OFFICIAL JOURNAL OF THE REPUBLIC OF HONDURAS Section A Tegucigalpa, M. D. C., September 21, 2005 THE CONSTITUTIONAL PRESIDENT OF THE REPUBLIC WHEREAS: That the State recognizes the right to health protection and it is everyone's duty to participate in the promotion and preservation of personal and population health. WHEREAS: That corresponds to the State through its dependencies and the bodies constituted by law, regulation, supervision and control of food, chemical, pharmaceutical and biological products, as well as establishments related to products. WHEREAS: That corresponds to the State through its dependencies and the bodies constituted by law, the regulation and control of institutions and health services. WHEREAS: What is the function of the Secretary of State in the Health Office through the General Directorate of Sanitary Regulation of Health Surveillance and Control of products, services and establishments of interest sanitary. THEREFORE: In use of the powers vested in it and in application to the provisions of articles 145, 146, 147 and 245, Numeral 11 and 29 of the Constitution of the Republic; Article 29 of the General Law of Administration Public; Article 67, numbers 2,6,7,8,9 of the Regulation of Organization, Operation and. Competition of Power Executive; counting on the favorable opinion of the Attorney General's Office in accordance with article 41 of the Administrative Procedure Law. A C U E R DA: APPROVE THE REGULATIONS FOR THE SANITARY CONTROL OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST INDEX CHAPTER I: PURPOSES AND PRINCIPLES CHAPTER II: GENERAL PROVISIONS CHAPTER III: SCOPE OF APPLICATION AND COMPETITION REPUBLI CA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30.84 CHAPTER IV: SANITARY RULES APPLICABLE TO PRODUCTS, SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST. CHAPTER V: OF PRODUCTS, SERVICES AND ESTABLISHMENTS. - SECCI ON PRI MERA: FROM LIME NTOS AND BEBI DAS. - IT IS GIVEN UP: OF THE FOOD FACTORIES. - SECTION THREE: OF THE ESTABLISHMENTS WHERE MANIPUL AND N, EXPAND AND SERVE FOOD. - SECTION ON FOUR: OF THE REQUIREMENTS OF THE AIR MANIPULATOR. - SECTION FIVE: FOOD STORAGE. - SECTION ON SIXTH: PHARMACEUTICAL PRODUCTS. - SECTION SEVENTH: DI'ì THE ESTABLISHMENTS OF SALU D. - SECC I ON OCTAVA: I HAVE THE D IS POSITS AND THE USE OF THE SURGICAL TEAM. CHAPTER VI: OF LABELS AND PACKAGING OF PRODUCTS. - SECTION ONE: OF THE LABELS. - SECTION ON SECOND: OF THE CONTAINERS. CAPITU VI VI: MEASURES AND ADMINISTRATIVE CTOS DEI. SANITARY CONTROL OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST. - SECTION ONE: GENERAL PROVISIONS. - SECOND SECTION: DH THE HEALTH LICENSE. UNIT I D E THE RE Q I S I T'O S PA RA OBT ENE R HEALTH LICENSE. UNIT II DE LA MO DI FI CA CI ON DE, LA LI CE NCI A SANITARIA. UNIT III OF THE NO MENCL ATURA OF THE HEALTH SCIENCE. SECTION THREE: REGISTRATION SANITA- AO UNIT I GENERAL DISPOSITION. UNIT II OF WHAT IS RE ISI TO S FOR OB TE NE R E L HEALTH REGISTRY. UNIT III OF THE REC Y NO CI M IE NTO DEL RE GIS T RO SANITARIO. UNIT IV OF THE MOD I FI CA TION OF THE RE GI ST RO SANITARIO. UNIT V DE LA NOME NC L AT UR A DE L RE G IST RO SANITARIO. UNIT VI OF THE PROCESS OF THE LICENSE AND SANITARY REGISTRATION. UNIT VII OF THE RE NOVA TION OF THE LI C ENCI A AND SANITARY REGISTRY. SECTION C UARTA: INSTRUCTIONS SANITARY. SECTION FIVE: CERTIFICATES AND AUTHORIZATIONS. UNIT I OF THE REQUIREMENTS FOR OBT E N ER CERTIFIED FREE SHIPPING, EXPORT AND GOOD CERTIFICATES MANUFACTURE PRACTICES. j, j • J_ q jrJ_ç_jșg OFFICIAL JOURNAL OF THE REPUBLIC OF HONDURAS DECANO DE LA PRENSAHONDUREÑA FOR BETTER SECURITY HEARS ITS PUBLICATIONS RAÚL OCTAVIO VG’úER0 General Manager MARCO ANTONIO RODRÍGUEZ CASTILLO SUgorvision and Coordination EMPRESĄ NACION4L OE ARTES GRĂFIC4S E.N.A.G. Golonia Miralloreş Telephone / FąF: Geren ¢ ia 23O • 49ö6 AdminiştraGŁójł: 230 • 6767 Flat: £ 30-3026 CENTROGIVICOGUBERNAMENTAL Ç MPUBLI CA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 UNIT II OF THE PROCESS OF L (IS CERTIFICATES. UNIT III OF THE I NG RESO OF P RO DU CTO S AND OF THE RAW MATERIALS. UNIT IV OF THE RF.Q U I SI3'OS TO OBTAIN THE OFFICE AUTHORIZATION OF IMPORT FOR PROD UC TO S AND S IISTANCE AS QUIM CONTROLLED ICAS UNIT V OF THE TRANSITION OF THE SOLICI3 “YOU. CA P I'F U L O V11I: OF THE P U BL I CI DAD OF PRODUCTS, SERVICE! AND ESTABLISHMENTS DL SANITARY INTEREST. CA PITU LO IX: D IT L AS I N l'’RA CCIO NES, SANCTIONS AND PROCEDURES. - SECTION ONE: GENERAL PROVISIONS - SECOND SECTION: OF THE PROCEDURE TO APPLY SANCTIONS. - SECTION ON THIRD: OF INFRINGEMENTS AND SANCTIONS. CHAPTER X: FEES FOR RECOVERY FOR RIGHTS AND SERVICES. CAPI TU LO XI: DIS POS I CI ONES FIN ALES AND TRANSITORIAS. CHAPTER I RINES AND PRINCIPLES Article 1.- The present P.eglainento has as a purpose, to develop and monitor compliance with the provisions of Book II of the Promotion and Protection d ‹: Health, Title II of Food and Beverage, Book III of the Health Recovery, Title I of Pharmaceutical Products and Medical Equipment, Title II of Health Institutions, Book IV, Title 11 Measures and Administrative Acts, Title III Procedure in the Actions of the Health Authorities of the Health Code. Article 2.- The following are fundamental principles of this Regulation: a) Protect the Health and life of users and consumers in relation to products, services and Health Interest establishments. b) Regulate the conditions of safety, efficacy and safety of the products, services and establishments of Health interest. CHAPTER II GENERAL PROVISIONS Article 3.- This Regulation regulates the products, services and establishments of health interest and the personnel linked to them, and for the purposes of their application the following terms or concepts are defined: Abandonment: Declaration of early termination of a procedure, which is not concluded by not responding to time the requirements made to complete the process. Sample record: Document containing the proof of sampling. Citation Act: Document by means of which, the inspector quotes the regent, legal representative or the owner of the establishment to appear before the corresponding dependency of the Ministry of Health. Inspection Act: Document that reflects the result of the inspection carried out by the health authority (s) competent duly subscribed by them and the interested party. Customs: Official competent body that regulates the import and export of merchandise from the country. Food for Medical Use: The one that has been subjected to processes that modify the relative concentration of the various nutrients, of their constitution or their quality, or by incorporation of substances outside its composition, they acquire therapeutic properties. Written reprimand: Action to reprimand someone, by writing motivated by omission, execution of a activity or conduct contrary to legal or regulatory provisions. Hearing: Citation that is made to the public employee in order to render discharges on actions that are imputed or attributed. Outpatient Care: Actions aimed at patient care for diagnosis and treatment, when Check that it does not require hospitalization. Hospital Care: Actions aimed at the care of patients who, due to their state of health, need to be integrated for more than 24 hours for diagnosis or medical or surgical treatment. s REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 At a tion in Medicine: Set of services that are provided to the individual, for the purpose of prevention, healing and health rehabilitation. Preventive Care: A set of general promotion and specific protection actions provided to the individual and the general population with the purpose of reducing morbidity. Rehabilitation Care: Actions aimed at correcting physical or mental disability. Health Care: Promotional, preventive, curative and rehabilitation actions provided by a multidisciplinary team in the health area. Health Authority: Instance, Organ or Public Official that by Law or by delegation has the power to ensure for compliance with nonnas, policies, criteria, systems and procedures of a technical nature that must govern the administrative and executing units of health services. Goods: Any of the things that can satisfy human needs. Bioavailability: Measurement of the amount of medication contained in a pharmaceutical form that reaches the formation systemic and the speed at which this process occurs. Bioeq uivalen cia: Condition that exists between two medications that are pharmaceutical equivalents and that show the same or sinúlar bioavailability according to criteria established in the technical nonna. Medical Emergency Kit: Establishments approved by the General Directorate of Health Regulation a request of a registered doctor and with your rights, so that you have pharmaceutical products for emergent use Cancellation of the Sanitary Registry: Definitive deprivation of the authorization that had been conferred, for having incurred in facts or conduct contrary to sanitary provisions. Cancellation of health license: Deprivation of the authorization granted for the operation of a Establishment Free Sale Certificate (C. L. V.): Document issued by the regulatory authority in which it is certified that the product referred to in the certificate is authorized for sale or distribution in the country or region of the scope of the regulatory authority. Export Certificate: Document issued by the Regulatory Authority of the country of origin proving that the Controlled product is suitable or authorized for export. Temporary closure of the establishment: Suspension for up to ninety (90) days of the right conferring the granting of an operating license, for having incurred omissions, facts or conduct contrary to the provisions Legal or regulatory. Definitive closure of the establishment: Deprivation of the authorization that had been granted through a License Health, for having incurred omissions, facts or conduct contrary to legal provisions or Regulatory Clinic: Local where users health care functions are performed. Dental Clinic: Health facility that develops diagnostic, promotion, prevention, treatment and rehabilitation of oral health, whose operation conforms to the provisions of the Health Code and its regulation. University Dental Clinic: Facilities that provide services and teaching in universities and that meets the requirements described by the Health Code and its Regulations. Complexity: It is the criterion used to identify an establishment taking into account the magnitude of the risk sanitary, the technology it uses and the man hours necessary for its sanitary inspection. Quality Control: Planned system of activities whose purpose is to ensure a top quality product. Smuggling: Consists of the importation or entry into the country of goods that do not meet the requirements legal established for this purpose. Sanitary Control: It is the action of checking, supervising, inspecting, intervening, registering, monitoring, regulating sanitary hygienic conditions of the establishments, of the personnel where goods are produced or provided and services of health interest, in order to protect the health of the population. Technical Control: It is the action carried out by the Ministry of Health of Honduras, in pharmaceutical establishments. Basic Medication Chart: It is the official list, prepared for this purpose by the State Health Institutions. Guilt: Modality of violating leyporimperice, negligence or unpredictability. M M1'UBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 DCI: International Common Denomination: Common name for medicines, recommended by the World Organization of Health, in order to achieve its international identification. Confiscation: Confiscation or seizure of substances, artifacts or products to prevent further elaboration articles or products that reach the public without complying with the legal or regulatory provisions. Dependence on a medication: Condition in which the user of a medication feels compelling desire to continue the use of it. The use of the expressions drug addiction and habituation is currently recommended medicated; Drug dependence is used as a synonym for drug dependence. Cross dependence: The ability of a drug to suppress manifestations of physical dependence induced by another medicine and replace it in the maintenance of a state of physical dependence. Physical dependence: Elevated or adapted physiological state that occurs in an individual through administration Repeated medication. Physical dependence induced by prolonged use of a medication is only revealed when it is abruptly discontinued or when its shares are diminished by the administration of a specific antagonist Psychological dependence: Condition characterized by strong emotional or mental desire to continue using a medicine. Dental Deposits: Establishments dedicated to importation, sale, marketing, manufacturing, storage and distribution of bio materials, dental equipment and instruments for care or ‹lontology, as well as materials, equipment and instruments for the use of dental laboratories. Customs clearance: It is the process for the nationalization of merchandise that legally enters the country. Withdrawal: Act by which the petitioner's request is accepted not to continue with the process giving rise to file of the file containing the proceedings. Dispensing: It consists in the delivery of medications to the user patient usually as a result of a medical prescription. Availability: Relationship between the volume of demand and type of existing resource to meet the needs of offer attention. It is a dimension of supply risk. Device and Equipment for Medical Use: Instrument, apparatus, implement, machine, implant or other similar item or related that by itself or in combination with any accessory or program for its proper operation is used in prevention, healing, rehabilitation and health research. Dolo: Modality of breaking the Law with full knowledge of the cause. Therapeutic dose: Amount of active ingredient that produces the desired therapeutic effects in a given period of time. Drug / drug substance / medicine: In legal and technical use, these terms have 2 meanings: 1. In the first, the term drug or medication is used to describe the active substance or drug that for its Administration must be fomiulated. 2. In the second one, medication or drug is understood as any pharmaceutical product used for the prevention, diagnosis and treatment of a disease or pathological state or to modify systems physiological benefits for the person to whom it was administered. Drugstore: Establishment dedicated to the importation, storage, distribution and sale of medicines in bulk and minor, where direct supply to the public is prohibited except in cases authorized by the Ministry of Health, under the responsibility of a duly registered pharmaceutical professional. Packaging and Packaging: All material used to protect a product for its conservation, handling and transport. Packaging: Any container intended to contain products SdRÍtdfÍOS. Primary Container: It is one that is in direct contact with the product. Secondary Container: It is one that is in direct contact with the primary container. Pharmaceutical Equivalence: Two medications are considered to have pharmaceutical equivalence when they contain equal amounts of the same active ingredient (s) in identical doses and dosage forms to be administered by the same route and that meet the same specifications. Pharmaceutical Specialty: Is that medicine produced by a manufacturer under a brand name or generic of a way that is characteristic. II E'Z MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 Sputum: Nasopharyngeal secretion that spits. Establishment of health interest: Entity that produces, manipulates, stores, transports, distributes, sells and dispenses products of health interest, as well as provides health services in a formally organized manner, classified according to the degree of complexity in Category I low complexity, Category II medium complexity and Category III high complexity. Food Establishments: Factories, stores, places where food is manufactured, handled, dispensed and served and drinks, vehicles that transport food and food stalls on public roads. Health Establishments: Are those public or private establishments, in which directed care is provided fundamentally to the prevention, cure, diagnosis and rehabilitation of health; like hospitals, Mathematics, polyclinics, health centers, offices, medical clinics, dental clinics, clinics Homeopathic and natural, acupuncture clinics, dispensaries, sanatoriums, nursing homes, resting things, laboratories dental mechanics, dental deposits, optics, blood banks and derivatives, breast milk banks, banks of body tissues, psychotherapy, physiotherapy and radiotherapy establishments, health laboratories, laboratories analysis, diagnostic centers, pharmaceutical laboratories, drug stores, pharmacies, medicine stalls and medical emergency kits, community drug funds, aesthetic and nutrition establishments, ambulances, mobile units: land, air and sea; and others defined by the health authority. Stability Studies: Tests that are carried out to obtain information on the conditions under which they are due process and store raw materials or semi-processed products prepared, as the case may be, these tests They are also used to determine the shelf life of the medicine in its original container and in storage conditions Specific. Narcotic: Name used in the Single Convention on Narcotic Drugs (United Nations, 1961) and in the Legislation from many countries to refer to substances with high potential for dependence and abuse. The term narcotic can apply to substances that belong to different pharmacological categories (narcotic analgesics, central nervous system stimulants or depressants, hallucinogens, etc.). Label