0A4F4F9BD490A749D5437F821CF06DF1
Governmental Agreement 712- 99, Articles 91-94 (1999)
https://asisehace.gt/media/ag_712_99.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
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p.(None): verify the respective introduction to the country, according to the corresponding customs documents.
p.(None): If for any reason the products are not entered into the country in the period of validity described in the paragraph
p.(None): above, the interested party can request an extension as long as it is accompanied by the justification
p.(None): relevant. Said extension may not exceed sixty (60) business days.
p.(None): ARTICLE 60. ABOUT THE CONTROLS TO BE CARRIED OUT BY THE PHARMACIES.
p.(None): The technical directors and owners of pharmacies must present the affidavit of
p.(None): movements by means of the corresponding input and output balance of narcotic and psychotropic products
p.(None): until the tenth (10th) of each month in the corresponding form.
p.(None): In this form, the name and the patient and the prescriber must be detailed. All this information must have
p.(None): sustenance in the recipes and is under the responsibility of the owner and the technical director and must be made
p.(None): view of THE DEPARTMENT, when required.
p.(None): The owners and technical directors are obliged to keep for two (2) years the original recipes that
p.(None): Dispatch and in which these drugs are prescribed, as well as the purchase invoices for them.
p.(None): ARTICLE 61. RESPONSIBILITY OF THE PRESCRIPTOR.
p.(None): Those prescriptions that are issued will have therapeutic support and the prescriber must be in technical capacity to
p.(None): Objectively demonstrate the reason for the prescription. In case there is not enough support
p.(None): scientist regarding the use and dose used, the prescriber must answer to THE DEPARTMENT, without
p.(None): prejudice of the sanctions that may correspond by virtue of crime or fault.
p.(None): However, when it comes to any prescription that must be formulated in the official recipe book, prior
p.(None): their offices will have to be authorized by THE DEPARTMENT. When it's business hours, pharmacies are
p.(None): obliged to send the original recipes within twenty-four hours after their dispatch, for their
p.(None): authorization and registration.
p.(None): ARTICLE 62. ON THE USE AND PRESCRIPTION OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only duly registered medical, dental and veterinary university professionals
p.(None): authorized for this purpose by THE DEPARTMENT, they may apply the drugs contained in their respective patients
p.(None): the instruments referred to in Article 57 of these Regulations.
p.(None): Narcotic and psychotropic prescriptions should only be made for therapeutic purposes,
p.(None): using the registered pharmaceutical specialties, or official and master formulas, in the
p.(None): maximum concentrations set by THE DEPARTMENT.
p.(None): The recipes for narcotic products issued by the professionals mentioned in this article must bear the
p.(None): issue date, name and address of the patient, name, signature, number of active member and stamp registered by the
p.(None): professional before THE DEPARTMENT. The name of the prescribed drug, the amount in
p.(None): numbers and letters. Psychotropic and narcotic prescriptions will not be dispensed to minors.
p.(None): ARTICLE 63. OF THE FORM FOR THE EXTENSION OF PRESCRIPTIONS OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): An official form is established for the prescription of products that contain any of the contemplated substances
p.(None): in list I of the 1961 Single Convention on Narcotic Drugs, in the Substances Convention
...
Searching for indicator illegal:
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p.(None): the instruments referred to in Article 57 of these Regulations.
p.(None): Narcotic and psychotropic prescriptions should only be made for therapeutic purposes,
p.(None): using the registered pharmaceutical specialties, or official and master formulas, in the
p.(None): maximum concentrations set by THE DEPARTMENT.
p.(None): The recipes for narcotic products issued by the professionals mentioned in this article must bear the
p.(None): issue date, name and address of the patient, name, signature, number of active member and stamp registered by the
p.(None): professional before THE DEPARTMENT. The name of the prescribed drug, the amount in
p.(None): numbers and letters. Psychotropic and narcotic prescriptions will not be dispensed to minors.
p.(None): ARTICLE 63. OF THE FORM FOR THE EXTENSION OF PRESCRIPTIONS OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): An official form is established for the prescription of products that contain any of the contemplated substances
p.(None): in list I of the 1961 Single Convention on Narcotic Drugs, in the Substances Convention
p.(None): Psychotropic of 1971 and in the United Nations Convention against Illicit Traffic in
p.(None): Narcotic Drugs and Psychotropic Substances.
p.(None): These recipes will be provided to physicians by THE DEPARTMENT, at cost price; will have a special format
p.(None): and they will contain the data that is necessary for said dependency.
p.(None): Pharmacies will dispense prescriptions that are formulated in the official recipe book and authorized by EL
p.(None): DEPARTMENT. Otherwise, the dispatch of such medications is considered as illegal supply of
p.(None): narcotics and sanctioned as such.
p.(None): In case of loss or removal of a recipe book, the doctor is obliged to immediately report it to EL
p.(None): DEPARTMENT so that this office makes it known to all technical directors of pharmacies
p.(None): in order to avoid its fraudulent use.
p.(None): ARTICLE 64. OF THE AUTHORIZED FEES FOR DISPATCH.
p.(None): THE DEPARTMENT must formulate the list of narcotic and psychotropic products, with the dose allowed for
p.(None): twenty-four (24) hours.
p.(None): However, it is allowed that professionals in legal practice can prescribe and pharmacies
p.(None): Dispense higher doses, provided that its application is directly controlled by the physician and
p.(None): authorized by THE DEPARTMENT, the treating doctor being responsible for the misuse of his
p.(None): prescription is made.
p.(None): It is also the doctor's obligation when he has to administer narcotic drugs for periods of more than eight days,
p.(None): inform THE DEPARTMENT of the diagnosis and the dose to be used daily and request the corresponding weekly fee
p.(None): or biweekly, depending on the case, which will be submitted to the agency's consideration
p.(None): mentioned, which in consultation can authorize or deny it.
p.(None): In the case of people who have become accustomed to the use of narcotic drugs, treating doctors
p.(None): They must inform THE DEPARTMENT and they will proceed in the manner indicated in the previous paragraph.
p.(None): The prescriptions for the taxicómanos must be extended in the official form by a doctor of the Health Center
p.(None): respective, the number and date of the agreement by which the designated agency authorized the
p.(None): share. These recipes will be delivered personally to the interested party weekly, biweekly or monthly,
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Political / criminal
Searching for indicator criminal:
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p.(None): substances considered as such by the laws of the country and by the provisions dictated by the
p.(None): health authorities.
p.(None): ARTICLE 58. OF THE IMPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only laboratories and drugstores can import raw materials for the manufacture of
p.(None): narcotic and psychotropic drugs, or import them already finished for distribution, in accordance with the
p.(None): previously authorized fees. Regarding the raw materials that constitute precursors, the provisions of
p.(None): the Specific Precursor Regulation.
p.(None): The drugstores and laboratories must request and obtain from THE DEPARTMENT, authorization to import drugs,
p.(None): narcotic and psychotropic drugs and present the balance referred to in the following paragraph, except in the case of
p.(None): first import request. The import authorization request will be made through a form
p.(None): provided by the aforementioned agency.
p.(None): The import or export request must accompany the balance of imports,
p.(None): productions, products in process, existence of inventory and exports, if that were the case. East
p.(None): Balance must be presented under affidavit of the legal representative and the pharmaceutical technical director
p.(None): responsable.
p.(None): If for any reason the importer does not receive the narcotic drugs in the authorized quantities,
p.(None): must inform the health authorities and provide the necessary means of proof to
p.(None): justify the loss or missing. All without prejudice to any other explanation that the competent authority
p.(None): could demand.
p.(None): In the event that the importer does not comply with the aforementioned, without prejudice to criminal sanctions
p.(None): and civilians that may correspond, will be sanctioned in accordance with the Health Code.
p.(None): ARTICLE 59. OF THE CERTIFICATES OF IMPORT AND EXPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Certificates authorizing the import or export of drugs, narcotic drugs and psychotropics must be
p.(None): extended by THE DEPARTMENT in original and four copies, one copy being used for:
p.(None): 59.1) THE DEPARTMENT.
p.(None): 59.2) The corresponding office of the importing or exporting country. 59.3) For the exporting house.
p.(None): 59.4) Other for the importer, and
p.(None): 59.5) For the Executive Secretary of the Commission Against Addictions and Illicit Drug Trafficking
p.(None): (SECCATID) of the Vice Presidency of the Republic.
p.(None): Any extended certificate for the import and export of drugs, narcotic drugs and psychotropics must be
p.(None): presented in the corresponding form in which the necessary documents and times of
p.(None): delivery. This certificate is valid for six months from the date it was issued, and must
p.(None): verify the respective introduction to the country, according to the corresponding customs documents.
p.(None): If for any reason the products are not entered into the country in the period of validity described in the paragraph
p.(None): above, the interested party can request an extension as long as it is accompanied by the justification
p.(None): relevant. Said extension may not exceed sixty (60) business days.
p.(None): ARTICLE 60. ABOUT THE CONTROLS TO BE CARRIED OUT BY THE PHARMACIES.
p.(None): The technical directors and owners of pharmacies must present the affidavit of
p.(None): movements by means of the corresponding input and output balance of narcotic and psychotropic products
...
