directorate of Health Regulation or Headquarters of the Departmental Health Region,
p.(None): as appropriate.
p.(None): b) Name and generals of the owner or legal representative of the establishment and the legal representative.
p.(None): c) Corporate name or company name.
p.(None): d) Exact address of the establishment, including telephone, fax, email.
p.(None): e) Data and classification of the product: Commercial name and / or generic name, manufacturer, type of product, country of
p.(None): origin and / or manufacture and Sanitary License number of the establishment that manufactures or markets it, when the
p.(None): Product is of national origin.
p.(None): f) "type of packaging or primary and secondary packaging.
p.(None): g) Commercial form or presentation.
p.(None): ) Place and date.
p.(None): j) Signature of the applicant.
p.(None): k) To this application adhere a stamp of L. 50.00 per product.
...
Searching for indicator police:
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p.(None): 5. Occupational safety and industrial safety.
p.(None): 6. Hygienic conditions of the establishments.
p.(None): 7. Products.
p.(None): 8. Good Manufacturing Practices, in force in the Industry.
p.(None): Article 170.-The General Directorate of Health Regulation shall define and establish the technical procedures and
p.(None): operational for the verification of the requirements in health interest establishments.
p.(None): Article 171.- The owners, representatives or managers of the establishments, premises or sites, remain
p.(None): obliged at any time to allow the entry of certified inspectors of the Ministry of Health.
p.(None): Article 172.- Inspections may be ordinary, carried out during the normal working day of the
p.(None): Health Authority and extraordinary, when carried out at any other time, due to sanitary surveillance,
p.(None): attention to complaints or emergencies for presumption of health risk.
p.(None): Article 173.- The Health Authority will have free access to all premises and facilities dependencies.
p.(None): of sanitary interest, being obliged the owner, representative or responsible to give all kinds of
p.(None): facilities and provide the reports of health interest that are required.
p.(None): Article 174.- The refusal of the owner, representative or responsible for the establishment of health interest, for
p.(None): to punish the access of the Sanitary Authority, will be sufficient reason to resort to the police authority, with the
p.(None): object that obliges it to allow inspection, without prejudice to the corresponding sanctions.
p.(None): Article 175.- The sanitary inspection must be oriented to verify compliance with the minimum requirements
p.(None): essentials established according to the activity to which it is based on the guides of current good practices that
p.(None): apply
p.(None): Article 176.- The inspection shall not be limited only to the punitive aspects, but also to those related to
p.(None): guidance in health education and motivation in compliance with legal and regulatory provisions.
p.(None): Article 177.- The sanitary authority, when performing the inspection in any establishment of sanitary interest,
p.(None): will take official minutes of the proceedings.
p.(None): At the end of the inspection, the person responsible for the establishment will be given the opportunity to state what is in his right
p.(None): agrees, recording it in the minutes to be drawn up, and the latter must also sign said minutes.- In case of refusing to
p.(None): sign will be entered in it, being the actaválida.
p.(None): At the end of the inspection, a copy of the minutes must be delivered to the person in charge of the establishment, stating
p.(None): this made in the original
p.(None): Article 178.- The sanitary conditions found shall be recorded in the inspection record and the
p.(None): Correction to the identified problem.- The testimonies of other persons present and of
p.(None): any document or part of it, when necessary, always trying to avoid causing inconvenience
p.(None): or unnecessary damages.
...
p.(None): a) The importance of the infraction to the detriment of the health of the population.
p.(None): b) The recidivism in the infraction or omission of the sanitary dispositions.
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C .; NOVEMBER 4, 2005 N ‘. 30,841
p.(None): c) To incur the infraction with full knowledge of its harmful and harmful effects on the health of the
p.(None): population either as author or accomplice.
p.(None): d) Committing the infraction with the purpose of hiding another '.
p.(None): e) Shun the responsibility or attribute it to another or others.
p.(None): Article 208.- The imposition of any of the sanctions indicated in this chapter shall be made without prejudice to requiring
p.(None): to the offender responsible for compliance with the measures determined by the health authority, for the purpose that
p.(None): the effects of the infraction are repaired or minimized as the case may be, for which the term shall be indicated
p.(None): correspondent.
p.(None): Article 209.- The fines that are imposed must be made effective in compliance with the Recovered Funds Regulations.
p.(None): of the Ministry of Health, within the term of ten (10) business days from the date on which
p.(None): notify the offender of the resolution; The amount of the financial penalty may not be reduced or waived.
p.(None): Article 210.- Failure to comply with the resolutions emanating from the health authority shall be sufficient grounds for
p.(None): execute them by means of the forced fulfillment contemplated in Articles 109 and 110 of the Law of Procedure
p.(None): Administrative, for which the Health Authority will request the support of the National Police or the Municipal Authority
p.(None): correspondent.
p.(None): Article 211.- The temporary closure of an establishment entails the suspension of the Sanitary License and may
p.(None): be issued for up to thirty (30) calendar days
p.(None): If the causes that gave rise to the sanction disappeared, the interested party's request has been filed, the authority
p.(None): corresponding sanitary, prior to its * erification will resolve its reopening and restitution of the sanitary license
p.(None): Article 21 2.- The definitive closure of an establishment entails the cancellation of the Sanitary License.
p.(None): Article 213.- To proceed to the temporary or definitive closure of an establishment that violates provisions
p.(None): legal and regulatory, the competent health authority will place posters
p.(None): In the case of temporary closure, access to the establishment will be allowed to maintain the equipment or
p.(None): machinery that by its nature require special care.
p.(None): In the case of definitive closure the offender will have access to the establishment to remove the machinery, equipment,
p.(None): furniture and other prior authorization of the competent authority.
p.(None): Article 214.- To retain or deposit products, goods, raw materials, substances and others, you must
p.(None): the respective inventory and official certificate signed by the interested party, two witnesses and the health authority be taken up;
p.(None): proceeding to place seals or seals that guarantee their conservation and permanence in the establishment
p.(None): inspected.- In case of not wanting or being able to sign the witnesses and / or the interested party, it will be recorded in the minutes,
p.(None): which does not invalidate it.
p.(None): Article 215.- In order to comply with the provisions of the Health Code and this Regulation, the authority
p.(None): When required, it will request the support of the Public Prosecutor's Office, the Municipal Offices, the Police
p.(None): National, the Attorney General's Office, the Secretary of Natural Resources and Environment and the Secretariat of
p.(None): Agriculture and Livestock.
p.(None): In all the proceedings that are carried out, only the aforementioned authorities will participate, avoiding notoriety
p.(None): public, unnecessary inconvenience or damage to the establishment.
p.(None): Article 216.- In those cases that from the violation of the legal and regulatory provisions risks and
p.(None): serious damage to people's health or the environment, the health authority will immediately notify the
p.(None): General Directorate of Health Regulation. This, when the case merits it will make public the fact and
p.(None): notify the respective authority, to prevent major risks or damages.
p.(None): Article 217.- The application of the administrative sanctions of which the Health Code deals with and this
p.(None): Regulations, do not exempt the offender from civil or criminal liability to have place for the act sanctioned.
p.(None): or tapes in visible places in the entrances and in the machines, Article 218.- In the cases that
p.(None): of the violation of
p.(None): equipment, locks and others, with the legend: “Closed legal and regulatory provisions result
p.(None): Responsibility Temporarily or Closed Definitely by the Criminal Authority, the health authority
p.(None): communicate immediately to the Sanitary ”, with the purpose of preventing the continuation of the General Directorate of
p.(None): Sanitary Regulation, so that this activity, entry or use, as appropriate.
...
Social / Property Ownership
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p.(None): according to this classification.
p.(None): Article 127.- Any establishment of health interest of complexity I, II and III, prior to its operation in the
p.(None): country requires an extended license by the competent health authority.
p.(None): Article 128.- The sanitary license for establishments of sanitary interest, at the option of the interested party, shall have
p.(None): validity of two (2), four (4) and six (6) years, from the date of its granting.- Except for
p.(None): the infractions to the sanitary laws or their regulations, the suspension or cancellation of the same is necessary.
p.(None): UNIT I
p.(None): OF THE REQUIREMENTS TO OBTAIN THE HEALTH LICENSE
p.(None): Article 129.-To obtain the sanitary license it is required:
p.(None): 1. Submit an application with the Sum indicating: HEALTH LICENSE IS REQUESTED, with the following information:
p.(None): a) Body to which it is addressed: General Directorate of Health Regulation or Departmental Regional Headquarters, according to
p.(None): correspond.
p.(None): b) Name and generals of the owner or legal representative of the establishment and the legal representative.
p.(None): ) Corporate name or company name
p.(None): d) Name of the establishment.
p.(None): e) Exact address of the establishment, including telephone, fax, email.
p.(None): Activity or activities to be dedicated. Place and date of the request
p.(None): Fimia of the applicant.
p.(None): 2.- Power granted to the legal professional.
p.(None): 3.- Photocopy of the deed of incorporation of the company or individual merchant, duly registered in the
p.(None): Registration of Real Estate and Commercial Property.
p.(None): 4.- Photocopy of the card of the professional who will act as Regent, or Medical Director, when appropriate.
p.(None): 5.- Payment receipt for health license services.
p.(None): 6.- Presentation of the plans of the physical, electrical, drinking water and wastewater facilities of the
p.(None): Establishment approved by the corresponding City Hall.
p.(None): TO.
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Vehicles and means of transpoi’te of food products and health services (ambulances, services
p.(None): mobiles) must present the report of the means of transport and legal document that proves it.
p.(None): UNIT II
p.(None): OF THE MODIFICATION OF THE LICENSE
p.(None): SANITARY
p.(None): Article 130.-The following cases are considered a modification of the sanitary license: transfer of ownership,
p.(None): modification of the name or business name of the establishment, transfer, remodeling, reconstruction, extension
p.(None): of goods and services and others that the health authority determines.
p.(None): Article 131.-Every owner or representative of establishments must request through a professional
p.(None): collegiate law, modifications of the sanitary license.
p.(None): Article 132.-The General Directorate of Sanitary Regulation shall authorize the modification of the sanitary license,
p.(None): by reasoned resolution after ruling, preserving the nomenclature and validity of the license granted
p.(None): initially. If the modification produces a change in the category of the establishment, the nomenclature is
p.(None): modify and apply the corresponding payment rate.
p.(None): of the Department of Sanitary Control of Products, Services and Establishments or Delegated Department, Units
p.(None): Regional Departmental and Municipal Regulation, grant the Sanitary Registry of Food, Beverages,
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): by competent authority.
p.(None): c) Make the request of the representative or owner of the establishment to appear before the
p.(None): competent authority to solve the problems or deficiencies found.
p.(None): d) Other delegates.
p.(None): CHAPTER IV
p.(None): SANITARY RULES APPLICABLE TO PRODUCTS, SERVICES AND
p.(None): ESTABLISHMENTS OF HEALTH INTEREST.
p.(None): Article 8.- For the application of this Regulation, the Secretary of State in the Department of Health, through
p.(None): the competent bodies adopt the mandatory national regulations in force and those that are approved in the
p.(None): future, as well as international standards on products, services and establishments of health interest
p.(None): contained in international conventions and treaties ratified by Honduras.
p.(None): If REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): Article 9.- In the case of food, food additives, packaging and labeling, they will be applied in the order of
p.(None): following priority: a) This Regulation, b) Central American Customs Regulations, c) Technical Standards
p.(None): Hondurbñas,
p.(None): d) Nonnas of the Codex Alimentarius, e) Regulations of the Federal Code of Regulations of the Office of Administration of
p.(None): Food and Drug Administration (FDA) of the United States of America and f) Pan-American Sanitary Standards of the Organization
p.(None): Pan American Health (PAHO).
p.(None): Article 10.-In the case of establishments where they are produced, handled, stored, distributed and sold
p.(None): food, this Regulation provides as mandatory: a) Customs Union Regulations
p.(None): Central American and, b) Honduran Technical Standards for Aliinentos Establishments.
p.(None): Article 11.-In the case of Medical Devices and Devices, in the application of these Regulations they are considered
p.(None): Mandatory provisions established in the Honduran Technical Standard and the Norms and / or Regulations of the Union
p.(None): Central American Customs.
p.(None): Article 12.-The physical-chemical, microbiological and biological evaluation of famiaceutical products must comply
p.(None): according to order of priority with the following standards: Honduran Technical Standard, the specifications established in the
p.(None): USP Pharmacopoeias of the United States of America, British, European, International, Japanese, French, Argentina,
p.(None): German, Helvetic Mexican, Spanish, Mexican Homeopathic Pharmacopoeia, Codex Frances, Code of Regulations
p.(None): Federal and in the case of new products not included in the previous pharmacopoeias the methodology will be accepted
p.(None): duly validated and specifications developed by the manufacturer. In either case, you must comply
p.(None): with the Risk Criteria.
p.(None): For the medical evacuation of mcdicarrientos the Central American Farcuacological Standard is considered and
p.(None): of Dominican Republic.
p.(None): Article 13.-The health establishments, included in these Regulations must carry out a priority order
p.(None): with the following standards: Noiria Hondurena Technique, Manual
p.(None): Technical Standards for Health Establishments, Stability Standard of the Customs Union, Labeling Standard for
p.(None): the Central American Customs Union, Standard of Natural Products of the Customs Union, Medical Supplies Standards
p.(None): Surgical, Regulation and Guide of Practical Mariufactura Buelias of the Central American Customs Union, Good
p.(None): WHO Manufacturing Practices, Good Pharmacy Practices, Good Storage Practices, Good
p.(None): Laboratory Practical, Biosafety Standards and others recognized nationally and internationally.
p.(None): CHAPTER V
p.(None): OF PRODUCTS, SERVICES AND
p.(None): FIRST SECTION ESTABLISHMENTS
p.(None): OF FOODS AND DRINKS
p.(None): Article 14.- Sa1 must be fortified with iodine, sugar with vitamin A, wheat and corn flour with
p.(None): iron, folic acid, niacin, riboflavin.- Food fortification may be extended to products other than
p.(None): Ministry of Health determine through the competent Directorate General.
p.(None): Article 15.- Foods in accordance with the risk they represent and for the purposes of effective surveillance are
p.(None): classified as follows:
p.(None): a) High Risk "A"
p.(None): b) Risk "B" Medium Risk
p.(None): c) Risk "C" Low Risk
p.(None): Article 16.- The Ministry of Health through the General Directorate of Competent Health shall prepare and approve by means of
p.(None): according to the food and beverage listings according to risk classification, which must be updated
p.(None): periodically
p.(None): SECOND SECTION
p.(None): OF THE RABniCAS BE ALIIYIENJ OS
p.(None): Article 17.- Depending on the type of food that the factories manufacture or elaborate in particular, they must comply as well.
p.(None): with what is established in the norms indicated in Article 10 of this Regulation.
p.(None): Article 18.- Food factories must comply with the sanitary norms established in the Regulation
...
p.(None): they present the lowest potential risk of harm to the patient and are devices that do not come into contact with the patient or
p.(None): They only do it superficially with the skin.
p.(None): Article 102.-Any device and equipment for surgical medical use that is intended to be donated must be subject to
p.(None): the provisions established in the External Cooperation Standards in force in the Ministry of Health.
p.(None): Article 103.-The competent Health Authority shall carry out inspection visits to the establishments and their
p.(None): devices and equipment for surgical medical use, in order to guide, educate and apply the measures
p.(None): corrective and corresponding health security.
p.(None): Article 97.-The devices and equipment for medical use Article 104.- All devices and equipment of
p.(None): Surgical medical use are classified according to your risk in: A (High Risk), B surgical entering the country must
p.(None): comply with the provisions of (Medium Risk), C (Low Risk). the
p.(None): corresponding standard.
p.(None): §J REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D.C. NOVEMBER 4, 2005 N °. 30.84
p.(None): CHAPTER VI
p.(None): OF PRODUCT LABELS AND CONTAINERS
p.(None): FIRST SECTION OF LABELS
p.(None): Article 105.- The labels of the products that are elaborated or commercialized in the national territory must
p.(None): contain the requirements that are determined in this Chapter, in the Customs Union Labeling Standard, and according to
p.(None): current regulations.
p.(None): Article 106.- On the label of domestic and foreign products, the following information must appear:
p.(None): a) Name of the product that must indicate its true nature, being normally specific or generic,
p.(None): that does not mislead or mislead the buyer or consumer.
p.(None): b) Name or business name of the owner, manufacturer or distributor of the product as applicable.
p.(None): c) Place of origin of the product, name of the country.
p.(None): d) List of ingredients or qualitative and quantitative formula as applicable.
p.(None): e) Lot number.
p.(None): f) Expiration date.
p.(None): g) Net content, declared in units of the International System, as applicable.
p.(None): h) Health registration number.
p.(None): i) The labels must be written in Spanish. Otherwise translate it to Spanish endorsed by
p.(None): External relationships.
p.(None): Article 107.- The labels may be made of paper or any other material that may be attached to the
p.(None): packaging or permanent printing on them.
p.(None): Article 108.- The inscriptions on the labels must not disappear under normal use conditions, be easily
p.(None): Visible to the naked eye and written in Spanish, except for those registered products that are
p.(None): exclusively for export.
p.(None): Article 109.- The labels of the products written in a foreign language that are marketed in the country, must
p.(None): have the corresponding translation into the Spanish language, with equal character
p.(None): Article 110.- The labels that adhere to the package may have descriptions on the back of them, provided
p.(None): that are clearly visible through the package with its contents as long as it is not the mandatory information.
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.(None): fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals,
p.(None): Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics
p.(None): Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories
p.(None): dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of
p.(None): body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories
p.(None): analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
p.(None): Slight failure: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions and not
p.(None): It constitutes a risk that harms or may harm the health of the population.
p.(None): Less serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions, which are
p.(None): It constitutes a moderate risk to affect the health of the population, intervening the voluntary action or omission.
p.(None): Serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): medical prescription.
p.(None): Availability: Relationship between the volume of demand and type of existing resource to meet the needs
p.(None): of offer attention. It is a dimension of supply risk.
p.(None): Device and Equipment for Medical Use: Instrument, apparatus, implement, machine, implant or other similar item or
p.(None): related that by itself or in combination with any accessory or program for its proper operation is
p.(None): used in prevention, healing, rehabilitation and health research.
p.(None): Dolo: Modality of breaking the Law with full knowledge of the cause.
p.(None): Therapeutic dose: Amount of active ingredient that produces the desired therapeutic effects in a given period
p.(None): of time.
p.(None): Drug / drug substance / medicine: In legal and technical use, these terms have 2 meanings:
p.(None): 1. In the first, the term drug or medication is used to describe the active substance or drug that for its
p.(None): Administration must be fomiulated.
p.(None): 2. In the second one, medication or drug is understood as any pharmaceutical product used for the
p.(None): prevention, diagnosis and treatment of a disease or pathological state or to modify systems
p.(None): physiological benefits for the person to whom it was administered.
p.(None): Drugstore: Establishment dedicated to the importation, storage, distribution and sale of medicines in bulk and
p.(None): minor, where direct supply to the public is prohibited except in cases authorized by the Ministry of Health,
p.(None): under the responsibility of a duly registered pharmaceutical professional.
p.(None): Packaging and Packaging: All material used to protect a product for its conservation, handling and transport.
p.(None): Packaging: Any container intended to contain products
p.(None): SdRÍtdfÍOS.
p.(None): Primary Container: It is one that is in direct contact with the product.
p.(None): Secondary Container: It is one that is in direct contact with the primary container.
p.(None): Pharmaceutical Equivalence: Two medications are considered to have pharmaceutical equivalence when they contain
p.(None): equal amounts of the same active ingredient (s) in identical doses and dosage forms to be administered
p.(None): by the same route and that meet the same specifications.
p.(None): Pharmaceutical Specialty: Is that medicine produced by a manufacturer under a brand name or generic of
p.(None): a way that is characteristic.
p.(None): II E'Z MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Sputum: Nasopharyngeal secretion that spits.
p.(None): Establishment of health interest: Entity that produces, manipulates, stores, transports, distributes, sells and
p.(None): dispenses products of health interest, as well as provides health services in a formally organized manner,
p.(None): classified according to the degree of complexity in Category I low complexity, Category II medium complexity and
p.(None): Category III high complexity.
p.(None): Food Establishments: Factories, stores, places where food is manufactured, handled, dispensed and served
p.(None): and drinks, vehicles that transport food and food stalls on public roads.
p.(None): Health Establishments: Are those public or private establishments, in which directed care is provided
...
p.(None): Article 236.- Personal notification or by table will be recorded in the corresponding file.
p.(None): Article 237.- Against the resolutions issued by the health authority and that impose sanctions the appeals proceed
p.(None): of replacement and appeal.- These appeals will be substantiated in accordance with the Law of Procedure
p.(None): Adininistrative.
p.(None): THIRD SECTION
p.(None): OFFENCES AND PENALTIES
p.(None): Article 238.- Violations of the provisions of the Health Code and these Regulations will be sanctioned without
p.(None): penalty of the penalties to which the offender becomes creditor for the configuration
p.(None): of crimes against public health, in which case the Ministry of Health will put the background in knowledge
p.(None): of the Public Ministry, to proceed before the competent courts.
p.(None): Article 239.- For the purposes of the health authority, of the infractions and sanctions provided in Article 245
p.(None): of this Regulation, the following badges are established:
p.(None): 1.- The competent authority to apply the sanctions shall have the following:
p.(None): The General Directorate of Competent Health will be identified with numeral I.
p.(None): The Department of Sanitary Control of Products, Services and Facilities of Health Interest or Department
p.(None): Delegate will be identified with the numeral ß.
p.(None): The Departmental Health Region will be identified with numeral III.
p.(None): The Coordination of the Departmental Unit of Sanitary Regulation will be identified with numeral IV.
p.(None): 2.- The infractions are classified as: minor, serious and serious. 3.- To identify the sanctions will be used
p.(None): the following codes: The written reprimand will be identified with the literal a).
p.(None): The single or successive fines will be identified with the bite.
p.(None): The confiscation of products, substances or artifacts will be identified with the literal c).
p.(None): The suspension of registration or sanitary license will be identified with the district d).
p.(None): The temporary closure of buildings and establishments will be identified with the literal e).
p.(None): The cancellation of the sanitary registration or sanitary license will be identified with the site f).
p.(None): The final closure of buildings and establishments will be identified with the literal g).
p.(None): Article 240.- The application of sanctions for violation of the provisions of the Health Code and of the present
p.(None): Regulation, will be carried out by the health authority, in accordance with the descriptive table below:
p.(None): RE PUBLI CA DE HON DURA S - TEGUCIGALPA, M. D. C., 4 Dfi NOVIfiiM IIUE DEL 2005 N “. 30,841
p.(None): INFi ACTIONS
p.(None): Mild
p.(None): Aiito- Ira. Self-2nd. 3rd. Auto- 4 ".
p.(None): Aiub ›Ridatl code Realty li: einc. Iity ‘Reinc. rity
p.(None): Recinc. ritlu ‹l
p.(None): First of all Sanita-Cod / Sani- I.?od/ Sani-
p.(None): Cod / Sani- € “od / Sani-
p.(None): Situational provisions Sancióli riu Sai) c. I would! ’ianc.
p.(None): Tai’ia Salte. taria Sanc. liuiii
p.(None): l.- Chapter V, Section III: l- a) I.-IV l .- b) and c) I-III '. .- b)
p.(None): 1.- III 1.- d) and e) 1.-III 1.- f) and g) 1.-1 (Art. 19 and 20)
p.(None): 2.- Capíkilo V, Section IV:
p.(None): (Art. 21, 22, 23, 24, 25, 25 2.- a)
p.(None): 27 and 28)
p.(None): 2.-lV 2.- b) 2.-III i! .- b) 2.- 1 II 2.- d) and e) 2.-III 2.- t) and
...