or bullet: It is any expression existing both in the internal container as in the external or packaging that serves to Identify it and characterize it. Equipment: Collection of in5unctions and special devices to perform certain jobs. File: Set of documents related to the history of a natural person, legal entity or a process. Excipient: Auxiliary substance in the manufacture of a product. Manufacturer: Natural or legal person who is dedicated to the - elaboration of products that require Sanitary Registration. Slight failure: Violation of the sanitary provisions contained in the Health Code, these Regulations, the technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions and not It constitutes a risk that harms or may harm the health of the population. Less serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the technical standards and other provisions issued by the Ministry of Health, in the exercise of its functions, which are It constitutes a moderate risk to affect the health of the population, intervening the voluntary action or omission. Serious offense: Violation of the sanitary provisions contained in the Health Code, these Regulations, the technical standards and also DIS] 3O5itions issued by the Ministry of Health, in the exercise of its functions, which are constitutes a gi’ave risk or has caused or damage to the health of the population and that mediates negligence or malicious intent. ., Fqrmacia; It is the establishment that is dedicated to the preparation of recipes, dispensing and supply of medicines and related products directly to the public. Germs: Microbes or microorganisms. Systematization Sheet: Document in which the data of the application for registration, renewal or modification Hermetic: Complete and impenetrable closure. Ingredients: Any component that is used in the preparation of the products regulated by this regulation. Innocuous: What is not harmful to health. Health Registration: It is the authorization for the commercialization granted to an importer or distributor of a product that has been previously registered, should also be understood as the registration before the health authority of a category C product or a category I establishment, for marketing and respective operation. Waterproof: Impenetrable to water or other fluids. Challenge: Legal action through which the disagreement of an administrative act is manifested in the first instance requesting its renewal or modification. Ç REPUBLICA DE HONDURAS ‘- TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 Control report: It consists of the report as a result of an inspection visit. Violation: Violation of the legal norm. , ' Disabling of professional practice: Temporary or permanent suspension in professional practice by the respective school. Insert: Document addressed to the medical or patient body where in a summary form it explains the main indications, contraindications, warnings, adverse reactions, doses, toxicological record and commercial presentations. Inspection: Act of reviewing or verifying the operating status of a health interest establishment and the management of uncontrolled, controlled and precursor products for compliance with the provisions of these regulations issued by the Ministry of Health. Eye inspection: Judicial test method by conducting a visuiil inspection route. Sanitary inspector: Sanitary Authority that acts in an official capacity with powers to inspect and inspect supervisions, and corrective action. Inventory or stoclt: Physical quantity in stock of a product. JIFfi: International Narcotics Control Board: Supervisory body that has to assume the functions that He is assigned the different International Drug Control Conx'enios, one of whose functions consists of monitor licit drug trade subject to international control Dental Laboratories: Establishments dedicated to the support of dental professionals in manufacturing of devices be they acrylic, metallic, porcelain or others that contribute to the rehabilitation of health oral. Narcotics control book: Special format book that records entries, exits and balances of narcotics. Book of control of psychotropics: Book of special format where the registry of entrances, exits and Psychotropic balances. Raw material control book: Special format book where the record of entries, exits and balances is kept raw material. Book of finished product and transfers: Book of special format where the register of entrances and exits of Controlled product, as well as transfers. Licensing: Mandatory administrative technical procedure aimed at verifying compliance with minimum requirements in force. Sanitary License: It is the authorization for an establishment to manufacture, import, export, transport, distribute, handle, store, pack, sell and dispense products of sanitary interest; as well as Provide health services, once all technical and legal requirements are met. Batch: Quantity of a product that is produced in a single manufacturing cycle. Manipulator —Seller: Person who performs his work of handling or selling food. Manual of Pharmacological Standards: Properly classified organization of recognized Pharmacological Standards and officialized by the Ministry of Health. IY Raw material: Any active or inactive substance ‹jut: is used to manufacture products of interest sanitary ›regulated in this regulation whether it is unaltered, modified or eliminated in the course of production process. Medication: Any active substance or mixture of the misrrios with or without the addition of excipients, prepared to be Presented as a pharmaceutical form. Controlled medication: a) Any psychotropic medication and hypertension under the control regimen according to the Conventions on narcotic and psychotropic substances respectively, Ul contrc 1 on this type of substances is exercised by the Junt ‹i National Drug Control. b) A substance that can be incorporated into pharmaceutical post-linguistic forms only within the limits Specific deRrminated by studies. c) A substance approved by the Ministry of Health but subject to restrictions that exclude its use in a considerable proportion of the potential population of patients to whom it would be destined. Drug of strict control: They are pharmaceutical preparations based on narcotic drugs which requires a special recipe booklet for your prescription. Orphan Drug: It is said of the potential active ingredients in which there is no interest on the part of producing laboratories for its development as medicines, REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841 since such development does not present an economic incentive, although they can meet health needs. Over-the-counter medication: It is the one that due to its composition and the pharmacological action of its active substances can used by the public without a prescription. Essential Medication: It is the one considered most important, indispensable and necessary to satisfy the health needs of most of the population. Multifuente Medication: It is one that must meet the same standards of quality, safety and efficacy applicable to the innovative medicine. Innovative Medicine: It is the original that demonstrated safety and efficacy with preclinical, clinical and post studies marketing and established quality standards, which will be used as a reference medicine. New Medication: Any Medication that has not been registered or released to the market for medical purposes including new salts or esters of an active substance, new fixed combinations of substances that are already on the market, or any medication previously registered or offered on the market, provided that its indications for use mode of administration or formulation have been changed. Official Medication: It is the one recorded in the respective monograph of the Normative Code that can bear the name of its active ingredients; Official Generic; or that of your patent registration; Official Patented Reference Medicine: Is the innovator or defined by the health authority. Similar Drug: It is the one that contains the same or same active ingredients, has the same concentration, form pharmaceutical, route of administration, dosage and therapeutic indication of the reference medicine, registered by the regulatory authority responsible, being able to differ only in characteristics related to the size and shape of the product, expiration date, packaging, label, excipients and vehicles must always be identified by trade or brand name New Molecule: Active substance that is not contained in any type of pharmaceutical product previously Registered by the health authority. A new salt, be or derived from an approved active substance, must be considered Medical sample: Representative units or small amounts of a drug that is provided free of charge For your promotion. Sampling: Taking units of a product that are representative of their total. Fine: Pecuniary penalty that is imposed for the execution or omission of a conduct, contrary to the provisions sanitary Generic Name: It is the name of the active substance that generally corresponds to the common denomination International (D.C.I.) recommended by WHO. Chemical Name: It is the name used intemacionahnente for a chemical substance, following the rules of Nomenclature of the I.U.P.A.C., which unequivocally denotes the composition and structure of the substance. Honduran Standard: It is one that has been adopted or adapted from an international standard or formulated and approved in the country and that is related to products, services or establishments of health interest. Sanitary Notification: Document sent by the manufacturer that certifies any change of a scientific nature and duly justified and documented. Lot Code Number: The designation (in numbers or letters) or coding of the product that identifies the lot to That this one belongs. Organoleptic: Evaluation of any product of health interest made through the senses (sight, smell, touch, taste, yoido). Perishable: Product that is easily altered or decomposed in a short period of time. Precursor or precursor substance: It is the substance or substances from which it can be synthesized, manufacture, process and obtain products that can produce physical or psychological dependence. Pharmaceutical or Commercial Presentation: It is the quantity expressed in units of pharmaceutical form, volume, weight or number of doses in case of aerosols, pharmaceutical or cosmetic product. Forecast: Amount planned for the consumption of controlled medicines for the period of one year. as a new molecule and therefore demonstrate the documentation Active ingredient: Substance or mixture of Related substances related to efficacy, safety and quality. endowed with a specific pharmacological effect Sertión A Atueriłos y leycs K REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘. 30,841 Product: Thing produced, resulting from the work done on a raw material. Altered Product: When replaced, totally or partially added or replaced constituent elements that are part of the officially registered composition or when substances that may have been added modify its effects or its physicochemical or organoleptic characteristics. Cosmetic Product: It is any substance or formula of local application to be used on different surfaces external of the human body and its annexes including mucosa, buccal and teeth in order to clean, perfume, improve its appearance and protect or maintain it. Alines Products: They are natural products, cosmetics, hygienic products, laboratory reagents, material and Dental and health laboratory equipment, devices, equipment and surgical medical equipment. Bulk Product: It is any processed substitution found in its final form and which has been uncle packed in final distribution packages. Products of interest s “year: They are food and beverages, medicines, biologicals, cosmetics, hygienic products, hazardous substances, medical devices and equipment, natural products, reagents laboratory and others that in their time are considered by the sanitary authority; those that are classified zsí: Risk "A" or high risk Risk "B" or medium risk Risk "C" or low risk Finished Pharmaceutical Product: A preparation containing é1 or the active ingredients and excipients; formulated in a famiaceutical form. Natural Product: Processed, industrialized and labeled product are attributed medicinal qualities, Qite contains in its formulation ingredients obtained from plants, animals, minerals or mixtures thereof. Products that, being inezclas, have a chemical active ingredient included, are not considered natural products. Seini-elaborated product: It is any substance or mixture of substances that is still in the manufacturing process. Expired Product: The one that has fulfilled its expiration or expiration date. Finished Product: Prepared ready for dispensing. Products (ligienicos: Are those products intended to be applied in homes, buildings and facilities public and private, industries and other places, as well as objects and utensils that are in contact with people, used with In order to clean dewatering, deodorizing yaromatize. Prospectus: Document addressed to the medical body or patients where in a summary form it explains the indications, main contraindications, warnings, adverse reactions, doses, toxicologist record and commercial presentations. Stall of Sale: Local, site, furniture, food and non-alcoholic beverage sales in public premises legally authorized. Position of Sale of Medicines: Establishments destined in restricted form, only the dispensing of medicines authorized by the competent authority, and in which the preparation of prescriptions and handling of Controlled medications. Recipe: Any written and eligible prescription extended by a competent professional duly registered to the specific person and that contains the addresses for its correct use, of a simple or compound medicine, in Any pharmaceutical form intended for therapeutic purposes. Special Recipe: It is the prescription on safety paper provided by the Doctor for psychotropic products or controlled. Regent or Technical Director: The university professional, in full exercise of his rights and duties assumed by the technical, scientific direction and professional responsibility of a health establishment. Sanitary Registry: This authorization so that a product of sanitary interest can be manufactured, imported, packaged or expended once all technical and legal requirements are met. Resolution denied: Administrative act by which a request, renewal or change on a Registry is rejected for not meeting the requirements of the Regulation. Sanction: Administrative provision imposed on the holder of the sanitary registration of a product or license health of an establishment that by action or omission violates health regulations. Services: Function or benefit performed by an organization and its staff. Health Care Services: The set of resources that systematically intervene for prevention and cure of diseases that affect individuals, as well as their rehabilitation. JtEPIJBLI €: 'A 13E Hf3NDI! RAS - TEGU CIGALPA, KJ. II. C., NOVEMBER 4, 2005 N “. 30,841 LU iriti ‹iscritti, Secretary tacne ra1 de lu Sec i elaria dc Industrie y Co me rc io. ’L“ I1 AN SCItI13 I- .: 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 THE OFFICES € “Hf1S UE INDIJS" ​​FRIA Y COMEItCI O, TEGU €? 1GALPA, NlUNIf01'IODEL CENTRAL DISFRITO, AT NULL DAYS DELMES nr sErrirunnr nrL YEAR TWO THOUSAND FIVE. VIEW: Pai a i esol see the sofie itud contained in the administrative file Nri. 519-2005, content of the application submitted by Ab ‹i¡ja‹ 1st JOiIl? L YNTONIf9 ZiiLAYA AL1'AMZq enrolled in the College of A bogatlos de Hontlrnas under the Nt ›. 10344, Legal Representative of the Lord , WSSh'.IAíYfl 'MASSfl IYIASStJ, constituted as a single merchant naediantc Instrument lo. 31 G of 30 June 200fi, authorized by the Lawyer and N ‹itario I • public JOSE C. NUEZ VELASQUEZ, who for the development of Its activities use 1 ‹i JENY JAMES IN VÜRSIfJNES, having its domicile in the city from Tegucigalpa, municipality of the Central District, contracted to request LICEN £? DISA’RTBUIDOR, of the Granting Company A.ILC.-2000, INC., domiciled ‹n Nevada, Fluid States of America. CONSII1I'H ANDO: That the Directorate of Servic ius Le¡ia1es after va1 ‹› i'ai the c4ocuireiitación acr ›mpañatla a la request, and considering the report of the General Directorate of Productive Sectors dictated that the applicant Complies with the requirements set forth in the National Representatives, Distributors and Agents Law and Foreigners and their Regulations, being pr Western to grant the requested License. I * OR TAN "£ O: t. A sr cim raiiía DE ESTÉTO IN THE DESI • EU INDIAN ISSUES" FItIA AND C’ObJERC! IO 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, 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 Distributors and A i: etites, of Ü tupresas Naci ona le • s and E.xti ünjer ‹i.s. .3 of his Reformed Regret iuedi ‹urte ho. Agreement 749-8. ,) 'fi, ric its Regulations iiiodiíicado by Agreement No. 1 80-00, of October 31 the 2000, RESINLVE: PRIA4ERt3: l9eclarar WITH 1.IIGAR, the Application for LICENt'IA Dfiî l9ISTRIBL'IIJf3R filed pt ›r e1 Advocate JOIIEL ANTONIO Z.ELAYA AI .. $ ’'AREZ, Legal Representative of Mr. JESSY JAME NIASSO hlASSIJ, constituted corn‹ ›€“ oniei‘ciante Individual through Instrument No. 31.6 from 30 d * i * = * dcl 2005, authorized ¡i ‹x‘ el .4bogado and h otario l ° úbIico lklüt “. € “. NUÑEZ VEI..ASQLIEZ., Who The development of its useful activities is rare, with ilenonaination and JAMES INVESTING, having its domicile in l ‹i ciu‹ lad me 4’egucigalpa, municipality of the Central District, for complying with the requirements Establishments in the Law of Representatives, Distributors and Agents, of National and Foreign Companies and its Regulation. SEGI.iNDO: Conceive Mr. IESSY JAME AIN $ .SO íYlASStl, who ] I ‹iru the desaiTOllo of its activities uses the JEíSS deniiuiución .IAMES IN ¥ 'ERSIONkS, who has his domicile in the city of ’Tegucigalpa, municipality of the Centiu1 District, the LICE. to, for a definite time until July 14, 2006, with jin isdiccióH in the territory of the Republic of Honduras, for distribute the pt‘oduct ‹› s of the CEGAL brand, pet4eneciente to the granting company A.P.C.