Political / political affiliation
Searching for indicator party:
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p.(None): 7.2) Rural medicine cabinet: Medicine sales service for dispersed populations which will be in charge of a
p.(None): community organized group coordinated by a social medicine sale. The person in charge of
p.(None): rural medicine cabinet is a promoter or guardian of
p.(None): Health.
p.(None): 7.3) Good manufacturing practices: Installation conditions and established procedures for all
p.(None): production processes and control of the products mentioned in Article 1 of these Regulations, in order to
p.(None): guarantee its uniform quality, within the internationally accepted and valid limits for each
p.(None): one of
p.(None): they.
p.(None): 7.4) Certificate of good manufacturing practices: Document issued by the competent authority of the country where
p.(None): the manufacturer is located, indicating that the facilities where the products are manufactured are
p.(None): subjected to regular inspections that apply good manufacturing practices.
p.(None): 7.5) Trademark Certificate: Document that proves the protection of the product name or
p.(None): products mentioned in the first article of this Regulation for their commercialization, extended in the
p.(None): dependency that authority
p.(None): designate.
p.(None): 7.6) Marketing certification of pharmaceutical products type World Health Organization
p.(None): (WHO), hereinafter WHO type certificate: Document issued by the health authority of the country where the
p.(None): product, at the request of the interested party in which it must be stated that: a) The producer establishment is subject to
p.(None): periodic inspections and complies with good manufacturing practices; b) You have the authorization to
p.(None): manufacture and / or distribute the product to be imported; c) That its sale is allowed in the producing country or the
p.(None): country responsible for its commercialization; d) That it describes the complete qualitative and quantitative formula. e) That your
p.(None): sale is subject to some restrictive regime or special control, when it is the
p.(None): case.
p.(None): 7.7) Risk criteria: Determination of risk factors. Risk factor is the circumstance
p.(None): related to the degree of toxicity or lack of effectiveness of a substance, product, accessory or input that
p.(None): It can cause damage to health, life and / or the environment, temporarily or permanently.
p.(None): 7.8) International non-proprietary name: Corresponds to the name of pharmaceutical active principles accepted by
p.(None): the World Health Organization (WHO) under the signs and acronyms "Common Denominations
p.(None): Internacionales "(DCI) or" International Nonproprietary Names "(INN).
p.(None): 7.9) Dental deposit: Establishment for the import, distribution and sale of materials, products and equipment
p.(None): dental.
p.(None): 7.10) Dispensation: is the act of providing one or more medications to a patient, generally in response to
p.(None): the presentation of a recipe prepared by a licensed professional.
p.(None): 7.11) Drugstore: Pharmaceutical establishment destined for importation, packaging fractionation,
p.(None): distribution and sale of pharmaceutical specialties and
p.(None): related products.
...
p.(None): ARTICLE 13. * NECESSARY DOCUMENTATION FOR SANITARY REGISTRATION OF REFERENCE AND SANITARY REGISTRATION OF PRODUCTS
p.(None): IMPORTED.
p.(None): To obtain the marketing authorization for pharmaceutical products, you must comply with the
p.(None): following:
p.(None): 13.1. To grant the marketing authorization of a product
p.(None): new:
p.(None): 13.1.1. Document accrediting the legal representation granted by the owner to the natural or legal person
p.(None): responsible for the product to register; as well as the document that proves the legal representation of the
p.(None): responsible for the product to register (original or legalized photocopy of
p.(None): document).
p.(None): 13.1.2. Registration application signed and sealed by the Pharmaceutical Chemist
p.(None): responsable.
p.(None): 13.1.3. Qualitative-quantitative formula complete with the signature and seal of the responsible Chemist-Pharmacist.
p.(None): 13.1.4. Simple photocopy of the monograph
p.(None): of the product.
p.(None): 13.1.5. Validated analytical methodology of the product, for non-pharmacopoeic products, according to the
p.(None): regulation
p.(None): valid.
p.(None): 13.1.6. Specifications of the
p.(None): product.
p.(None): 13.1.7. Labeling of the primary and secondary packaging / packaging or your project, containing information
p.(None): according to the Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use,
p.(None): approved by resolution
p.(None): I START.
p.(None): 13.1.8. Mandatory prospectus, or your project, in over-the-counter products, when the required information is not
p.(None): find in the primary packaging / packaging or
p.(None): secondary.
p.(None): 13.1.9. Manufacturing contract for third parties indicating whether the applicant was manufactured by a third party
p.(None): the product, in accordance with the provisions of article 78 hereof
p.(None): Regulation.
p.(None): 13.1.10. Certificate authorizing the marketing of a pharmaceutical product, in accordance with the unique format of
p.(None): pharmaceutical product certificate to be marketed within the Customs Union, approved by
p.(None): COMIECO resolution, or equivalent document for products manufactured outside the territory of the States Parties
p.(None): (original or authenticated photocopy of the document) This certificate will be issued by the country's regulatory authority
p.(None): of origin or provenance, and will be valid for two years after its issue date.
p.(None): 13.1.11. Stability study in accordance with the Central American Technical Regulations for Stability Studies of
p.(None): Pharmaceutical Products for Human Use, approved by COMIECO resolution.
p.(None): 13.1.12. In addition to the certificate required in 13.1.10 one of the
p.(None): following:
p.(None): a) Written consent of the person who obtained the approval in another
p.(None): country; or
p.(None): b) Evidence that the approval in the other country became effective more than five (5)
p.(None): years.
p.(None): Additionally, if any other data, study or sufficient information is submitted to demonstrate the safety and
p.(None): efficacy of the pharmaceutical product as provided in this chapter, in particular in articles 15 to 19 of the
p.(None): Governmental Agreement 712-99, they must be accompanied by the written consent of the generator
p.(None): of the data, studies or
p.(None): information.
...
p.(None): the right to protection of undisclosed information, granted to the owner. The competent authority will not grant
p.(None): a marketing approval based on evidence of marketing approval in another territory or
p.(None): information regarding safety and efficacy that was previously submitted for approval
p.(None): for marketing in that other territory, except when the information is also presented to the
p.(None): Department.
p.(None): * Added the third paragraph by Article 9 of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 40. * SIMPLIFIED PROCEDURES FOR THE SANITARY REGISTRY OF REFERENCE OF PESTICIDES FOR DOMESTIC USE AND
p.(None): FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): In the case of products sufficiently evaluated by the United Nations Organization for the
p.(None): Agriculture and Food (FAO), the World Health Organization (WHO), the European Union (EU), EL
p.(None): DEPARTMENT may simplify the sanitary registration procedure and specify the documents
p.(None): necessary for this purpose, provided that these procedures meet the requirements to protect the
p.(None): undisclosed information or data from unfair commercial uses and disclosure under Articles 37, 38 and 39
p.(None): of these Regulations and article 177 of Decree 57-2000 of the Congress of the Republic.
p.(None): * Amended by Article 10 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 41. ON THE ADVERTISING OF PESTICIDES OF DOMESTIC USE AND PESTICIDES OF USE OF PUBLIC HEALTH PROGRAMS.
p.(None): Before presenting advertising for a product in any media, the interested party must obtain the
p.(None): authorization of THE DEPARTMENT in accordance with the specific rules and procedures established.
p.(None): CHAPTER IV
p.(None): OF RELATED PRODUCTS PURPOSE OF CONTROL
p.(None): ARTICLE 42. OF THE CLASSIFICATION.
p.(None): The following are considered related products subject to control:
p.(None): 42.1) Cosmetics, personal hygiene and home products. 42.2) Phyto and zootherapeutic products and the like.
p.(None): 42.3) Healing material and medical surgical material. 42.4) Laboratory reagents for diagnosis.
p.(None): 42.5) Materials, products and dental equipment.
p.(None): ARTICLE 43. OF MEDICINAL PLANTS AND PHYTOTHERAPEUTIC PRODUCTS.
p.(None): Plants and their mixtures in the form of extracts, lyophilisates, distillates, tinctures, cooking or any other
p.(None): Galenic preparation that is presented with therapeutic, diagnostic or preventive utility, will follow the regimen
p.(None): established in these Regulations for magisterial formulas or officinal preparations as appropriate. The
p.(None): Phytotherapeutic products must be subject to health registration as established in
p.(None): these Regulations and the corresponding procedures.