Social / education
Searching for indicator education:
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p.(None): Article 172.- Inspections may be ordinary, carried out during the normal working day of the
p.(None): Health Authority and extraordinary, when carried out at any other time, due to sanitary surveillance,
p.(None): attention to complaints or emergencies for presumption of health risk.
p.(None): Article 173.- The Health Authority will have free access to all premises and facilities dependencies.
p.(None): of sanitary interest, being obliged the owner, representative or responsible to give all kinds of
p.(None): facilities and provide the reports of health interest that are required.
p.(None): Article 174.- The refusal of the owner, representative or responsible for the establishment of health interest, for
p.(None): to punish the access of the Sanitary Authority, will be sufficient reason to resort to the police authority, with the
p.(None): object that obliges it to allow inspection, without prejudice to the corresponding sanctions.
p.(None): Article 175.- The sanitary inspection must be oriented to verify compliance with the minimum requirements
p.(None): essentials established according to the activity to which it is based on the guides of current good practices that
p.(None): apply
p.(None): Article 176.- The inspection shall not be limited only to the punitive aspects, but also to those related to
p.(None): guidance in health education and motivation in compliance with legal and regulatory provisions.
p.(None): Article 177.- The sanitary authority, when performing the inspection in any establishment of sanitary interest,
p.(None): will take official minutes of the proceedings.
p.(None): At the end of the inspection, the person responsible for the establishment will be given the opportunity to state what is in his right
p.(None): agrees, recording it in the minutes to be drawn up, and the latter must also sign said minutes.- In case of refusing to
p.(None): sign will be entered in it, being the actaválida.
p.(None): At the end of the inspection, a copy of the minutes must be delivered to the person in charge of the establishment, stating
p.(None): this made in the original
p.(None): Article 178.- The sanitary conditions found shall be recorded in the inspection record and the
p.(None): Correction to the identified problem.- The testimonies of other persons present and of
p.(None): any document or part of it, when necessary, always trying to avoid causing inconvenience
p.(None): or unnecessary damages.
p.(None): Article 179.- The sanitary authority that has carried out the inspection shall deliver to the higher authority in the
p.(None): term of the twenty-four (24) hours following his return to the workplace, the minutes drawn up and the samples
p.(None): taken, according to the established norm if applicable.
p.(None): Article 180.- The health authority must prepare the corresponding minutes when taking samples that
p.(None): are necessary in health surveillance, to perform the relevant laboratory analyzes and investigations,
...
p.(None): Article 195.- Admitted the request, within five (5) business days following the health authority
p.(None): competent, will issue a reasoned resolution granting or denying the requested authorization.
p.(None): Article 196.- Prior to the authorization of the clearance of controlled chemical products and substances, the Authority
p.(None): Sanitary competent in coordination with the General Directorate of Customs must check the contents of the shipment
p.(None): Checking it with the Official Import Authorization.- If they do not conform to the established sanitary norms,
p.(None): order its re-export to the place of origin, after a reasoned resolution of the competent health authority.
p.(None): CHAPTER VIII
p.(None): OF THE BROADCASTING OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF INTEREST
p.(None): SANITARY
p.(None): Article 197.- The Ministry of Health shall establish the criteria for the Advertising of Sale Medicines without
p.(None): Medical Prescription or Prescription Without Prescription (OTC).
p.(None): Article 198.- The advertising of products, services and establishments of health interest must conform to the
p.(None): truth and therefore the benefits that its use or use may offer cannot be overstated,
p.(None): control corresponds to the competent health authority.
p.(None): Article 199.- The health authority shall prohibit the advertising of products, services and establishments of interest.
p.(None): health in the following cases:
p.(None): a) When it contravenes the general rules applicable to health, nutrition or therapeutic education.
p.(None): b) When expressing properties or benefits that induce deception or error.
p.(None): c) When you impute, defame or make pejorative comparisons
p.(None): for other products and establishments of health interest and services.
p.(None): M REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): d) When the message is contrary to the law or good customs.
p.(None): e) When the products are authorized for sale with a prescription or retained prescription.
p.(None): , '
p.(None): f) When it is incompatible with the professional condition or discipline of the people who promote them.
p.(None): Article 200.- The Ministry of Health is obliged to permanently inform the general public and the
p.(None): Health professionals lists generic interchangeable drugs from laboratories that meet the
p.(None): rule.
p.(None): Article 201.- The General Directorate of Health Regulation will issue the corresponding regulations to regulate the
p.(None): advertising and promotion of products, services and establishments of health interest.
p.(None): Article 202.- The health authority, as the governing body for the registration and control of medicines in its
p.(None): different processes, you must control the advertising of over-the-counter medicines, complying with the criteria
p.(None): following:
p.(None): a) They are promoted only with the information and arguments approved by the competent health authority.
p.(None): b) Do not suggest that the use of these medications can delay or avoid using a doctor.
p.(None): c) Do not suggest its use permanently, limiting the term of authorized administration.
p.(None): d) Do not use phrases or words that exaggerate the benefits of the product in the text.
...
Social / employees
Searching for indicator employees:
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p.(None): Article 217.- The application of the administrative sanctions of which the Health Code deals with and this
p.(None): Regulations, do not exempt the offender from civil or criminal liability to have place for the act sanctioned.
p.(None): or tapes in visible places in the entrances and in the machines, Article 218.- In the cases that
p.(None): of the violation of
p.(None): equipment, locks and others, with the legend: “Closed legal and regulatory provisions result
p.(None): Responsibility Temporarily or Closed Definitely by the Criminal Authority, the health authority
p.(None): communicate immediately to the Sanitary ”, with the purpose of preventing the continuation of the General Directorate of
p.(None): Sanitary Regulation, so that this activity, entry or use, as appropriate.
p.(None): file the respective complaint with the corresponding authority.
p.(None): Ç MPUBLICA DE HONDURAS - TEGUCIGALPA, IYI. D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84.
p.(None): Article 219.- For the purposes of the sanctions established by this regulation, the persons shall be liable
p.(None): natural or legal that sell products or provide health services.
p.(None): Article 220.- To verify the facts and determine the
p.(None): Article 225.- t.a citation will be made to the owner of the establishment or legal representative of the company by
p.(None): ID card that will be delivered to you personally; if you are not in the establishment, delivery will be made to
p.(None): any of your
p.(None): family members or employees who are in it or in their
p.(None): Violations of the legal provisions health authority may make use of the
p.(None): a) Inspections
p.(None): b) Witness Statement
p.(None): c) Sampling
p.(None): d) Laboratory analysis or tests
p.(None): Regulatory, the first steps:
p.(None): residence.- Delivery of the identity card, the owner or legal representative shall be deemed legally cited.
p.(None): Article 226.- The citation card must contain:
p.(None): a) Name of the health authority issuing it
p.(None): b) The name and surname of the person to whom the citation is made
p.(None): SECOND SECTION
p.(None): OF THE PROCEDURE TO APPLY
p.(None): SANCTIONS
p.(None): Article 221.- The procedure to apply the sanctions established in these Regulations may be initiated:
p.(None): a) Ex officio, by mandate of the competent body, either on its own initiative or as a result of an order of the
p.(None): hierarchical superior, or by reasoned knowledge of having broken a sanitary law.
p.(None): b) By deliunciation of interested natural or legal person.
p.(None): Article 222.- The complaint or complaint may be made in writing, in folmaverbal or anonymously, by any
p.(None): means of communication, before the competent health authority and the following should be recorded: Appear in day,
p.(None): time and place determined; where you will be informed of the
p.(None): infringements or omissions imputed to him, listening to his disclaimers; everything acted should be recorded in
p.(None): minutes.
p.(None): Article 224.- If during the inspection, the health authority identifies situations that represent a danger
...
Social / orphan
Searching for indicator orphan:
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p.(None): Manual of Pharmacological Standards: Properly classified organization of recognized Pharmacological Standards
p.(None): and officialized by the Ministry of Health.
p.(None): IY Raw material: Any active or inactive substance ‹jut: is used to manufacture products of interest
p.(None): sanitary ›regulated in this regulation whether it is unaltered, modified or eliminated in the course of
p.(None): production process.
p.(None): Medication: Any active substance or mixture of the misrrios with or without the addition of excipients, prepared to be
p.(None): Presented as a pharmaceutical form.
p.(None): Controlled medication:
p.(None): a) Any psychotropic medication and hypertension under the control regimen according to the Conventions on
p.(None): narcotic and psychotropic substances respectively, Ul contrc 1 on this type of substances is exercised by the
p.(None): Junt ‹i National Drug Control.
p.(None): b) A substance that can be incorporated into pharmaceutical post-linguistic forms only within the limits
p.(None): Specific deRrminated by studies.
p.(None): c) A substance approved by the Ministry of Health but subject to restrictions that exclude its use in a
p.(None): considerable proportion of the potential population of patients to whom it would be destined.
p.(None): Drug of strict control: They are pharmaceutical preparations based on narcotic drugs which requires a
p.(None): special recipe booklet for your prescription.
p.(None): Orphan Drug: It is said of the potential active ingredients in which there is no interest on the part of
p.(None): producing laboratories for its development as medicines,
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): since such development does not present an economic incentive, although they can meet health needs.
p.(None): Over-the-counter medication: It is the one that due to its composition and the pharmacological action of its active substances can
p.(None): used by the public without a prescription.
p.(None): Essential Medication: It is the one considered most important, indispensable and necessary to satisfy the
p.(None): health needs of most of the population.
p.(None): Multifuente Medication: It is one that must meet the same standards of quality, safety and efficacy applicable
p.(None): to the innovative medicine.
p.(None): Innovative Medicine: It is the original that demonstrated safety and efficacy with preclinical, clinical and post studies
p.(None): marketing and established quality standards, which will be used as a reference medicine.
p.(None): New Medication: Any Medication that has not been registered or released to the market for medical purposes including new
p.(None): salts or esters of an active substance, new fixed combinations of substances that are already on the market, or
p.(None): any medication previously registered or offered on the market, provided that its indications for use
p.(None): mode of administration or formulation have been changed.
p.(None): Official Medication: It is the one recorded in the respective monograph of the Normative Code that can bear the name of
p.(None): its active ingredients; Official Generic; or that of your patent registration; Official Patented
...
p.(None): sanitary registration, notwithstanding the provisions of Article 144 of these Regulations.
p.(None): Article 141.-Foods not subjected to any processing or packaging process, as well as raw materials
p.(None): of the
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Other products of health interest do not require sanitary registration, but they will be subject to surveillance and
p.(None): control exercised by the health authority.
p.(None): Article 142.-Food products, beverages, medicines and related products, and others produced in
p.(None): Central America and other countries where equal treatment is granted to those produced in our country, will be
p.(None): subject to treaties or agreements signed by the State of Honduras.
p.(None): Article 143.-The General Directorate of Health Regulation may exceptionally authorize the importation of products
p.(None): food, beverages, medicines, biologicals and related products, without having obtained the sanitary registration, which
p.(None): they will be subject to control and without paying the fees for analysis and registration services established by this Regulation,
p.(None): in the following cases:
p.(None): a) When circumstances of disasters and emergencies arise, qualified by decree of the Power
p.(None): Executive.
p.(None): b) In the case of samples in the necessary quantities required by the competent General Directorate for
p.(None): Health registration process.
p.(None): c) In the case of donations to state or charitable institutions, prior resolution of the Directorate
p.(None): General of competent Health.
p.(None): d) In the case of orphan drugs.
p.(None): Article 144.-The Executive Directorate of Revenue through its dependencies will only allow entry into the country of
p.(None): food products, natural, biological, cosmetics, pharmaceuticals, products subject to control
p.(None): national and international and others that the health authority determines, if it proves to have a health record or
p.(None): current authorization issued by the competent health authority of the Ministry of Health.
p.(None): In the case of controlled products prior to entering the country, you must accredit Certificate of Authorization
p.(None): Import Officer extended by the competent authority.
p.(None): Any official or public employee who allows the entry of the aforementioned products without complying with the
p.(None): requirement established in this article will be denounced before the Public Ministry to be deducted
p.(None): case responsibilities.
p.(None): determine, in the facilities of the importer or distributor and there they will remain until you obtain the registration
p.(None): respectively, the necessary controls will be established for this purpose, without prejudice to the corresponding sanctions.
p.(None): UNIT II
p.(None): OF THE REQUIREMENTS TO OBTAIN THE SANITARY RECORD
p.(None): Article 146.-To obtain the sanitary registration, you must comply with the following general requirements:
p.(None): 1) Submit an application with the Sum indicating: SANITARY REGISTRATION IS REQUESTED, with the following information:
p.(None): a) Body to which it is addressed: General Directorate of Health Regulation or Headquarters of the Departmental Health Region,
p.(None): as appropriate.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): OFFICIAL JOURNAL OF THE REPUBLIC OF HONDURAS
p.(None): Section A
p.(None): Tegucigalpa, M. D. C., September 21, 2005 THE CONSTITUTIONAL PRESIDENT OF THE
p.(None): REPUBLIC
p.(None): WHEREAS: That the State recognizes the right to health protection and it is everyone's duty to participate in the
p.(None): promotion and preservation of personal and population health.
p.(None): WHEREAS: That corresponds to the State through its dependencies and the bodies constituted by law,
p.(None): regulation, supervision and control of food, chemical, pharmaceutical and biological products, as well as
p.(None): establishments related to products.
p.(None): WHEREAS: That corresponds to the State through its dependencies and the bodies constituted by law, the
p.(None): regulation and control of institutions and health services.
p.(None): WHEREAS: What is the function of the Secretary of State in the Health Office through the General Directorate of
p.(None): Sanitary Regulation of Health Surveillance and Control of products, services and establishments of interest
p.(None): sanitary.
p.(None): THEREFORE: In use of the powers vested in it and in application to the provisions of articles 145,
p.(None): 146, 147 and 245, Numeral 11 and 29 of the Constitution of the Republic; Article 29 of the General Law of Administration
p.(None): Public; Article 67, numbers 2,6,7,8,9 of the Regulation of Organization, Operation and. Competition of
p.(None): Power
p.(None): Executive; counting on the favorable opinion of the Attorney General's Office in accordance with article 41
p.(None): of the Administrative Procedure Law.
p.(None): A C U E R DA:
p.(None): APPROVE THE REGULATIONS FOR THE SANITARY CONTROL OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF
p.(None): HEALTH INTEREST
p.(None): INDEX
p.(None): CHAPTER I: PURPOSES AND PRINCIPLES CHAPTER II: GENERAL PROVISIONS
p.(None): CHAPTER III: SCOPE OF APPLICATION AND COMPETITION
p.(None): REPUBLI CA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): CHAPTER IV: SANITARY RULES APPLICABLE TO PRODUCTS, SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST.
p.(None): CHAPTER V: OF PRODUCTS, SERVICES AND ESTABLISHMENTS.
p.(None): - SECCI ON PRI MERA: FROM LIME NTOS AND BEBI DAS.
p.(None): - IT IS GIVEN UP: OF THE FOOD FACTORIES.
p.(None): - SECTION THREE: OF THE ESTABLISHMENTS WHERE MANIPUL AND N, EXPAND AND SERVE FOOD.
p.(None): - SECTION ON FOUR: OF THE REQUIREMENTS OF THE AIR MANIPULATOR.
p.(None): - SECTION FIVE: FOOD STORAGE.
p.(None): - SECTION ON SIXTH: PHARMACEUTICAL PRODUCTS.
p.(None): - SECTION SEVENTH: DI'ì THE ESTABLISHMENTS OF SALU D.
p.(None): - SECC I ON OCTAVA: I HAVE THE D IS POSITS AND THE USE OF THE SURGICAL TEAM.
p.(None): CHAPTER VI: OF LABELS AND PACKAGING OF PRODUCTS.
p.(None): - SECTION ONE: OF THE LABELS.
p.(None): - SECTION ON SECOND: OF THE CONTAINERS.
p.(None): CAPITU VI VI: MEASURES AND ADMINISTRATIVE CTOS DEI. SANITARY CONTROL OF PRODUCTS, SERVICES AND
p.(None): ESTABLISHMENTS OF HEALTH INTEREST.
p.(None): - SECTION ONE: GENERAL PROVISIONS.
p.(None): - SECOND SECTION: DH THE HEALTH LICENSE.
p.(None): UNIT I
p.(None): D E THE RE Q I S I T'O S PA RA OBT ENE R HEALTH LICENSE.
p.(None): UNIT II
p.(None): DE LA MO DI FI CA CI ON DE, LA LI CE NCI A SANITARIA.
p.(None): UNIT III
p.(None): OF THE NO MENCL ATURA OF THE HEALTH SCIENCE.
p.(None): SECTION THREE: REGISTRATION SANITA-
p.(None): AO
p.(None): UNIT I
...
p.(None): send the proceedings to the corresponding instance, with the object that within twenty (20) days
p.(None): Skills carry out the inspection of the establishment or the analysis of. respective laboratory.
p.(None): REPUBLICA DE HONDunAs - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): The competent authority shall provide whether laboratory tests are performed or not, as well as which tests and tests
p.(None): perform. The original samples, technical product information, the original samples will be sent to the respective laboratory
p.(None): standards of active ingredients, with the order of analysis.
p.(None): The following products will not require analysis for sanitary registration purposes: chemical elements not
p.(None): controlled, uncontrolled chemicals, hygienic products, cosmetics, topical products,
p.(None): uncontrolled chemicals, dietary supplements, laboratory reagents, raw materials, food
p.(None): risk b and c.
p.(None): In any case, they will pay the respective rights for health surveillance and control.
p.(None): Article 162.- The authority that has carried out the inspection must deliver within three (3)
p.(None): working days the minutes drawn up with the corresponding technical information by sending it to your immediate superior manager.
p.(None): Article 163.- Received the minutes and technical report referred to in the preceding article, the General Directorate of
p.(None): Sanitary Regulation or the Departmental Regional Headquarters, will transfer the administrative file to the Legal Unit
p.(None): so that within three (3) business days issue the corresponding opinion; This Unit will return said file to the
p.(None): General Directorate of Health Regulation or the Departmental Regional Headquarters, so that within five (5) days
p.(None): next business issues the reasoned resolution granting or denying the requested license.
p.(None): Article 164.- The instance that has practiced laboratory analyzes, in the case of food products,
p.(None): you must deliver within the term of fifteen (15) business days the corresponding technical report by sending it
p.(None): to your immediate superior boss for your respective opinion. In the case of food products, beverages,
p.(None): medicines and related products and natural products, the results of laboratory quality control
p.(None): official or other designated by the Ministry of Health, will be delivered in a term up to twenty (20) days
p.(None): Skilled to the Delegated Department, who will prepare the corresponding technical report. In both cases you must be
p.(None): Deliver a copy of the laboratory analysis to the interested party at no cost.
p.(None): Article 165.- Once the technical report indicated in the previous article has been completed, the competent Delegated Department
p.(None): will proceed to the legal analysis of the file so that within the term of three
p.(None): (3) business days, the analysis is completed for the issuance of the corresponding decision. Once the analysis is finished
p.(None): corresponding queorigió the application for the license or sanitary registration, the file is sent to the Directorate
p.(None): General of Sanitary Regulation or
p.(None): the Regional Department of Health, so that within a term of five (5) business days issue resolution
p.(None): motivated, granting or denying the sanitary registration.
p.(None): UNIT VII
p.(None): ON THE RENEWAL OF THE LICENSE AND HEALTH REGISTRATION
p.(None): Article 166.- For the renewal of the Sanitary license of the Establishments and sanitary registration of the
p.(None): products, must be requested before the competent General Directorate or Head of Departmental Health Region, to
p.(None): through the legal representative or legal representative, within three (3) months for the health license of the
p.(None): establishments and five (5) months for sanitary registration of products, prior to the expiration date. May
p.(None): have extemporaneous renewal up to six (6) months after the expiration date of the license or registration
...