-2000, INC., with donation in Nevada, United States. of Anléricii. THIRD: Publish this Resolution in the Official Gazette, on behalf of the interested party and the presentation of the copy in which the publication is recorded, register in the respective Registry that for such the effect is the Dú’eccióti € íeneial of Productive Sectors. NOJJFIQtIESFí. IRVING ELIAS GUERRERO, Secretary of State in the l3espachos de Industria y Comercio, RAFAEI .. AN "I" ONIO ’I’REJO, Secretary € íeneraI. For the purposes that interest Gorivenha, the present is extended, in the city of ’fesucigalpa, municipality of Central District, on the nineteenth day of September of two thousand and five. RENE RODRIGUEZ.OCHOA Head of the General Secretariat 4 N. 2005 The undersigned, Secretary General of the Secretary of State in the Offices of Industry and Commerce, J'RANSCRIBE: the Resolution that literally says: RESfilLIJCION N °. 715-i005, SECRE R. ANIA STATE IN THE OFFICES HE INDUSTRY AND COMMERCE.- TEGUCIGALPA, MUNICIPALITY OF THE CENTRAL DISTRICT, October 24, 2005. ¥ 'ISTA: To resolve application No. 614-2005, filed with this .Secretary of State on the eleventh date of October two thousand five, by Mr. ROLANDO ARTURO TOME MOLINA, I urge the Bar Association of Honduras under No. 07109, as Legal Representative of the Appointed “EhIPRESA DE SERVICIOS MtTl.TIPLkS IVA CANEÑ A”, domiciled in the municipality of Cane, department of I.a Paz, contracted to request that the granting of the Legal Personality be granted to its representative. approval of Statutes and Registration. WHEREAS: That through Agreement ho. 254-97 dated December 14, 1997, the Office of Development of the Social Sector Ía Economía (O.D.S.), having among other attributions, the qualification of documents of £? Onstitution and Registration of Orsanizacioiies and Companies of the Social Sector of the Economy, which include service companies multiple. €? ON SIII E RAN DO: That the document rita c i ‹in accompanying the merit application is confirmed, is duly legalized, so it was determined that the so-called “EhIPRESA Dk SERVIC? IOS MULTIPLES LA €? ANEÑA”, is a company of social economy of FIRST GItA IO, for being constituted with a minimum of ten natural persons, vertically integrated, with a social credit of not less than one thousand Lempiras (Lps. 1,000.00), of in accordance with the provisions of the Law of the Social Sector of the Economy and its Regulations. WHEREAS: That the Directorate for the Promotion of Micro, Small and Medium-sized Errtpresa and the Social Sector of the Economy, Development Office REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C.,, NOVEMBER 4, 2005 N °. 30.84 g) Written reprimands. h) Impose economic sanctions from twenty Lempiras (L.20.00) to twenty thousand Lempiras (L.20,000.00), through motivated resolution ' i) Apply the corresponding sanctions in accordance with the provisions of Section Two and Third of the Chapter IX of this Regulation. j) Temporary closure of buildings and establishments, by reasoned resolution. k) Suspension of registration or sanitary license, by reasoned resolution. I) Confiscation of products, substances and artifacts, by means of a niotivated resolution. m) Control the advertising of products, establishments of health interest and health services, through irotivated resolution n) Resolve matters delegated by the General Directorate of Health Regulation. o) What is not provided for in this Regulation but is related to it and in accordance with the current legal system in the country. III. Depai tamental Health Region: It has powers to: a) Issue reports on matters arising from the General Directorate of Health Regulation. b) Impose economic sanctions from twenty Lempiras (L.20.00) to twenty thousand Lempiras (L.20, 000.00), through motivated resolution. c) Grant / deny sanitary registration of products; according to delegated risk through motivated resolution. d) Grant / deny sanitary license of establishments, according to complexity through niotivated resolution. e) Resolve matters delegated by the General Directorate of Health Regulation. 1) Apply the corresponding sanctions in accordance with the provisions of Section Two and Third of the Chapter 10 of this Regulation. g) The release, confiscation, denaturation or destruction of products, substances and artifacts. h) Tenipoial closure of establishments according to delegated complexity, by reasoned resolution. i) Suspension of registration and sanitary license. j) What is not provided for in this Regulation but related to it and of confidence with the legal process in force in the country. IV. Head of the Department of Health Regulation in Health Regions: It has powers to: a) Dictate the request for the sanitary registration of products of sanitary interest according to the risk, in order to be granted or denied by the regional headquarters. b) Dictate the request for sanitary licenses of establishments according to complexity, in order to serotorgado or denied by the regional headquarters. c) Issuance for the imposition of the following sanctions: 1) Fines from Velnte Lempiras (L.20.00) to twenty thousand Lempiras (L.20, 000.00). 2) The release, confiscation, denaturation or destruction of products, substances and artifacts. 3) Temporary closure of establishments according to complexity delegate d) Written reprimands. e) What is not provided for in this Regulation but related to it and in accordance with the legal system in force in the country. V. Sanitary Province: It has powers to: a) Perform inspections of products, services and establishments of health interest. b) Take samples of products of health interest. c) Retain products, substances and artifacts that are considered hazardous to health. d) Execute the confiscation, denaturation and destruction of products of health interest, prior resolution. e) Execute or notify the actions and penalties contemplated in this Regulation according to the resolution issued by competent authority. c) Make the request of the representative or owner of the establishment to appear before the competent authority to solve the problems or deficiencies found. d) Other delegates. CHAPTER IV SANITARY RULES APPLICABLE TO PRODUCTS, SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST. Article 8.- For the application of this Regulation, the Secretary of State in the Department of Health, through the competent bodies adopt the mandatory national regulations in force and those that are approved in the future, as well as international standards on products, services and establishments of health interest contained in international conventions and treaties ratified by Honduras. If REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 Article 9.- In the case of food, food additives, packaging and labeling, they will be applied in the order of following priority: a) This Regulation, b) Central American Customs Regulations, c) Technical Standards Hondurbñas, d) Nonnas of the Codex Alimentarius, e) Regulations of the Federal Code of Regulations of the Office of Administration of Food and Drug Administration (FDA) of the United States of America and f) Pan-American Sanitary Standards of the Organization Pan American Health (PAHO). Article 10.-In the case of establishments where they are produced, handled, stored, distributed and sold food, this Regulation provides as mandatory: a) Customs Union Regulations Central American and, b) Honduran Technical Standards for Aliinentos Establishments. Article 11.-In the case of Medical Devices and Devices, in the application of these Regulations they are considered Mandatory provisions established in the Honduran Technical Standard and the Norms and / or Regulations of the Union Central American Customs. Article 12.-The physical-chemical, microbiological and biological evaluation of famiaceutical products must comply according to order of priority with the following standards: Honduran Technical Standard, the specifications established in the USP Pharmacopoeias of the United States of America, British, European, International, Japanese, French, Argentina, German, Helvetic Mexican, Spanish, Mexican Homeopathic Pharmacopoeia, Codex Frances, Code of Regulations Federal and in the case of new products not included in the previous pharmacopoeias the methodology will be accepted duly validated and specifications developed by the manufacturer. In either case, you must comply with the Risk Criteria. For the medical evacuation of mcdicarrientos the Central American Farcuacological Standard is considered and of Dominican Republic. Article 13.-The health establishments, included in these Regulations must carry out a priority order with the following standards: Noiria Hondurena Technique, Manual Technical Standards for Health Establishments, Stability Standard of the Customs Union, Labeling Standard for the Central American Customs Union, Standard of Natural Products of the Customs Union, Medical Supplies Standards Surgical, Regulation and Guide of Practical Mariufactura Buelias of the Central American Customs Union, Good WHO Manufacturing Practices, Good Pharmacy Practices, Good Storage Practices, Good Laboratory Practical, Biosafety Standards and others recognized nationally and internationally. CHAPTER V OF PRODUCTS, SERVICES AND FIRST SECTION ESTABLISHMENTS OF FOODS AND DRINKS Article 14.- Sa1 must be fortified with iodine, sugar with vitamin A, wheat and corn flour with iron, folic acid, niacin, riboflavin.- Food fortification may be extended to products other than Ministry of Health determine through the competent Directorate General. Article 15.- Foods in accordance with the risk they represent and for the purposes of effective surveillance are classified as follows: a) High Risk "A" b) Risk "B" Medium Risk c) Risk "C" Low Risk Article 16.- The Ministry of Health through the General Directorate of Competent Health shall prepare and approve by means of according to the food and beverage listings according to risk classification, which must be updated periodically SECOND SECTION OF THE RABniCAS BE ALIIYIENJ OS Article 17.- Depending on the type of food that the factories manufacture or elaborate in particular, they must comply as well. with what is established in the norms indicated in Article 10 of this Regulation. Article 18.- Food factories must comply with the sanitary norms established in the Regulation Technician of Good Manufacturing Practices and other current Standards or Technical Regulations. THIRD SECTION OF THE ESTABLISHMENTS WHERE MANIPULATE, EXPAND AND SERVE FOOD Article 19.-Establishments where food is handled, dispensed and served must comply with the conditions next hygienic-sanitary: a) To be protested from the external environment against insects and rodents and located in places isolated from any unhealthy focus. b) The establishments and their surroundings will be clean, garbage accumulation fibers, stagnations of waters and their operation should not cause inconvenience to conitiriity. g2 REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 ) Have sufficient space and adequate ventilation and lighting and operate in separate areas or environments. d) Have a potable water supply with adequate distribution for handling, preparation of food, cleaning, washing and disinfection of premises, equipment, utensils and personal hygiene. e) Have a good disposal system for sewage and excreta. Have adequate storage system and garbage collection on a daily basis or when necessary; this one deposit in metal or plastic containers provided with a lid. g) Be subjected to scrupulous cleaning or cleaning daily. h) Be protected internally against rodents and insects and use a system-for permanent control of these. i) Floors, walls and ceilings should be constructed with materials that allow their cleanliness and conservation. The walls of food preparation areas should be smooth and easy to clean. j) They must have sanitary and urinary services connected to the excreta drainage system, in sufficient quantity according to the size of the establishment, and must be isolated from the process areas, Food handling and service. k) The premises will be equipped with doors of the environments of the extensive environment. i) There must be a sink equipped with drinking water, soap and disposable towels or automatic dryers. The equipment, utensils and other artefacts destined to the elaboration and conservation of the foods, must be made of appropriate stainless or plastic materials that maintain the good state of preservation and cleaning. m) Plates, glasses, cups, cutlery, other containers and utensils intended to serve food must be made of waterproof materials that allow cleaning and liquefaction after use, including Physical or chemical disinfection. n) The furniture destined to store the dishes, linens and other kitchen utensils must be of closing that guarantee the protection of its content and easy cleaning. Those destined to the service of food and other furniture They should be built with materials that allow easy cleaning and conservation. ñ) The linens in use must always be clean. o) Containers or containers intended for the sale of food consumed outside the establishment must be made of resistant impemieable materials and the food must be served properly protected with lids or appropriate covers and will be disposable at first use. p) Foods that are easily damaged should be stored in refrigerated units, legumes and fruits on shelves open with sufficient ventilation; Packaged foods should be placed on shelves. q) Foods prepared for sale or service must be protected from the environment by display cabinets, furniture, lined with glass, metal mesh, plastic material or any other that ensures its protection and prevents its pollution. r) The containers, containers and all material destined to contain the food must be stored in places that ensure your protection and avoid contamination. s) To facilitate sanitation, equipment or other appliances must be placed on rollers or pallets. t) In the preparation of food, adulterated, expired or contaminated raw materials should not be used. If additives are used, they must be those permitted by current regulations. Article 20.-For establishments where food is handled, dispensed and served, the provisions are stipulated. following prohibitions: a) The entry of people without proper uniform to the process or handling section, as well as the presence of people outside it. b) Eating, drinking, sleeping, smoking, spitting in the areas related to the process, packaging, storage and food service. c) Use the premises, facilities, furniture, equipment and utensils for uses other than those of the exercise. d) Sell or give free of charge food not suitable for human consumption. e) The permanence of people suffering from contagious infectious diseases. í) The entry and permanence of domestic animals. g) Storage of hazardous substances. FOURTH SECTION OF THE MANIPULATOR REQUIREMENTS OF FOODS Article 21.-Food handling is not allowed for people suffering from respiratory infections. acute, infection in the pharynx, tonsil and larynx, conjunctivitis, infectious otitis, diarrheal diseases and Infected skin lesions or healing process and other infectious infectious diseases. Article 22.-Any person who handles and food supplies shall undergo medical evaluations and controls in medical centers. public or private health, of which a record must be kept in the company's files, such controls They should be practiced every six months. Section A Acuerttos y ieyes' REPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841 Article 23.-The medical and clinical controls to which the food handler must be submitted are the following: general medical exam, clinical exams: stool exam, urine test, infectious hepatitis screening and Other infectious and contagious pathologies. Article 24.- Every food handler must meet the following requirements: a) Possess good health b) Personal hygiene and good presentation c) Practice hygiene habits d) Have a health card Article 25.- Every food handler must comply with the following hygiene habits: a) Keep your hands clean. b) Bathe daily. c) Keep your face shaved. d) Short nails clean and without enamel. e) Short or collected and clean hair, with its respective hat or hairnet. íj Always wear the full uniform (light colored hat and gabacha), keep it clean, wear a mask when This is determined by the health authority. g) Wear closed shoes and gloves when necessary. h) Stay quiet when handling food. i) Handle food without watches, rings and other jewelry in your arms and hands. j) Wipe the sweat with clean and disposable tissues. k) Do not fuse when handling food. l) Cover your mouth or nose with clean tissues when you cough or sneeze when you are not wearing a mask. m) Take the dishes, plates and fees by the base or handle. n) Take cutlery, knives, spoons and tongs by the handle. o) Collect utensils, crockery and leftover food, trying to avoid contamination of the hands. Article 26.- Every manipulator must wash and disinfect their hands in the following cases: a) When you start and finish your work b) After using the sanitary service, scratch or touch any part of the body especially nose, mouth, ears and head c) When sneezing and coughing. d) When collecting used utensils or food leftovers. e) When wiping sweat. í) When handling garbage containers. g) After handling money and other substances or non-food items. Article 27.