p.(None): The Minister of Health will prepare a list of plants whose sale to the public will be restricted or
p.(None): prohibited because of its toxicity.
p.(None): ARTICLE 44. OF THE APPLICATION FOR REGISTRATION.
p.(None): All the products mentioned in Article 42 of these Regulations are subject to health registration and must
p.(None): appear before THE DEPARTMENT in the corresponding format, signed by a professional responsible to
p.(None): end the specialty and with knowledge of the risk criteria, who will guarantee that the product
...
p.(None): issued by the health authority of the producing country, summary batch production protocol and protocol
p.(None): summary of batch quality control. These products upon entering the country must have at least eighty
p.(None): percent (80%) of its validity period.
p.(None): The customs authorities of the Republic will only allow the import of the products listed in the
p.(None): Article 1 of these Regulations, which are duly registered or registered as appropriate. To comply with
p.(None): above, customs policies and forms must be previously submitted, for authorization, to EL
p.(None): DEPARTMENT.
p.(None): ARTICLE 53. EXPORTS.
p.(None): Pharmaceuticals and other related products may be exported by laboratories, factories, drugstores and
p.(None): distributors that have their current health license.
p.(None): ARTICLE 54. OF THE POLICIES AND FORMS OF IMPORT OF PHARMACEUTICAL AND RELATED PRODUCTS.
p.(None): The customs policies and forms of importation of these products, prior to their authorization by EL
p.(None): DEPARTMENT, except for the exceptions mentioned in Article 33 of these Regulations, must be signed
p.(None): and sealed by the technical director of the establishment, and must appear on the invoices attached to these
p.(None): documents the corresponding registration or registration number (s).
p.(None): ARTICLE 55. IMPORT OF NON-EXISTING MEDICINES IN THE COUNTRY.
p.(None): Import and manufacture of medicines or pharmaceutical specialties in number is allowed
p.(None): limited, in the following cases:
p.(None): 55.1) For registration purposes.
p.(None): 55.2) For emergency cases, of products that do not exist in the country.
p.(None): 55.3) For the execution of clinical trials, for which the interested party must previously meet the requirements
p.(None): established in articles 93 and 94 of these Regulations.
p.(None): THE DEPARTMENT must establish the requirements for the approval of these cases, for the best
p.(None): application of this article.
p.(None): ARTICLE 56. OF THE IMPORT, MANUFACTURE AND DISTRIBUTION OF MEDICAL SAMPLES.
p.(None): The importation or manufacture of medicines or pharmaceutical specialties in the form of
p.(None): samples, in order to carry out promotion exclusively within the medical union, so
p.(None): free. The foregoing does not apply to medicines or pharmaceutical specialties that contain
p.(None): narcotic and psychotropic.
p.(None): The Ministry of Health must establish the procedures for the authorization and distribution of said
p.(None): samples.
p.(None): TITLE III
p.(None): NARCOTIC DRUGS, PSYCHOTROPICS AND PRECURSORS. SOLE CHAPTER
p.(None): ARTICLE 57. OF THE CLASSIFICATION OF NARCOTICS AND PSYCHOTROPICS.
p.(None): The narcotic and psychotropic drugs referred to in this Regulation are those listed in the
p.(None): Single Convention on Narcotic Drugs of 1961, in the Convention on Psychotropic Substances of 1971 and in the
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and others
p.(None): substances considered as such by the laws of the country and by the provisions dictated by the
p.(None): health authorities.
p.(None): ARTICLE 58. OF THE IMPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only laboratories and drugstores can import raw materials for the manufacture of
p.(None): narcotic and psychotropic drugs, or import them already finished for distribution, in accordance with the
p.(None): previously authorized fees. Regarding the raw materials that constitute precursors, the provisions of
...
p.(None): must inform the health authorities and provide the necessary means of proof to
p.(None): justify the loss or missing. All without prejudice to any other explanation that the competent authority
p.(None): could demand.
p.(None): In the event that the importer does not comply with the aforementioned, without prejudice to criminal sanctions
p.(None): and civilians that may correspond, will be sanctioned in accordance with the Health Code.
p.(None): ARTICLE 59. OF THE CERTIFICATES OF IMPORT AND EXPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Certificates authorizing the import or export of drugs, narcotic drugs and psychotropics must be
p.(None): extended by THE DEPARTMENT in original and four copies, one copy being used for:
p.(None): 59.1) THE DEPARTMENT.
p.(None): 59.2) The corresponding office of the importing or exporting country. 59.3) For the exporting house.
p.(None): 59.4) Other for the importer, and
p.(None): 59.5) For the Executive Secretary of the Commission Against Addictions and Illicit Drug Trafficking
p.(None): (SECCATID) of the Vice Presidency of the Republic.
p.(None): Any extended certificate for the import and export of drugs, narcotic drugs and psychotropics must be
p.(None): presented in the corresponding form in which the necessary documents and times of
p.(None): delivery. This certificate is valid for six months from the date it was issued, and must
p.(None): verify the respective introduction to the country, according to the corresponding customs documents.
p.(None): If for any reason the products are not entered into the country in the period of validity described in the paragraph
p.(None): above, the interested party can request an extension as long as it is accompanied by the justification
p.(None): relevant. Said extension may not exceed sixty (60) business days.
p.(None): ARTICLE 60. ABOUT THE CONTROLS TO BE CARRIED OUT BY THE PHARMACIES.
p.(None): The technical directors and owners of pharmacies must present the affidavit of
p.(None): movements by means of the corresponding input and output balance of narcotic and psychotropic products
p.(None): until the tenth (10th) of each month in the corresponding form.
p.(None): In this form, the name and the patient and the prescriber must be detailed. All this information must have
p.(None): sustenance in the recipes and is under the responsibility of the owner and the technical director and must be made
p.(None): view of THE DEPARTMENT, when required.
p.(None): The owners and technical directors are obliged to keep for two (2) years the original recipes that
p.(None): Dispatch and in which these drugs are prescribed, as well as the purchase invoices for them.
p.(None): ARTICLE 61. RESPONSIBILITY OF THE PRESCRIPTOR.
p.(None): Those prescriptions that are issued will have therapeutic support and the prescriber must be in technical capacity to
p.(None): Objectively demonstrate the reason for the prescription. In case there is not enough support
p.(None): scientist regarding the use and dose used, the prescriber must answer to THE DEPARTMENT, without
p.(None): prejudice of the sanctions that may correspond by virtue of crime or fault.
p.(None): However, when it comes to any prescription that must be formulated in the official recipe book, prior
p.(None): their offices will have to be authorized by THE DEPARTMENT. When it's business hours, pharmacies are
p.(None): obliged to send the original recipes within twenty-four hours after their dispatch, for their
...
p.(None): narcotics and sanctioned as such.
p.(None): In case of loss or removal of a recipe book, the doctor is obliged to immediately report it to EL
p.(None): DEPARTMENT so that this office makes it known to all technical directors of pharmacies
p.(None): in order to avoid its fraudulent use.
p.(None): ARTICLE 64. OF THE AUTHORIZED FEES FOR DISPATCH.
p.(None): THE DEPARTMENT must formulate the list of narcotic and psychotropic products, with the dose allowed for
p.(None): twenty-four (24) hours.
p.(None): However, it is allowed that professionals in legal practice can prescribe and pharmacies
p.(None): Dispense higher doses, provided that its application is directly controlled by the physician and
p.(None): authorized by THE DEPARTMENT, the treating doctor being responsible for the misuse of his
p.(None): prescription is made.
p.(None): It is also the doctor's obligation when he has to administer narcotic drugs for periods of more than eight days,
p.(None): inform THE DEPARTMENT of the diagnosis and the dose to be used daily and request the corresponding weekly fee
p.(None): or biweekly, depending on the case, which will be submitted to the agency's consideration
p.(None): mentioned, which in consultation can authorize or deny it.
p.(None): In the case of people who have become accustomed to the use of narcotic drugs, treating doctors
p.(None): They must inform THE DEPARTMENT and they will proceed in the manner indicated in the previous paragraph.
p.(None): The prescriptions for the taxicómanos must be extended in the official form by a doctor of the Health Center
p.(None): respective, the number and date of the agreement by which the designated agency authorized the
p.(None): share. These recipes will be delivered personally to the interested party weekly, biweekly or monthly,
p.(None): according to the case, and will be signed and sealed by the head of said agency.
p.(None): Doctors are obliged to inform THE DEPARTMENT when they stop assisting these patients, or their
p.(None): death, if applicable, within the following thirty (30) days, in order to proceed with the
p.(None): cancellation of the quota that they have authorized.