Social / public official
Searching for indicator publicXofficial:
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p.(None): Food for Medical Use: The one that has been subjected to processes that modify the relative concentration
p.(None): of the various nutrients, of their constitution or their quality, or by incorporation of substances
p.(None): outside its composition, they acquire therapeutic properties.
p.(None): Written reprimand: Action to reprimand someone, by writing motivated by omission, execution of a
p.(None): activity or conduct contrary to legal or regulatory provisions.
p.(None): Hearing: Citation that is made to the public employee in order to render discharges on actions that are
p.(None): imputed or attributed.
p.(None): Outpatient Care: Actions aimed at patient care for diagnosis and treatment, when
p.(None): Check that it does not require hospitalization.
p.(None): Hospital Care: Actions aimed at the care of patients who, due to their state of health, need to be
p.(None): integrated for more than 24 hours for diagnosis or medical or surgical treatment.
p.(None): s REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and
p.(None): health rehabilitation.
p.(None): Preventive Care: A set of general promotion and specific protection actions provided to the
p.(None): individual and the general population with the purpose of reducing morbidity.
p.(None): Rehabilitation Care: Actions aimed at correcting physical or mental disability.
p.(None): Health Care: Promotional, preventive, curative and rehabilitation actions provided by a
p.(None): multidisciplinary team in the health area.
p.(None): Health Authority: Instance, Organ or Public Official that by Law or by delegation has the power to ensure
p.(None): for compliance with nonnas, policies, criteria, systems and procedures of a technical nature that must govern
p.(None): the administrative and executing units of health services.
p.(None): Goods: Any of the things that can satisfy human needs.
p.(None): Bioavailability: Measurement of the amount of medication contained in a pharmaceutical form that reaches the formation
p.(None): systemic and the speed at which this process occurs.
p.(None): Bioeq uivalen cia: Condition that exists between two medications that are pharmaceutical equivalents and that show
p.(None): the same or sinúlar bioavailability according to criteria established in the technical nonna.
p.(None): Medical Emergency Kit: Establishments approved by the General Directorate of Health Regulation a
p.(None): request of a registered doctor and with your rights, so that you have pharmaceutical products for
p.(None): emergent use
p.(None): Cancellation of the Sanitary Registry: Definitive deprivation of the authorization that had been conferred, for having incurred
p.(None): in facts or conduct contrary to sanitary provisions.
p.(None): Cancellation of health license: Deprivation of the authorization granted for the operation of a
p.(None): Establishment
p.(None): Free Sale Certificate (C. L. V.): Document issued by the regulatory authority in which it is certified
p.(None): that the product referred to in the certificate is authorized for sale or distribution in the country or region
p.(None): of the scope of the regulatory authority.
p.(None): Export Certificate: Document issued by the Regulatory Authority of the country of origin proving that the
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
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p.(None): Health, in order to achieve its international identification.
p.(None): Confiscation: Confiscation or seizure of substances, artifacts or products to prevent further elaboration
p.(None): articles or products that reach the public without complying with the legal or regulatory provisions.
p.(None): Dependence on a medication: Condition in which the user of a medication feels compelling desire to continue
p.(None): the use of it. The use of the expressions drug addiction and habituation is currently recommended
p.(None): medicated; Drug dependence is used as a synonym for drug dependence.
p.(None): Cross dependence: The ability of a drug to suppress manifestations of physical dependence induced by
p.(None): another medicine and replace it in the maintenance of a state of physical dependence.
p.(None): Physical dependence: Elevated or adapted physiological state that occurs in an individual through administration
p.(None): Repeated medication. Physical dependence induced by prolonged use of a medication is only revealed
p.(None): when it is abruptly discontinued or when its shares are diminished by the administration of a
p.(None): specific antagonist
p.(None): Psychological dependence: Condition characterized by strong emotional or mental desire to continue using a
p.(None): medicine.
p.(None): Dental Deposits: Establishments dedicated to importation, sale, marketing, manufacturing,
p.(None): storage and distribution of bio materials, dental equipment and instruments for care or ‹lontology, as well
p.(None): as materials, equipment and instruments for the use of dental laboratories.
p.(None): Customs clearance: It is the process for the nationalization of merchandise that legally enters the country.
p.(None): Withdrawal: Act by which the petitioner's request is accepted not to continue with the process giving rise to
p.(None): file of the file containing the proceedings.
p.(None): Dispensing: It consists in the delivery of medications to the user patient usually as a result of a
p.(None): medical prescription.
p.(None): Availability: Relationship between the volume of demand and type of existing resource to meet the needs
p.(None): of offer attention. It is a dimension of supply risk.
p.(None): Device and Equipment for Medical Use: Instrument, apparatus, implement, machine, implant or other similar item or
p.(None): related that by itself or in combination with any accessory or program for its proper operation is
p.(None): used in prevention, healing, rehabilitation and health research.
p.(None): Dolo: Modality of breaking the Law with full knowledge of the cause.
p.(None): Therapeutic dose: Amount of active ingredient that produces the desired therapeutic effects in a given period
p.(None): of time.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): integrated for more than 24 hours for diagnosis or medical or surgical treatment.
p.(None): s REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and
p.(None): health rehabilitation.
p.(None): Preventive Care: A set of general promotion and specific protection actions provided to the
p.(None): individual and the general population with the purpose of reducing morbidity.
p.(None): Rehabilitation Care: Actions aimed at correcting physical or mental disability.
p.(None): Health Care: Promotional, preventive, curative and rehabilitation actions provided by a
p.(None): multidisciplinary team in the health area.
p.(None): Health Authority: Instance, Organ or Public Official that by Law or by delegation has the power to ensure
p.(None): for compliance with nonnas, policies, criteria, systems and procedures of a technical nature that must govern
p.(None): the administrative and executing units of health services.
p.(None): Goods: Any of the things that can satisfy human needs.
p.(None): Bioavailability: Measurement of the amount of medication contained in a pharmaceutical form that reaches the formation
p.(None): systemic and the speed at which this process occurs.
p.(None): Bioeq uivalen cia: Condition that exists between two medications that are pharmaceutical equivalents and that show
p.(None): the same or sinúlar bioavailability according to criteria established in the technical nonna.
p.(None): Medical Emergency Kit: Establishments approved by the General Directorate of Health Regulation a
p.(None): request of a registered doctor and with your rights, so that you have pharmaceutical products for
p.(None): emergent use
p.(None): Cancellation of the Sanitary Registry: Definitive deprivation of the authorization that had been conferred, for having incurred
p.(None): in facts or conduct contrary to sanitary provisions.
p.(None): Cancellation of health license: Deprivation of the authorization granted for the operation of a
p.(None): Establishment
p.(None): Free Sale Certificate (C. L. V.): Document issued by the regulatory authority in which it is certified
p.(None): that the product referred to in the certificate is authorized for sale or distribution in the country or region
p.(None): of the scope of the regulatory authority.
p.(None): Export Certificate: Document issued by the Regulatory Authority of the country of origin proving that the
p.(None): Controlled product is suitable or authorized for export.
p.(None): Temporary closure of the establishment: Suspension for up to ninety (90) days of the right conferring the granting of
p.(None): an operating license, for having incurred omissions, facts or conduct contrary to the provisions
p.(None): Legal or regulatory.
p.(None): Definitive closure of the establishment: Deprivation of the authorization that had been granted through a License
p.(None): Health, for having incurred omissions, facts or conduct contrary to legal provisions or
p.(None): Regulatory
p.(None): Clinic: Local where users health care functions are performed.
p.(None): Dental Clinic: Health facility that develops diagnostic, promotion, prevention,
...
p.(None): by the same route and that meet the same specifications.
p.(None): Pharmaceutical Specialty: Is that medicine produced by a manufacturer under a brand name or generic of
p.(None): a way that is characteristic.
p.(None): II E'Z MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Sputum: Nasopharyngeal secretion that spits.
p.(None): Establishment of health interest: Entity that produces, manipulates, stores, transports, distributes, sells and
p.(None): dispenses products of health interest, as well as provides health services in a formally organized manner,
p.(None): classified according to the degree of complexity in Category I low complexity, Category II medium complexity and
p.(None): Category III high complexity.
p.(None): Food Establishments: Factories, stores, places where food is manufactured, handled, dispensed and served
p.(None): and drinks, vehicles that transport food and food stalls on public roads.
p.(None): Health Establishments: Are those public or private establishments, in which directed care is provided
p.(None): fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals,
p.(None): Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics
p.(None): Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories
p.(None): dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of
p.(None): body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories
p.(None): analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
...
p.(None): del Códi, po ‹lc Salud, de.:ilirncntos y I ebidas, of natural products, laboi‹ it ‹› i u ›s for the analysis of calitlad
p.(None): of pl products of intcrćs sanit.ii’ii ›, distributors of insulins and laboratory equipment, distritloi cs of
p.(None): raw materials of products of health interest, irl distl ibui ‹ioi cs of chemical substances, distributors of
p.(None): insilmos y equi¡ao ‹lc laboratories, tlisti ibudores de irlsrnros and rnérlico quiiiii’i: it. or, distributors
p.(None): of inputs and otlontological equipment, cstarán siljcl ‹› s
p.(None): g2 MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): to this regulation for which they must meet the minimum essential requirements related to structure
p.(None): physics and facilities, equipment, human resources, waste management, organization and operation
p.(None): established in the technical standard.
p.(None): Article 72.- The sanitary control of the establishments of sanitary interest will be exercised by the Ministry of Health for
p.(None): through the General Directorate of Sanitary Regulation, Department of Sanitary Control of Products, Services and
p.(None): Establishments or Delegated Department and the Departmental Regions and municipal authorities.
p.(None): Article 73.- The sale of drugstores and laboratories is strictly prohibited.
p.(None): narcotic drugs, psychotropic and other controlled drugs that may cause dependence or habit, to the positions of
p.(None): sale of medicines and in general to non-pharmaceutical establishments; such products will be subject to
p.(None): provisions established in Articles 150, 151, 152,153 and 154 of the Health Code.
p.(None): Article 74.- Drugstores may only sell products in the medical emergency kits.
p.(None): amounts established in the list approved by the competent health authority.
p.(None): Article 75.- The establishments will occupy independent premises according to the activity or service that
p.(None): lend and separate from any other commercial, residential establishment complying with the technical standard of
p.(None): minimum essential requirements.
p.(None): Article 76.- Establishments of Health Interest Complexity I and II may be installed in commercial centers,
p.(None): supermarkets, department stores and other similar establishments, in individual locations that
p.(None): guarantee the safety and hygiene of the services provided.
p.(None): Article 77.- All pharmaceutical establishments according to their category must comply with good manufacturing practices
p.(None): or product handling.
p.(None): Article 78.- The pharmaceutical shift is mandatory for all pharmacies where it is so established by the
p.(None): competent health authority, however, in times of epidemic or any other public need the Secretariat
p.(None): Health by resolution may order that all pharmacies provide such services continuously to the public,
p.(None): as long as the cause that originates persists.- The Ministry of Health will coordinate with the Ministry of Security
p.(None): protection to the establishment in turn.
p.(None): Article 79.- Every pharmacy will be under the responsibility of a regent, who is obliged to remain in the
p.(None): same
p.(None): within normal working hours and during the shift service, as well as health laboratories also
p.(None): They will be in charge of a regent.
...
p.(None): Associations of Pharmacy Owners and endorsed by the College of Chemist-Pharmacists of Honduras.- The cadres
p.(None): Shifts should be prepared according to the needs of each community and will be given the greatest possible disclosure
p.(None): in the first days of the month of January of the corresponding year.
p.(None): Article 81.- The pharmacies will fulfill the obligatory turn of attention to the public from 6:00 pm to 10:00 pm according to
p.(None): calendar prepared by the competent authority. This provision is without prejudice that other pharmacies provide the
p.(None): 24-hour public service, every day, subject to the provisions of this Regulation.
p.(None): Article 82.- Pharmacies, while they are providing the shift service, must have a visible place of
p.(None): establishment of a bright advertisement with clear characters that says “TURN” so that the public knows that the pharmacy
p.(None): He is rendering the service on an extraordinary day.
p.(None): Article 83.- Pharmacies will display in a visible place on the front of the establishment a sign with the payroll of the
p.(None): pharmacies on duty, with indication of their respective addresses.
p.(None): Article 84.- The Medicine Sales Posts must have a previously trained person and will be authorized by
p.(None): the competent authority.
p.(None): Article 85.- The Medicine Sales Posts will only sell the medicines included in the list
p.(None): approved by the competent sariitaria authority.-Its opening will only be authorized, in the places where they do not exist
p.(None): Pharmacies providing the service.
p.(None): Article 86.- The Emergency Medical Kit will be installed inside the authorized doctor's clinic.
p.(None): Article 87.- Medical Emergency First Aid kits may only keep medications according to the list authorized by the
p.(None): competent health authority.
p.(None): Article 88.- In Medical Emergency Kits, medications may not be sold directly to the public, only
p.(None): to doctor's patients, in case of emergency.
p.(None): Article 89.- The regent is the professional who assumes the technical and scientific direction of the establishments
p.(None): pharmacists
p.(None): ItEPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): and clinicians, being responsible for the good condition of the products and services provided as well as the
p.(None): contraventions to the legal and regulatory dispositions that derive from their operation.
p.(None): ‹'
p.(None): Article 90.- In the case of pharmaceutical establishments, the regent is responsible for control and custody
p.(None): of narcotic, psychotropic and other substances under control; any abnormality should be reduced
p.(None): immediately to the competent health authority.
p.(None): Article 91.- In the case of health facilities such as: medical, dental and medical care clinics
p.(None): veterinary, the management of psychotropic and other controlled products, will be the responsibility ‹le professionals
p.(None): competent.
p.(None): Article 92- Within any health facility, the certificate that will
p.(None): accredit as regent.
p.(None): Article 93.- In accordance with Article 160 of the Health Code, it corresponds to the Ministry of Health regular and
p.(None): promote the installation of registration and information systems for adequate technical, epidemiological and
p.(None): care of all public and private health institutions.- To comply with this provision, the
p.(None): General Directorate of Health Regulation in coordination with the corresponding bodies, will establish the rules and
p.(None): minimum procedures that all health facility operators must observe.
p.(None): Article 94.- The health establishments regulated in this Regulation are obliged to exhibit
p.(None): request of the General Directorate of Health Regulation, all those provisions and internal regulations that
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): Book II of the Promotion and Protection d ‹: Health, Title II of Food and Beverage, Book III of the
p.(None): Health Recovery, Title I of Pharmaceutical Products and Medical Equipment, Title II of
p.(None): Health Institutions, Book IV, Title 11 Measures and Administrative Acts, Title III Procedure in the
p.(None): Actions of the Health Authorities of the Health Code.
p.(None): Article 2.- The following are fundamental principles of this Regulation:
p.(None): a) Protect the Health and life of users and consumers in relation to products, services and
p.(None): Health Interest establishments.
p.(None): b) Regulate the conditions of safety, efficacy and safety of the products, services and establishments of
p.(None): Health interest.
p.(None): CHAPTER II GENERAL PROVISIONS
p.(None): Article 3.- This Regulation regulates the products, services and establishments of health interest and the
p.(None): personnel linked to them, and for the purposes of their application the following terms or concepts are defined:
p.(None): Abandonment: Declaration of early termination of a procedure, which is not concluded by not responding to
p.(None): time the requirements made to complete the process.
p.(None): Sample record: Document containing the proof of sampling.
p.(None): Citation Act: Document by means of which, the inspector quotes the regent, legal representative or the owner
p.(None): of the establishment to appear before the corresponding dependency of the Ministry of Health.
p.(None): Inspection Act: Document that reflects the result of the inspection carried out by the health authority (s)
p.(None): competent duly subscribed by them and the interested party.
p.(None): Customs: Official competent body that regulates the import and export of merchandise from the country.
p.(None): Food for Medical Use: The one that has been subjected to processes that modify the relative concentration
p.(None): of the various nutrients, of their constitution or their quality, or by incorporation of substances
p.(None): outside its composition, they acquire therapeutic properties.
p.(None): Written reprimand: Action to reprimand someone, by writing motivated by omission, execution of a
p.(None): activity or conduct contrary to legal or regulatory provisions.
p.(None): Hearing: Citation that is made to the public employee in order to render discharges on actions that are
p.(None): imputed or attributed.
p.(None): Outpatient Care: Actions aimed at patient care for diagnosis and treatment, when
p.(None): Check that it does not require hospitalization.
p.(None): Hospital Care: Actions aimed at the care of patients who, due to their state of health, need to be
p.(None): integrated for more than 24 hours for diagnosis or medical or surgical treatment.
p.(None): s REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and
p.(None): health rehabilitation.
p.(None): Preventive Care: A set of general promotion and specific protection actions provided to the
p.(None): individual and the general population with the purpose of reducing morbidity.
p.(None): Rehabilitation Care: Actions aimed at correcting physical or mental disability.
p.(None): Health Care: Promotional, preventive, curative and rehabilitation actions provided by a
p.(None): multidisciplinary team in the health area.
p.(None): Health Authority: Instance, Organ or Public Official that by Law or by delegation has the power to ensure
p.(None): for compliance with nonnas, policies, criteria, systems and procedures of a technical nature that must govern
p.(None): the administrative and executing units of health services.
p.(None): Goods: Any of the things that can satisfy human needs.
p.(None): Bioavailability: Measurement of the amount of medication contained in a pharmaceutical form that reaches the formation
p.(None): systemic and the speed at which this process occurs.
p.(None): Bioeq uivalen cia: Condition that exists between two medications that are pharmaceutical equivalents and that show
p.(None): the same or sinúlar bioavailability according to criteria established in the technical nonna.
p.(None): Medical Emergency Kit: Establishments approved by the General Directorate of Health Regulation a
p.(None): request of a registered doctor and with your rights, so that you have pharmaceutical products for
p.(None): emergent use
p.(None): Cancellation of the Sanitary Registry: Definitive deprivation of the authorization that had been conferred, for having incurred
p.(None): in facts or conduct contrary to sanitary provisions.
p.(None): Cancellation of health license: Deprivation of the authorization granted for the operation of a
p.(None): Establishment
p.(None): Free Sale Certificate (C. L. V.): Document issued by the regulatory authority in which it is certified
p.(None): that the product referred to in the certificate is authorized for sale or distribution in the country or region
p.(None): of the scope of the regulatory authority.
p.(None): Export Certificate: Document issued by the Regulatory Authority of the country of origin proving that the
p.(None): Controlled product is suitable or authorized for export.
p.(None): Temporary closure of the establishment: Suspension for up to ninety (90) days of the right conferring the granting of
p.(None): an operating license, for having incurred omissions, facts or conduct contrary to the provisions
p.(None): Legal or regulatory.
p.(None): Definitive closure of the establishment: Deprivation of the authorization that had been granted through a License
p.(None): Health, for having incurred omissions, facts or conduct contrary to legal provisions or
p.(None): Regulatory
p.(None): Clinic: Local where users health care functions are performed.
p.(None): Dental Clinic: Health facility that develops diagnostic, promotion, prevention,
p.(None): treatment and rehabilitation of oral health, whose operation conforms to the provisions of the Health Code and its
p.(None): regulation.
p.(None): University Dental Clinic: Facilities that provide services and teaching in universities and that meets the
p.(None): requirements described by the Health Code and its Regulations.
p.(None): Complexity: It is the criterion used to identify an establishment taking into account the magnitude of the risk
p.(None): sanitary, the technology it uses and the man hours necessary for its sanitary inspection.
p.(None): Quality Control: Planned system of activities whose purpose is to ensure a top quality product.
p.(None): Smuggling: Consists of the importation or entry into the country of goods that do not meet the requirements
p.(None): legal established for this purpose.
p.(None): Sanitary Control: It is the action of checking, supervising, inspecting, intervening, registering, monitoring, regulating
p.(None): sanitary hygienic conditions of the establishments, of the personnel where goods are produced or provided and
...
p.(None): II E'Z MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Sputum: Nasopharyngeal secretion that spits.
p.(None): Establishment of health interest: Entity that produces, manipulates, stores, transports, distributes, sells and
p.(None): dispenses products of health interest, as well as provides health services in a formally organized manner,
p.(None): classified according to the degree of complexity in Category I low complexity, Category II medium complexity and
p.(None): Category III high complexity.
p.(None): Food Establishments: Factories, stores, places where food is manufactured, handled, dispensed and served
p.(None): and drinks, vehicles that transport food and food stalls on public roads.