- In food preparation the manipulator must: a) Wash the utensils carefully before and after being used b) Wash the surface where you peel, chop or prepare food before and after each use. c) Wash dishes, cutlery and glasses before serving food and drinks again, when these are not disposable d) Wash the spoon or utensil used to taste a food well. e) Mix salads using utensils, never with your hands. Article 28.- The manipulator must not: a) Clean your hands and utensils with your gabacha or apron b) Insert your fingers into the utensils and touch the prepared or prepared food. c) Allow people outside the process to intervene in the preparation and service of food. FIFTH SECTION FOOD STORAGE Article 29.- Food storage shall meet the following conditions: a) Distribution of food in pallets or lots that keep the proper distance between them with the walls, floors and roofs. b) Adequate Use of surface spaces and height of such form that movement, reception, Handling and shipping is facilitated. c) Rotation of stocks and periodic removals based on storage time and storage conditions conservation required by each product. d) The inspection of the conditions of the premises and the state of the food must be carried out periodically. e) The withdrawal of damaged, expired, altered, infected or contaminated food, as well as those whose containers appear broken or dented, they will proceed according to the cases to their uselessness or they will be destined to other uses other than human consumption. Article 30.-In the storage of food the following general measures will be taken: a) Adequate temperatures so that food does not suffer alterations or changes in its characteristics initials. b) Relative humidity according to the nature of the product c) Convenient air circulation. d) Protection against direct sunlight, when it is harmful to the product. M? f i 'REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 e) Isolation of substances or products that emit odors from those that can absorb them. f} Adequate control of insects and rodents. Article 31.- It is prohibited: a) Store and transport food products with hazardous substances. b) Store and transport altered, contaminated, adulterated or counterfeit food along with others that are Suitable for human consumption. SECTION SIX OF PHARMACEUTICAL PRODUCTS Article 32.- The regulation of pharmaceutical products in the national territory shall be done in accordance with the established in the Health Code, its Regulations and international conventions and treaties adopted by the State of Honduras.- This regulation will be implemented gradually, according to the technical standards of Good Practices Manufar: Tura (BPM) of the Pan American Health Organization (PAHO) to the validity of this regulation. Article 33.- The Ministry of Health will prepare special regulations for medicines destined for the market of generics Article 34.- Over-the-counter medicines authorized by the competent health authority may be marketed also in non-pharmaceutical establishments such as supermarkets, warehouses and grocery stores complying with the Good storage practices. Article 35.- The quality control of products of sanitary interest shall be carried out in laboratories that establish national legislation or others that are recognized and certified by the sanitary authority.- For those products that are subject to mutual recognition between countries, through international agreements, their control is will perform once they are in the national territory. ' Article 36.- The regulation of drugs classified as controlled shall be in accordance with the provisions. in these Regulations and the provisions of the United Nations Conventions: Single Convention of 1 961 on Narcotic Drugs issued by the 1972 Protocol, Convention on Psychotropic Substances of 1971, United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988, International Narcotics Control Board, National Narcotics and Other Drug Control Board Dangerous and other agreements that the country be signatory and ratify. Article 37.- Three (3) regimes are established: Prohibition, Strict Control and Control. I. a) It is prohibited, for medical or scientific purposes, the cultivation, production, manufacture, distribution and use of the following narcotic drugs: Cannabis and its resins Ketobemidone (4-meta-hydroxyphenyl2-methyl-4propioni1pi- peridine) Desomorphine (Dihydiodeoxymorphine) Heroin (Diacetylmorphine) The preparation, distribution, trade and use of Lysergic Acid Dietilamide (LSD), of the Psilocybin, mezcalin and other similar substances. II. The narcotic substances mentioned in List I, List 11 and are subject to strict control List III of the Single Convention of 1961. III. The psychotropic substances mentioned in List I, List II, List III and List IV remain under control of the Single Convention of 1971. Article 38.- In accordance with the provisions of Articles 150, 151, 152 and 154 of the Health Code, the regulation and the control of narcotic drugs, psychotropic products and chemicals, like other dangerous drugs that they can create dependencies or habits, regarding their import, export, production, storage, distribution, prescription and dispensation will be done through the Ministry of Health applying the rules and regulations established in international agreements. Article 39.- The dispensation of psychotropic products, narcotics and preparations containing them, may only be made by the pharmaceutical regent, upon presentation of the corresponding special prescription, which will contain the following requirements: a) Letterhead, stamp and signature of the prescribing physician. b) Date of issue. c) Name and age of the patient. d) Patient address. e) Commercial and generic name readable of the prescribing drug. f) Dose and quantity prescribed in letters and number. Article 40.- Psychotropic drugs, narcotics and other controlled drugs may only be marketed by Pharmaceutical laboratories, drug stores and pharmacies nationwide. Article 41.- For the management of psychotropic and other controlled drugs, veterinarians and dentists shall be governed by Ready for medical professionals. Ę REPUBLICA DE HONDURAS - "1" EGIJCIGALPA, M.D. C., NOVEMBER 4, 2005 No. 30,841 Article 42.- The validity of psychotropic prescriptions will be fifteen days and three days for narcotics, counted from the date of issue. When circumstances of force majeure arise competent health authority may authorize prescriptions that have expired said terms. Article 43.-These are duties and obligations of the pharmaceutical regents regarding the handling of narcotic drugs, Psychotropic and controlled products the following: a) To personally dispense the recipes of these products. b) Dispense such products only to persons of legal age c) Keep the products controlled in a special section, under have and instead not accessible to the public. d) Seal the prescriptions dispatched with the seal of the pharmacy and the pharmaceutical regent. e) Reject prescriptions that have amendments or deletions or without the seal of the doctor who extends it. Ę Bring the control books to 1 day. g) Authorize cpn your signature for orders, reports or requests that refer to these products. h) Inform the competent health authority about the anonymity that is known regarding these products. Article 44.- The General Directorate of Health Regulation through the competent health authority shall remain updated list of psychotropic drugs and other controlled products, as well as substances Chemicals subject to control and inspection. Article 45.- Every importer of psychotropic drugs, narcotics and controlled chemical substances must send a monthly report to the competent health authority, indicating the movements of entry, exit and balances, as well as specifying the people or establishments to which the product was sold, being verified, audited and inspected when the health authority deems it convenient. Article 46.- Narcotic drugs, psychotropic drugs may only be exported by laboratories and drug stores to establishments legally authorized for this purpose in the importing country. Article 47.- The amounts of psychotropics, narcotic drugs and controlled chemical substances that are required with Medical, scientific or production purposes must be reported before April 10 of each year to the authorities competent by the interested parties, indicating if they will be imported or acquired localinente. Article 48.- The competent health authority, in accordance with the previous article, shall approve the quota within the annual forecasts established according to the needs of the country, to each authorized establishment to import or manufacture Psychotropic, narcotic, and controlled or prepared chemical substances containing them. Article 49.- The competent health authority shall keep a record of the forecasts and of the fees set. for each establishment.- If at the end of the year the quantities authorized to manufacture have not been used in in its entirety, the surplus will be deducted from the amount authorized for the following year. Article 50.- The pharmaceutical laboratory that manufactures controlled chemical products and substances must have with two control books, one for the movement of raw material and another for the transfer of finished product. Article 51.- The control books of the producing, importing, distributing and dispensing establishments of controlled chemical products and substances must be labeled, folded and sealed by the authority competent sanitary registering the corresponding information. Article 52.- For the transformation of raw material into a controlled, finished product, the manufacturing laboratory must submit an application at least five (5) business days to the competent health authority, who Appoint the respective inspector (s) to carry out the corresponding procedures. Article 53.- The laboratory shall be obliged to provide the necessary samples for the corresponding analyzes. of quality control, as well as defray their costs. Article 54.- The laboratory must request readjustment of the amount of its stock in the case of materials Hygroscopic premiums. Article 55.- Raw material transformation operations for controlled products carried out by the laboratory, as well as requests made to the competent health authority must be endorsed by the Regent. Article 56.- Only narcotics, șicotropics, products and products may be imported into the national territory. Chemical substances controlled by the customs of Pueno Cortes, Toncontín, La Mesa and others that in the future authorize the competent health authority. Article 57.- Drugstores may sell controlled products to duly authorized doctors who provide its services in the rural area, where there are no pharmacies, for this purpose, the medical professional must submit the corresponding card issued by the competent health authority, which will be valid for a (1) Aryan. K MPUBLICA DE HON DIJRAS - TEGUCIGALPA, M. lß. C., NOVEMBER 4, 2005 N ". 30,841 At ticle 58.- For the sale of narcotic patients that are carried out between pharmaceutical establishments, will require authorization issued by the competent health authority; the cornprav ent of psychotropics that It is rea1 i ce, Between pharmacist establishments will be sent through notification; the sale of substances 9UC controlled chemicals will be performed between companies will require authorization issued by the health authority competent. Article I 59.- Controlled products must be identified with a red “C” and the law of Jdil C {ue say "Product susceptible to dependence" ›Title 60.- The products of strict control cny‹ i sale requires a cspccial mćJica prescription, they will be subject to Dispositions of Title I, Articles 150 at 154 of the SKİ Code and may only be dispensed prior to presentation of the i specti goes written prescription with tetra cl ‹ira y n (legible, signed and sealed and must be dispensed by customer according to the regulations established for paia ta1 fi’i. Article 61.- The special recipe books for products of strict cont1’o1 will be provided pei‘sonalnsente in the Ministry of Health by the cornpctcnte authority to the isiédicos collegiate. Article 62.- In order to obtain the book of special documents, the doctor must: a) Submit the application personally, finalized and scllad ‹i. b) Presentai ’came of association. c) Make the corresponding payment. d) For the request of a new checkbook you must submit the previous one. e) Present record of the Medical Colcgio cynic is entitled to exercise. Article 63.-. The doctors, dentists and vetci’i l) íll’İOS ț3Od1’ÜJ keep in their briefcase up to two vials tie Birth of strict control conditioning its use to the character of cirergencia. Article 64.- The quantities that may be prescribed for products of strict control shall be determined by the CIC. according to the corresponding national and intentional protocols and technical standards. Article 65.- For the tixitainiento of chronic or terminal enfcrnaedades, the Co-competent Health Authority based on the medical diagnosis, it will authorize in writing to the pharmacological establishment Dispense ‘the products controlled indicating drug, daily dose and days of tralarniento. Article 66.-In the case of national or international health organizations or bripadas duly authorized quc do Floor or manejcn cstrlpcfacient and psychotropic adeirás deíaci.ili request ‹iritorización ¡For t‹ il fin ‹i la Authority Sani till Ìil competeiite, acornJsananclo the following information: a.- Garlic tl plan that includes place, beginning and duration ‹1c l‹ i activity, b.- List of pi odnctos, including noisilare genéi’ic ‹i and commercial, present‹ 1 Phyloraceuticals, concentration, quantity ‹l (‹ ›n numbers; / letters) and expiration date. Article: ulo 67.- Controlled pi'od ucts and not counted oItIt IS that is known only to be justified and t] ue seam aptOS .ll’il USE. the Dii’cccióú Gcneral de Salud coiiipctente You can dot iai to public hospitals similar entities that need cll ‹is, from which the minutes will be taken and the respective resolution will be issued. Artíi: iılo 68. The Regent and the owner are rcsponsablcs ‹le that do not exist for sale Pharmaceutical products expired cm cl establishment. The pharmacological laboratory fabricantc cs responsal: ale by means of the regelite de ladrogueríó COn csponclici ite de retirur tlel nacl cado los rnedicarnentos lio aptos print cl consume ›, c) If they are damaged or expired. The regent ‹lc the fanvaci‹ i is responsible for the expired product being broken £ Î Î ütm ›and separated cJe unredited licenses. SECTION IS PTI MA Dłlś LOS ESJ’ABLECI M IE NTOS OF I NTERI £ S SANITARY Artíi:! N'6'9.- Sc consider the establishment of public health interest İCOS O) 3l’iVíldOS, COn or without ends tle I ucro, aqur'l l ‹› s related to falv’ication, iirport ‹itiún, export‹ ’› n, transports: and co-commercialization of protucts of health interest ‹ii’iti and its raw materials; So I know who Dontle is re ‹il iz‹ in activi: s de pi’estación ale servicios direcìa fitntlansentaliiiciite a la prevention, cut ación, Diagnosis and rehabilitation of lR Sil If l € Í, as well as any other person, whether legal or legal, that bi inde ün set via io similar to the population. Article ‹: ulo 70.- l • l’CV1O‹ I Function set ‹iiriento c installation lt› tlo establishment of health interest required License SíìlJiÍí‘‘il.- For the analysis, periodification and transfer of the establishments of interest: sarliÎílrio is authorized by the Secret ‹1l’Íil UC Salud. Article: No. 71.- 3 “oc cos cstablccirnientos dc interest saniliu i‹ ›: health institutions according to article 157 del Códi, po ‹lc Salud, de.:ilirncntos y I ebidas, of natural products, laboi‹ it ‹› i u ›s for the analysis of calitlad of pl products of intcrćs sanit.ii’ii ›, distributors of insulins and laboratory equipment, distritloi cs of raw materials of products of health interest, irl distl ibui ‹ioi cs of chemical substances, distributors of insilmos y equi¡ao ‹lc laboratories, tlisti ibudores de irlsrnros and rnérlico quiiiii’i: it. or, distributors of inputs and otlontological equipment, cstarán siljcl ‹› s g2 MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 to this regulation for which they must meet the minimum essential requirements related to structure physics and facilities, equipment, human resources, waste management, organization and operation established in the technical standard. Article 72.- The sanitary control of the establishments of sanitary interest will be exercised by the Ministry of Health for through the General Directorate of Sanitary Regulation, Department of Sanitary Control of Products, Services and Establishments or Delegated Department and the Departmental Regions and municipal authorities. Article 73.- The sale of drugstores and laboratories is strictly prohibited. narcotic drugs, psychotropic and other controlled drugs that may cause dependence or habit, to the positions of sale of medicines and in general to non-pharmaceutical establishments; such products will be subject to provisions established in Articles 150, 151, 152,153 and 154 of the Health Code. Article 74.- Drugstores may only sell products in the medical emergency kits. amounts established in the list approved by the competent health authority. Article 75.- The establishments will occupy independent premises according to the activity or service that lend and separate from any other commercial, residential establishment complying with the technical standard of minimum essential requirements. Article 76.