p.(None): ARTICLE 65. OF THE CONTROLS IN HEALTHCARE HOUSES, SANATORIES AND HOSPITALS.
p.(None): Health houses, sanitariums and hospitals that do not have pharmacies served by doctors, can
p.(None): keep in their emergency kits, quantities of narcotic drugs and psychotropic drugs for use
p.(None): Therapeutic exclusively, provided they meet the following requirements:
p.(None): 65.1) Be duly registered in THE DEPARTMENT.
p.(None): 65.2) Request a monthly fee from the DEPARTMENT for psychotropic and narcotic drugs.
p.(None): 65.3) Send monthly to THE DEPARTMENT, under sworn declaration of the director of the establishment or the professional
p.(None): responsible pharmacist, the balance of entries and exits, during the first ten days of each month. In said
p.(None): Form must detail the name of the patient and the prescriber. All this information must have
p.(None): sustenance in the recipes and is under the responsibility of the director of the health establishment or the professional
p.(None): pharmacist, which must be placed in view of THE DEPARTMENT when required.
p.(None): 65.4) Keep for two years the original prescriptions in which these medications are prescribed as well as the invoices
p.(None): with which its acquisition is verified.
p.(None): 65.5) Only the medical director of the establishment, who must be registered as such in the Ministry of Health,
p.(None): may sign the purchase requests, in the form set by these Regulations, being obliged to comply with all
...
p.(None): that implies in the person in which it is performed, they are admissible.
p.(None): 93.2) Clinical trials must be carried out under conditions of respect for the fundamental rights of the person and
p.(None): the ethical postulates that affect biomedical research in which human beings are affected, following
p.(None): for this purpose, the contents of the Declaration of Helsinki and subsequent declarations that update the aforementioned
p.(None): postulates.
p.(None): 93.3) They are also object of authorization, the studies that have like purpose the evaluation of the efficacy and
p.(None): safety of known medications.
p.(None): 93.4) In the case of new drugs or drugs that carry risk, you must have the
p.(None): freely expressed consent, preferably in writing or, failing that, before witnesses, of the person in whom
p.(None): the test must be carried out, after being instructed by the health professional in charge of the
p.(None): research on the nature, importance, scope and risks of the trial and having understood the
p.(None): information.
p.(None): 93.5) In the case of clinical trials of particular therapeutic interest for the subject of experimentation, the
p.(None): His consent will always be in writing.
p.(None): 93.6) The instruction and exposition of the scope and risks of the trial, as well as the consent referred to in the
p.(None): previous sections will be made before and will be granted by the legal representative in the case of people who cannot
p.(None): cast it freely. In addition, the consent of the represented party will be necessary if its conditions allow it to understand
p.(None): the nature, importance, scope and risks of the trial.
p.(None): ARTICLE 94. OF THE REQUIREMENTS FOR CLINICAL TRIALS.
p.(None): In order to carry out clinical trials, a research protocol must be submitted, which will be evaluated by a
p.(None): commission made up of a representative of the Department of Regulation and Control of Related Pharmaceutical Products,
p.(None): a representative of the National Pharmacovigilance Program, a representative of the Ministry of Health who
p.(None): relate to the type of clinical trial to be performed, a professional specialist representative, within the
p.(None): scheme of the national network, related to the subject of the trial, appointed by the Ministry of Health and a
p.(None): PAHO representative in an advisory capacity. After the evaluation, if applicable, THE DEPARTMENT
p.(None): will grant the respective authorization.
p.(None): TITLE VI
p.(None): OF THE RATIONAL USE OF MEDICINES CHAPTER I
p.(None): OF THE DISPENSATION OF MEDICINES AND OF THE PRESCRIPTION
p.(None): ARTICLE 95. DISPENSATION OF MEDICINES.
p.(None): As a general rule, medications will only be dispensed by prescription. The Ministry of Health must
p.(None): establish the requirements, minimums and characteristics of prescriptions and hospital orders.
p.(None): The Ministry of Health will establish special requirements for the prescription and dispensing of
p.(None): narcotic, psychotropic and other medications that by their nature require it or for treatments
p.(None): specific.
p.(None): Pharmaceutical specialties that do not require a doctor's prescription may be authorized in order to be
p.(None): dispensed and used whenever they are intended for pathologies that do not need an accurate diagnosis and that
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p.(None): GOVERNMENT AGREEMENT NUMBER 712-99
p.(None): Guatemala, September 17, 1999.
p.(None): The President of the Republic, CONSIDERING:
p.(None): That by mandate contained in Articles 94, 95 and 96 of the Political Constitution of the Republic,
p.(None): it is the State's obligation to develop the necessary actions regarding the preservation of quality
p.(None): of food, pharmaceutical, chemical products and all those that may affect the health and well-being of
p.(None): population.
p.(None): CONSIDERING:
p.(None): That article 244 of the Health Code, Decree number 90-97 of the Congress of the Republic, establishes that the Body
p.(None): Executive, through the Ministry of Public Health and Social Assistance, will issue the Regulations
p.(None): contemplated in that law and will readjust those that are necessary for the correct application of it.
p.(None): CONSIDERING:
p.(None): That an updated regulatory framework is required to establish the competence and responsibilities of each
p.(None): of those involved in the manufacture, marketing, surveillance and control of products
p.(None): pharmaceuticals and other related to contribute to the existence of safe, effective, quality products,
p.(None): correctly identified and with appropriate information.
p.(None): SO:
p.(None): In exercise of the functions conferred on him by article 183, paragraphs a) and e), of the Political Constitution of the
p.(None): Republic of Guatemala,
p.(None): AGREES:
p.(None): Issue the following:
p.(None): REGULATION FOR THE SANITARY CONTROL OF MEDICINES AND RELATED PRODUCTS
p.(None): TITLE I GENERAL PROVISIONS
p.(None): SOLE CHAPTER
p.(None): ARTICLE 1. SCOPE OF APPLICATION.
p.(None): The purpose of this Regulation is to regulate the sanitary control of the following
p.(None): products: drugs, narcotic drugs, psychotropic drugs and their precursors, phyto and zootherapeutic products and
p.(None): similar, cosmetics, personal and household hygiene products, household pesticides, healing materials,
p.(None): laboratory reagents for diagnostic use, dental products and equipment.
p.(None): It also regulates the principles, rules, criteria and basic requirements on the efficacy, safety and quality of the
p.(None): products subject to these Regulations.
p.(None): ARTICLE 2. COMPETENCE OF THE MINISTRY OF HEALTH.
p.(None): Corresponds to the Ministry of Public Health and Social Assistance, hereinafter called the Ministry of
p.(None): Health, the regulation of the sanitary reference registry, sanitary registration, manufacturing,
p.(None): fractionation, quality control, distribution, marketing, import, storage, prescription,
p.(None): dispensing, conformity assessment of the products listed in the previous article, as well as their
p.(None): rational use and its intervention in aspects related to narcotic drugs, psychotropic drugs and their precursors.
p.(None): Defines the actions of individuals or legal entities as they intervene in industrial processes or
p.(None): commercial of the products referred to in this Regulation or that due to their professional quality can guarantee them,
p.(None): control, prescribe, or dispense them.
p.(None): ARTICLE 3. RESPONSIBILITIES.
p.(None): Laboratories, importers, drugstores, distributors, pharmacies, hospital pharmacy services,
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Health / Cognitive Impairment
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p.(None): DEPARTMENT, will issue the regulations and forms necessary for the implementation of the different
p.(None): processes and procedures detailed in these Regulations. The forms must be clear, objective, of
p.(None): general application and compliance and indicate the necessary documents to be submitted, the mechanisms for
p.(None): clarification and resolution time. Prior to its implementation, it will be announced to the different sectors
p.(None): organized that relate to medications.
p.(None): The requested documents must meet all the requirements established in the current legal order
p.(None): in order to be valid in the country, mainly when they are of foreign origin.
p.(None): ARTICLE 5. INSPECTIONS.
p.(None): THE DEPARTMENT may carry out the inspections it deems necessary to establishments under control, with
p.(None): in order to verify compliance with these Regulations. These inspections will be carried out during
p.(None): operation of the establishments subject to inspection. The owner or person responsible must allow
p.(None): authorized officials or inspectors carry out the relevant sanitary inspections. THE DEPARTMENT may,
p.(None): Likewise, implement self-evaluation and statistical verification procedures.
p.(None): ARTICLE 6. PREVENTIVE MEASURES.
p.(None): To guarantee the effectiveness of the inspection and, where appropriate, the probable confiscation of substances or products that
p.(None): represent a health risk, the official or employee who performs the inspection may
p.(None): order, by means of minutes, the immobilization of these, being able to also seal the packages,
p.(None): boxes, containers, enclosures or establishments so that the continuation of the inspection is not impeded nor
p.(None): the effectiveness of the sanctions that may be derived from it are impaired.