p.(None): Health Establishments: Are those public or private establishments, in which directed care is provided
p.(None): fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals,
p.(None): Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics
p.(None): Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories
p.(None): dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of
p.(None): body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories
p.(None): analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls
p.(None): and medical emergency kits, community drug funds, aesthetic and nutrition establishments,
p.(None): ambulances, mobile units: land, air and sea; and others defined by the health authority.
p.(None): Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due
p.(None): process and store raw materials or semi-processed products prepared, as the case may be, these tests
p.(None): They are also used to determine the shelf life of the medicine in its original container and in storage conditions
p.(None): Specific.
p.(None): Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation
p.(None): from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can
p.(None): apply to substances that belong to different pharmacological categories (narcotic analgesics,
p.(None): central nervous system stimulants or depressants, hallucinogens, etc.).
p.(None): Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to
p.(None): Identify it and characterize it.
p.(None): Equipment: Collection of in5unctions and special devices to perform certain jobs.
p.(None): File: Set of documents related to the history of a natural person, legal entity or a process.
p.(None): Excipient: Auxiliary substance in the manufacture of a product.
p.(None): Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration.
p.(None): Slight failure: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions and not
p.(None): It constitutes a risk that harms or may harm the health of the population.
p.(None): Less serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions, which are
p.(None): It constitutes a moderate risk to affect the health of the population, intervening the voluntary action or omission.
p.(None): Serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the
p.(None): technical standards and also DIS] 3O5itions issued by the Ministry of Health, in the exercise of its functions, which are
p.(None): constitutes a gi’ave risk or has caused or damage to the health of the population and that mediates negligence or
p.(None): malicious intent.
p.(None): ., Fqrmacia; It is the establishment that is dedicated to the preparation of recipes, dispensing and supply
p.(None): of medicines and related products directly to the public.
p.(None): Germs: Microbes or microorganisms.
p.(None): Systematization Sheet: Document in which the data of the application for registration, renewal or
p.(None): modification
p.(None): Hermetic: Complete and impenetrable closure.
p.(None): Ingredients: Any component that is used in the preparation of the products regulated by this regulation.
p.(None): Innocuous: What is not harmful to health.
p.(None): Health Registration: It is the authorization for the commercialization granted to an importer or
p.(None): distributor of a product that has been previously registered, should also be understood as the registration before the
p.(None): health authority of a category C product or a category I establishment, for marketing and
p.(None): respective operation.
p.(None): Waterproof: Impenetrable to water or other fluids.
p.(None): Challenge: Legal action through which the disagreement of an administrative act is manifested in the first instance
p.(None): requesting its renewal or modification.
p.(None): Ç REPUBLICA DE HONDURAS ‘- TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Control report: It consists of the report as a result of an inspection visit.
p.(None): Violation: Violation of the legal norm. , '
p.(None): Disabling of professional practice: Temporary or permanent suspension in professional practice by the
p.(None): respective school.
p.(None): Insert: Document addressed to the medical or patient body where in a summary form it explains the main indications,
p.(None): contraindications, warnings, adverse reactions, doses, toxicological record and commercial presentations.
p.(None): Inspection: Act of reviewing or verifying the operating status of a health interest establishment
p.(None): and the management of uncontrolled, controlled and precursor products for compliance with the provisions of
p.(None): these regulations issued by the Ministry of Health.
p.(None): Eye inspection: Judicial test method by conducting a visuiil inspection route.
p.(None): Sanitary inspector: Sanitary Authority that acts in an official capacity with powers to inspect and inspect
p.(None): supervisions, and corrective action.
p.(None): Inventory or stoclt: Physical quantity in stock of a product.
p.(None): JIFfi: International Narcotics Control Board: Supervisory body that has to assume the functions that
p.(None): He is assigned the different International Drug Control Conx'enios, one of whose functions consists of
p.(None): monitor licit drug trade subject to international control
p.(None): Dental Laboratories: Establishments dedicated to the support of dental professionals in manufacturing
p.(None): of devices be they acrylic, metallic, porcelain or others that contribute to the rehabilitation of health
p.(None): oral.
p.(None): Narcotics control book: Special format book that records entries, exits and balances
p.(None): of narcotics.
p.(None): Book of control of psychotropics: Book of special format where the registry of entrances, exits and
p.(None): Psychotropic balances.
p.(None): Raw material control book: Special format book where the record of entries, exits and balances is kept
p.(None): raw material.
p.(None): Book of finished product and transfers: Book of special format where the register of entrances and exits of
p.(None): Controlled product, as well as transfers.
p.(None): Licensing: Mandatory administrative technical procedure aimed at verifying compliance with
p.(None): minimum requirements in force.
p.(None): Sanitary License: It is the authorization for an establishment to manufacture, import, export,
p.(None): transport, distribute, handle, store, pack, sell and dispense products of sanitary interest; as well as
p.(None): Provide health services, once all technical and legal requirements are met.
...
p.(None): producing laboratories for its development as medicines,
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): since such development does not present an economic incentive, although they can meet health needs.
p.(None): Over-the-counter medication: It is the one that due to its composition and the pharmacological action of its active substances can
p.(None): used by the public without a prescription.
p.(None): Essential Medication: It is the one considered most important, indispensable and necessary to satisfy the
p.(None): health needs of most of the population.
p.(None): Multifuente Medication: It is one that must meet the same standards of quality, safety and efficacy applicable
p.(None): to the innovative medicine.
p.(None): Innovative Medicine: It is the original that demonstrated safety and efficacy with preclinical, clinical and post studies
p.(None): marketing and established quality standards, which will be used as a reference medicine.
p.(None): New Medication: Any Medication that has not been registered or released to the market for medical purposes including new
p.(None): salts or esters of an active substance, new fixed combinations of substances that are already on the market, or
p.(None): any medication previously registered or offered on the market, provided that its indications for use
p.(None): mode of administration or formulation have been changed.
p.(None): Official Medication: It is the one recorded in the respective monograph of the Normative Code that can bear the name of
p.(None): its active ingredients; Official Generic; or that of your patent registration; Official Patented
p.(None): Reference Medicine: Is the innovator or defined by the health authority.
p.(None): Similar Drug: It is the one that contains the same or same active ingredients, has the same concentration, form
p.(None): pharmaceutical, route of administration, dosage and therapeutic indication of the reference medicine, registered by
p.(None): the regulatory authority responsible, being able to differ only in characteristics related to the size and shape of the
p.(None): product, expiration date, packaging, label, excipients and vehicles must always be identified by
p.(None): trade or brand name
p.(None): New Molecule: Active substance that is not contained in any type of pharmaceutical product previously
p.(None): Registered by the health authority. A new salt, be or derived from an approved active substance, must
p.(None): be considered
p.(None): Medical sample: Representative units or small amounts of a drug that is provided free of charge
p.(None): For your promotion.
p.(None): Sampling: Taking units of a product that are representative of their total.
p.(None): Fine: Pecuniary penalty that is imposed for the execution or omission of a conduct, contrary to the provisions
p.(None): sanitary
p.(None): Generic Name: It is the name of the active substance that generally corresponds to the common denomination
p.(None): International (D.C.I.) recommended by WHO.
p.(None): Chemical Name: It is the name used intemacionahnente for a chemical substance, following the rules of
p.(None): Nomenclature of the I.U.P.A.C., which unequivocally denotes the composition and structure of the substance.
p.(None): Honduran Standard: It is one that has been adopted or adapted from an international standard or formulated and
p.(None): approved in the country and that is related to products, services or establishments of health interest.
p.(None): Sanitary Notification: Document sent by the manufacturer that certifies any change of a scientific nature and
p.(None): duly justified and documented.
p.(None): Lot Code Number: The designation (in numbers or letters) or coding of the product that identifies the lot to
p.(None): That this one belongs.
p.(None): Organoleptic: Evaluation of any product of health interest made through the senses (sight, smell,
p.(None): touch, taste, yoido).
p.(None): Perishable: Product that is easily altered or decomposed in a short period of time.
...
p.(None): as a new molecule and therefore demonstrate the documentation Active ingredient: Substance or mixture of
p.(None): Related substances related to efficacy, safety and quality. endowed with a
p.(None): specific pharmacological effect
p.(None): Sertión A Atueriłos y leycs
p.(None): K REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘. 30,841
p.(None): Product: Thing produced, resulting from the work done on a raw material.
p.(None): Altered Product: When replaced, totally or partially added or replaced constituent elements
p.(None): that are part of the officially registered composition or when substances that may have been added
p.(None): modify its effects or its physicochemical or organoleptic characteristics.
p.(None): Cosmetic Product: It is any substance or formula of local application to be used on different surfaces
p.(None): external of the human body and its annexes including mucosa, buccal and teeth in order to clean, perfume,
p.(None): improve its appearance and protect or maintain it.
p.(None): Alines Products: They are natural products, cosmetics, hygienic products, laboratory reagents, material and
p.(None): Dental and health laboratory equipment, devices, equipment and surgical medical equipment.
p.(None): Bulk Product: It is any processed substitution found in its final form and which has been uncle
p.(None): packed in final distribution packages.
p.(None): Products of interest s “year: They are food and beverages, medicines, biologicals, cosmetics,
p.(None): hygienic products, hazardous substances, medical devices and equipment, natural products, reagents
p.(None): laboratory and others that in their time are considered by the sanitary authority; those that are classified zsí:
p.(None): Risk "A" or high risk Risk "B" or medium risk Risk "C" or low risk
p.(None): Finished Pharmaceutical Product: A preparation containing é1 or the active ingredients and excipients; formulated in a
p.(None): famiaceutical form.
p.(None): Natural Product: Processed, industrialized and labeled product are attributed medicinal qualities,
p.(None): Qite contains in its formulation ingredients obtained from plants, animals, minerals or mixtures thereof.
p.(None): Products that, being inezclas, have a chemical active ingredient included, are not considered natural products.
p.(None): Seini-elaborated product: It is any substance or mixture of substances that is still in the manufacturing process.
p.(None): Expired Product: The one that has fulfilled its expiration or expiration date.
p.(None): Finished Product: Prepared ready for dispensing.
p.(None): Products (ligienicos: Are those products intended to be applied in homes, buildings and facilities
p.(None): public and
p.(None): private, industries and other places, as well as objects and utensils that are in contact with people, used with
p.(None): In order to clean dewatering, deodorizing yaromatize.
p.(None): Prospectus: Document addressed to the medical body or patients where in a summary form it explains the indications, main
p.(None): contraindications, warnings, adverse reactions, doses, toxicologist record and commercial presentations.
p.(None): Stall of Sale: Local, site, furniture, food and non-alcoholic beverage sales in public premises
p.(None): legally authorized.
p.(None): Position of Sale of Medicines: Establishments destined in restricted form, only the dispensing of
p.(None): medicines authorized by the competent authority, and in which the preparation of prescriptions and handling of
p.(None): Controlled medications.
p.(None): Recipe: Any written and eligible prescription extended by a competent professional duly registered to the
p.(None): specific person and that contains the addresses for its correct use, of a simple or compound medicine, in
p.(None): Any pharmaceutical form intended for therapeutic purposes.
p.(None): Special Recipe: It is the prescription on safety paper provided by the Doctor for psychotropic products or
p.(None): controlled.
p.(None): Regent or Technical Director: The university professional, in full exercise of his rights and duties assumed by the
p.(None): technical, scientific direction and professional responsibility of a health establishment.
p.(None): Sanitary Registry: This authorization so that a product of sanitary interest can be manufactured, imported,
p.(None): packaged or expended once all technical and legal requirements are met.
p.(None): Resolution denied: Administrative act by which a request, renewal or change on a Registry is rejected
p.(None): for not meeting the requirements of the Regulation.
p.(None): Sanction: Administrative provision imposed on the holder of the sanitary registration of a product or license
p.(None): health of an establishment that by action or omission violates health regulations.
p.(None): Services: Function or benefit performed by an organization and its staff.
p.(None): Health Care Services: The set of resources that systematically intervene for prevention and cure
p.(None): of diseases that affect individuals, as well as their rehabilitation.
p.(None): JtEPIJBLI €: 'A 13E Hf3NDI! RAS - TEGU CIGALPA, KJ. II. C., NOVEMBER 4, 2005 N “. 30,841
p.(None): LU iriti ‹iscritti, Secretary tacne ra1 de lu Sec i elaria dc Industrie y Co me rc io. ’L“ I1 AN SCItI13 I- .:
...
p.(None): i) Suspension of registration and sanitary license.
p.(None): j) What is not provided for in this Regulation but related to it and of confidence with the legal process
p.(None): in force in the country.
p.(None): IV. Head of the Department of Health Regulation in
p.(None): Health Regions:
p.(None): It has powers to:
p.(None): a) Dictate the request for the sanitary registration of products of sanitary interest according to the risk,
p.(None): in order to be granted or denied by the regional headquarters.
p.(None): b) Dictate the request for sanitary licenses of establishments according to complexity, in order to
p.(None): serotorgado or denied by the regional headquarters.
p.(None): c) Issuance for the imposition of the following sanctions:
p.(None): 1) Fines from Velnte Lempiras (L.20.00) to twenty thousand Lempiras (L.20, 000.00).
p.(None): 2) The release, confiscation, denaturation or destruction of products, substances and artifacts.
p.(None): 3) Temporary closure of establishments according to complexity
p.(None): delegate
p.(None): d) Written reprimands.
p.(None): e) What is not provided for in this Regulation but related to it and in accordance with the legal system in force in
p.(None): the country.
p.(None): V. Sanitary Province: It has powers to:
p.(None): a) Perform inspections of products, services and establishments of health interest.
p.(None): b) Take samples of products of health interest.
p.(None): c) Retain products, substances and artifacts that are considered hazardous to health.
p.(None): d) Execute the confiscation, denaturation and destruction of products of health interest, prior resolution.
p.(None): e) Execute or notify the actions and penalties contemplated in this Regulation according to the resolution issued
p.(None): by competent authority.
p.(None): c) Make the request of the representative or owner of the establishment to appear before the
p.(None): competent authority to solve the problems or deficiencies found.
p.(None): d) Other delegates.
p.(None): CHAPTER IV
p.(None): SANITARY RULES APPLICABLE TO PRODUCTS, SERVICES AND
p.(None): ESTABLISHMENTS OF HEALTH INTEREST.
p.(None): Article 8.- For the application of this Regulation, the Secretary of State in the Department of Health, through
p.(None): the competent bodies adopt the mandatory national regulations in force and those that are approved in the
p.(None): future, as well as international standards on products, services and establishments of health interest
p.(None): contained in international conventions and treaties ratified by Honduras.
p.(None): If REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): Article 9.- In the case of food, food additives, packaging and labeling, they will be applied in the order of
p.(None): following priority: a) This Regulation, b) Central American Customs Regulations, c) Technical Standards
p.(None): Hondurbñas,
p.(None): d) Nonnas of the Codex Alimentarius, e) Regulations of the Federal Code of Regulations of the Office of Administration of
p.(None): Food and Drug Administration (FDA) of the United States of America and f) Pan-American Sanitary Standards of the Organization
p.(None): Pan American Health (PAHO).
p.(None): Article 10.-In the case of establishments where they are produced, handled, stored, distributed and sold
p.(None): food, this Regulation provides as mandatory: a) Customs Union Regulations
p.(None): Central American and, b) Honduran Technical Standards for Aliinentos Establishments.
p.(None): Article 11.-In the case of Medical Devices and Devices, in the application of these Regulations they are considered
...
p.(None): g) Storage of hazardous substances.
p.(None): FOURTH SECTION
p.(None): OF THE MANIPULATOR REQUIREMENTS OF
p.(None): FOODS
p.(None): Article 21.-Food handling is not allowed for people suffering from respiratory infections.
p.(None): acute, infection in the pharynx, tonsil and larynx, conjunctivitis, infectious otitis, diarrheal diseases and
p.(None): Infected skin lesions or healing process and other infectious infectious diseases.
p.(None): Article 22.-Any person who handles and food supplies shall undergo medical evaluations and controls in medical centers.
p.(None): public or private health, of which a record must be kept in the company's files, such controls
p.(None): They should be practiced every six months.
p.(None): Section A Acuerttos y ieyes'
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Article 23.-The medical and clinical controls to which the food handler must be submitted are the following:
p.(None): general medical exam, clinical exams: stool exam, urine test, infectious hepatitis screening and
p.(None): Other infectious and contagious pathologies.
p.(None): Article 24.- Every food handler must meet the following requirements:
p.(None): a) Possess good health
p.(None): b) Personal hygiene and good presentation
p.(None): c) Practice hygiene habits
p.(None): d) Have a health card
p.(None): Article 25.- Every food handler must comply with the following hygiene habits:
p.(None): a) Keep your hands clean.
p.(None): b) Bathe daily.
p.(None): c) Keep your face shaved.
p.(None): d) Short nails clean and without enamel.
p.(None): e) Short or collected and clean hair, with its respective hat or hairnet.
p.(None): íj Always wear the full uniform (light colored hat and gabacha), keep it clean, wear a mask when
p.(None): This is determined by the health authority.
p.(None): g) Wear closed shoes and gloves when necessary.
p.(None): h) Stay quiet when handling food.
p.(None): i) Handle food without watches, rings and other jewelry in your arms and hands.
p.(None): j) Wipe the sweat with clean and disposable tissues.
p.(None): k) Do not fuse when handling food.
p.(None): l) Cover your mouth or nose with clean tissues when you cough or sneeze when you are not wearing a mask.
p.(None): m) Take the dishes, plates and fees by the base or handle.
p.(None): n) Take cutlery, knives, spoons and tongs by the handle.
p.(None): o) Collect utensils, crockery and leftover food, trying to avoid contamination of the hands.
p.(None): Article 26.- Every manipulator must wash and disinfect their hands in the following cases:
p.(None): a) When you start and finish your work
p.(None): b) After using the sanitary service, scratch or touch any part of the body especially nose, mouth,
p.(None): ears and head
p.(None): c) When sneezing and coughing.
p.(None): d) When collecting used utensils or food leftovers.
p.(None): e) When wiping sweat.
p.(None): í) When handling garbage containers.
p.(None): g) After handling money and other substances or non-food items.
p.(None): Article 27.- In food preparation the manipulator must:
p.(None): a) Wash the utensils carefully before and after being used
p.(None): b) Wash the surface where you peel, chop or prepare food before and after each use.
p.(None): c) Wash dishes, cutlery and glasses before serving food and drinks again, when these are not
p.(None): disposable
p.(None): d) Wash the spoon or utensil used to taste a food well.
p.(None): e) Mix salads using utensils, never with your hands.
p.(None): Article 28.- The manipulator must not:
p.(None): a) Clean your hands and utensils with your gabacha or apron
p.(None): b) Insert your fingers into the utensils and touch the prepared or prepared food.