- Establishments of Health Interest Complexity I and II may be installed in commercial centers, supermarkets, department stores and other similar establishments, in individual locations that guarantee the safety and hygiene of the services provided. Article 77.- All pharmaceutical establishments according to their category must comply with good manufacturing practices or product handling. Article 78.- The pharmaceutical shift is mandatory for all pharmacies where it is so established by the competent health authority, however, in times of epidemic or any other public need the Secretariat Health by resolution may order that all pharmacies provide such services continuously to the public, as long as the cause that originates persists.- The Ministry of Health will coordinate with the Ministry of Security protection to the establishment in turn. Article 79.- Every pharmacy will be under the responsibility of a regent, who is obliged to remain in the same within normal working hours and during the shift service, as well as health laboratories also They will be in charge of a regent. Article 80.- The competent health authority shall prepare and approve no later than December 10 of each year, the Annual shift schedules of pharmacies across the country, based on the projects proposed by the Associations of Pharmacy Owners and endorsed by the College of Chemist-Pharmacists of Honduras.- The cadres Shifts should be prepared according to the needs of each community and will be given the greatest possible disclosure in the first days of the month of January of the corresponding year. Article 81.- The pharmacies will fulfill the obligatory turn of attention to the public from 6:00 pm to 10:00 pm according to calendar prepared by the competent authority. This provision is without prejudice that other pharmacies provide the 24-hour public service, every day, subject to the provisions of this Regulation. Article 82.- Pharmacies, while they are providing the shift service, must have a visible place of establishment of a bright advertisement with clear characters that says “TURN” so that the public knows that the pharmacy He is rendering the service on an extraordinary day. Article 83.- Pharmacies will display in a visible place on the front of the establishment a sign with the payroll of the pharmacies on duty, with indication of their respective addresses. Article 84.- The Medicine Sales Posts must have a previously trained person and will be authorized by the competent authority. Article 85.- The Medicine Sales Posts will only sell the medicines included in the list approved by the competent sariitaria authority.-Its opening will only be authorized, in the places where they do not exist Pharmacies providing the service. Article 86.- The Emergency Medical Kit will be installed inside the authorized doctor's clinic. Article 87.- Medical Emergency First Aid kits may only keep medications according to the list authorized by the competent health authority. Article 88.- In Medical Emergency Kits, medications may not be sold directly to the public, only to doctor's patients, in case of emergency. Article 89.- The regent is the professional who assumes the technical and scientific direction of the establishments pharmacists ItEPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C., NOVEMBER 4, 2005 N °. 30,841 and clinicians, being responsible for the good condition of the products and services provided as well as the contraventions to the legal and regulatory dispositions that derive from their operation. ‹' Article 90.- In the case of pharmaceutical establishments, the regent is responsible for control and custody of narcotic, psychotropic and other substances under control; any abnormality should be reduced immediately to the competent health authority. Article 91.- In the case of health facilities such as: medical, dental and medical care clinics veterinary, the management of psychotropic and other controlled products, will be the responsibility ‹le professionals competent. Article 92- Within any health facility, the certificate that will accredit as regent. Article 93.- In accordance with Article 160 of the Health Code, it corresponds to the Ministry of Health regular and promote the installation of registration and information systems for adequate technical, epidemiological and care of all public and private health institutions.- To comply with this provision, the General Directorate of Health Regulation in coordination with the corresponding bodies, will establish the rules and minimum procedures that all health facility operators must observe. Article 94.- The health establishments regulated in this Regulation are obliged to exhibit request of the General Directorate of Health Regulation, all those provisions and internal regulations that regulate health services and actions. Article 95.- The owners or legal representatives of the Establishments must inform the Secretariat of Health, in a term not exceeding thirty days, when they decide to stop providing temporary temporary services or definitive EIGHTH SECTION OF DEVICES AND USE EQUIPMENT SURGICAL DOCTOR Article 96.-The Ministry of Health corresponds through the General Directorate of Health Regulation, the sanitary regulation of importation, manufacturing, marketing, transportation, storage, handling and use of Devices and equipment for surgical medical use. Article 98.-The devices and equipment for surgical medical use Risk A includes the following: a) Those destined to administer energy to the human body in a potentially dangerous way. b) Non-invasive ones that come into contact with the injured skin, in wounds with rupture of the dermis and that only Heal by second intention. c) Invasive surgical type for short-term use, if they are intended to diagnose, monitor or correct a cardiac, central circulatory system and respiratory system alteration. d) The invasives. Surgical-type surgical, long-term use that is used in direct contact with the heart, the central circulatory system or the central nervous system. e) Non-invasive used to modify the biological or chemical composition of blood or other liquids or body fluids, with the purpose of being introduced to the human body by infusion or other route of administration, whose characteristics mean that during the modification process a strange substance can be introduced into a potentially dangerous concentration. Article 99.- The Ministry of Health through the General Directorate of Health Regulation will prepare and approve by agreement the lists of devices and equipment for surgical medical use according to risk classification, same that must be updated periodically. Article 100.-The devices and equipment of surgical medical use Risk B, are those that can be indirectly invasive, which induce or store substances that at some time can be surgically implanted in the body human. Article 101.- Devices and equipment for surgical medical use Risk C, considered non-invasive or invasive that they present the lowest potential risk of harm to the patient and are devices that do not come into contact with the patient or They only do it superficially with the skin. Article 102.-Any device and equipment for surgical medical use that is intended to be donated must be subject to the provisions established in the External Cooperation Standards in force in the Ministry of Health. Article 103.-The competent Health Authority shall carry out inspection visits to the establishments and their devices and equipment for surgical medical use, in order to guide, educate and apply the measures corrective and corresponding health security. Article 97.-The devices and equipment for medical use Article 104.- All devices and equipment of Surgical medical use are classified according to your risk in: A (High Risk), B surgical entering the country must comply with the provisions of (Medium Risk), C (Low Risk). the corresponding standard. §J REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D.C. NOVEMBER 4, 2005 N °. 30.84 CHAPTER VI OF PRODUCT LABELS AND CONTAINERS FIRST SECTION OF LABELS Article 105.- The labels of the products that are elaborated or commercialized in the national territory must contain the requirements that are determined in this Chapter, in the Customs Union Labeling Standard, and according to current regulations. Article 106.- On the label of domestic and foreign products, the following information must appear: a) Name of the product that must indicate its true nature, being normally specific or generic, that does not mislead or mislead the buyer or consumer. b) Name or business name of the owner, manufacturer or distributor of the product as applicable. c) Place of origin of the product, name of the country. d) List of ingredients or qualitative and quantitative formula as applicable. e) Lot number. f) Expiration date. g) Net content, declared in units of the International System, as applicable. h) Health registration number. i) The labels must be written in Spanish. Otherwise translate it to Spanish endorsed by External relationships. Article 107.- The labels may be made of paper or any other material that may be attached to the packaging or permanent printing on them. Article 108.- The inscriptions on the labels must not disappear under normal use conditions, be easily Visible to the naked eye and written in Spanish, except for those registered products that are exclusively for export. Article 109.- The labels of the products written in a foreign language that are marketed in the country, must have the corresponding translation into the Spanish language, with equal character Article 110.- The labels that adhere to the package may have descriptions on the back of them, provided that are clearly visible through the package with its contents as long as it is not the mandatory information. Article 111.- When the product needs special storage conditions, it must be clearly indicated in the label. Article 112.- Any product that has been treated with radiation / ionizing energy must carry the label very close of the name of the product, an indication of such treatment. When an irradiated product is used as an ingredient in another product, this circumstance must be declared in the list of ingredients. Article 113.- Packaged products must not be described or presented with a label containing phrases, words, denominations, symbols, figures or drawings, geographical names, indications that lead to interpretations false or error, deceit or confusion, as to its origin, origin, nature, composition and quality with another product. Article 114.- The label will not be allowed on the inner side of the container or wrap when in contact with the product. Articles 115.- It will not be allowed to write the mandatory data of the label in seals, caps, caps or another part that is used when opening the container, unless authorized by the General Directorate of Health Regulation. SECOND SECTION OF PACKAGING Article 116.- Product packaging can be made of plastic, metallic, paper, glass, cardboard and other material. authorized by the General Directorate of Sanitary Regulation through the Department of Sanitary Control of Products, Services and Establishments. Article 117.- The materials destined to be in contact with the products must be manufactured with materials premiums and additives authorized according to established national and international standards. Article 118.-The materials for packing or packaging shall protect the product from the outside environment by complying with the requirements of impermeability and closure to gases, humidity and ultraviolet radiation, when the action of These agents could alter or contaminate them during the contact time. Article 119.- The materials, polymers of the containers will not yield or displace the product, substances that may determine modification in their organoleptic characteristics and composition during the time of use or marketing them. As regards maximum migrations, they must comply with the limits established in the applicable sanitary norms. ■ l REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 Article 120.- Packaging materials will not absorb or yield to the product, in their contact, constituents in amounts that undermine their stability or quality or that are the cause of significant loss of content. Article 121.-The quality control of the packaging materials in contact with the products shall be carried out according to the case: 1. In the packaged product, 2. In the empty container; Y, 3. In the raw material with which the packaging is made. The controls will be carried out in the first instance in official or private laboratories recognized by the Secretariat of Health and in second instance in recognized laboratories abroad.- Quality controls will be applied of ISO Standards or Good Manufacturing Practices. CHAPTER VII OF THE ADMINISTRATIVE MEASURES AND ACTS OF SANITARY PRODUCT CONTROL, SERVICES AND ESTABLISHMENTS OF HEALTH INTEREST SECTION ONE GENERAL PROVISIONS Article 122.- To exercise the sanitary control of products, establishments and services, the Ministry of Health will use the following control mechanisms: Sanitary License, Sanitary Registry, Sanitary Inspection, Audits, Accreditation and Certification. Article 123.- If, in order to comply with the previous article, the use of other public laboratories or private, the Ministry of Health may use its services, ensuring that they are duly accredited by National or international institution recognized. Article 124.- The Ministry of Health may contract professional services for sanitary inspection, audits, accreditation and certification, if necessary. Article 125.- The Ministry of Health shall formulate the technical norms for hiring professional services. in the specific areas of health regulation. SECOND SECTION OF THE HEALTH LICENSE Article 126.- For the purpose of applying this Regulation, the establishments of health interest are classified as the following classes: Complexity I (Low Risk), complexity II (Medium Risk) and complexity III (High Risk). The Ministry of Health through the General Directorate of Health Regulation will issue the establishment list of according to this classification. Article 127.- Any establishment of health interest of complexity I, II and III, prior to its operation in the country requires an extended license by the competent health authority. Article 128.- The sanitary license for establishments of sanitary interest, at the option of the interested party, shall have validity of two (2), four (4) and six (6) years, from the date of its granting.- Except for the infractions to the sanitary laws or their regulations, the suspension or cancellation of the same is necessary. UNIT I OF THE REQUIREMENTS TO OBTAIN THE HEALTH LICENSE Article 129.-To obtain the sanitary license it is required: 1. Submit an application with the Sum indicating: HEALTH LICENSE IS REQUESTED, with the following information: a) Body to which it is addressed: General Directorate of Health Regulation or Departmental Regional Headquarters, according to correspond. b) Name and generals of the owner or legal representative of the establishment and the legal representative. ) Corporate name or company name d) Name of the establishment. e) Exact address of the establishment, including telephone, fax, email. Activity or activities to be dedicated. Place and date of the request Fimia of the applicant. 2.- Power granted to the legal professional. 3.- Photocopy of the deed of incorporation of the company or individual merchant, duly registered in the Registration of Real Estate and Commercial Property. 4.- Photocopy of the card of the professional who will act as Regent, or Medical Director, when appropriate. 5.- Payment receipt for health license services. 6.- Presentation of the plans of the physical, electrical, drinking water and wastewater facilities of the Establishment approved by the corresponding City Hall. TO. REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 Vehicles and means of transpoi’te of food products and health services (ambulances, services mobiles) must present the report of the means of transport and legal document that proves it. UNIT II OF THE MODIFICATION OF THE LICENSE SANITARY Article 130.-The following cases are considered a modification of the sanitary license: transfer of ownership, modification of the name or business name of the establishment, transfer, remodeling, reconstruction, extension of goods and services and others that the health authority determines. Article 131.-Every owner or representative of establishments must request through a professional collegiate law, modifications of the sanitary license. Article 132.-The General Directorate of Sanitary Regulation shall authorize the modification of the sanitary license, by reasoned resolution after ruling, preserving the nomenclature and validity of the license granted initially. If the modification produces a change in the category of the establishment, the nomenclature is modify and apply the corresponding payment rate. of the Department of Sanitary Control of Products, Services and Establishments or Delegated Department, Units Regional Departmental and Municipal Regulation, grant the Sanitary Registry of Food, Beverages, Medicines and Related Products. Article 135.-It corresponds to the Ministry of Health through the General Directorate of Health Regulation through of the Department of Sanitary Control of Products, Services and Establishments or delegated department, grant the Sanitary Registry of controlled raw materials. Article 136.-The same sanitary registry may cover: 1. Variations of aromas or fragrances in different types of cosmetics (talc, deodorants, soaps, shampoo, conditioners, creams, etc.) as long as they do not become the main feature of the product (perfumes). 