p.(None): ARTICLE 7. * DEFINITIONS.
p.(None): For the purposes of these Regulations,
p.(None): understand by:
p.(None): 7.1) Pharmacy assistant: He is the person responsible for the sales of medicines, duly recognized and authorized
p.(None): in accordance with the specific regulations issued by the corresponding authority.
p.(None): 7.2) Rural medicine cabinet: Medicine sales service for dispersed populations which will be in charge of a
p.(None): community organized group coordinated by a social medicine sale. The person in charge of
p.(None): rural medicine cabinet is a promoter or guardian of
p.(None): Health.
p.(None): 7.3) Good manufacturing practices: Installation conditions and established procedures for all
p.(None): production processes and control of the products mentioned in Article 1 of these Regulations, in order to
p.(None): guarantee its uniform quality, within the internationally accepted and valid limits for each
p.(None): one of
p.(None): they.
p.(None): 7.4) Certificate of good manufacturing practices: Document issued by the competent authority of the country where
p.(None): the manufacturer is located, indicating that the facilities where the products are manufactured are
p.(None): subjected to regular inspections that apply good manufacturing practices.
p.(None): 7.5) Trademark Certificate: Document that proves the protection of the product name or
p.(None): products mentioned in the first article of this Regulation for their commercialization, extended in the
p.(None): dependency that authority
p.(None): designate.
p.(None): 7.6) Marketing certification of pharmaceutical products type World Health Organization
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Health / Drug Dependence
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p.(None): the effectiveness of the sanctions that may be derived from it are impaired.
p.(None): ARTICLE 7. * DEFINITIONS.
p.(None): For the purposes of these Regulations,
p.(None): understand by:
p.(None): 7.1) Pharmacy assistant: He is the person responsible for the sales of medicines, duly recognized and authorized
p.(None): in accordance with the specific regulations issued by the corresponding authority.
p.(None): 7.2) Rural medicine cabinet: Medicine sales service for dispersed populations which will be in charge of a
p.(None): community organized group coordinated by a social medicine sale. The person in charge of
p.(None): rural medicine cabinet is a promoter or guardian of
p.(None): Health.
p.(None): 7.3) Good manufacturing practices: Installation conditions and established procedures for all
p.(None): production processes and control of the products mentioned in Article 1 of these Regulations, in order to
p.(None): guarantee its uniform quality, within the internationally accepted and valid limits for each
p.(None): one of
p.(None): they.
p.(None): 7.4) Certificate of good manufacturing practices: Document issued by the competent authority of the country where
p.(None): the manufacturer is located, indicating that the facilities where the products are manufactured are
p.(None): subjected to regular inspections that apply good manufacturing practices.
p.(None): 7.5) Trademark Certificate: Document that proves the protection of the product name or
p.(None): products mentioned in the first article of this Regulation for their commercialization, extended in the
p.(None): dependency that authority
p.(None): designate.
p.(None): 7.6) Marketing certification of pharmaceutical products type World Health Organization
p.(None): (WHO), hereinafter WHO type certificate: Document issued by the health authority of the country where the
p.(None): product, at the request of the interested party in which it must be stated that: a) The producer establishment is subject to
p.(None): periodic inspections and complies with good manufacturing practices; b) You have the authorization to
p.(None): manufacture and / or distribute the product to be imported; c) That its sale is allowed in the producing country or the
p.(None): country responsible for its commercialization; d) That it describes the complete qualitative and quantitative formula. e) That your
p.(None): sale is subject to some restrictive regime or special control, when it is the
p.(None): case.
p.(None): 7.7) Risk criteria: Determination of risk factors. Risk factor is the circumstance
p.(None): related to the degree of toxicity or lack of effectiveness of a substance, product, accessory or input that
p.(None): It can cause damage to health, life and / or the environment, temporarily or permanently.
p.(None): 7.8) International non-proprietary name: Corresponds to the name of pharmaceutical active principles accepted by
p.(None): the World Health Organization (WHO) under the signs and acronyms "Common Denominations
p.(None): Internacionales "(DCI) or" International Nonproprietary Names "(INN).
...
p.(None): authorization and registration.
p.(None): ARTICLE 62. ON THE USE AND PRESCRIPTION OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only duly registered medical, dental and veterinary university professionals
p.(None): authorized for this purpose by THE DEPARTMENT, they may apply the drugs contained in their respective patients
p.(None): the instruments referred to in Article 57 of these Regulations.
p.(None): Narcotic and psychotropic prescriptions should only be made for therapeutic purposes,
p.(None): using the registered pharmaceutical specialties, or official and master formulas, in the
p.(None): maximum concentrations set by THE DEPARTMENT.
p.(None): The recipes for narcotic products issued by the professionals mentioned in this article must bear the
p.(None): issue date, name and address of the patient, name, signature, number of active member and stamp registered by the
p.(None): professional before THE DEPARTMENT. The name of the prescribed drug, the amount in
p.(None): numbers and letters. Psychotropic and narcotic prescriptions will not be dispensed to minors.
p.(None): ARTICLE 63. OF THE FORM FOR THE EXTENSION OF PRESCRIPTIONS OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): An official form is established for the prescription of products that contain any of the contemplated substances
p.(None): in list I of the 1961 Single Convention on Narcotic Drugs, in the Substances Convention
p.(None): Psychotropic of 1971 and in the United Nations Convention against Illicit Traffic in
p.(None): Narcotic Drugs and Psychotropic Substances.
p.(None): These recipes will be provided to physicians by THE DEPARTMENT, at cost price; will have a special format
p.(None): and they will contain the data that is necessary for said dependency.
p.(None): Pharmacies will dispense prescriptions that are formulated in the official recipe book and authorized by EL
p.(None): DEPARTMENT. Otherwise, the dispatch of such medications is considered as illegal supply of
p.(None): narcotics and sanctioned as such.
p.(None): In case of loss or removal of a recipe book, the doctor is obliged to immediately report it to EL
p.(None): DEPARTMENT so that this office makes it known to all technical directors of pharmacies
p.(None): in order to avoid its fraudulent use.
p.(None): ARTICLE 64. OF THE AUTHORIZED FEES FOR DISPATCH.
p.(None): THE DEPARTMENT must formulate the list of narcotic and psychotropic products, with the dose allowed for
p.(None): twenty-four (24) hours.
p.(None): However, it is allowed that professionals in legal practice can prescribe and pharmacies
p.(None): Dispense higher doses, provided that its application is directly controlled by the physician and
p.(None): authorized by THE DEPARTMENT, the treating doctor being responsible for the misuse of his
p.(None): prescription is made.
p.(None): It is also the doctor's obligation when he has to administer narcotic drugs for periods of more than eight days,
p.(None): inform THE DEPARTMENT of the diagnosis and the dose to be used daily and request the corresponding weekly fee
p.(None): or biweekly, depending on the case, which will be submitted to the agency's consideration
p.(None): mentioned, which in consultation can authorize or deny it.
p.(None): In the case of people who have become accustomed to the use of narcotic drugs, treating doctors
p.(None): They must inform THE DEPARTMENT and they will proceed in the manner indicated in the previous paragraph.
p.(None): The prescriptions for the taxicómanos must be extended in the official form by a doctor of the Health Center
...
p.(None): omitting any expression that considers partial truths. Descriptions or images relating to events
p.(None): verifiable, must be subject to reliable and scientifically based verification, when required.
p.(None): Special care should be taken in advertising aimed at children and young people, avoiding taking advantage of their credulity or
p.(None): lack of experience.
p.(None): 98.3) That does not suggest that the use of over-the-counter medications can delay or avoid resorting to the
p.(None): medical and / or diagnostic or rehabilitation procedures.
p.(None): 98.4) That the description of the indications and actions of an over-the-counter medicine be made in
p.(None): colloquial language without using medical or technical terms that confuse or mislead the consumer.
p.(None): When technical or scientific information is required, it must be presented in a clear way, without exaggerating
p.(None): its results or implications. The amount or variety of information in the ads should not cause
p.(None): any confusion about the ultimate use, effects, and benefits of over-the-counter medications.
p.(None): 98.5) That in the content of the text, phrases or words that exaggerate the benefits of the
p.(None): Pharmaceutical specialty in question, such as wonderful, magical, infallible medicine,
p.(None): insurmountable, safe, cure, healing, healthy, snatchy, the best, the most effective, the only, the most powerful or others
p.(None): similar to these or involving unfair competition.