...
p.(None): other than human consumption.
p.(None): Article 30.-In the storage of food the following general measures will be taken:
p.(None): a) Adequate temperatures so that food does not suffer alterations or changes in its characteristics
p.(None): initials.
p.(None): b) Relative humidity according to the nature of the product
p.(None): c) Convenient air circulation.
p.(None): d) Protection against direct sunlight, when it is harmful to the product.
p.(None): M? f i 'REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): e) Isolation of substances or products that emit odors from those that can absorb them.
p.(None): f} Adequate control of insects and rodents.
p.(None): Article 31.- It is prohibited:
p.(None): a) Store and transport food products with hazardous substances.
p.(None): b) Store and transport altered, contaminated, adulterated or counterfeit food along with others that are
p.(None): Suitable for human consumption.
p.(None): SECTION SIX
p.(None): OF PHARMACEUTICAL PRODUCTS
p.(None): Article 32.- The regulation of pharmaceutical products in the national territory shall be done in accordance with the
p.(None): established in the Health Code, its Regulations and international conventions and treaties adopted by the State
p.(None): of Honduras.- This regulation will be implemented gradually, according to the technical standards of Good Practices
p.(None): Manufar: Tura (BPM) of the Pan American Health Organization (PAHO) to the validity of this regulation.
p.(None): Article 33.- The Ministry of Health will prepare special regulations for medicines destined for the market
p.(None): of generics
p.(None): Article 34.- Over-the-counter medicines authorized by the competent health authority may be marketed
p.(None): also in non-pharmaceutical establishments such as supermarkets, warehouses and grocery stores complying with the
p.(None): Good storage practices.
p.(None): Article 35.- The quality control of products of sanitary interest shall be carried out in laboratories that establish
p.(None): national legislation or others that are recognized and certified by the sanitary authority.- For those
p.(None): products that are subject to mutual recognition between countries, through international agreements, their control is
p.(None): will perform once they are in the national territory. '
p.(None): Article 36.- The regulation of drugs classified as controlled shall be in accordance with the provisions.
p.(None): in these Regulations and the provisions of the United Nations Conventions: Single Convention of 1 961
p.(None): on Narcotic Drugs issued by the 1972 Protocol, Convention on Psychotropic Substances of 1971,
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988,
p.(None): International Narcotics Control Board, National Narcotics and Other Drug Control Board
p.(None): Dangerous and other agreements that the country be signatory and ratify.
p.(None): Article 37.- Three (3) regimes are established: Prohibition, Strict Control and Control.
p.(None): I. a) It is prohibited, for medical or scientific purposes, the cultivation, production, manufacture,
p.(None): distribution and use of the following narcotic drugs:
p.(None): Cannabis and its resins
p.(None): Ketobemidone (4-meta-hydroxyphenyl2-methyl-4propioni1pi-
p.(None): peridine) Desomorphine (Dihydiodeoxymorphine) Heroin (Diacetylmorphine)
p.(None): The preparation, distribution, trade and use of Lysergic Acid Dietilamide (LSD), of the
p.(None): Psilocybin, mezcalin and other similar substances.
p.(None): II. The narcotic substances mentioned in List I, List 11 and are subject to strict control
p.(None): List III of the Single Convention of 1961.
p.(None): III. The psychotropic substances mentioned in List I, List II, List III and List IV remain under control
...
p.(None): the control of narcotic drugs, psychotropic products and chemicals, like other dangerous drugs that
p.(None): they can create dependencies or habits, regarding their import, export, production, storage,
p.(None): distribution, prescription and dispensation will be done through the Ministry of Health applying the rules and
p.(None): regulations established in international agreements.
p.(None): Article 39.- The dispensation of psychotropic products, narcotics and preparations containing them, may only
p.(None): be made by the pharmaceutical regent, upon presentation of the corresponding special prescription, which will contain
p.(None): the following requirements:
p.(None): a) Letterhead, stamp and signature of the prescribing physician.
p.(None): b) Date of issue.
p.(None): c) Name and age of the patient.
p.(None): d) Patient address.
p.(None): e) Commercial and generic name readable of the prescribing drug.
p.(None): f) Dose and quantity prescribed in letters and number.
p.(None): Article 40.- Psychotropic drugs, narcotics and other controlled drugs may only be marketed by
p.(None): Pharmaceutical laboratories, drug stores and pharmacies nationwide.
p.(None): Article 41.- For the management of psychotropic and other controlled drugs, veterinarians and dentists shall be governed by
p.(None): Ready for medical professionals.
p.(None): Ę REPUBLICA DE HONDURAS - "1" EGIJCIGALPA, M.D. C., NOVEMBER 4, 2005
p.(None): No. 30,841
p.(None): Article 42.- The validity of psychotropic prescriptions will be fifteen days and three days for narcotics,
p.(None): counted from the date of issue. When circumstances of force majeure arise
p.(None): competent health authority may authorize prescriptions that have expired said terms.
p.(None): Article 43.-These are duties and obligations of the pharmaceutical regents regarding the handling of narcotic drugs,
p.(None): Psychotropic and controlled products the following:
p.(None): a) To personally dispense the recipes of these products.
p.(None): b) Dispense such products only to persons of legal age
p.(None): c) Keep the products controlled in a special section, under have and instead not accessible to the public.
p.(None): d) Seal the prescriptions dispatched with the seal of the pharmacy and the pharmaceutical regent.
p.(None): e) Reject prescriptions that have amendments or deletions or without the seal of the doctor who extends it.
p.(None): Ę Bring the control books to 1 day.
p.(None): g) Authorize cpn your signature for orders, reports or requests that refer to these products.
p.(None): h) Inform the competent health authority about the anonymity that is known regarding
p.(None): these products.
p.(None): Article 44.- The General Directorate of Health Regulation through the competent health authority shall remain
p.(None): updated list of psychotropic drugs and other controlled products, as well as substances
p.(None): Chemicals subject to control and inspection.
p.(None): Article 45.- Every importer of psychotropic drugs, narcotics and controlled chemical substances must send
p.(None): a monthly report to the competent health authority, indicating the movements of entry, exit and balances, as well
p.(None): as specifying the people or establishments to which the product was sold, being verified, audited and
p.(None): inspected when the health authority deems it convenient.
p.(None): Article 46.- Narcotic drugs, psychotropic drugs may only be exported by laboratories and drug stores to
p.(None): establishments legally authorized for this purpose in the importing country.
p.(None): Article 47.- The amounts of psychotropics, narcotic drugs and controlled chemical substances that are required with
p.(None): Medical, scientific or production purposes must be reported before April 10 of each year to the authorities
p.(None): competent by the interested parties, indicating if they will be imported or acquired localinente.
p.(None): Article 48.- The competent health authority, in accordance with the previous article, shall approve the quota
p.(None): within the annual forecasts established according to the needs of the country, to each authorized establishment
p.(None): to import or manufacture
p.(None): Psychotropic, narcotic, and controlled or prepared chemical substances containing them.
p.(None): Article 49.- The competent health authority shall keep a record of the forecasts and of the fees set.
p.(None): for each establishment.- If at the end of the year the quantities authorized to manufacture have not been used in
p.(None): in its entirety, the surplus will be deducted from the amount authorized for the following year.
p.(None): Article 50.- The pharmaceutical laboratory that manufactures controlled chemical products and substances must have
p.(None): with two control books, one for the movement of raw material and another for the transfer of finished product.
p.(None): Article 51.- The control books of the producing, importing, distributing and dispensing establishments of
p.(None): controlled chemical products and substances must be labeled, folded and sealed by the authority
p.(None): competent sanitary registering the corresponding information.
p.(None): Article 52.- For the transformation of raw material into a controlled, finished product, the manufacturing laboratory must
p.(None): submit an application at least five (5) business days to the competent health authority, who
p.(None): Appoint the respective inspector (s) to carry out the corresponding procedures.
p.(None): Article 53.- The laboratory shall be obliged to provide the necessary samples for the corresponding analyzes.
p.(None): of quality control, as well as defray their costs.
p.(None): Article 54.- The laboratory must request readjustment of the amount of its stock in the case of materials
p.(None): Hygroscopic premiums.
p.(None): Article 55.- Raw material transformation operations for controlled products carried out by the
p.(None): laboratory, as well as requests made to the competent health authority must be endorsed by the
p.(None): Regent.
p.(None): Article 56.- Only narcotics, șicotropics, products and products may be imported into the national territory.
p.(None): Chemical substances controlled by the customs of Pueno Cortes, Toncontín, La Mesa and others that in the future authorize the
p.(None): competent health authority.
p.(None): Article 57.- Drugstores may sell controlled products to duly authorized doctors who provide
p.(None): its services in the rural area, where there are no pharmacies, for this purpose, the medical professional must
p.(None): submit the corresponding card issued by the competent health authority, which will be valid for a
p.(None): (1) Aryan.
p.(None): K MPUBLICA DE HON DIJRAS - TEGUCIGALPA, M. lß. C., NOVEMBER 4, 2005 N ".
p.(None): 30,841
p.(None): At ticle 58.- For the sale of narcotic patients that are carried out between pharmaceutical establishments,
p.(None): will require authorization issued by the competent health authority; the cornprav ent of psychotropics that
p.(None): It is rea1 i ce, Between pharmacist establishments will be sent through notification; the sale of substances
p.(None): 9UC controlled chemicals will be performed between companies will require authorization issued by the health authority
p.(None): competent.
p.(None): Article I 59.- Controlled products must be identified with a red “C” and the law of Jdil C {ue
p.(None): say "Product susceptible to dependence"
p.(None): ›Title 60.- The products of strict control cny‹ i sale requires a cspccial mćJica prescription, they will be subject to
p.(None): Dispositions of Title I, Articles 150 at 154 of the SKİ Code and may only be dispensed prior to
p.(None): presentation of the i specti goes written prescription with tetra cl ‹ira y n (legible, signed and
p.(None): sealed and must be dispensed by customer according to the regulations established for paia ta1 fi’i.
p.(None): Article 61.- The special recipe books for products of strict cont1’o1 will be provided
p.(None): pei‘sonalnsente in the Ministry of Health by the cornpctcnte authority to the isiédicos collegiate.
p.(None): Article 62.- In order to obtain the book of special documents, the doctor must:
p.(None): a) Submit the application personally, finalized and scllad ‹i.
p.(None): b) Presentai ’came of association.
p.(None): c) Make the corresponding payment.
p.(None): d) For the request of a new checkbook you must submit the previous one.
p.(None): e) Present record of the Medical Colcgio cynic is entitled to exercise.
p.(None): Article 63.-. The doctors, dentists and vetci’i l) íll’İOS ț3Od1’ÜJ keep in their briefcase up to two vials tie
p.(None): Birth of strict control conditioning its use to the character of cirergencia.
p.(None): Article 64.- The quantities that may be prescribed for products of strict control shall be determined by the CIC.
p.(None): according to the corresponding national and intentional protocols and technical standards.
p.(None): Article 65.- For the tixitainiento of chronic or terminal enfcrnaedades, the Co-competent Health Authority
p.(None): based on the medical diagnosis, it will authorize in writing to the pharmacological establishment Dispense ‘the products
p.(None): controlled indicating drug, daily dose and days of tralarniento.
p.(None): Article 66.-In the case of national or international health organizations or bripadas duly authorized quc
p.(None): do
p.(None): Floor or manejcn cstrlpcfacient and psychotropic adeirás deíaci.ili request ‹iritorización ¡For t‹ il fin ‹i la
p.(None): Authority Sani till Ìil competeiite, acornJsananclo the following information:
p.(None): a.- Garlic tl plan that includes place, beginning and duration ‹1c l‹ i activity,
p.(None): b.- List of pi odnctos, including noisilare genéi’ic ‹i and commercial, present‹ 1 Phyloraceuticals,
p.(None): concentration, quantity ‹l (‹ ›n numbers; / letters) and expiration date.
p.(None): Article: ulo 67.- Controlled pi'od ucts and not counted oItIt IS that is known only to be justified and t] ue
p.(None): seam aptOS .ll’il USE. the Dii’cccióú Gcneral de Salud coiiipctente You can dot iai to public hospitals
p.(None): similar entities that need cll ‹is, from which the minutes will be taken and the respective resolution will be issued.
p.(None): Artíi: iılo 68. The Regent and the owner are rcsponsablcs ‹le that do not exist for sale Pharmaceutical products
p.(None): expired cm cl establishment. The pharmacological laboratory fabricantc cs responsal: ale by means of the regelite
p.(None): de ladrogueríó COn csponclici ite de retirur tlel nacl cado los rnedicarnentos lio aptos print cl consume ›,
p.(None): c) If they are damaged or expired. The regent ‹lc the fanvaci‹ i is responsible for the expired product being broken £ Î Î
p.(None): ütm ›and separated cJe unredited licenses.
p.(None): SECTION IS PTI MA
p.(None): Dłlś LOS ESJ’ABLECI M IE NTOS OF I NTERI £ S
p.(None): SANITARY
p.(None): Artíi:! N'6'9.- Sc consider the establishment of public health interest İCOS O) 3l’iVíldOS, COn or without ends
p.(None): tle I ucro, aqur'l l ‹› s related to falv’ication, iirport ‹itiún, export‹ ’› n, transports:
p.(None): and co-commercialization of protucts of health interest ‹ii’iti and its raw materials; So I know who Dontle is
p.(None): re ‹il iz‹ in activi: s de pi’estación ale servicios direcìa fitntlansentaliiiciite a la prevention, cut ación,
...
p.(None): of pl products of intcrćs sanit.ii’ii ›, distributors of insulins and laboratory equipment, distritloi cs of
p.(None): raw materials of products of health interest, irl distl ibui ‹ioi cs of chemical substances, distributors of
p.(None): insilmos y equi¡ao ‹lc laboratories, tlisti ibudores de irlsrnros and rnérlico quiiiii’i: it. or, distributors
p.(None): of inputs and otlontological equipment, cstarán siljcl ‹› s
p.(None): g2 MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): to this regulation for which they must meet the minimum essential requirements related to structure
p.(None): physics and facilities, equipment, human resources, waste management, organization and operation
p.(None): established in the technical standard.
p.(None): Article 72.- The sanitary control of the establishments of sanitary interest will be exercised by the Ministry of Health for
p.(None): through the General Directorate of Sanitary Regulation, Department of Sanitary Control of Products, Services and
p.(None): Establishments or Delegated Department and the Departmental Regions and municipal authorities.
p.(None): Article 73.- The sale of drugstores and laboratories is strictly prohibited.
p.(None): narcotic drugs, psychotropic and other controlled drugs that may cause dependence or habit, to the positions of
p.(None): sale of medicines and in general to non-pharmaceutical establishments; such products will be subject to
p.(None): provisions established in Articles 150, 151, 152,153 and 154 of the Health Code.
p.(None): Article 74.- Drugstores may only sell products in the medical emergency kits.
p.(None): amounts established in the list approved by the competent health authority.
p.(None): Article 75.- The establishments will occupy independent premises according to the activity or service that
p.(None): lend and separate from any other commercial, residential establishment complying with the technical standard of
p.(None): minimum essential requirements.
p.(None): Article 76.- Establishments of Health Interest Complexity I and II may be installed in commercial centers,
p.(None): supermarkets, department stores and other similar establishments, in individual locations that
p.(None): guarantee the safety and hygiene of the services provided.
p.(None): Article 77.- All pharmaceutical establishments according to their category must comply with good manufacturing practices
p.(None): or product handling.
p.(None): Article 78.- The pharmaceutical shift is mandatory for all pharmacies where it is so established by the
p.(None): competent health authority, however, in times of epidemic or any other public need the Secretariat
p.(None): Health by resolution may order that all pharmacies provide such services continuously to the public,
p.(None): as long as the cause that originates persists.- The Ministry of Health will coordinate with the Ministry of Security
p.(None): protection to the establishment in turn.
p.(None): Article 79.- Every pharmacy will be under the responsibility of a regent, who is obliged to remain in the
p.(None): same
p.(None): within normal working hours and during the shift service, as well as health laboratories also
p.(None): They will be in charge of a regent.
p.(None): Article 80.- The competent health authority shall prepare and approve no later than December 10 of each year, the
p.(None): Annual shift schedules of pharmacies across the country, based on the projects proposed by the
p.(None): Associations of Pharmacy Owners and endorsed by the College of Chemist-Pharmacists of Honduras.- The cadres
p.(None): Shifts should be prepared according to the needs of each community and will be given the greatest possible disclosure
p.(None): in the first days of the month of January of the corresponding year.
p.(None): Article 81.- The pharmacies will fulfill the obligatory turn of attention to the public from 6:00 pm to 10:00 pm according to
p.(None): calendar prepared by the competent authority. This provision is without prejudice that other pharmacies provide the
p.(None): 24-hour public service, every day, subject to the provisions of this Regulation.
p.(None): Article 82.- Pharmacies, while they are providing the shift service, must have a visible place of
p.(None): establishment of a bright advertisement with clear characters that says “TURN” so that the public knows that the pharmacy
p.(None): He is rendering the service on an extraordinary day.
p.(None): Article 83.- Pharmacies will display in a visible place on the front of the establishment a sign with the payroll of the
p.(None): pharmacies on duty, with indication of their respective addresses.
p.(None): Article 84.- The Medicine Sales Posts must have a previously trained person and will be authorized by
p.(None): the competent authority.
p.(None): Article 85.- The Medicine Sales Posts will only sell the medicines included in the list
p.(None): approved by the competent sariitaria authority.-Its opening will only be authorized, in the places where they do not exist
p.(None): Pharmacies providing the service.
p.(None): Article 86.- The Emergency Medical Kit will be installed inside the authorized doctor's clinic.
p.(None): Article 87.- Medical Emergency First Aid kits may only keep medications according to the list authorized by the
p.(None): competent health authority.
p.(None): Article 88.- In Medical Emergency Kits, medications may not be sold directly to the public, only
p.(None): to doctor's patients, in case of emergency.
p.(None): Article 89.- The regent is the professional who assumes the technical and scientific direction of the establishments
p.(None): pharmacists
p.(None): ItEPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): and clinicians, being responsible for the good condition of the products and services provided as well as the
p.(None): contraventions to the legal and regulatory dispositions that derive from their operation.
p.(None): ‹'
p.(None): Article 90.- In the case of pharmaceutical establishments, the regent is responsible for control and custody
p.(None): of narcotic, psychotropic and other substances under control; any abnormality should be reduced
p.(None): immediately to the competent health authority.
p.(None): Article 91.- In the case of health facilities such as: medical, dental and medical care clinics
p.(None): veterinary, the management of psychotropic and other controlled products, will be the responsibility ‹le professionals
p.(None): competent.
p.(None): Article 92- Within any health facility, the certificate that will
p.(None): accredit as regent.
p.(None): Article 93.- In accordance with Article 160 of the Health Code, it corresponds to the Ministry of Health regular and
p.(None): promote the installation of registration and information systems for adequate technical, epidemiological and
p.(None): care of all public and private health institutions.- To comply with this provision, the
p.(None): General Directorate of Health Regulation in coordination with the corresponding bodies, will establish the rules and
p.(None): minimum procedures that all health facility operators must observe.
p.(None): Article 94.- The health establishments regulated in this Regulation are obliged to exhibit
p.(None): request of the General Directorate of Health Regulation, all those provisions and internal regulations that
p.(None): regulate health services and actions.
p.(None): Article 95.- The owners or legal representatives of the Establishments must inform the Secretariat of
p.(None): Health, in a term not exceeding thirty days, when they decide to stop providing temporary temporary services or
p.(None): definitive
p.(None): EIGHTH SECTION
p.(None): OF DEVICES AND USE EQUIPMENT
p.(None): SURGICAL DOCTOR
p.(None): Article 96.-The Ministry of Health corresponds through the General Directorate of Health Regulation, the
p.(None): sanitary regulation of importation, manufacturing, marketing, transportation, storage, handling and use of
p.(None): Devices and equipment for surgical medical use.
...
p.(None): e) Non-invasive used to modify the biological or chemical composition of blood or other liquids or
p.(None): body fluids, with the purpose of being introduced to the human body by infusion or other route of administration,
p.(None): whose characteristics mean that during the modification process a strange substance can be introduced into a
p.(None): potentially dangerous concentration.
p.(None): Article 99.- The Ministry of Health through the General Directorate of Health Regulation will prepare and approve
p.(None): by agreement the lists of devices and equipment for surgical medical use according to risk classification,
p.(None): same that must be updated periodically.
p.(None): Article 100.-The devices and equipment of surgical medical use Risk B, are those that can be indirectly
p.(None): invasive, which induce or store substances that at some time can be surgically implanted in the body
p.(None): human.
p.(None): Article 101.- Devices and equipment for surgical medical use Risk C, considered non-invasive or invasive that
p.(None): they present the lowest potential risk of harm to the patient and are devices that do not come into contact with the patient or
p.(None): They only do it superficially with the skin.
p.(None): Article 102.-Any device and equipment for surgical medical use that is intended to be donated must be subject to
p.(None): the provisions established in the External Cooperation Standards in force in the Ministry of Health.
p.(None): Article 103.-The competent Health Authority shall carry out inspection visits to the establishments and their
p.(None): devices and equipment for surgical medical use, in order to guide, educate and apply the measures
p.(None): corrective and corresponding health security.
p.(None): Article 97.-The devices and equipment for medical use Article 104.- All devices and equipment of
p.(None): Surgical medical use are classified according to your risk in: A (High Risk), B surgical entering the country must
p.(None): comply with the provisions of (Medium Risk), C (Low Risk). the
p.(None): corresponding standard.
p.(None): §J REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D.C. NOVEMBER 4, 2005 N °. 30.84
p.(None): CHAPTER VI
p.(None): OF PRODUCT LABELS AND CONTAINERS
p.(None): FIRST SECTION OF LABELS
p.(None): Article 105.- The labels of the products that are elaborated or commercialized in the national territory must
p.(None): contain the requirements that are determined in this Chapter, in the Customs Union Labeling Standard, and according to
p.(None): current regulations.
p.(None): Article 106.- On the label of domestic and foreign products, the following information must appear:
p.(None): a) Name of the product that must indicate its true nature, being normally specific or generic,
p.(None): that does not mislead or mislead the buyer or consumer.
p.(None): b) Name or business name of the owner, manufacturer or distributor of the product as applicable.
p.(None): c) Place of origin of the product, name of the country.
p.(None): d) List of ingredients or qualitative and quantitative formula as applicable.
p.(None): e) Lot number.
p.(None): f) Expiration date.
...
p.(None): SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST
p.(None): SECTION ONE GENERAL PROVISIONS
p.(None): Article 122.- To exercise the sanitary control of products, establishments and services, the Ministry of Health
p.(None): will use the following control mechanisms: Sanitary License, Sanitary Registry, Sanitary Inspection,
p.(None): Audits, Accreditation and Certification.
p.(None): Article 123.- If, in order to comply with the previous article, the use of other public laboratories or
p.(None): private, the Ministry of Health may use its services, ensuring that they are duly accredited by
p.(None): National or international institution recognized.
p.(None): Article 124.- The Ministry of Health may contract professional services for sanitary inspection,
p.(None): audits, accreditation and certification, if necessary.
p.(None): Article 125.- The Ministry of Health shall formulate the technical norms for hiring professional services.
p.(None): in the specific areas of health regulation.
p.(None): SECOND SECTION
p.(None): OF THE HEALTH LICENSE
p.(None): Article 126.- For the purpose of applying this Regulation, the establishments of health interest are classified as
p.(None): the following classes:
p.(None): Complexity I (Low Risk), complexity II (Medium Risk) and complexity III (High Risk).
p.(None): The Ministry of Health through the General Directorate of Health Regulation will issue the establishment list of
p.(None): according to this classification.
p.(None): Article 127.- Any establishment of health interest of complexity I, II and III, prior to its operation in the
p.(None): country requires an extended license by the competent health authority.
p.(None): Article 128.- The sanitary license for establishments of sanitary interest, at the option of the interested party, shall have
p.(None): validity of two (2), four (4) and six (6) years, from the date of its granting.- Except for
p.(None): the infractions to the sanitary laws or their regulations, the suspension or cancellation of the same is necessary.
p.(None): UNIT I
p.(None): OF THE REQUIREMENTS TO OBTAIN THE HEALTH LICENSE
p.(None): Article 129.-To obtain the sanitary license it is required:
p.(None): 1. Submit an application with the Sum indicating: HEALTH LICENSE IS REQUESTED, with the following information:
p.(None): a) Body to which it is addressed: General Directorate of Health Regulation or Departmental Regional Headquarters, according to
p.(None): correspond.
p.(None): b) Name and generals of the owner or legal representative of the establishment and the legal representative.
p.(None): ) Corporate name or company name
p.(None): d) Name of the establishment.
p.(None): e) Exact address of the establishment, including telephone, fax, email.
p.(None): Activity or activities to be dedicated. Place and date of the request
p.(None): Fimia of the applicant.
p.(None): 2.- Power granted to the legal professional.
p.(None): 3.- Photocopy of the deed of incorporation of the company or individual merchant, duly registered in the
p.(None): Registration of Real Estate and Commercial Property.
p.(None): 4.- Photocopy of the card of the professional who will act as Regent, or Medical Director, when appropriate.
p.(None): 5.- Payment receipt for health license services.
p.(None): 6.- Presentation of the plans of the physical, electrical, drinking water and wastewater facilities of the
p.(None): Establishment approved by the corresponding City Hall.
p.(None): TO.