2. The different shades of color that are added to the different cosmetics (lipsticks, nail polish, soaps, hair dyes, makeup and blushes liquids, makeups and compact blushes, etc.). Article 137.- The same sanitary registry may cover: UNIT III OF THE NOMENCLATURE OF THE LICENSE SANITARY Article 133.- The health license shall have the following nomenclature: b) The number that corresponds to the Departmental Health Region. c) The number that identifies the municipality in which the establishment is located. d) Two (2) letters and two (2) numbers that identify type of establishment. e) Six (6) digit correlative numbering, with which the establishment is identified in the records, starting with the number 000001. fj Four digits corresponding to the month and year in which the sanitary license is granted THIRD SECTION OF THE SANITARY REGISTRY UNIT I GENERAL DISPOSITION Article 134.- It corresponds to the Ministry of Health through the General Directorate of Health Regulation through 1. Variations of aromas or fragrances in different types of hygiene products and chemicals as long as they do not become the main feature of the product. 2. The different shades of color that are added to the different types of hygiene products and products Chemicals Article 138.-All food products, beverages, medicines, biological, homeopathic and related products, which are commercialize or dispense with a specific name requires a health record issued by the Ministry of Health to through the competent health authority. Article 139.- The validity of the sanitary registry shall be five (5) years from the date of its granting, except for violations of health regulations and laws or By regulation, the competent authority resolves its cancellation. Article 140.-It is not allowed to manufacture, import, store, transport, distribute, package, market wholesale or in detail, dispense or advertise any product indicated in the preceding Article 138 that does not have sanitary registration, notwithstanding the provisions of Article 144 of these Regulations. Article 141.-Foods not subjected to any processing or packaging process, as well as raw materials of the REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 Other products of health interest do not require sanitary registration, but they will be subject to surveillance and control exercised by the health authority. Article 142.-Food products, beverages, medicines and related products, and others produced in Central America and other countries where equal treatment is granted to those produced in our country, will be subject to treaties or agreements signed by the State of Honduras. Article 143.-The General Directorate of Health Regulation may exceptionally authorize the importation of products food, beverages, medicines, biologicals and related products, without having obtained the sanitary registration, which they will be subject to control and without paying the fees for analysis and registration services established by this Regulation, in the following cases: a) When circumstances of disasters and emergencies arise, qualified by decree of the Power Executive. b) In the case of samples in the necessary quantities required by the competent General Directorate for Health registration process. c) In the case of donations to state or charitable institutions, prior resolution of the Directorate General of competent Health. d) In the case of orphan drugs. Article 144.-The Executive Directorate of Revenue through its dependencies will only allow entry into the country of food products, natural, biological, cosmetics, pharmaceuticals, products subject to control national and international and others that the health authority determines, if it proves to have a health record or current authorization issued by the competent health authority of the Ministry of Health. In the case of controlled products prior to entering the country, you must accredit Certificate of Authorization Import Officer extended by the competent authority. Any official or public employee who allows the entry of the aforementioned products without complying with the requirement established in this article will be denounced before the Public Ministry to be deducted case responsibilities. determine, in the facilities of the importer or distributor and there they will remain until you obtain the registration respectively, the necessary controls will be established for this purpose, without prejudice to the corresponding sanctions. UNIT II OF THE REQUIREMENTS TO OBTAIN THE SANITARY RECORD Article 146.-To obtain the sanitary registration, you must comply with the following general requirements: 1) Submit an application with the Sum indicating: SANITARY REGISTRATION IS REQUESTED, with the following information: a) Body to which it is addressed: General Directorate of Health Regulation or Headquarters of the Departmental Health Region, as appropriate. b) Name and generals of the owner or legal representative of the establishment and the legal representative. c) Corporate name or company name. d) Exact address of the establishment, including telephone, fax, email. e) Data and classification of the product: Commercial name and / or generic name, manufacturer, type of product, country of origin and / or manufacture and Sanitary License number of the establishment that manufactures or markets it, when the Product is of national origin. f) "type of packaging or primary and secondary packaging. g) Commercial form or presentation. ) Place and date. j) Signature of the applicant. k) To this application adhere a stamp of L. 50.00 per product. 2.- Primary and secondary labels / packaging or your project that contains information in accordance with the technical standard of current labeling. 3.- Product samples in quantity according to technical standard. 4.- Power of attorney granted to the legal professional duly authenticated if applicable. 5.- Receipt of payment granted by the Ministry of Health for rights to process sanitary registration and services of analysis. Specific requirements: I. For food products and beverages must present: a) Qualitative and quantitative product formula. b) Certificate of Free Sale for imported products. c) In the case of imported products that cannot be credited Article 145.- The health authority in qualified cases requirements a and b, must present document that may dictate the retention of food products, beverages, declare the formula qualitative, table of factors medicines and related products and others that the health authority Nutrition and affidavit of the importer of SJ REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84i. product where responsibility for the quality and safety of it is assumed. II.- Pharmaceutical products also require the following technical information: a) Qualitative and Quantitative Formula complete, signed and stamped by the responsible Pharmaceutical Chemist. (Original). b) Commercial presentation (s). ) General method of elaboration d) Product monograph. f) Phase III clinical studies of the product (for new molecules in the market) g) Technical specifications of the product. h) Justification of the commercial presentation and of the pharmaceutical form, based on the dose and duration of the treatment. International standards or standards. j) Analytical method validated by the manufacturing laboratory when the product is not pharmacopeic. k) Quality control certificate of the active substance and finished product. Document proving the commercial relationship between the owner and the manufacturer of the products, when they are different. m) Stability study, in accordance with established norm. n) Mandatory insert or your project in over-the-counter products, when the required information is not found in the primary or secondary packaging according to current labeling standard. Free Sale Certificate in the country of origin or certificate of WHO pharmaceutical product. p) Certificate of Good Manufacturing Practices (in case it is not attached to the free sale certificate, export or equivalent document) where it is established that the laboratory is subject to periodic inspections by the corresponding regulatory entity. III.- Biological products, in addition to what is required previous: a) Technical product information. b) Preclinical information ) Clinical information d) Document issued by the regulatory authority of the country of origin, related to the cold chain. e) Certificate of lot release issued by the competent authority of the country of origin. Due to their complexity, the different pniebas to request these products will be based on what is established in the series of WHO technical reports, Volume XII. g) Document proving that the product must be prequalified by WHO or by the regulatory authority of a country recognized by WHO. Article 147.- To market the vaccines after obtaining the sanitary registration, the interested party must obtain batch release approval submitting documents a) Batch release certificate, issued by the competent authority of the country of origin. b) Summary protocol of production of the reference lot. c) Summary protocol of the quality control of the last three lots. d) Others determined by the National Technical Standard. Article 148.- To market the blood products, the following must be accredited: a) Origin of plasma b) Type of donors c) Controls to donors d) Evidence of commercialization e) Viral inactivation methods í) Others contemplated by national legislation or international standards Article 149.- For cosmetic products in addition to the general requirements established in Article 146, You must comply with the following: a) Free Sale Certificate, export or equivalent document of the authenticated country of origin. b) Specifications of the finished product. c) Qualitative formula of the product stating the quantities of restricted or controlled substances when applicable Article 150.- For hygienic products and chemical products, in addition to the general requirements established in Article 146 must comply with the following: a) Certificate of Free Sale, export or equivalent document, authenticated. b) Product Safety Sheet in accordance with international standard when applicable. c) Original document containing the qualitative formula, signed and stamped by the responsible technical professional. d) Method and standards (with its certificate of purity) for laboratory analysis, (in the case of pesticides for use domestic, industrial and public health). Ñ ​​REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘. 30.84 .. Article 151.- For natural products, in addition to the general requirements established in Article 146 must comply with the following: a) Methodology of physicochemical and microbiological analysis. b) Specifications of the finished product. Article 152.- For surgical and dental medical devices and supplies, you must present: a) Free Sale Certificate for imported products. b) In case you cannot prove requirement a), you must submit an affidavit from the importer of the product where responsibility for the quality and safety of it is assumed. UNIT III REGISTRATION RECOGNITION SANITARY Article 153.- To obtain the Health Registry Recognition of food, beverages, medicines and products related, will be regulated in accordance with international conventions or treaties ratified by Honduras. Article 154.- It is the obligation of the holder of the recognized sanitary registry to issue the instructions to the distributor to in order to facilitate inspectors the necessary sampling of products.- Samples will be taken in Any establishment of the marketing or service chain.- The number of samples will be in accordance with the Technical Standard; The results of the analyzes will be delivered to the regulatory authority and to the holder of the registry sanitary or to the distributor, in a maximum period of thirty (30) days. UNIT IV REGISTRATION MODIFICATION SANITARY Article 155.-Every holder of the sanitary registry must request from the competent sanitary authority, modification of the sanitary registration, when changes of any existing condition occur at the time of being initially granted, such as be: name of the manufacturer or distributor of the product, name of the registered product, of the business name, of the container, of the label and packaging, of the commercial presentation, of the excipients of the product that do not change the nature of the product.- The application will be processed expeditiously. Article 156.- The competent sanitary authority shall authorize the modification of the sanitary registry, keeping the same nomenclature and validity of the registry initially granted. Article 157.- Pharmaceutical and natural products that undergo modification of the active substance, form pharmaceutical, chemical formula, concentration of active substance, excipients that modify the nature of the Products, route of administration, country of origin of the manufacturer, must be processed with a new sanitary registration. Article 158.- In the case of food products, beverages, and related products, which undergo modification of the principle active, chemical formula, concentration of active principle, excipients that modify the nature of the products, via of administration, country of origin of the manufacturer, must be processed with a new sanitary registration. UNIT V REGISTRATION NOMENCLATURE SANITARY. Article 159.- The sanitary registry shall have the following nomenclature: a) Capital letters RS: What does the Sanitary Registry mean? b) The number corresponding to the Departmental Health Region, where applicable. The letter and number that identify the class and type of product. d) Four digits corresponding to the month and year in which the Sanitary Registry is granted. e) Six (6) digit correlative numbering, with which the product is identified in the records, starting with the number 000001. UNIT VI OF THE PROCESS OF THE LICENSE AND REGISTRATION SANITARY Article 160.-Once the application is submitted, it will be verified if it contains the requirements established in the chapter above and if not met, the petitioner will be required so that within the corresponding term established in the Administrative Procedure Law proceed to complete it with the warning that if it does not do so, will file the proceedings without further processing. If requested, the documentation will be returned to the interested party. Article 161.-The competent health authority shall issue a ruling taking the application as admitted and ordering send the proceedings to the corresponding instance, with the object that within twenty (20) days Skills carry out the inspection of the establishment or the analysis of. respective laboratory. REPUBLICA DE HONDunAs - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 The competent authority shall provide whether laboratory tests are performed or not, as well as which tests and tests perform. The original samples, technical product information, the original samples will be sent to the respective laboratory standards of active ingredients, with the order of analysis. The following products will not require analysis for sanitary registration purposes: chemical elements not controlled, uncontrolled chemicals, hygienic products, cosmetics, topical products, uncontrolled chemicals, dietary supplements, laboratory reagents, raw materials, food risk b and c. In any case, they will pay the respective rights for health surveillance and control. Article 162.- The authority that has carried out the inspection must deliver within three (3) working days the minutes drawn up with the corresponding technical information by sending it to your immediate superior manager. Article 163.- Received the minutes and technical report referred to in the preceding article, the General Directorate of Sanitary Regulation or the Departmental Regional Headquarters, will transfer the administrative file to the Legal Unit so that within three (3) business days issue the corresponding opinion; This Unit will return said file to the General Directorate of Health Regulation or the Departmental Regional Headquarters, so that within five (5) days next business issues the reasoned resolution granting or denying the requested license. Article 164.- The instance that has practiced laboratory analyzes, in the case of food products, you must deliver within the term of fifteen (15) business days the corresponding technical report by sending it to your immediate superior boss for your respective opinion. In the case of food products, beverages, medicines and related products and natural products, the results of laboratory quality control official or other designated by the Ministry of Health, will be delivered in a term up to twenty (20) days Skilled to the Delegated Department, who will prepare the corresponding technical report. In both cases you must be Deliver a copy of the laboratory analysis to the interested party at no cost. Article 165.- Once the technical report indicated in the previous article has been completed, the competent Delegated Department will proceed to the legal analysis of the file so that within the term of three (3) business days, the analysis is completed for the issuance of the corresponding decision. Once the analysis is finished corresponding queorigió the application for the license or sanitary registration, the file is sent to the Directorate General of Sanitary Regulation or the Regional Department of Health, so that within a term of five (5) business days issue resolution motivated, granting or denying the sanitary registration. UNIT VII ON THE RENEWAL OF THE LICENSE AND HEALTH REGISTRATION Article 166.