p.(None): 98.6) That the advertisements do not suggest the use of over-the-counter medications permanently,
p.(None): limiting itself to the authorized administration term for the competent dependency of the Ministry of Health. Remain
p.(None): excepted from this principle, products such as vitamins or mineral supplements whose administration
p.(None): It can be carried out for long periods. Also excluded are those products whose role is preventive,
p.(None): therefore, its administration can be carried out for prolonged periods.
p.(None): 98.7) That the arguments that are raised regarding a product, are based on clinical studies or
p.(None): Statistics designed and executed in accordance with generally accepted scientific principles or standards.
p.(None): 98.8) That testimonial arguments of notorious persons or entities are not used in teaching,
p.(None): research or health sciences that may induce consumption; and also the fact that the
p.(None): medicine is authorized by the health authorities of any country or is being controlled or analyzed
p.(None): by the same authorities; and lastly, that the State of Guatemala has acquired said medications
p.(None): to use in your health programs.
p.(None): 98.9) That phrases or words that exaggerate the benefits of the pharmaceutical specialty are not used in advertising.
p.(None): The authorization referred to in the previous section must be granted by THE DEPARTMENT in a
p.(None): forty-eight (48) hour term when referring to campaigns promoted in the media.
p.(None): ARTICLE 99. INFORMATION AND PROMOTION DIRECTED TO HEALTHCARE PROFESSIONALS.
p.(None): The information and promotion aimed at health professionals must be in accordance with the data
p.(None): contained in the reference health registry and must be rigorous, well-founded, objective and not
p.(None): mislead, in accordance with current legislation and conform to the respective monograph.
p.(None): The information and promotional media used as support, whether written, audiovisual or otherwise
p.(None): nature, must be basically scientific in nature and must be exclusively directed and distributed to
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Health / Drug Usage
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p.(None): The quality control methods established in the pharmacopoeias must be executed by the manufacturer.
p.(None): authorized, with reference to raw materials, products in process, groats and final products, as well as
p.(None): of packaging, labeling and packaging material where appropriate.
p.(None): The responsible laboratory must carry out tests to guarantee stability in accordance with the
p.(None): indicated storage conditions.
p.(None): The Ministry of Health, through THE DEPARTMENT, will establish the controls required of the manufacturer according to the
p.(None): referred literature, the National Health Laboratory will carry out the analytical controls.
p.(None): ARTICLE 19. PHARMACOPEAS AND TEXTS ACCEPTED FOR PHARMACEUTICAL SPECIALTIES.
p.(None): For the purposes of establishing the identity, quality, potency, purity and stability of the active ingredients and
p.(None): pharmaceutical forms of the drugs whose authorization is requested, the regulatory entity accepts the following
p.(None): bibliography and its supplements:
p.(None): 19.1) British Pharmacopoeia.
p.(None): 19.2) United States Pharmacopeia and National Form (USP / NF). 19.3) European Pharmacopoeia.
p.(None): 19.4) French Pharmacopoeia.
p.(None): 19.5) Farrmacopea helvetica.
p.(None): 19.6) International Pharmacopoeia.
p.(None): 19.7) Japanese Pharmacopeia.
p.(None): On these texts, the United States Pharmacopeia and National Form (USP / NF) has
p.(None): preeminence.
p.(None): In the case of a new pharmaceutical product that does not appear in any official text previously indicated, the entity
p.(None): Regulatory may qualify technical support information.
p.(None): For the pharmacological evaluation, base texts are considered, the pharmacological norms established by the
p.(None): regulatory authority, Drug Information of the United States Pharmacopeia (USPDI);
p.(None): Martindale and recognized pharmacologies.
p.(None): ARTICLE 20. IDENTIFICATION GUARANTEES FOR PHARMACEUTICAL SPECIALTIES.
p.(None): a) Name of the pharmaceutical specialties. A pharmaceutical specialty may be designated with a name of
p.(None): trademark or with an international common name. When it is a trademark it cannot be confused
p.(None): with an international common name, nor mislead about the therapeutic properties of
p.(None): nature of the specialty.
p.(None): On packaging, containers and labels, as well as in the written advertising of a pharmaceutical specialty that only
p.(None): has an active ingredient, the international non-proprietary name must necessarily appear in characters
p.(None): readable, along with the trademark. In the monograph and in the prospectus the name must appear
p.(None): clearly highlighted international common of other medicinal substances contained in the specialty
p.(None): pharmaceutical.
p.(None): b) Declaration of the composition: In the application for sanitary registration of reference and in the monograph of the
p.(None): pharmaceutical specialties, must include identification data, qualitative composition
p.(None): and exact and complete quantitative, including in addition to the active ingredients all the excipients.
p.(None): ARTICLE 21. GUARANTEES OF INFORMATION.
p.(None): The holder of the pharmaceutical or pesticide specialty subject to these Regulations must provide written information
p.(None): enough about its identification, indications and precautions to observe in its use. Texts must be submitted
p.(None): In Spanish language. Said written information must be recorded on the packaging, container, package leaflet and
p.(None): monograph with the length and by minors that correspond to each of these elements according to their nature.
...
p.(None): two other countries.
p.(None): The packaging material must contain the necessary information for its correct identification and
p.(None): use. Also, you must ensure the quality of the product during its marketing period.
p.(None): For nationally manufactured products without international reference, authorized and monitored studies will be carried out
p.(None): by THE DEPARTMENT.
p.(None): ARTICLE 46. REGISTRATION OF COSMETICS, PRODUCTS OF PERSONAL HYGIENE AND HOME.
p.(None): Cosmetics, personal hygiene and household products must guarantee their safety by using materials
p.(None): bonuses accepted in internationally recognized literature.
p.(None): Its quality must adhere to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to quality control and risk criteria surveillance established by EL
p.(None): DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use; should
p.(None): also ensure the quality of the product during its marketing period.
p.(None): In the case of products whose fundamental base is maintained and the change consists of pigments, dyes and aromas, it is
p.(None): It is necessary to record the different ingredients in use and it will be registered as a single product.
p.(None): ARTICLE 47. HEALING MATERIAL, MEDICAL SURGICAL MATERIALS AND PRODUCTS AND DENTAL EQUIPMENT.
p.(None): Healing materials, medical-surgical materials, and dental products and equipment must be
p.(None): manufactured under safety and quality standards, using international standards recognized by
p.(None): organizations such as the Food and Drug Administration of the United States of America (FDA) and the
p.(None): European Union (EU).
p.(None): Its quality must conform to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to the risk criteria surveillance control established by EL
p.(None): DEPARTMENT.
p.(None): All those products or supplies that are of invasive use are analyzed, understanding by
p.(None): invasive those products that break a natural barrier (for example, skin and mucosa) of the organism and which
p.(None): can cause a health risk, requiring qualitative, quantitative and
p.(None): microbiographical, as the case may be. These analyzes will be carried out by the National Health Laboratory.
p.(None): The packaging material must contain the necessary information for its correct identification and use.
p.(None): It must also ensure the quality and stability of the product during its marketing period.
p.(None): ARTICLE 48. REGISTRATION OF LABORATORY REAGENTS FOR DIAGNOSIS.
p.(None): Laboratory reagents for diagnosis must guarantee accurate results through their use and
p.(None): reliable on the corresponding tests.
p.(None): The registration will be by test, its quality must conform to the declaration of the documentation indicating all the
p.(None): reagents and materials involved in the test. These products are subject to surveillance control of
p.(None): risk criteria established by THE DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use;
p.(None): Likewise, it must ensure the original quality of the product during its marketing period.