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Vehicles and means of transpoi’te of food products and health services (ambulances, services
p.(None): mobiles) must present the report of the means of transport and legal document that proves it.
p.(None): UNIT II
p.(None): OF THE MODIFICATION OF THE LICENSE
p.(None): SANITARY
p.(None): Article 130.-The following cases are considered a modification of the sanitary license: transfer of ownership,
p.(None): modification of the name or business name of the establishment, transfer, remodeling, reconstruction, extension
p.(None): of goods and services and others that the health authority determines.
p.(None): Article 131.-Every owner or representative of establishments must request through a professional
p.(None): collegiate law, modifications of the sanitary license.
p.(None): Article 132.-The General Directorate of Sanitary Regulation shall authorize the modification of the sanitary license,
p.(None): by reasoned resolution after ruling, preserving the nomenclature and validity of the license granted
p.(None): initially. If the modification produces a change in the category of the establishment, the nomenclature is
p.(None): modify and apply the corresponding payment rate.
p.(None): of the Department of Sanitary Control of Products, Services and Establishments or Delegated Department, Units
p.(None): Regional Departmental and Municipal Regulation, grant the Sanitary Registry of Food, Beverages,
p.(None): Medicines and Related Products.
p.(None): Article 135.-It corresponds to the Ministry of Health through the General Directorate of Health Regulation through
p.(None): of the Department of Sanitary Control of Products, Services and Establishments or delegated department, grant the
p.(None): Sanitary Registry of controlled raw materials.
p.(None): Article 136.-The same sanitary registry may cover:
p.(None): 1. Variations of aromas or fragrances in different types of cosmetics (talc, deodorants, soaps,
p.(None): shampoo, conditioners, creams, etc.) as long as they do not become the main feature of the
p.(None): product (perfumes).
p.(None): 2. The different shades of color that are added to the
p.(None): different cosmetics (lipsticks, nail polish, soaps, hair dyes, makeup and blushes
p.(None): liquids, makeups and compact blushes, etc.).
p.(None): Article 137.- The same sanitary registry may cover:
p.(None): UNIT III
p.(None): OF THE NOMENCLATURE OF THE LICENSE
p.(None): SANITARY
p.(None): Article 133.- The health license shall have the following nomenclature:
p.(None): b) The number that corresponds to the Departmental Health Region.
p.(None): c) The number that identifies the municipality in which the establishment is located.
p.(None): d) Two (2) letters and two (2) numbers that identify type of establishment.
p.(None): e) Six (6) digit correlative numbering, with which the establishment is identified in the records,
p.(None): starting with the number 000001.
p.(None): fj Four digits corresponding to the month and year in which the sanitary license is granted
p.(None): THIRD SECTION
p.(None): OF THE SANITARY REGISTRY UNIT I
p.(None): GENERAL DISPOSITION
p.(None): Article 134.- It corresponds to the Ministry of Health through the General Directorate of Health Regulation through
p.(None): 1. Variations of aromas or fragrances in different types of hygiene products and chemicals
p.(None): as long as they do not become the main feature of the product.
p.(None): 2. The different shades of color that are added to the different types of hygiene products and products
p.(None): Chemicals
p.(None): Article 138.-All food products, beverages, medicines, biological, homeopathic and related products, which are
p.(None): commercialize or dispense with a specific name requires a health record issued by the Ministry of Health to
p.(None): through the competent health authority.
p.(None): Article 139.- The validity of the sanitary registry shall be five
p.(None): (5) years from the date of its granting, except for violations of health regulations and laws or
p.(None): By regulation, the competent authority resolves its cancellation.
p.(None): Article 140.-It is not allowed to manufacture, import, store, transport, distribute, package, market wholesale
p.(None): or in detail, dispense or advertise any product indicated in the preceding Article 138 that does not have
p.(None): sanitary registration, notwithstanding the provisions of Article 144 of these Regulations.
p.(None): Article 141.-Foods not subjected to any processing or packaging process, as well as raw materials
p.(None): of the
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Other products of health interest do not require sanitary registration, but they will be subject to surveillance and
p.(None): control exercised by the health authority.
p.(None): Article 142.-Food products, beverages, medicines and related products, and others produced in
p.(None): Central America and other countries where equal treatment is granted to those produced in our country, will be
p.(None): subject to treaties or agreements signed by the State of Honduras.
p.(None): Article 143.-The General Directorate of Health Regulation may exceptionally authorize the importation of products
p.(None): food, beverages, medicines, biologicals and related products, without having obtained the sanitary registration, which
p.(None): they will be subject to control and without paying the fees for analysis and registration services established by this Regulation,
p.(None): in the following cases:
p.(None): a) When circumstances of disasters and emergencies arise, qualified by decree of the Power
p.(None): Executive.
p.(None): b) In the case of samples in the necessary quantities required by the competent General Directorate for
p.(None): Health registration process.
p.(None): c) In the case of donations to state or charitable institutions, prior resolution of the Directorate
p.(None): General of competent Health.
p.(None): d) In the case of orphan drugs.
p.(None): Article 144.-The Executive Directorate of Revenue through its dependencies will only allow entry into the country of
p.(None): food products, natural, biological, cosmetics, pharmaceuticals, products subject to control
p.(None): national and international and others that the health authority determines, if it proves to have a health record or
p.(None): current authorization issued by the competent health authority of the Ministry of Health.
p.(None): In the case of controlled products prior to entering the country, you must accredit Certificate of Authorization
p.(None): Import Officer extended by the competent authority.
p.(None): Any official or public employee who allows the entry of the aforementioned products without complying with the
p.(None): requirement established in this article will be denounced before the Public Ministry to be deducted
p.(None): case responsibilities.
p.(None): determine, in the facilities of the importer or distributor and there they will remain until you obtain the registration
p.(None): respectively, the necessary controls will be established for this purpose, without prejudice to the corresponding sanctions.
p.(None): UNIT II
p.(None): OF THE REQUIREMENTS TO OBTAIN THE SANITARY RECORD
p.(None): Article 146.-To obtain the sanitary registration, you must comply with the following general requirements:
p.(None): 1) Submit an application with the Sum indicating: SANITARY REGISTRATION IS REQUESTED, with the following information:
p.(None): a) Body to which it is addressed: General Directorate of Health Regulation or Headquarters of the Departmental Health Region,
p.(None): as appropriate.
p.(None): b) Name and generals of the owner or legal representative of the establishment and the legal representative.
p.(None): c) Corporate name or company name.
p.(None): d) Exact address of the establishment, including telephone, fax, email.
p.(None): e) Data and classification of the product: Commercial name and / or generic name, manufacturer, type of product, country of
p.(None): origin and / or manufacture and Sanitary License number of the establishment that manufactures or markets it, when the
p.(None): Product is of national origin.
p.(None): f) "type of packaging or primary and secondary packaging.
p.(None): g) Commercial form or presentation.
p.(None): ) Place and date.
p.(None): j) Signature of the applicant.
p.(None): k) To this application adhere a stamp of L. 50.00 per product.
p.(None): 2.- Primary and secondary labels / packaging or your project that contains information in accordance with the technical standard of
p.(None): current labeling.
p.(None): 3.- Product samples in quantity according to technical standard. 4.- Power of attorney granted to the legal professional
p.(None): duly
p.(None): authenticated if applicable.
p.(None): 5.- Receipt of payment granted by the Ministry of Health for rights to process sanitary registration and services
p.(None): of analysis.
p.(None): Specific requirements:
p.(None): I. For food products and beverages must present:
p.(None): a) Qualitative and quantitative product formula.
p.(None): b) Certificate of Free Sale for imported products.
p.(None): c) In the case of imported products that cannot be credited
p.(None): Article 145.- The health authority in qualified cases requirements a and b, must present
p.(None): document that may dictate the retention of food products, beverages, declare the formula
p.(None): qualitative, table of factors medicines and related products and others that the health authority
p.(None): Nutrition and affidavit of the importer of
p.(None): SJ REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84i.
p.(None): product where responsibility for the quality and safety of it is assumed.
p.(None): II.- Pharmaceutical products also require the following technical information:
p.(None): a) Qualitative and Quantitative Formula complete, signed and stamped by the responsible Pharmaceutical Chemist.
p.(None): (Original).
p.(None): b) Commercial presentation (s).
p.(None): ) General method of elaboration
p.(None): d) Product monograph.
p.(None): f) Phase III clinical studies of the product (for new molecules in the market)
p.(None): g) Technical specifications of the product.
p.(None): h) Justification of the commercial presentation and of the pharmaceutical form, based on the dose and duration of the
p.(None): treatment. International standards or standards.
p.(None): j) Analytical method validated by the manufacturing laboratory when the product is not pharmacopeic.
p.(None): k) Quality control certificate of the active substance and finished product.
p.(None): Document proving the commercial relationship between the owner and the manufacturer of the products, when they are
p.(None): different.
p.(None): m) Stability study, in accordance with established norm.
p.(None): n) Mandatory insert or your project in over-the-counter products, when the required information is not found in
p.(None): the primary or secondary packaging according to current labeling standard.
p.(None): Free Sale Certificate in the country of origin or certificate of WHO pharmaceutical product.
p.(None): p) Certificate of Good Manufacturing Practices (in case it is not attached to the free sale certificate,
p.(None): export or equivalent document) where it is established that the laboratory is subject to periodic inspections by the
p.(None): corresponding regulatory entity.
p.(None): III.- Biological products, in addition to what is required
p.(None): previous:
p.(None): a) Technical product information.
p.(None): b) Preclinical information
p.(None): ) Clinical information
p.(None): d) Document issued by the regulatory authority of the country of origin, related to the cold chain.
p.(None): e) Certificate of lot release issued by the competent authority of the country of origin.
p.(None): Due to their complexity, the different pniebas to request these products will be based on what is established in the series of
p.(None): WHO technical reports, Volume XII.
p.(None): g) Document proving that the product must be prequalified by WHO or by the regulatory authority of a
p.(None): country recognized by WHO.
p.(None): Article 147.- To market the vaccines after obtaining the sanitary registration, the interested party must obtain
p.(None): batch release approval submitting documents
p.(None): a) Batch release certificate, issued by the competent authority of the country of origin.
p.(None): b) Summary protocol of production of the reference lot.
p.(None): c) Summary protocol of the quality control of the last three lots.
p.(None): d) Others determined by the National Technical Standard.
p.(None): Article 148.- To market the blood products, the following must be accredited:
p.(None): a) Origin of plasma
p.(None): b) Type of donors
p.(None): c) Controls to donors
p.(None): d) Evidence of commercialization
p.(None): e) Viral inactivation methods
p.(None): í) Others contemplated by national legislation or international standards
p.(None): Article 149.- For cosmetic products in addition to the general requirements established in Article 146,
p.(None): You must comply with the following:
p.(None): a) Free Sale Certificate, export or equivalent document of the authenticated country of origin.
p.(None): b) Specifications of the finished product.
p.(None): c) Qualitative formula of the product stating the quantities of restricted or controlled substances
p.(None): when applicable
p.(None): Article 150.- For hygienic products and chemical products, in addition to the general requirements established in
p.(None): Article 146 must comply with the following:
p.(None): a) Certificate of Free Sale, export or equivalent document, authenticated.
p.(None): b) Product Safety Sheet in accordance with international standard when applicable.
p.(None): c) Original document containing the qualitative formula, signed and stamped by the responsible technical professional.
p.(None): d) Method and standards (with its certificate of purity) for laboratory analysis, (in the case of pesticides for use
p.(None): domestic, industrial and public health).
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p.(None): Article 151.- For natural products, in addition to the general requirements established in Article 146 must
p.(None): comply with the following:
p.(None): a) Methodology of physicochemical and microbiological analysis.
p.(None): b) Specifications of the finished product.
p.(None): Article 152.- For surgical and dental medical devices and supplies, you must present:
p.(None): a) Free Sale Certificate for imported products.
p.(None): b) In case you cannot prove requirement a), you must submit an affidavit from the importer of the product
p.(None): where responsibility for the quality and safety of it is assumed.
p.(None): UNIT III
p.(None): REGISTRATION RECOGNITION
p.(None): SANITARY
p.(None): Article 153.- To obtain the Health Registry Recognition of food, beverages, medicines and products
p.(None): related, will be regulated in accordance with international conventions or treaties ratified by Honduras.
p.(None): Article 154.- It is the obligation of the holder of the recognized sanitary registry to issue the instructions to the distributor to
p.(None): in order to facilitate inspectors the necessary sampling of products.- Samples will be taken in
p.(None): Any establishment of the marketing or service chain.- The number of samples will be in accordance with
p.(None): the Technical Standard; The results of the analyzes will be delivered to the regulatory authority and to the holder of the registry
p.(None): sanitary or to the distributor, in a maximum period of thirty (30) days.
p.(None): UNIT IV
p.(None): REGISTRATION MODIFICATION
p.(None): SANITARY
p.(None): Article 155.-Every holder of the sanitary registry must request from the competent sanitary authority, modification of the
p.(None): sanitary registration, when changes of any existing condition occur at the time of being initially granted, such as
p.(None): be: name of the manufacturer or distributor of the product, name of the registered product, of the business name, of the container,
p.(None): of the label and packaging, of the commercial presentation, of the excipients of the product that do not change the nature
p.(None): of the product.- The application will be processed expeditiously.
p.(None): Article 156.- The competent sanitary authority shall authorize the modification of the sanitary registry, keeping the
p.(None): same nomenclature and validity of the registry initially granted.
p.(None): Article 157.- Pharmaceutical and natural products that undergo modification of the active substance, form
p.(None): pharmaceutical, chemical formula, concentration of active substance, excipients that modify the nature of the
p.(None): Products, route of administration, country of origin of the manufacturer, must be processed with a new sanitary registration.
p.(None): Article 158.- In the case of food products, beverages, and related products, which undergo modification of the principle
p.(None): active, chemical formula, concentration of active principle, excipients that modify the nature of the products, via
p.(None): of administration, country of origin of the manufacturer, must be processed with a new sanitary registration.
p.(None): UNIT V
p.(None): REGISTRATION NOMENCLATURE
p.(None): SANITARY.
p.(None): Article 159.- The sanitary registry shall have the following nomenclature:
p.(None): a) Capital letters RS: What does the Sanitary Registry mean?
p.(None): b) The number corresponding to the Departmental Health Region, where applicable.
p.(None): The letter and number that identify the class and type of product.
p.(None): d) Four digits corresponding to the month and year in which the Sanitary Registry is granted.
p.(None): e) Six (6) digit correlative numbering, with which the product is identified in the records, starting
p.(None): with the number 000001.
p.(None): UNIT VI
p.(None): OF THE PROCESS OF THE LICENSE AND REGISTRATION
p.(None): SANITARY
p.(None): Article 160.-Once the application is submitted, it will be verified if it contains the requirements established in the chapter
p.(None): above and if not met, the petitioner will be required so that within the corresponding term established in
p.(None): the Administrative Procedure Law proceed to complete it with the warning that if it does not do so,
p.(None): will file the proceedings without further processing. If requested, the documentation will be returned to the interested party.
p.(None): Article 161.-The competent health authority shall issue a ruling taking the application as admitted and ordering
p.(None): send the proceedings to the corresponding instance, with the object that within twenty (20) days
p.(None): Skills carry out the inspection of the establishment or the analysis of. respective laboratory.
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p.(None): The competent authority shall provide whether laboratory tests are performed or not, as well as which tests and tests
p.(None): perform. The original samples, technical product information, the original samples will be sent to the respective laboratory
p.(None): standards of active ingredients, with the order of analysis.
p.(None): The following products will not require analysis for sanitary registration purposes: chemical elements not
p.(None): controlled, uncontrolled chemicals, hygienic products, cosmetics, topical products,
p.(None): uncontrolled chemicals, dietary supplements, laboratory reagents, raw materials, food
p.(None): risk b and c.
p.(None): In any case, they will pay the respective rights for health surveillance and control.
p.(None): Article 162.- The authority that has carried out the inspection must deliver within three (3)
p.(None): working days the minutes drawn up with the corresponding technical information by sending it to your immediate superior manager.
p.(None): Article 163.- Received the minutes and technical report referred to in the preceding article, the General Directorate of
p.(None): Sanitary Regulation or the Departmental Regional Headquarters, will transfer the administrative file to the Legal Unit
p.(None): so that within three (3) business days issue the corresponding opinion; This Unit will return said file to the
p.(None): General Directorate of Health Regulation or the Departmental Regional Headquarters, so that within five (5) days
p.(None): next business issues the reasoned resolution granting or denying the requested license.
p.(None): Article 164.- The instance that has practiced laboratory analyzes, in the case of food products,
p.(None): you must deliver within the term of fifteen (15) business days the corresponding technical report by sending it
p.(None): to your immediate superior boss for your respective opinion. In the case of food products, beverages,
p.(None): medicines and related products and natural products, the results of laboratory quality control
p.(None): official or other designated by the Ministry of Health, will be delivered in a term up to twenty (20) days
p.(None): Skilled to the Delegated Department, who will prepare the corresponding technical report. In both cases you must be
p.(None): Deliver a copy of the laboratory analysis to the interested party at no cost.
p.(None): Article 165.- Once the technical report indicated in the previous article has been completed, the competent Delegated Department
...
p.(None): the Regional Department of Health, so that within a term of five (5) business days issue resolution
p.(None): motivated, granting or denying the sanitary registration.
p.(None): UNIT VII
p.(None): ON THE RENEWAL OF THE LICENSE AND HEALTH REGISTRATION
p.(None): Article 166.- For the renewal of the Sanitary license of the Establishments and sanitary registration of the
p.(None): products, must be requested before the competent General Directorate or Head of Departmental Health Region, to
p.(None): through the legal representative or legal representative, within three (3) months for the health license of the
p.(None): establishments and five (5) months for sanitary registration of products, prior to the expiration date. May
p.(None): have extemporaneous renewal up to six (6) months after the expiration date of the license or registration
p.(None): health, paying the rights to registration, in addition to a fine, whose value should not be less than the cost of registration
p.(None): sanitary. In any case, you must submit a certified affidavit stating that
p.(None): maintains the original conditions under which it was granted.
p.(None): Otherwise, you must carry out the procedure, indicated in Articles 130 and 146, as the case may be.
p.(None): In any case, be it renewal or new procedure, it will keep the original license number or sanitary registration.
p.(None): Article 167.- The period of validity expired without having requested the renewal of the license and registration
p.(None): health, will proceed according to the sanction regime.
p.(None): Article 168.- The payment of the rights by license and sanitary registration, as by the services of surveillance and
p.(None): Health control will be assumed by the interested party and canceled in the place determined by the health authority
p.(None): competent.
p.(None): FOURTH SECTION
p.(None): OF THE HEALTH INSPECTIONS
p.(None): Article 169.- The inspectors of the Ministry of Health, duly certified and accredited in the exercise of their
p.(None): functions, within their working hours and overtime when designated by their superior, will have
p.(None): free access to establishments, premises or sites of health interest, prior to the inspection order issued
p.(None): by the Competent Health Authority, in order to verify compliance with related sanitary standards
p.(None): with:
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): 1. Production, processing, handling, packaging, storage, conservation, transportation, distribution,
p.(None): dispensing, import, export of products of health interest.
p.(None): 2. Provision of health services.
p.(None): 3. Advertising and propaganda of health products, services and establishments of health interest.
p.(None): 4. Waste management generated by the establishments.
p.(None): 5. Occupational safety and industrial safety.
p.(None): 6. Hygienic conditions of the establishments.
p.(None): 7. Products.
p.(None): 8. Good Manufacturing Practices, in force in the Industry.
p.(None): Article 170.-The General Directorate of Health Regulation shall define and establish the technical procedures and
p.(None): operational for the verification of the requirements in health interest establishments.
p.(None): Article 171.- The owners, representatives or managers of the establishments, premises or sites, remain
p.(None): obliged at any time to allow the entry of certified inspectors of the Ministry of Health.
p.(None): Article 172.- Inspections may be ordinary, carried out during the normal working day of the
p.(None): Health Authority and extraordinary, when carried out at any other time, due to sanitary surveillance,
p.(None): attention to complaints or emergencies for presumption of health risk.
p.(None): Article 173.- The Health Authority will have free access to all premises and facilities dependencies.
p.(None): of sanitary interest, being obliged the owner, representative or responsible to give all kinds of
p.(None): facilities and provide the reports of health interest that are required.
p.(None): Article 174.- The refusal of the owner, representative or responsible for the establishment of health interest, for
p.(None): to punish the access of the Sanitary Authority, will be sufficient reason to resort to the police authority, with the
p.(None): object that obliges it to allow inspection, without prejudice to the corresponding sanctions.
p.(None): Article 175.- The sanitary inspection must be oriented to verify compliance with the minimum requirements
p.(None): essentials established according to the activity to which it is based on the guides of current good practices that
p.(None): apply
p.(None): Article 176.- The inspection shall not be limited only to the punitive aspects, but also to those related to
p.(None): guidance in health education and motivation in compliance with legal and regulatory provisions.
p.(None): Article 177.- The sanitary authority, when performing the inspection in any establishment of sanitary interest,
p.(None): will take official minutes of the proceedings.
p.(None): At the end of the inspection, the person responsible for the establishment will be given the opportunity to state what is in his right
p.(None): agrees, recording it in the minutes to be drawn up, and the latter must also sign said minutes.- In case of refusing to
p.(None): sign will be entered in it, being the actaválida.
p.(None): At the end of the inspection, a copy of the minutes must be delivered to the person in charge of the establishment, stating
p.(None): this made in the original
p.(None): Article 178.- The sanitary conditions found shall be recorded in the inspection record and the
p.(None): Correction to the identified problem.- The testimonies of other persons present and of
p.(None): any document or part of it, when necessary, always trying to avoid causing inconvenience
p.(None): or unnecessary damages.
p.(None): Article 179.- The sanitary authority that has carried out the inspection shall deliver to the higher authority in the
p.(None): term of the twenty-four (24) hours following his return to the workplace, the minutes drawn up and the samples
p.(None): taken, according to the established norm if applicable.
p.(None): Article 180.- The health authority must prepare the corresponding minutes when taking samples that
p.(None): are necessary in health surveillance, to perform the relevant laboratory analyzes and investigations,
p.(None): in order to establish the identity, quality, condition of the products or verify that they satisfy the
p.(None): requirements established in the sanitary norms, having to indicate in the minutes the form of sampling, name of the
p.(None): product, weight and quantity of samples taken.- The minutes must be signed by the people involved in the act
p.(None): and in case of refusal of the person in charge of the establishment, this will be stated, signing the witnesses, or that they
p.(None): They do not want to sign will be recorded in it, being the valid act.
p.(None): Article 181.- The samples that are taken for the inspection, will be representative, individualized,
p.(None): sealed to be inviolable, preserved in order to protect the characteristics according to the regulations
p.(None): in force and will be sent to the corresponding laboratory, within the next twenty-four hours, so that
p.(None): practice the corresponding analyzes.
p.(None): Article 182.- The Health Authority in qualified cases may dictate the retention of food products,
p.(None): beverages, medicines and related products and others that the Health Authority determines, in the facilities of the
p.(None): importer or distributor and will remain there until said Authority resolves according to the problem presented by the
p.(None): product up to a term of thirty
p.(None): (30 days.