- For the renewal of the Sanitary license of the Establishments and sanitary registration of the products, must be requested before the competent General Directorate or Head of Departmental Health Region, to through the legal representative or legal representative, within three (3) months for the health license of the establishments and five (5) months for sanitary registration of products, prior to the expiration date. May have extemporaneous renewal up to six (6) months after the expiration date of the license or registration health, paying the rights to registration, in addition to a fine, whose value should not be less than the cost of registration sanitary. In any case, you must submit a certified affidavit stating that maintains the original conditions under which it was granted. Otherwise, you must carry out the procedure, indicated in Articles 130 and 146, as the case may be. In any case, be it renewal or new procedure, it will keep the original license number or sanitary registration. Article 167.- The period of validity expired without having requested the renewal of the license and registration health, will proceed according to the sanction regime. Article 168.- The payment of the rights by license and sanitary registration, as by the services of surveillance and Health control will be assumed by the interested party and canceled in the place determined by the health authority competent. FOURTH SECTION OF THE HEALTH INSPECTIONS Article 169.- The inspectors of the Ministry of Health, duly certified and accredited in the exercise of their functions, within their working hours and overtime when designated by their superior, will have free access to establishments, premises or sites of health interest, prior to the inspection order issued by the Competent Health Authority, in order to verify compliance with related sanitary standards with: MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 1. Production, processing, handling, packaging, storage, conservation, transportation, distribution, dispensing, import, export of products of health interest. 2. Provision of health services. 3. Advertising and propaganda of health products, services and establishments of health interest. 4. Waste management generated by the establishments. 5. Occupational safety and industrial safety. 6. Hygienic conditions of the establishments. 7. Products. 8. Good Manufacturing Practices, in force in the Industry. Article 170.-The General Directorate of Health Regulation shall define and establish the technical procedures and operational for the verification of the requirements in health interest establishments. Article 171.- The owners, representatives or managers of the establishments, premises or sites, remain obliged at any time to allow the entry of certified inspectors of the Ministry of Health. Article 172.- Inspections may be ordinary, carried out during the normal working day of the Health Authority and extraordinary, when carried out at any other time, due to sanitary surveillance, attention to complaints or emergencies for presumption of health risk. Article 173.- The Health Authority will have free access to all premises and facilities dependencies. of sanitary interest, being obliged the owner, representative or responsible to give all kinds of facilities and provide the reports of health interest that are required. Article 174.- The refusal of the owner, representative or responsible for the establishment of health interest, for to punish the access of the Sanitary Authority, will be sufficient reason to resort to the police authority, with the object that obliges it to allow inspection, without prejudice to the corresponding sanctions. Article 175.- The sanitary inspection must be oriented to verify compliance with the minimum requirements essentials established according to the activity to which it is based on the guides of current good practices that apply Article 176.- The inspection shall not be limited only to the punitive aspects, but also to those related to guidance in health education and motivation in compliance with legal and regulatory provisions. Article 177.- The sanitary authority, when performing the inspection in any establishment of sanitary interest, will take official minutes of the proceedings. At the end of the inspection, the person responsible for the establishment will be given the opportunity to state what is in his right agrees, recording it in the minutes to be drawn up, and the latter must also sign said minutes.- In case of refusing to sign will be entered in it, being the actaválida. At the end of the inspection, a copy of the minutes must be delivered to the person in charge of the establishment, stating this made in the original Article 178.- The sanitary conditions found shall be recorded in the inspection record and the Correction to the identified problem.- The testimonies of other persons present and of any document or part of it, when necessary, always trying to avoid causing inconvenience or unnecessary damages. Article 179.- The sanitary authority that has carried out the inspection shall deliver to the higher authority in the term of the twenty-four (24) hours following his return to the workplace, the minutes drawn up and the samples taken, according to the established norm if applicable. Article 180.- The health authority must prepare the corresponding minutes when taking samples that are necessary in health surveillance, to perform the relevant laboratory analyzes and investigations, in order to establish the identity, quality, condition of the products or verify that they satisfy the requirements established in the sanitary norms, having to indicate in the minutes the form of sampling, name of the product, weight and quantity of samples taken.- The minutes must be signed by the people involved in the act and in case of refusal of the person in charge of the establishment, this will be stated, signing the witnesses, or that they They do not want to sign will be recorded in it, being the valid act. Article 181.- The samples that are taken for the inspection, will be representative, individualized, sealed to be inviolable, preserved in order to protect the characteristics according to the regulations in force and will be sent to the corresponding laboratory, within the next twenty-four hours, so that practice the corresponding analyzes. Article 182.- The Health Authority in qualified cases may dictate the retention of food products, beverages, medicines and related products and others that the Health Authority determines, in the facilities of the importer or distributor and will remain there until said Authority resolves according to the problem presented by the product up to a term of thirty (30 days. REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ‘. 30.84i FIFTH SECTION OF CERTIFICATES AND AUTHORIZATIONS UNIT I ‹ OF THE REQUIREMENTS TO OBTAIN CERTIFICATES OF FREE SALE, IMPORT AND EXPORT OF CONTROLLED PRODUCTS AND GOOD MANUFACTURE PRACTICES. Article 183.- In order to obtain the certificates, it must be submitted to the competent health authority, written request, which must contain the following requirements: a) Sum indicating: The Procedure in question. b) Body to which it is addressed: “General Directorate of Health Regulation”. c) Product name d) Corporate Name of the product owner and manufacturer e) General data of the applicant f) Address of the owner and manufacturer. g) Nomenclature of the current sanitary registration of the product and / or the Sanitary License when applicable. h) Place and date of the request. i) Signature and stamp of the applicant. j) Date of arrival of the shipment k) Route through which you will enter and name of the Customs. l) Identification of the means of transport. m) Pro-Forma Invoice that identifies the type, type and quantity of product or raw material. The request must be accompanied by the payment receipt for services. I.- For Export Certificates of Controlled Products, you must also comply with: a) Import Certificate issued by the competent Authority of the importing country. b) Name and address of the exporter and importer and the consignee. ) Product name. d) Quantity of the product to be exported. e) Customs office of entry and exit. Shipping date g) Document proving the Regent Pharmaceutical Chemist responsible for the custody of the product. Article 184.- The Certificate of Free Sale will be valid for two (2) years from the date of its Issue.- In the case of the sanitary registration that expires before this period, the validity of the certificate will be the same of the sanitary registry. The Certificate of Good Manufacturing Practices will be valid for one (1) year from the date of issue and its procedure will be done in accordance with the procedure established in section V of this Regulation and the norm established. The Export Certificate of controlled products will be valid for ninety (90) days and will be necessary Request one for each shipment. The Import Certificate of controlled products will be valid for one hundred and fifty (150) days and will be necessary to request one for each shipment, it will be valid only once Article 185.- The interested party in obtaining the Official Import Certificate for psychotropic substances and narcotics must submit to the General Directorate of Health Regulation the request relating the Following data: a) Name of the Regent or company manager. b) Name and address of the importer and exporter. c) Name of the pharmaceutical establishment that represents d) Provider Name e) Quantity í) Concentration if it is the case of finished product g) Product name h) Date of admission i) Customs office of entry j) Origin of shipment k) Bell of Lps. 5.00 (five lempiras) for each request. Article 186.- Narcotic drugs, psychotropic and controlled chemical substances may only be exported by laboratories and drug stores to establishments legally authorized for this purpose in the importing country. UNIT II THE PROCESS OF CERTIFICATES Article 187.- Once the application has been submitted, it will be registered in the corresponding book of entries, after which will verify if it contains the requirements established in the preceding articles.- If it does not meet them, it will be required to petitioner so that within ten (10) business days he may complete it, with the warning that Do it, the proceedings will be filed without further processing. If requested by the interested party, the documentation to the interested party. Article 188.- Admitted the request, within five (5) business days following the delegated health authority, will issue a reasoned resolution granting or denying the requested certificate. RH REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N ’. 30.84 UNIT III OF PRODUCT INCOME AND RAW MATERIALS Article 189.- For the importation of controlled chemical products and substances, official authorization is required. extended by the competent health authority. Article 190.- Food and beverages that are imported by anyone who is not the natural or legal person who registered and that does not have an exclusive distributor, must be registered, subjecting it to laboratory analysis by batch when the competent health authority deems it necessary, and the respective rights must be paid.- Imported products must comply with the labeling standard in force in the country. Article 191.- Prior to the clearance of all controlled products, the Executive Directorate of Revenue through the customs, will require the importer the Official Import Authorization extended by the General Directorate of Sanitary Regulation For this purpose, coordination mechanisms will be established at their different levels. In addition to the Official Import Authorization, pharmaceutical products and controlled quínucas substances they will be inspected and authorized by the competent health authority, who will sign and seal the document of import, prior to its clearance. Article 192.- In case the importer does not comply with the requirement of the Official Import Certificate, for psychotropic and narcotic substances and controlled chemical substances should be re-exported to your country of origin and the importer shall assume the conditions caused by the surveillance and contingency actions, exercised by the health authority without damage of the respective legalization process and of the sanctions that are imposed by violation of the provisions of this Regulation. Article 193.- In the case of rejection of imported products and raw material that is carried out in accordance with established in the Health Code and these Regulations, the General Directorate of Sanitary Regulation shall notify to the health authorities of the country of origin, so that the relevant measures in health protection of the consumers. UNIT IV OF THE PROCESS OF THE APPLICATION Article 194.- Once the application has been submitted, it will proceed to be registered in the corresponding book of entries then will verify if It contains the requirements established in the preceding articles.- If it does not meet them, the petitioner will be required so that within ten (10) business days proceed to complete it, with the warning that if not, the proceedings will be carried out without further processing. If requested, the documentation will be returned to the interested party. Article 195.- Admitted the request, within five (5) business days following the health authority competent, will issue a reasoned resolution granting or denying the requested authorization. Article 196.- Prior to the authorization of the clearance of controlled chemical products and substances, the Authority Sanitary competent in coordination with the General Directorate of Customs must check the contents of the shipment Checking it with the Official Import Authorization.- If they do not conform to the established sanitary norms, order its re-export to the place of origin, after a reasoned resolution of the competent health authority. CHAPTER VIII OF THE BROADCASTING OF PRODUCTS, SERVICES AND ESTABLISHMENTS OF INTEREST SANITARY Article 197.- The Ministry of Health shall establish the criteria for the Advertising of Sale Medicines without Medical Prescription or Prescription Without Prescription (OTC). Article 198.- The advertising of products, services and establishments of health interest must conform to the truth and therefore the benefits that its use or use may offer cannot be overstated, control corresponds to the competent health authority. Article 199.- The health authority shall prohibit the advertising of products, services and establishments of interest. health in the following cases: a) When it contravenes the general rules applicable to health, nutrition or therapeutic education. b) When expressing properties or benefits that induce deception or error. c) When you impute, defame or make pejorative comparisons for other products and establishments of health interest and services. M REPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30.84 d) When the message is contrary to the law or good customs. e) When the products are authorized for sale with a prescription or retained prescription. , ' f) When it is incompatible with the professional condition or discipline of the people who promote them. Article 200.- The Ministry of Health is obliged to permanently inform the general public and the Health professionals lists generic interchangeable drugs from laboratories that meet the rule. Article 201.- The General Directorate of Health Regulation will issue the corresponding regulations to regulate the advertising and promotion of products, services and establishments of health interest. Article 202.- The health authority, as the governing body for the registration and control of medicines in its different processes, you must control the advertising of over-the-counter medicines, complying with the criteria following: a) They are promoted only with the information and arguments approved by the competent health authority. b) Do not suggest that the use of these medications can delay or avoid using a doctor. c) Do not suggest its use permanently, limiting the term of authorized administration. d) Do not use phrases or words that exaggerate the benefits of the product in the text. e) They are expressed in colloquial language, without using medical or technical terms that confuse the consumer. f} Do not use testimonial arguments of notorious persons or entities in teaching, research or Health sciences, which can induce consumption. CHAPTER IX OF BREACHES, SANCTIONS AND PROCEDURES SECTION ONE GENERAL PROVISIONS Article 203.- Any infraction by intentional act or omission or negligence that contravenes the provisions of the Health Code, these Regulations, the Technical Standards or the provisions issued by the Secretariat in the exercise of its functions and competences, committed by the owner representative of the establishment and the workers who are at the service of the same, which harms or may harm the legal good protected from life and the health of the population will be repressed with one or more of the sanctions referred to in Article 206 of this Regulation, taking into account their significance to the detriment of the health of the population and its recidivism, by reasoned administrative act without prejudice to the civil and criminal liability incurred. Article 204.- For the purpose of applying the sanctions contained in this Regulation, the infractions are classified as follows: a) Slight lack b) Less serious offense; Y, c) Serious foul. Article 205.- The application of sanctions for violation of this Regulation shall be carried out in accordance with the procedure established and guaranteeing at all times the right of defense to the accused; the penalties will be applied after resolution issued by the Director General or Departmental Regional Chiefs, based on the mandatory and optional reports and opinions of the corresponding technical and legal units. Article 206.