...
p.(None): narcotic and psychotropic drugs and present the balance referred to in the following paragraph, except in the case of
p.(None): first import request. The import authorization request will be made through a form
p.(None): provided by the aforementioned agency.
p.(None): The import or export request must accompany the balance of imports,
p.(None): productions, products in process, existence of inventory and exports, if that were the case. East
p.(None): Balance must be presented under affidavit of the legal representative and the pharmaceutical technical director
p.(None): responsable.
p.(None): If for any reason the importer does not receive the narcotic drugs in the authorized quantities,
p.(None): must inform the health authorities and provide the necessary means of proof to
p.(None): justify the loss or missing. All without prejudice to any other explanation that the competent authority
p.(None): could demand.
p.(None): In the event that the importer does not comply with the aforementioned, without prejudice to criminal sanctions
p.(None): and civilians that may correspond, will be sanctioned in accordance with the Health Code.
p.(None): ARTICLE 59. OF THE CERTIFICATES OF IMPORT AND EXPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Certificates authorizing the import or export of drugs, narcotic drugs and psychotropics must be
p.(None): extended by THE DEPARTMENT in original and four copies, one copy being used for:
p.(None): 59.1) THE DEPARTMENT.
p.(None): 59.2) The corresponding office of the importing or exporting country. 59.3) For the exporting house.
p.(None): 59.4) Other for the importer, and
p.(None): 59.5) For the Executive Secretary of the Commission Against Addictions and Illicit Drug Trafficking
p.(None): (SECCATID) of the Vice Presidency of the Republic.
p.(None): Any extended certificate for the import and export of drugs, narcotic drugs and psychotropics must be
p.(None): presented in the corresponding form in which the necessary documents and times of
p.(None): delivery. This certificate is valid for six months from the date it was issued, and must
p.(None): verify the respective introduction to the country, according to the corresponding customs documents.
p.(None): If for any reason the products are not entered into the country in the period of validity described in the paragraph
p.(None): above, the interested party can request an extension as long as it is accompanied by the justification
p.(None): relevant. Said extension may not exceed sixty (60) business days.
p.(None): ARTICLE 60. ABOUT THE CONTROLS TO BE CARRIED OUT BY THE PHARMACIES.
p.(None): The technical directors and owners of pharmacies must present the affidavit of
p.(None): movements by means of the corresponding input and output balance of narcotic and psychotropic products
p.(None): until the tenth (10th) of each month in the corresponding form.
p.(None): In this form, the name and the patient and the prescriber must be detailed. All this information must have
p.(None): sustenance in the recipes and is under the responsibility of the owner and the technical director and must be made
p.(None): view of THE DEPARTMENT, when required.
p.(None): The owners and technical directors are obliged to keep for two (2) years the original recipes that
p.(None): Dispatch and in which these drugs are prescribed, as well as the purchase invoices for them.
p.(None): ARTICLE 61. RESPONSIBILITY OF THE PRESCRIPTOR.
p.(None): Those prescriptions that are issued will have therapeutic support and the prescriber must be in technical capacity to
p.(None): Objectively demonstrate the reason for the prescription. In case there is not enough support
p.(None): scientist regarding the use and dose used, the prescriber must answer to THE DEPARTMENT, without
p.(None): prejudice of the sanctions that may correspond by virtue of crime or fault.
p.(None): However, when it comes to any prescription that must be formulated in the official recipe book, prior
p.(None): their offices will have to be authorized by THE DEPARTMENT. When it's business hours, pharmacies are
p.(None): obliged to send the original recipes within twenty-four hours after their dispatch, for their
p.(None): authorization and registration.
p.(None): ARTICLE 62. ON THE USE AND PRESCRIPTION OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only duly registered medical, dental and veterinary university professionals
p.(None): authorized for this purpose by THE DEPARTMENT, they may apply the drugs contained in their respective patients
p.(None): the instruments referred to in Article 57 of these Regulations.
p.(None): Narcotic and psychotropic prescriptions should only be made for therapeutic purposes,
p.(None): using the registered pharmaceutical specialties, or official and master formulas, in the
p.(None): maximum concentrations set by THE DEPARTMENT.
p.(None): The recipes for narcotic products issued by the professionals mentioned in this article must bear the
p.(None): issue date, name and address of the patient, name, signature, number of active member and stamp registered by the
p.(None): professional before THE DEPARTMENT. The name of the prescribed drug, the amount in
p.(None): numbers and letters. Psychotropic and narcotic prescriptions will not be dispensed to minors.
p.(None): ARTICLE 63. OF THE FORM FOR THE EXTENSION OF PRESCRIPTIONS OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): An official form is established for the prescription of products that contain any of the contemplated substances
p.(None): in list I of the 1961 Single Convention on Narcotic Drugs, in the Substances Convention
p.(None): Psychotropic of 1971 and in the United Nations Convention against Illicit Traffic in
p.(None): Narcotic Drugs and Psychotropic Substances.
p.(None): These recipes will be provided to physicians by THE DEPARTMENT, at cost price; will have a special format
p.(None): and they will contain the data that is necessary for said dependency.
p.(None): Pharmacies will dispense prescriptions that are formulated in the official recipe book and authorized by EL
p.(None): DEPARTMENT. Otherwise, the dispatch of such medications is considered as illegal supply of
p.(None): narcotics and sanctioned as such.
p.(None): In case of loss or removal of a recipe book, the doctor is obliged to immediately report it to EL
p.(None): DEPARTMENT so that this office makes it known to all technical directors of pharmacies
p.(None): in order to avoid its fraudulent use.
p.(None): ARTICLE 64. OF THE AUTHORIZED FEES FOR DISPATCH.
p.(None): THE DEPARTMENT must formulate the list of narcotic and psychotropic products, with the dose allowed for
p.(None): twenty-four (24) hours.
p.(None): However, it is allowed that professionals in legal practice can prescribe and pharmacies
p.(None): Dispense higher doses, provided that its application is directly controlled by the physician and
...
p.(None): according to the established categories. The rural kits are within the authorization of the social sales of
p.(None): medicines.
p.(None): ARTICLE 84. MEDICATION STORES ESTABLISHMENTS.
p.(None): The establishments for the sale of medicines are classified into:
p.(None): 84.1) Pharmacies:
p.(None): · Private pharmacies.
p.(None): · State pharmacies.
p.(None): · Municipal pharmacies.
p.(None): 84.2) Medicine sales:
p.(None): · Sale of private medicine.
p.(None): · Social sale of medicines (Rural Medicine Cabinet).
p.(None): Laboratories and drugstores are responsible for distributing to pharmaceutical establishments according to their category,
p.(None): Only the medicines on the list authorized by THE DEPARTMENT.
p.(None): ARTICLE 85. OF THE TURNS.
p.(None): Night, day, Sunday and work break are mandatory for all pharmacies and sales
p.(None): of medicine of the Republic. In populations where there is more than one pharmacy or sale of medicine,
p.(None): This service must be carried out through the weekly shift system according to the table prepared by the Head of
p.(None): Health Area, according to the jurisdiction where the pharmacy is located.
p.(None): ARTICLE 86. OF THE TECHNICAL DIRECTOR OF PHARMACEUTICAL ESTABLISHMENTS.
p.(None): It is mandatory for all pharmaceutical establishments to have the supervision of a technical director, who
p.(None): will be responsible for the quality, safety and efficacy of the products that are manufactured and for the adequate storage and
p.(None): sale in the case of marketing. The company has the power to include it at the organizational level that
p.(None): consider relevant.
p.(None): In the case of pharmaceutical product laboratories, zoo and phytotherapeutic product laboratories,
p.(None): household pesticide laboratories, drug stores and pharmacies, the technical director must be a
p.(None): Pharmaceutical chemical professional. The technical director for the other manufacturing establishments not included in the
p.(None): previous paragraph, must be a professional related to the specialty and with knowledge of the risk criteria, which
p.(None): can demonstrate experience and ability to ensure the quality and safety of the products they make. For him
p.(None): In the case of drug distribution and dispensing establishments, they will serve as director
p.(None): Technician the following: Medicine Sales: pharmacy assistant. Rural kit: volunteer health worker.
p.(None): ARTICLE 87. ON THE CONTINUITY OF THE TECHNICAL SUPERVISION OF PHARMACEUTICAL ESTABLISHMENTS.
p.(None): The legal representative and / or the owner and the technical director must ensure the continuity of supervision
p.(None): technique of pharmaceutical establishments.
p.(None): TITLE V SOLE CHAPTER
p.(None): PHARMACOVIGILANCE
p.(None): ARTICLE 88. NATIONAL PHARMACOVIGILANCO PROGRAM.
p.(None): The national pharmacovigilance program coordinated by the Ministry of Health integrates the activities that the services
p.(None): public and private health services carry out to collect and elaborate information on efficacy and
p.(None): clinical effectiveness; adverse reactions, convenience and safety of medicines.
p.(None): In this program, doctors, dentists, veterinarians, pharmacists are required to collaborate,
p.(None): nurses and other health professionals.
p.(None): ARTICLE 89. OBJECTIVE OF THE PHARMACOVIGILANCE PROGRAM.
p.(None): The national pharmacovigilance program aims to monitor the action of medicines on
p.(None): the population and provide validated information that allows regulating policies for the rational use of medicines, as well as
p.(None): of ethical promotion criteria.
p.(None): ARTICLE 90. OBLIGATION TO DECLARE OF THE HEALTHCARE PROFESSIONALS.
p.(None): Health professionals have a duty to communicate to health authorities or centers
p.(None): specialized that they designate, of therapeutic failures, adverse reactions,
p.(None): Drug interactions and drug-related illnesses that affect people or public health.
p.(None): ARTICLE 91. OF THE OBLIGATION TO DECLARE OF MANUFACTURERS AND DISTRIBUTORS.
p.(None): Manufacturers and holders of health authorizations for medicines are obliged to declare EL
p.(None): DEPARTMENT, the unexpected or toxic effects of which they are aware and that could have been caused by
p.(None): the drugs they manufacture or market.