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p.(None): 30.84i
p.(None): FIFTH SECTION
p.(None): OF CERTIFICATES AND AUTHORIZATIONS
p.(None): UNIT I ‹
p.(None): OF THE REQUIREMENTS TO OBTAIN CERTIFICATES OF FREE SALE, IMPORT AND EXPORT OF CONTROLLED PRODUCTS
p.(None): AND GOOD MANUFACTURE PRACTICES.
p.(None): Article 183.- In order to obtain the certificates, it must be submitted to the competent health authority,
p.(None): written request, which must contain the following requirements:
p.(None): a) Sum indicating: The Procedure in question.
p.(None): b) Body to which it is addressed: “General Directorate of Health Regulation”.
p.(None): c) Product name
p.(None): d) Corporate Name of the product owner and manufacturer
p.(None): e) General data of the applicant
p.(None): f) Address of the owner and manufacturer.
p.(None): g) Nomenclature of the current sanitary registration of the product and / or the Sanitary License when applicable.
p.(None): h) Place and date of the request.
p.(None): i) Signature and stamp of the applicant.
p.(None): j) Date of arrival of the shipment
p.(None): k) Route through which you will enter and name of the Customs.
p.(None): l) Identification of the means of transport.
p.(None): m) Pro-Forma Invoice that identifies the type, type and quantity of product or raw material.
p.(None): The request must be accompanied by the payment receipt for services.
p.(None): I.- For Export Certificates of Controlled Products, you must also comply with:
p.(None): a) Import Certificate issued by the competent Authority of the importing country.
p.(None): b) Name and address of the exporter and importer and the consignee.
p.(None): ) Product name.
p.(None): d) Quantity of the product to be exported.
p.(None): e) Customs office of entry and exit.
p.(None): Shipping date
p.(None): g) Document proving the Regent Pharmaceutical Chemist responsible for the custody of the product.
p.(None): Article 184.- The Certificate of Free Sale will be valid for two (2) years from the date of its
p.(None): Issue.- In the case of the sanitary registration that expires before this period, the validity of the certificate will be the
p.(None): same of the sanitary registry.
p.(None): The Certificate of Good Manufacturing Practices will be valid for one (1) year from the date of issue
p.(None): and its procedure will be done in accordance with the procedure established in section V of this Regulation and the norm
p.(None): established.
p.(None): The Export Certificate of controlled products will be valid for ninety (90) days and will be necessary
p.(None): Request one for each shipment.
p.(None): The Import Certificate of controlled products will be valid for one hundred and fifty (150) days and will be
p.(None): necessary to request one for each shipment, it will be valid only once
p.(None): Article 185.- The interested party in obtaining the Official Import Certificate for psychotropic substances and
p.(None): narcotics must submit to the General Directorate of Health Regulation the request relating the
p.(None): Following data:
p.(None): a) Name of the Regent or company manager.
p.(None): b) Name and address of the importer and exporter.
p.(None): c) Name of the pharmaceutical establishment that represents
p.(None): d) Provider Name
p.(None): e) Quantity
p.(None): í) Concentration if it is the case of finished product
p.(None): g) Product name
p.(None): h) Date of admission
p.(None): i) Customs office of entry
p.(None): j) Origin of shipment
p.(None): k) Bell of Lps. 5.00 (five lempiras) for each request.
p.(None): Article 186.- Narcotic drugs, psychotropic and controlled chemical substances may only be exported by
p.(None): laboratories and drug stores to establishments legally authorized for this purpose in the importing country.
p.(None): UNIT II
p.(None): THE PROCESS OF CERTIFICATES
p.(None): Article 187.- Once the application has been submitted, it will be registered in the corresponding book of entries, after which
p.(None): will verify if it contains the requirements established in the preceding articles.- If it does not meet them, it will be required to
p.(None): petitioner so that within ten (10) business days he may complete it, with the warning that
p.(None): Do it, the proceedings will be filed without further processing. If requested by the interested party, the
p.(None): documentation to the interested party.
p.(None): Article 188.- Admitted the request, within five (5) business days following the delegated health authority,
p.(None): will issue a reasoned resolution granting or denying the requested certificate.
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p.(None): UNIT III
p.(None): OF PRODUCT INCOME AND RAW MATERIALS
p.(None): Article 189.- For the importation of controlled chemical products and substances, official authorization is required.
p.(None): extended by the competent health authority.
p.(None): Article 190.- Food and beverages that are imported by anyone who is not the natural or legal person who
p.(None): registered and that does not have an exclusive distributor, must be registered, subjecting it to laboratory analysis by batch
p.(None): when the competent health authority deems it necessary, and the respective rights must be paid.-
p.(None): Imported products must comply with the labeling standard in force in the country.
p.(None): Article 191.- Prior to the clearance of all controlled products, the Executive Directorate of Revenue through the
p.(None): customs, will require the importer the Official Import Authorization extended by the General Directorate of
p.(None): Sanitary Regulation For this purpose, coordination mechanisms will be established at their different levels.
p.(None): In addition to the Official Import Authorization, pharmaceutical products and controlled quínucas substances
p.(None): they will be inspected and authorized by the competent health authority, who will sign and seal the document of
p.(None): import, prior to its clearance.
p.(None): Article 192.- In case the importer does not comply with the requirement of the Official Import Certificate, for
p.(None): psychotropic and narcotic substances and controlled chemical substances should be re-exported to your country
p.(None): of origin and the importer
p.(None): shall assume the conditions caused by the surveillance and contingency actions, exercised by the health authority without
p.(None): damage of the respective legalization process and of the sanctions that are imposed by
p.(None): violation of the provisions of this Regulation.
p.(None): Article 193.- In the case of rejection of imported products and raw material that is carried out in accordance with
p.(None): established in the Health Code and these Regulations, the General Directorate of Sanitary Regulation shall notify
p.(None): to the health authorities of the country of origin, so that the relevant measures in health protection of
p.(None): the consumers.
p.(None): UNIT IV
p.(None): OF THE PROCESS OF THE APPLICATION
p.(None): Article 194.- Once the application has been submitted, it will proceed to be registered in the corresponding book of entries then
p.(None): will verify if
p.(None): It contains the requirements established in the preceding articles.- If it does not meet them, the petitioner will be required
p.(None): so that within ten (10) business days proceed to complete it, with the warning that if not,
p.(None): the proceedings will be carried out without further processing. If requested, the documentation will be returned to the interested party.
p.(None): Article 195.- Admitted the request, within five (5) business days following the health authority
p.(None): competent, will issue a reasoned resolution granting or denying the requested authorization.
p.(None): Article 196.- Prior to the authorization of the clearance of controlled chemical products and substances, the Authority
p.(None): Sanitary competent in coordination with the General Directorate of Customs must check the contents of the shipment
p.(None): Checking it with the Official Import Authorization.- If they do not conform to the established sanitary norms,
p.(None): order its re-export to the place of origin, after a reasoned resolution of the competent health authority.
p.(None): CHAPTER VIII
p.(None): OF THE BROADCASTING OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF INTEREST
p.(None): SANITARY
p.(None): Article 197.- The Ministry of Health shall establish the criteria for the Advertising of Sale Medicines without
p.(None): Medical Prescription or Prescription Without Prescription (OTC).
p.(None): Article 198.- The advertising of products, services and establishments of health interest must conform to the
p.(None): truth and therefore the benefits that its use or use may offer cannot be overstated,
p.(None): control corresponds to the competent health authority.
p.(None): Article 199.- The health authority shall prohibit the advertising of products, services and establishments of interest.
p.(None): health in the following cases:
p.(None): a) When it contravenes the general rules applicable to health, nutrition or therapeutic education.
p.(None): b) When expressing properties or benefits that induce deception or error.
p.(None): c) When you impute, defame or make pejorative comparisons
p.(None): for other products and establishments of health interest and services.
p.(None): M REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84
p.(None): d) When the message is contrary to the law or good customs.
p.(None): e) When the products are authorized for sale with a prescription or retained prescription.
p.(None): , '
p.(None): f) When it is incompatible with the professional condition or discipline of the people who promote them.
p.(None): Article 200.- The Ministry of Health is obliged to permanently inform the general public and the
p.(None): Health professionals lists generic interchangeable drugs from laboratories that meet the
p.(None): rule.
p.(None): Article 201.- The General Directorate of Health Regulation will issue the corresponding regulations to regulate the
p.(None): advertising and promotion of products, services and establishments of health interest.
p.(None): Article 202.- The health authority, as the governing body for the registration and control of medicines in its
p.(None): different processes, you must control the advertising of over-the-counter medicines, complying with the criteria
p.(None): following:
p.(None): a) They are promoted only with the information and arguments approved by the competent health authority.
p.(None): b) Do not suggest that the use of these medications can delay or avoid using a doctor.
p.(None): c) Do not suggest its use permanently, limiting the term of authorized administration.
p.(None): d) Do not use phrases or words that exaggerate the benefits of the product in the text.
p.(None): e) They are expressed in colloquial language, without using medical or technical terms that confuse the consumer.
p.(None): f} Do not use testimonial arguments of notorious persons or entities in teaching, research or
p.(None): Health sciences, which can induce consumption.
p.(None): CHAPTER IX
p.(None): OF BREACHES, SANCTIONS AND PROCEDURES
p.(None): SECTION ONE GENERAL PROVISIONS
p.(None): Article 203.- Any infraction by intentional act or omission or negligence that contravenes the
p.(None): provisions of the Health Code, these Regulations, the Technical Standards or the provisions issued by the Secretariat in
p.(None): the exercise of its functions and competences, committed by the owner
p.(None): representative of the establishment and the workers who are at the service of the same, which harms or
p.(None): may harm the legal good protected from life and the health of the population will be repressed with one or more of
p.(None): the sanctions referred to in Article 206 of this Regulation, taking into account their significance
p.(None): to the detriment of the health of the population and its recidivism, by reasoned administrative act without prejudice to the
p.(None): civil and criminal liability incurred.
p.(None): Article 204.- For the purpose of applying the sanctions contained in this Regulation, the infractions are
p.(None): classified as follows:
p.(None): a) Slight lack
p.(None): b) Less serious offense; Y,
p.(None): c) Serious foul.
p.(None): Article 205.- The application of sanctions for violation of this Regulation shall be carried out in accordance with
p.(None): the procedure established and guaranteeing at all times the right of defense to the accused; the penalties will be
p.(None): applied after resolution issued by the Director General or Departmental Regional Chiefs, based on the
p.(None): mandatory and optional reports and opinions of the corresponding technical and legal units.
p.(None): Article 206.- The sanctions that the sanitary authorities must impose for the inquiries to the dispositions
p.(None): contained in these Regulations are the following:
p.(None): a) Written warning
p.(None): b) Single or successive fines, depending on the case, ranging between twenty lempiras (L. 20.00) and fifty thousand lempiras
p.(None): (L. 50,000.00).
p.(None): c) Confiscation of products, substances or artifacts.
p.(None): d) Suspension or cancellation of health records or licenses.
p.(None): e) Temporary or definitive closure of buildings and establishments.
p.(None): Article 207.- For the application of the sanctions referred to in the previous Article, the health authority shall have
p.(None): Discretionary account of the following:
p.(None): a) The importance of the infraction to the detriment of the health of the population.
p.(None): b) The recidivism in the infraction or omission of the sanitary dispositions.
p.(None): MPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C .; NOVEMBER 4, 2005 N ‘. 30,841
p.(None): c) To incur the infraction with full knowledge of its harmful and harmful effects on the health of the
p.(None): population either as author or accomplice.
p.(None): d) Committing the infraction with the purpose of hiding another '.
p.(None): e) Shun the responsibility or attribute it to another or others.
p.(None): Article 208.- The imposition of any of the sanctions indicated in this chapter shall be made without prejudice to requiring
p.(None): to the offender responsible for compliance with the measures determined by the health authority, for the purpose that
p.(None): the effects of the infraction are repaired or minimized as the case may be, for which the term shall be indicated
p.(None): correspondent.
p.(None): Article 209.- The fines that are imposed must be made effective in compliance with the Recovered Funds Regulations.
p.(None): of the Ministry of Health, within the term of ten (10) business days from the date on which
p.(None): notify the offender of the resolution; The amount of the financial penalty may not be reduced or waived.
p.(None): Article 210.- Failure to comply with the resolutions emanating from the health authority shall be sufficient grounds for
p.(None): execute them by means of the forced fulfillment contemplated in Articles 109 and 110 of the Law of Procedure
p.(None): Administrative, for which the Health Authority will request the support of the National Police or the Municipal Authority
p.(None): correspondent.
p.(None): Article 211.- The temporary closure of an establishment entails the suspension of the Sanitary License and may
p.(None): be issued for up to thirty (30) calendar days
p.(None): If the causes that gave rise to the sanction disappeared, the interested party's request has been filed, the authority
p.(None): corresponding sanitary, prior to its * erification will resolve its reopening and restitution of the sanitary license
p.(None): Article 21 2.- The definitive closure of an establishment entails the cancellation of the Sanitary License.
p.(None): Article 213.- To proceed to the temporary or definitive closure of an establishment that violates provisions
p.(None): legal and regulatory, the competent health authority will place posters
p.(None): In the case of temporary closure, access to the establishment will be allowed to maintain the equipment or
p.(None): machinery that by its nature require special care.
p.(None): In the case of definitive closure the offender will have access to the establishment to remove the machinery, equipment,
p.(None): furniture and other prior authorization of the competent authority.
p.(None): Article 214.- To retain or deposit products, goods, raw materials, substances and others, you must
p.(None): the respective inventory and official certificate signed by the interested party, two witnesses and the health authority be taken up;
p.(None): proceeding to place seals or seals that guarantee their conservation and permanence in the establishment
p.(None): inspected.- In case of not wanting or being able to sign the witnesses and / or the interested party, it will be recorded in the minutes,
p.(None): which does not invalidate it.
p.(None): Article 215.- In order to comply with the provisions of the Health Code and this Regulation, the authority
p.(None): When required, it will request the support of the Public Prosecutor's Office, the Municipal Offices, the Police
p.(None): National, the Attorney General's Office, the Secretary of Natural Resources and Environment and the Secretariat of
p.(None): Agriculture and Livestock.
p.(None): In all the proceedings that are carried out, only the aforementioned authorities will participate, avoiding notoriety
p.(None): public, unnecessary inconvenience or damage to the establishment.
p.(None): Article 216.- In those cases that from the violation of the legal and regulatory provisions risks and
p.(None): serious damage to people's health or the environment, the health authority will immediately notify the
p.(None): General Directorate of Health Regulation. This, when the case merits it will make public the fact and
p.(None): notify the respective authority, to prevent major risks or damages.
p.(None): Article 217.- The application of the administrative sanctions of which the Health Code deals with and this
p.(None): Regulations, do not exempt the offender from civil or criminal liability to have place for the act sanctioned.
p.(None): or tapes in visible places in the entrances and in the machines, Article 218.- In the cases that
p.(None): of the violation of
p.(None): equipment, locks and others, with the legend: “Closed legal and regulatory provisions result
p.(None): Responsibility Temporarily or Closed Definitely by the Criminal Authority, the health authority
p.(None): communicate immediately to the Sanitary ”, with the purpose of preventing the continuation of the General Directorate of
p.(None): Sanitary Regulation, so that this activity, entry or use, as appropriate.
p.(None): file the respective complaint with the corresponding authority.
p.(None): Ç MPUBLICA DE HONDURAS - TEGUCIGALPA, IYI. D. C., NOVEMBER 4, 2005 N °.
p.(None): 30.84.
p.(None): Article 219.- For the purposes of the sanctions established by this regulation, the persons shall be liable
p.(None): natural or legal that sell products or provide health services.
p.(None): Article 220.- To verify the facts and determine the
p.(None): Article 225.- t.a citation will be made to the owner of the establishment or legal representative of the company by
p.(None): ID card that will be delivered to you personally; if you are not in the establishment, delivery will be made to
p.(None): any of your
p.(None): family members or employees who are in it or in their
p.(None): Violations of the legal provisions health authority may make use of the
p.(None): a) Inspections
p.(None): b) Witness Statement
p.(None): c) Sampling
p.(None): d) Laboratory analysis or tests
p.(None): Regulatory, the first steps:
p.(None): residence.- Delivery of the identity card, the owner or legal representative shall be deemed legally cited.
p.(None): Article 226.- The citation card must contain:
p.(None): a) Name of the health authority issuing it
p.(None): b) The name and surname of the person to whom the citation is made
p.(None): SECOND SECTION
p.(None): OF THE PROCEDURE TO APPLY
p.(None): SANCTIONS
p.(None): Article 221.- The procedure to apply the sanctions established in these Regulations may be initiated:
p.(None): a) Ex officio, by mandate of the competent body, either on its own initiative or as a result of an order of the
p.(None): hierarchical superior, or by reasoned knowledge of having broken a sanitary law.
p.(None): b) By deliunciation of interested natural or legal person.
p.(None): Article 222.- The complaint or complaint may be made in writing, in folmaverbal or anonymously, by any
p.(None): means of communication, before the competent health authority and the following should be recorded: Appear in day,
p.(None): time and place determined; where you will be informed of the
p.(None): infringements or omissions imputed to him, listening to his disclaimers; everything acted should be recorded in
p.(None): minutes.
p.(None): Article 224.- If during the inspection, the health authority identifies situations that represent a danger
p.(None): health for people and the community, you can immediately take the preventive health measures of the case,
p.(None): how to be:
p.(None): a) Order or carry out the measures of disinfection, disinfection and deratization
p.(None): b) Order the suspension of work and services,
p.(None): c) Retain or deposit products, raw materials, substances, equipment, utensils and objects.
p.(None): d) All conducive to health prevention.
p.(None): and the character with which he is quoted.
p.(None): c) The causes or reasons why the citation is made.
p.(None): d) Place, date and time to appear.
p.(None): e) The prevention that the non-appearance will cause the damages to which there was place in law.
p.(None): f} Place and date on which the card is issued.
p.(None): g) Signature of the competent health authority.
p.(None): Article 227.- If the aforementioned does not appear by means of a legal representative duly accredited to the place, date and time
p.(None): referred to in the citation, it will be taken for granted by declaring in absentia and will proceed to issue the resolution that
p.(None): in appropriate law.