- The sanctions that the sanitary authorities must impose for the inquiries to the dispositions contained in these Regulations are the following: a) Written warning b) Single or successive fines, depending on the case, ranging between twenty lempiras (L. 20.00) and fifty thousand lempiras (L. 50,000.00). c) Confiscation of products, substances or artifacts. d) Suspension or cancellation of health records or licenses. e) Temporary or definitive closure of buildings and establishments. Article 207.- For the application of the sanctions referred to in the previous Article, the health authority shall have Discretionary account of the following: a) The importance of the infraction to the detriment of the health of the population. b) The recidivism in the infraction or omission of the sanitary dispositions. MPUBLICA DE HONDURAS - TEGUCIGALPA, M. D. C .; NOVEMBER 4, 2005 N ‘. 30,841 c) To incur the infraction with full knowledge of its harmful and harmful effects on the health of the population either as author or accomplice. d) Committing the infraction with the purpose of hiding another '. e) Shun the responsibility or attribute it to another or others. Article 208.- The imposition of any of the sanctions indicated in this chapter shall be made without prejudice to requiring to the offender responsible for compliance with the measures determined by the health authority, for the purpose that the effects of the infraction are repaired or minimized as the case may be, for which the term shall be indicated correspondent. Article 209.- The fines that are imposed must be made effective in compliance with the Recovered Funds Regulations. of the Ministry of Health, within the term of ten (10) business days from the date on which notify the offender of the resolution; The amount of the financial penalty may not be reduced or waived. Article 210.- Failure to comply with the resolutions emanating from the health authority shall be sufficient grounds for execute them by means of the forced fulfillment contemplated in Articles 109 and 110 of the Law of Procedure Administrative, for which the Health Authority will request the support of the National Police or the Municipal Authority correspondent. Article 211.- The temporary closure of an establishment entails the suspension of the Sanitary License and may be issued for up to thirty (30) calendar days If the causes that gave rise to the sanction disappeared, the interested party's request has been filed, the authority corresponding sanitary, prior to its * erification will resolve its reopening and restitution of the sanitary license Article 21 2.- The definitive closure of an establishment entails the cancellation of the Sanitary License. Article 213.- To proceed to the temporary or definitive closure of an establishment that violates provisions legal and regulatory, the competent health authority will place posters In the case of temporary closure, access to the establishment will be allowed to maintain the equipment or machinery that by its nature require special care. In the case of definitive closure the offender will have access to the establishment to remove the machinery, equipment, furniture and other prior authorization of the competent authority. Article 214.- To retain or deposit products, goods, raw materials, substances and others, you must the respective inventory and official certificate signed by the interested party, two witnesses and the health authority be taken up; proceeding to place seals or seals that guarantee their conservation and permanence in the establishment 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, which does not invalidate it. Article 215.- In order to comply with the provisions of the Health Code and this Regulation, the authority When required, it will request the support of the Public Prosecutor's Office, the Municipal Offices, the Police National, the Attorney General's Office, the Secretary of Natural Resources and Environment and the Secretariat of Agriculture and Livestock. In all the proceedings that are carried out, only the aforementioned authorities will participate, avoiding notoriety public, unnecessary inconvenience or damage to the establishment. Article 216.- In those cases that from the violation of the legal and regulatory provisions risks and serious damage to people's health or the environment, the health authority will immediately notify the General Directorate of Health Regulation. This, when the case merits it will make public the fact and notify the respective authority, to prevent major risks or damages. Article 217.- The application of the administrative sanctions of which the Health Code deals with and this Regulations, do not exempt the offender from civil or criminal liability to have place for the act sanctioned. or tapes in visible places in the entrances and in the machines, Article 218.- In the cases that of the violation of equipment, locks and others, with the legend: “Closed legal and regulatory provisions result Responsibility Temporarily or Closed Definitely by the Criminal Authority, the health authority communicate immediately to the Sanitary ”, with the purpose of preventing the continuation of the General Directorate of Sanitary Regulation, so that this activity, entry or use, as appropriate. file the respective complaint with the corresponding authority. Ç MPUBLICA DE HONDURAS - TEGUCIGALPA, IYI. D. C., NOVEMBER 4, 2005 N °. 30.84. Article 219.- For the purposes of the sanctions established by this regulation, the persons shall be liable natural or legal that sell products or provide health services. Article 220.- To verify the facts and determine the Article 225.- t.a citation will be made to the owner of the establishment or legal representative of the company by ID card that will be delivered to you personally; if you are not in the establishment, delivery will be made to any of your family members or employees who are in it or in their Violations of the legal provisions health authority may make use of the a) Inspections b) Witness Statement c) Sampling d) Laboratory analysis or tests Regulatory, the first steps: residence.- Delivery of the identity card, the owner or legal representative shall be deemed legally cited. Article 226.- The citation card must contain: a) Name of the health authority issuing it b) The name and surname of the person to whom the citation is made SECOND SECTION OF THE PROCEDURE TO APPLY SANCTIONS Article 221.- The procedure to apply the sanctions established in these Regulations may be initiated: a) Ex officio, by mandate of the competent body, either on its own initiative or as a result of an order of the hierarchical superior, or by reasoned knowledge of having broken a sanitary law. b) By deliunciation of interested natural or legal person. Article 222.- The complaint or complaint may be made in writing, in folmaverbal or anonymously, by any means of communication, before the competent health authority and the following should be recorded: Appear in day, time and place determined; where you will be informed of the infringements or omissions imputed to him, listening to his disclaimers; everything acted should be recorded in minutes. Article 224.- If during the inspection, the health authority identifies situations that represent a danger health for people and the community, you can immediately take the preventive health measures of the case, how to be: a) Order or carry out the measures of disinfection, disinfection and deratization b) Order the suspension of work and services, c) Retain or deposit products, raw materials, substances, equipment, utensils and objects. d) All conducive to health prevention. and the character with which he is quoted. c) The causes or reasons why the citation is made. d) Place, date and time to appear. e) The prevention that the non-appearance will cause the damages to which there was place in law. f} Place and date on which the card is issued. g) Signature of the competent health authority. Article 227.- If the aforementioned does not appear by means of a legal representative duly accredited to the place, date and time referred to in the citation, it will be taken for granted by declaring in absentia and will proceed to issue the resolution that in appropriate law. Article 228.- If the evidence in the appearance were sufficient or the defendant admits the charges made, the Health authority will issue the corresponding resolution. Article 229.- When the charges are distorted in the appearance, the health authority shall issue a resolution acquittal in favor of the alleged offender, which must be notified. Article 230.- If the pniebas were insufficient and the defendant denied the charges, the health authority ex officio or 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 evacuate them; throughout In this case, the competent health authority may, at any time, have the practice of any evidence it deems pertinent for the best decision of the matter. Article 231.- After the probationary term and the proceedings of the case, the health authority will issue the resolution following the administrative procedure. StttİÓil A ÀtlltFd0S and ltïts M l PmØiJ'ZiIFP MPUBLICA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 N °. 30,841 Article 232.- The resolution must contain: a) Name of the issuing authority. b) Summary relationship of the facts. c) Statement of relevant considerations. d) Resolve categorically, clearly and precisely; citing the legal instruments, regulations or provisions sanitary in which it is based. e) Place and date of issue. f) Signature and seal of the competent health authority. Article 233.- In the event that the resolution is sanctioning, it will also provide: a) Imposition of the sanction. b) Prohibition of continuing illegal acts or violations of sanitary provisions. c) Warning at the offender that in case of recidivism or disobedience to the resolution, the more drastic sanctions provided for in this Regulation. d) The term to make effective the economic sanction imposed, which will be within ten (10) business days, counted from the day following the notification. e) The remedies that legally proceed against the resolution. f) The competent body before whom to lodge the resources and the term that has for it. Article 234.- Resolutions will be notified personally within a maximum period of five (5) business days from from the date of issuance and will be practiced by delivering the full copy of the resolution. Article 235. - Not having been able to personally notify the resolution within five (5) days, it will be made. fixing the operative part of the resolution in the table of notices of the office of the sanitary authority. Article 236.- Personal notification or by table will be recorded in the corresponding file. Article 237.- Against the resolutions issued by the health authority and that impose sanctions the appeals proceed of replacement and appeal.- These appeals will be substantiated in accordance with the Law of Procedure Adininistrative. THIRD SECTION OFFENCES AND PENALTIES Article 238.- Violations of the provisions of the Health Code and these Regulations will be sanctioned without penalty of the penalties to which the offender becomes creditor for the configuration of crimes against public health, in which case the Ministry of Health will put the background in knowledge of the Public Ministry, to proceed before the competent courts. Article 239.- For the purposes of the health authority, of the infractions and sanctions provided in Article 245 of this Regulation, the following badges are established: 1.- The competent authority to apply the sanctions shall have the following: The General Directorate of Competent Health will be identified with numeral I. The Department of Sanitary Control of Products, Services and Facilities of Health Interest or Department Delegate will be identified with the numeral ß. The Departmental Health Region will be identified with numeral III. The Coordination of the Departmental Unit of Sanitary Regulation will be identified with numeral IV. 2.- The infractions are classified as: minor, serious and serious. 3.- To identify the sanctions will be used the following codes: The written reprimand will be identified with the literal a). The single or successive fines will be identified with the bite. The confiscation of products, substances or artifacts will be identified with the literal c). The suspension of registration or sanitary license will be identified with the district d). The temporary closure of buildings and establishments will be identified with the literal e). The cancellation of the sanitary registration or sanitary license will be identified with the site f). The final closure of buildings and establishments will be identified with the literal g). Article 240.- The application of sanctions for violation of the provisions of the Health Code and of the present Regulation, will be carried out by the health authority, in accordance with the descriptive table below: RE PUBLI CA DE HON DURA S - TEGUCIGALPA, M. D. C., 4 Dfi NOVIfiiM IIUE DEL 2005 N “. 30,841 INFi ACTIONS Mild Aiito- Ira. Self-2nd. 3rd. Auto- 4 ". Aiub ›Ridatl code Realty li: einc. Iity ‘Reinc. rity Recinc. ritlu ‹l First of all Sanita-Cod / Sani- I.?od/ Sani- Cod / Sani- € “od / Sani- Situational provisions Sancióli riu Sai) c. I would! ’ianc. Tai’ia Salte. taria Sanc. liuiii l.- Chapter V, Section III: l- a) I.-IV l .- b) and c) I-III '. .- b) 1.- III 1.- d) and e) 1.-III 1.- f) and g) 1.-1 (Art. 19 and 20) 2.- Capíkilo V, Section IV: (Art. 21, 22, 23, 24, 25, 25 2.- a) 27 and 28) 2.-lV 2.- b) 2.-III i! .- b) 2.- 1 II 2.- d) and e) 2.-III 2.- t) and g) 2.-1 3.- C? Chapter V, Section V: 3.- a) 3.- l V 3.- d) and e) 3.- III 3. 13 and g) 3.- l (An. 29, 30; and, 31) 4.- Chapter V, Section Vl: 4.- a) 4.- I l 4.- b) 4, .- II -1.- b) 4.- II 4.- d) and e) 4.- III 4.- l) and g) 4.- 1 (Art. 32, 33, 36, 37, 38, 39; and, 41) 5.- Chapter V, Section VI1: 5.- a) 5.- 11 5.- b) 5.- Il 5. d) and e) 5.- III 5.- fj and g) 5.- I (Art. 79, 80, 81, 87, 88, S9, 90, 91, 92, 93, 94, 96, 97, '98, 99, 100, 102, 103, 104, [05, 10, 107, 109; and, 110) fi, - Chapter Vl, Section I: G.- a) (›.- l V 6.- b) and c) G.- III i› .- b) 6.- l l I G, - cJ) and e) 6.- III 6.- l) and g) fi.- 1 (Art. 121, 122, 1 23, 124, 125, 126, 127, 125, 129, 130, 131; and, 132) 7.- Chapter VI, Section II: 7.- a) 7.- l V 7.- b) and c) 7.- III ".- b) 7.- l II 7.- d) and e) 7.- III 7, - f) and g) 7.- l (Art. 133, 134, 135, 136, 137; and 135 S.- Chapter VII, Section 8.- a) 8.- l V S.- b) 8.- III li.- b) 8.- III 8.- e) S.- III S.- f) 8.- 1 III; (An. 1 or 9) * J.- Chapter VII: (Ar t. 212, 9.- a) 9.- l V 9.- b) and c) 9.- III 'L- b) '7.- Ill 9.- d) and e) 9.- III 9.- l) and g) 9.- l 213, 214; and, 217) 1.- Chapter IV: (Ai‘t. 8, 9, 1- c) 1.-111 1 .- b) and c) l-III 1. b) and c) 1.- 1 II 1.- d) and e) l.-Ill 1.- t) and g) 1.-1 10, 11, 1 2, 13; and, 14) 2.- Chapter V, Section 11: 2.- a) 2.-IV 2.- b) 2.-111 í! .- b) 2.- III 2.- d) and e) 2.-111 2.- f) and ¡i) l -1 (Ai‘t. 17 and 18) 3.- Chapter V, Section VI: 3.- a) and c) 3.- [l 3.- b) and c) 3.- II 3. c) and cl) 3.- l II 3.- f) and g) 3.- I (Art. 42, 47, 51, 52, 53, 55, REPUBLI CA DE HONDURAS - TEGUCIGALPA, M.D. C., NOVEMBER 4, 2005 2005 N °. 30,841 59, II, 62, 65, 66, 68, 70, 73, 74, 75, 76, 77; and, 78) 4.- Chapter V, Section VIII: (Art. 111, 117, 118 and 120) 5.- Chapter VII, Section II (Art. 144 and 145) 6.- Chapter VII, Section II: (Art. 147 and 148) 4.- a) 5.- a) and b) 6.- a) and b) 4.- 11 5.- III 6.-111 4.- b) 5.- b) . 6.- b) 4.- II 5.- III 6.- III 4.- b) and c) 5.- e) 6.-e) 4.- II 5.- III 6.- III 4.- d) and e) 5.- g) 6, - d) and e) 4.- III 5.- I 6.- III 4.- fl and g) 6.- f) and g) 4.- I fi.- I 7.- Chapter VII, Section III: 7.- a) and b) (Art. 153, 154, 155, 156 and 159) 7.-III 7.- b) 7.- III 7.- b) and c) 7.- III 7.- d) and e) 7.- III 7.- f) and g) 7.- I Serious l.- Chapter V, Section VI: (Art. 48, 50, 54, 56, 57, 63, 67, 69 and 71) 2.- Chapter VJI, Section IV: (Art. 184, 186, 187, 1 58; and 189) 1.- b) and c) 2.- b) 1.- II 2.- lIl 1.- c), d); and, e) 2.- c), d); and, e) 1.- III 2- III 1.- c), t); and, g) 2.- c), d); 1.- I 2.- I CHAPTER X FEE RECOVERY FEES AND SERVICES Article 241.- The granting of sanitary registrations, sanitary licenses, analysis services, certificates, authorizations, renewals and other services contemplated in this Regulation, will cause the rights in accordance with the values ​​contemplated in the Regulation of Recovery Quotas for Provision of Integrated Services of Regulation of Products, Services and Establishments of Health Interest of the Sccretariat of health CAPI "FULO Xf FINAL PROVISIONS AND TRAH'SITORIES Article 242.- In order to meet the objectives of this Regulation; the General Directorate of Health Regulation to through their respective units, they must establish the mechanisms of organization, operation and coordination. Article 243.- All) or provided for in this Regulation, shall comply with the provisions of the Health Code and the Law of Administrative Procedure and in the Technical Nomas that the Ministry of Health dedicates. Article 244.- The Regulation for the Sanitary Control of Foods (Agreement 0077-93) is repealed; Regulation for the Sanitary Registry of Pharmaceutical, Chemical, Cosmetic and Biological Products (Agreement 2368-92); Regulation for the Pharmaceutical Establishments (Agreement 0034-93); Regulation for the Control of Drugs, Psychotropic and Narcotic drugs of April 25, 1969. In addition, all related legal regulations that oppose it are repealed. Article 245.- This Regulation shall enter into force, twenty days (20) after its publication in the Journal. Official "The Gazette". C O M U N I Q U E S E RICARDO MADURO JOEST THE SECRETARY OF STATE IN THE HEALTH OFFICE MERLIN FERNANDEZ RÁPALO