p.(None): Article 228.- If the evidence in the appearance were sufficient or the defendant admits the charges made, the
p.(None): Health authority will issue the corresponding resolution.
p.(None): Article 229.- When the charges are distorted in the appearance, the health authority shall issue a resolution
p.(None): acquittal in favor of the alleged offender, which must be notified.
p.(None): Article 230.- If the pniebas were insufficient and the defendant denied the charges, the health authority ex officio or
p.(None): at the request of the party, it will order the opening of evidence, granting a term of ten (10) business days to propose them and
p.(None): evacuate them; throughout
p.(None): In this case, the competent health authority may, at any time, have the practice of any evidence it deems
p.(None): pertinent for the best decision of the matter.
p.(None): Article 231.- After the probationary term and the proceedings of the case, the health authority
p.(None): will issue the resolution following the administrative procedure.
p.(None): StttİÓil A ÀtlltFd0S and ltïts
p.(None): M l PmØiJ'ZiIFP MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841
p.(None): Article 232.- The resolution must contain:
p.(None): a) Name of the issuing authority.
p.(None): b) Summary relationship of the facts.
p.(None): c) Statement of relevant considerations.
p.(None): d) Resolve categorically, clearly and precisely; citing the legal instruments, regulations or provisions
p.(None): sanitary in which it is based.
p.(None): e) Place and date of issue.
p.(None): f) Signature and seal of the competent health authority.
p.(None): Article 233.- In the event that the resolution is sanctioning, it will also provide:
p.(None): a) Imposition of the sanction.
p.(None): b) Prohibition of continuing illegal acts or violations of sanitary provisions.
p.(None): c) Warning at the offender that in case of recidivism or disobedience to the resolution, the
p.(None): more drastic sanctions provided for in this Regulation.
p.(None): d) The term to make effective the economic sanction imposed, which will be within ten (10) business days,
p.(None): counted from the day following the notification.
p.(None): e) The remedies that legally proceed against the resolution.
p.(None): f) The competent body before whom to lodge the resources and the term that has for it.
p.(None): Article 234.- Resolutions will be notified personally within a maximum period of five (5) business days from
p.(None): from the date of issuance and will be practiced by delivering the full copy of the resolution.
p.(None): Article 235. - Not having been able to personally notify the resolution within five (5) days, it will be made.
p.(None): fixing the operative part of the resolution in the table of notices of the office of the sanitary authority.
p.(None): Article 236.- Personal notification or by table will be recorded in the corresponding file.
p.(None): Article 237.- Against the resolutions issued by the health authority and that impose sanctions the appeals proceed
p.(None): of replacement and appeal.- These appeals will be substantiated in accordance with the Law of Procedure
p.(None): Adininistrative.
p.(None): THIRD SECTION
p.(None): OFFENCES AND PENALTIES
p.(None): Article 238.- Violations of the provisions of the Health Code and these Regulations will be sanctioned without
p.(None): penalty of the penalties to which the offender becomes creditor for the configuration
p.(None): of crimes against public health, in which case the Ministry of Health will put the background in knowledge
p.(None): of the Public Ministry, to proceed before the competent courts.
p.(None): Article 239.- For the purposes of the health authority, of the infractions and sanctions provided in Article 245
p.(None): of this Regulation, the following badges are established:
p.(None): 1.- The competent authority to apply the sanctions shall have the following:
p.(None): The General Directorate of Competent Health will be identified with numeral I.
p.(None): The Department of Sanitary Control of Products, Services and Facilities of Health Interest or Department
p.(None): Delegate will be identified with the numeral ß.
p.(None): The Departmental Health Region will be identified with numeral III.
p.(None): The Coordination of the Departmental Unit of Sanitary Regulation will be identified with numeral IV.
p.(None): 2.- The infractions are classified as: minor, serious and serious. 3.- To identify the sanctions will be used
p.(None): the following codes: The written reprimand will be identified with the literal a).
p.(None): The single or successive fines will be identified with the bite.
p.(None): The confiscation of products, substances or artifacts will be identified with the literal c).
p.(None): The suspension of registration or sanitary license will be identified with the district d).
p.(None): The temporary closure of buildings and establishments will be identified with the literal e).
p.(None): The cancellation of the sanitary registration or sanitary license will be identified with the site f).
p.(None): The final closure of buildings and establishments will be identified with the literal g).
p.(None): Article 240.- The application of sanctions for violation of the provisions of the Health Code and of the present
p.(None): Regulation, will be carried out by the health authority, in accordance with the descriptive table below:
p.(None): RE PUBLI CA DE HON DURA S - TEGUCIGALPA, M. D. C., 4 Dfi NOVIfiiM IIUE DEL 2005 N “. 30,841
p.(None): INFi ACTIONS
p.(None): Mild
p.(None): Aiito- Ira. Self-2nd. 3rd. Auto- 4 ".
p.(None): Aiub ›Ridatl code Realty li: einc. Iity ‘Reinc. rity
p.(None): Recinc. ritlu ‹l
p.(None): First of all Sanita-Cod / Sani- I.?od/ Sani-
p.(None): Cod / Sani- € “od / Sani-
p.(None): Situational provisions Sancióli riu Sai) c. I would! ’ianc.
p.(None): Tai’ia Salte. taria Sanc. liuiii
p.(None): l.- Chapter V, Section III: l- a) I.-IV l .- b) and c) I-III '. .- b)
p.(None): 1.- III 1.- d) and e) 1.-III 1.- f) and g) 1.-1 (Art. 19 and 20)
p.(None): 2.- Capíkilo V, Section IV:
p.(None): (Art. 21, 22, 23, 24, 25, 25 2.- a)
p.(None): 27 and 28)
p.(None): 2.-lV 2.- b) 2.-III i! .- b) 2.- 1 II 2.- d) and e) 2.-III 2.- t) and
p.(None): g) 2.-1
p.(None): 3.- C? Chapter V, Section V: 3.- a) 3.- l V 3.- d) and e) 3.- III 3. 13 and g) 3.-
p.(None): l (An. 29, 30; and, 31)
p.(None): 4.- Chapter V, Section Vl: 4.- a) 4.- I l 4.- b) 4, .- II -1.- b)
p.(None): 4.- II 4.- d) and e) 4.- III 4.- l) and g) 4.- 1
p.(None): (Art. 32, 33, 36, 37, 38, 39;
p.(None): and, 41)
p.(None): 5.- Chapter V, Section VI1: 5.- a) 5.- 11 5.- b) 5.- Il 5. d) and e) 5.- III
p.(None): 5.- fj and g) 5.- I
p.(None): (Art. 79, 80, 81, 87, 88, S9,
p.(None): 90, 91, 92, 93, 94, 96, 97,
p.(None): '98, 99, 100, 102, 103, 104,
p.(None): [05, 10, 107, 109; and, 110)
p.(None): fi, - Chapter Vl, Section I: G.- a) (›.- l V 6.- b) and c) G.- III i› .- b)
p.(None): 6.- l l I G, - cJ) and e) 6.- III 6.- l) and g) fi.- 1 (Art. 121, 122, 1 23, 124,
p.(None): 125, 126, 127, 125, 129,
p.(None): 130, 131; and, 132)
p.(None): 7.- Chapter VI, Section II: 7.- a) 7.- l V 7.- b) and c) 7.- III ".- b) 7.- l
p.(None): II 7.- d) and e) 7.- III 7, - f) and g) 7.- l (Art. 133, 134, 135, 136,
p.(None): 137; and 135
...
General/Other / people living in remote/rural area
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p.(None): Article 51.- The control books of the producing, importing, distributing and dispensing establishments of
p.(None): controlled chemical products and substances must be labeled, folded and sealed by the authority
p.(None): competent sanitary registering the corresponding information.
p.(None): Article 52.- For the transformation of raw material into a controlled, finished product, the manufacturing laboratory must
p.(None): submit an application at least five (5) business days to the competent health authority, who
p.(None): Appoint the respective inspector (s) to carry out the corresponding procedures.
p.(None): Article 53.- The laboratory shall be obliged to provide the necessary samples for the corresponding analyzes.
p.(None): of quality control, as well as defray their costs.
p.(None): Article 54.- The laboratory must request readjustment of the amount of its stock in the case of materials
p.(None): Hygroscopic premiums.
p.(None): Article 55.- Raw material transformation operations for controlled products carried out by the
p.(None): laboratory, as well as requests made to the competent health authority must be endorsed by the
p.(None): Regent.
p.(None): Article 56.- Only narcotics, șicotropics, products and products may be imported into the national territory.
p.(None): Chemical substances controlled by the customs of Pueno Cortes, Toncontín, La Mesa and others that in the future authorize the
p.(None): competent health authority.
p.(None): Article 57.- Drugstores may sell controlled products to duly authorized doctors who provide
p.(None): its services in the rural area, where there are no pharmacies, for this purpose, the medical professional must
p.(None): submit the corresponding card issued by the competent health authority, which will be valid for a
p.(None): (1) Aryan.
p.(None): K MPUBLICA DE HON DIJRAS - TEGUCIGALPA, M. lß. C., NOVEMBER 4, 2005 N ".
p.(None): 30,841
p.(None): At ticle 58.- For the sale of narcotic patients that are carried out between pharmaceutical establishments,
p.(None): will require authorization issued by the competent health authority; the cornprav ent of psychotropics that
p.(None): It is rea1 i ce, Between pharmacist establishments will be sent through notification; the sale of substances
p.(None): 9UC controlled chemicals will be performed between companies will require authorization issued by the health authority
p.(None): competent.
p.(None): Article I 59.- Controlled products must be identified with a red “C” and the law of Jdil C {ue
p.(None): say "Product susceptible to dependence"
p.(None): ›Title 60.- The products of strict control cny‹ i sale requires a cspccial mćJica prescription, they will be subject to
p.(None): Dispositions of Title I, Articles 150 at 154 of the SKİ Code and may only be dispensed prior to
p.(None): presentation of the i specti goes written prescription with tetra cl ‹ira y n (legible, signed and
p.(None): sealed and must be dispensed by customer according to the regulations established for paia ta1 fi’i.
p.(None): Article 61.- The special recipe books for products of strict cont1’o1 will be provided
p.(None): pei‘sonalnsente in the Ministry of Health by the cornpctcnte authority to the isiédicos collegiate.
...
Orphaned Trigger Words
p.(None): vertically integrated, with a social credit of not less than one thousand Lempiras (Lps. 1,000.00), of
p.(None): in accordance with the provisions of the Law of the Social Sector of the Economy and its Regulations.
p.(None): WHEREAS: That the Directorate for the Promotion of Micro, Small and Medium-sized Errtpresa and the Social Sector of the Economy,
p.(None): Development Office
p.(None): REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C.,, NOVEMBER 4, 2005 N °. 30.84
p.(None): g) Written reprimands.
p.(None): h) Impose economic sanctions from twenty Lempiras (L.20.00) to twenty thousand Lempiras (L.20,000.00), through
p.(None): motivated resolution '
p.(None): i) Apply the corresponding sanctions in accordance with the provisions of Section Two and Third of the
p.(None): Chapter IX of this Regulation.
p.(None): j) Temporary closure of buildings and establishments, by reasoned resolution.
p.(None): k) Suspension of registration or sanitary license, by reasoned resolution.
p.(None): I) Confiscation of products, substances and artifacts, by means of a niotivated resolution.
p.(None): m) Control the advertising of products, establishments of health interest and health services, through
p.(None): irotivated resolution
p.(None): n) Resolve matters delegated by the General Directorate of Health Regulation.
p.(None): o) What is not provided for in this Regulation but is related to it and in accordance with the current legal system
p.(None): in the country.
p.(None): III. Depai tamental Health Region: It has powers to:
p.(None): a) Issue reports on matters arising from the General Directorate of Health Regulation.
p.(None): b) Impose economic sanctions from twenty Lempiras (L.20.00) to twenty thousand Lempiras (L.20, 000.00),
p.(None): through motivated resolution.
p.(None): c) Grant / deny sanitary registration of products; according to delegated risk through motivated resolution.
p.(None): d) Grant / deny sanitary license of establishments, according to complexity through niotivated resolution.
p.(None): e) Resolve matters delegated by the General Directorate of Health Regulation.
p.(None): 1) Apply the corresponding sanctions in accordance with the provisions of Section Two and Third of the
p.(None): Chapter 10 of this Regulation.
p.(None): g) The release, confiscation, denaturation or destruction of
p.(None): products, substances and artifacts.
p.(None): h) Tenipoial closure of establishments according to delegated complexity, by reasoned resolution.
p.(None): i) Suspension of registration and sanitary license.
p.(None): j) What is not provided for in this Regulation but related to it and of confidence with the legal process
p.(None): in force in the country.
p.(None): IV. Head of the Department of Health Regulation in
p.(None): Health Regions:
p.(None): It has powers to:
p.(None): a) Dictate the request for the sanitary registration of products of sanitary interest according to the risk,
p.(None): in order to be granted or denied by the regional headquarters.
p.(None): b) Dictate the request for sanitary licenses of establishments according to complexity, in order to
p.(None): serotorgado or denied by the regional headquarters.
p.(None): c) Issuance for the imposition of the following sanctions:
p.(None): 1) Fines from Velnte Lempiras (L.20.00) to twenty thousand Lempiras (L.20, 000.00).
p.(None): 2) The release, confiscation, denaturation or destruction of products, substances and artifacts.
p.(None): 3) Temporary closure of establishments according to complexity
p.(None): delegate
p.(None): d) Written reprimands.
p.(None): e) What is not provided for in this Regulation but related to it and in accordance with the legal system in force in
p.(None): the country.
...
p.(None): food, cleaning, washing and disinfection of premises, equipment, utensils and personal hygiene.
p.(None): e) Have a good disposal system for sewage and excreta.
p.(None): Have adequate storage system and garbage collection on a daily basis or when necessary; this one
p.(None): deposit in metal or plastic containers provided with a lid.
p.(None): g) Be subjected to scrupulous cleaning or cleaning daily.
p.(None): h) Be protected internally against rodents and insects and use a system-for permanent control of
p.(None): these.
p.(None): i) Floors, walls and ceilings should be constructed with materials that allow their cleanliness and conservation. The
p.(None): walls of food preparation areas should be smooth and easy to clean.
p.(None): j) They must have sanitary and urinary services connected to the excreta drainage system, in
p.(None): sufficient quantity according to the size of the establishment, and must be isolated from the process areas,
p.(None): Food handling and service.
p.(None): k) The premises will be equipped with doors of the environments of the extensive environment.
p.(None): i) There must be a sink equipped with drinking water, soap and disposable towels or automatic dryers.
p.(None): The equipment, utensils and other artefacts destined to the elaboration and conservation of the foods, must
p.(None): be made of appropriate stainless or plastic materials that maintain the good state of preservation and
p.(None): cleaning.
p.(None): m) Plates, glasses, cups, cutlery, other containers and utensils intended to serve food must
p.(None): be made of waterproof materials that allow cleaning and liquefaction after use, including
p.(None): Physical or chemical disinfection.
p.(None): n) The furniture destined to store the dishes, linens and other kitchen utensils must be of closing that
p.(None): guarantee the protection of its content and easy cleaning. Those destined to the service of food and other furniture
p.(None): They should be built with materials that allow easy cleaning and conservation.
p.(None): ñ) The linens in use must always be clean.
p.(None): o) Containers or containers intended for the sale of food consumed outside the establishment must
p.(None): be made of resistant impemieable materials and the food must be served properly protected with lids or
p.(None): appropriate covers and will be disposable at first use.
p.(None): p) Foods that are easily damaged should be stored in
p.(None): refrigerated units, legumes and fruits on shelves
p.(None): open with sufficient ventilation; Packaged foods should be placed on shelves.
p.(None): q) Foods prepared for sale or service must be protected from the environment by display cabinets,
p.(None): furniture, lined with glass, metal mesh, plastic material or any other that ensures its protection and prevents its
p.(None): pollution.
p.(None): r) The containers, containers and all material destined to contain the food must be stored in places that
p.(None): ensure your protection and avoid contamination.
p.(None): s) To facilitate sanitation, equipment or other appliances must be placed on rollers or pallets.
p.(None): t) In the preparation of food, adulterated, expired or contaminated raw materials should not be used.
p.(None): If additives are used, they must be those permitted by current regulations.
p.(None): Article 20.-For establishments where food is handled, dispensed and served, the provisions are stipulated.
p.(None): following prohibitions:
p.(None): a) The entry of people without proper uniform to the process or handling section, as well as the
p.(None): presence of people outside it.
p.(None): b) Eating, drinking, sleeping, smoking, spitting in the areas related to the process, packaging, storage
p.(None): and food service.
p.(None): c) Use the premises, facilities, furniture, equipment and utensils for uses other than those of the
p.(None): exercise.
p.(None): d) Sell or give free of charge food not suitable for human consumption.
p.(None): e) The permanence of people suffering from contagious infectious diseases.
p.(None): í) The entry and permanence of domestic animals.
p.(None): g) Storage of hazardous substances.
p.(None): FOURTH SECTION
p.(None): OF THE MANIPULATOR REQUIREMENTS OF
p.(None): FOODS
p.(None): Article 21.-Food handling is not allowed for people suffering from respiratory infections.
p.(None): acute, infection in the pharynx, tonsil and larynx, conjunctivitis, infectious otitis, diarrheal diseases and
p.(None): Infected skin lesions or healing process and other infectious infectious diseases.
p.(None): Article 22.-Any person who handles and food supplies shall undergo medical evaluations and controls in medical centers.
p.(None): public or private health, of which a record must be kept in the company's files, such controls
p.(None): They should be practiced every six months.
p.(None): Section A Acuerttos y ieyes'
...
p.(None): Article 111.- When the product needs special storage conditions, it must be clearly indicated in the
p.(None): label.
p.(None): Article 112.- Any product that has been treated with radiation / ionizing energy must carry the label very close
p.(None): of the name of the product, an indication of such treatment. When an irradiated product is used as an ingredient
p.(None): in another product, this circumstance must be declared in the list of ingredients.
p.(None): Article 113.- Packaged products must not be described or presented with a label containing phrases,
p.(None): words, denominations, symbols, figures or drawings, geographical names, indications that lead to interpretations
p.(None): false or error, deceit or confusion, as to its origin, origin, nature, composition and quality with another
p.(None): product.
p.(None): Article 114.- The label will not be allowed on the inner side of the container or wrap when in contact with the
p.(None): product.
p.(None): Articles 115.- It will not be allowed to write the mandatory data of the label in seals, caps, caps or
p.(None): another part that is used when opening the container, unless authorized by the General Directorate of Health Regulation.
p.(None): SECOND SECTION OF PACKAGING
p.(None): Article 116.- Product packaging can be made of plastic, metallic, paper, glass, cardboard and other material.
p.(None): authorized by the General Directorate of Sanitary Regulation through the Department of Sanitary Control of
p.(None): Products, Services and Establishments.
p.(None): Article 117.- The materials destined to be in contact with the products must be manufactured with materials
p.(None): premiums and additives authorized according to established national and international standards.
p.(None): Article 118.-The materials for packing or packaging shall protect the product from the outside environment by complying
p.(None): with the requirements of impermeability and closure to gases, humidity and ultraviolet radiation, when the action of
p.(None): These agents could alter or contaminate them during the contact time.
p.(None): Article 119.- The materials, polymers of the containers will not yield or displace the product, substances that
p.(None): may determine modification in their organoleptic characteristics and composition during the time of use or
p.(None): marketing them. As regards maximum migrations, they must comply with the limits established in
p.(None): the applicable sanitary norms.
p.(None): ■ l REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84
p.(None): Article 120.- Packaging materials will not absorb or yield to the product, in their contact, constituents in
p.(None): amounts that undermine their stability or quality or that are the cause of significant loss of
p.(None): content.
p.(None): Article 121.-The quality control of the packaging materials in contact with the products shall be carried out according to the
p.(None): case:
p.(None): 1. In the packaged product,
p.(None): 2. In the empty container; Y,
p.(None): 3. In the raw material with which the packaging is made.
p.(None): The controls will be carried out in the first instance in official or private laboratories recognized by the Secretariat of
p.(None): Health and in second instance in recognized laboratories abroad.- Quality controls will be applied
p.(None): of ISO Standards or Good Manufacturing Practices.
p.(None): CHAPTER VII
p.(None): OF THE ADMINISTRATIVE MEASURES AND ACTS OF SANITARY PRODUCT CONTROL,
p.(None): SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST
p.(None): SECTION ONE GENERAL PROVISIONS
p.(None): Article 122.- To exercise the sanitary control of products, establishments and services, the Ministry of Health
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| alcoholic | alcoholism |
| authority | Relationship to Authority |
| criminal | criminal |
| dependence | Drug Dependence |
| dependency | Drug Dependence |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ill | ill |
| illegal | Illegal Activity |
| injured | injured |
| language | Linguistic Proficiency |
| linguistic | Linguistic Proficiency |
| minor | Youth/Minors |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| party | political affiliation |
| police | Police Officer |
| property | Property Ownership |
| publicXofficial | public official |
| restricted | Incarcerated |
| rural area | people living in remote/rural area |
| single | Marital Status |
| substance | Drug Usage |
| terminal | Terminally Ill |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| dependence | ['dependency'] |
| dependency | ['dependence'] |
| drug | ['substance'] |
| language | ['linguistic'] |
| linguistic | ['language'] |
| officer | ['police'] |
| police | ['officer'] |
| substance | ['drug'] |
Trigger Words
capacity
harm
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input