p.(None): ARTICLE 92. OF CLINICAL TRIALS.
p.(None): For the purposes of these Regulations, a clinical trial is understood to be any experimental evaluation of a substance
p.(None): or medicine through its administration or application to human beings, oriented towards some of the
p.(None): following purposes:
p.(None): 92.1) Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the human body.
p.(None): 92.2) Establish its efficacy for a therapeutic, diagnostic, prophylactic indication (including vaccines) and
p.(None): determined rehabilitation.
p.(None): 92.3) Know the profile of their adverse reactions and establish their safety.
p.(None): ARTICLE 93. AUTHORIZATION OF CLINICAL TRIALS AND STUDIES OF USE OF MEDICINES.
p.(None): To be valid, clinical trials and studies of drug use with new molecules or already
p.(None): existing research protocols will be subject to the authorization of THE DEPARTMENT,
p.(None): the following requirements must also be met:
p.(None): 93.1) No phase III clinical trial may be started as long as not enough are available
p.(None): Scientific data and, in particular, from phase II pharmacological and toxicological tests that guarantee that the risks
p.(None): that implies in the person in which it is performed, they are admissible.
p.(None): 93.2) Clinical trials must be carried out under conditions of respect for the fundamental rights of the person and
p.(None): the ethical postulates that affect biomedical research in which human beings are affected, following
p.(None): for this purpose, the contents of the Declaration of Helsinki and subsequent declarations that update the aforementioned
p.(None): postulates.
p.(None): 93.3) They are also object of authorization, the studies that have like purpose the evaluation of the efficacy and
p.(None): safety of known medications.
p.(None): 93.4) In the case of new drugs or drugs that carry risk, you must have the
p.(None): freely expressed consent, preferably in writing or, failing that, before witnesses, of the person in whom
p.(None): the test must be carried out, after being instructed by the health professional in charge of the
p.(None): research on the nature, importance, scope and risks of the trial and having understood the
p.(None): information.
p.(None): 93.5) In the case of clinical trials of particular therapeutic interest for the subject of experimentation, the
p.(None): His consent will always be in writing.
...
p.(None): specific.
p.(None): Pharmaceutical specialties that do not require a doctor's prescription may be authorized in order to be
p.(None): dispensed and used whenever they are intended for pathologies that do not need an accurate diagnosis and that
p.(None): the data of its toxicological, clinical evaluation or its use and route of administration are not
p.(None): reveals the need for prescription with a view to avoiding the direct or indirect health risks of the
p.(None): people.
p.(None): The use of these medications will seek responsible self-medication and will only be products that demonstrate
p.(None): security and a clear benefit to the user.
p.(None): ARTICLE 96. RECIPE.
p.(None): The prescription is the document that supports the dispensation under medical prescription and is valid for the entire territory
p.(None): national.
p.(None): Prescriptions and hospital dispensing orders must be written in Spanish and contain basic information.
p.(None): identification of the prescriber, patient and medications.
p.(None): In prescriptions and orders, the doctor must include the pertinent warnings for the pharmacist and
p.(None): the instructions for the best observance of the treatment.
p.(None): The Ministry of Health may regulate on a basic basis the provisions of the preceding paragraphs and establish the
p.(None): requirement of other requirements that, because they affect public health or the health system, must be
p.(None): of general application in prescriptions or hospital orders.
p.(None): At the discretion of the doctor and in order to favor his patient with the Accessibility Program
p.(None): of medicines (PROAM), you can include the technical name of the medicine (Common Name
p.(None): International). Only under this criterion will the recipe be dispensed in the Program's distribution network.
p.(None): of drug accessibility.
p.(None): CHAPTER II
p.(None): ADVERTISING, PROMOTION AND INFORMATION ON MEDICINES
p.(None): ARTICLE 97. ADVERTISING OF PHARMACEUTICAL SPECIALTIES.
p.(None): The Ministry of Health must determine the pharmaceutical specialties that may be the subject of advertising directed at
p.(None): the population when they comply; at least the following requirements:
p.(None): 97.1) That are not intended for the prevention or cure of pathologies that require a doctor's diagnosis or prescription,
p.(None): as well as those other pathologies determined by the Ministry of Health.
p.(None): 97.2) That are intended for the prevention, relief or treatment of minor syndromes or symptoms.
p.(None): 97.3) That are formulated with the medicinal substances expressly established by the Ministry of Health in a list
p.(None): positive, which will be updated periodically.
p.(None): 97.4) That have proven, with extensive experience, to be safe and effective for the therapeutic indication
p.(None): correspondent.
p.(None): 97.5) That in its application the parenteral route cannot be used.
p.(None): 97.6) Subject to the conditions and criteria established in the corresponding authorization by the Ministry of
p.(None): Health with respect to each pharmaceutical specialty.
p.(None): ARTICLE 98. AUTHORIZATION OF ADVERTISING MESSAGES.
p.(None): To obtain authorization for advertising messages from pharmaceutical specialties, they must
p.(None): meet the following requirements:
p.(None): 98.1) That over-the-counter medicines are promoted only in the unions authorized by the Ministry of
p.(None): Health, either in the texts of the packages, containers or leaflets. Actions, degree of relief, benefits, etc. from
p.(None): These medications must also correspond to that authorized by the Ministry of Health.
...
p.(None): contained in the reference health registry and must be rigorous, well-founded, objective and not
p.(None): mislead, in accordance with current legislation and conform to the respective monograph.
p.(None): The information and promotional media used as support, whether written, audiovisual or otherwise
p.(None): nature, must be basically scientific in nature and must be exclusively directed and distributed to
p.(None): health professionals.
p.(None): CHAPTER III
p.(None): OF THE RATIONAL USE OF MEDICINAL PRODUCTS IN HOSPITAL AND SPECIALIZED CARE
p.(None): ARTICLE 100. OF THE USE OF THE INTERNATIONAL COMMON DENOMINATION.
p.(None): All state health institutions are obliged to use in the selection, supply and
p.(None): prescription of medicines the international common name.
p.(None): ARTICLE 101. SUPPORT STRUCTURES FOR THE RATIONAL USE OF MEDICINES IN HOSPITALS.
p.(None): Without prejudice to the responsibility that all health professionals have in the rational use of
p.(None): medicines, hospitals must have a hospital pharmacy service or units, directed by
p.(None): Pharmaceutical Chemists.
p.(None): To achieve the rational use of medications, the hospital pharmacy units or services will carry out the
p.(None): following functions:
p.(None): 101.1) Guarantee and assume technical responsibility for the acquisition, quality, correct conservation,
p.(None): coverage of needs, custody, preparation of magisterial formulas or official preparations and
p.(None): dispensing of the necessary drugs for in-hospital activities and those for treatment
p.(None): out-of-hospital requiring special surveillance, supervision or control.
p.(None): 101.2) Establish an effective and safe medicine distribution system, take measures to
p.(None): guarantee its correct administration and ensure compliance with drug legislation
p.(None): and psychotropic or any other medication that requires special control.
p.(None): 101.3) Being part of the hospital commissions where their knowledge can be useful for
p.(None): selection and scientific evaluation of medicines and their use.
p.(None): 101.4) Establish a medicine information service for all hospital personnel, a system of
p.(None): in-hospital pharmacovigilance, systematic studies of drug use and activities of
p.(None): clinical pharmacokinetics.
p.(None): 101.5) Carry out educational activities on aspects of its competence aimed at health personnel of the
p.(None): hospital and patients.
p.(None): 101.6) Carry out own research work or in collaboration with other units or services and participate in
p.(None): clinical trials with medications in accordance with the provisions of Title V of these Regulations.
p.(None): 101.7) Carry out as many functions as may lead to better use and control of medications.
p.(None): ARTICLE 102. HOSPITAL PHARMACY.
p.(None): Hospitals with twenty (20) or more beds must have a hospital pharmacy service under the
p.(None): ownership and responsibility of a pharmaceutical technical director, preferably with a specialty in pharmacy
p.(None): hospitable.
p.(None): The Ministry of Health must develop the regulations in the following aspects:
p.(None): 102.1) Establishment of requirements for its proper functioning, in accordance with the established functions. 102.2) That the
p.(None): performances are provided with the presence and professional performance of the pharmacist or pharmacists necessary for a correct
p.(None): assistance.
p.(None): TITLE VII FINAL AND TRANSITORY PROVISIONS
p.(None): SOLE CHAPTER
p.(None): ARTICLE 103. COST OF SERVICES.
p.(None): The granting of the sanitary registry of reference and the authorization or sanitary license, as well as other
p.(None): authorizations, certifications and registrations, constitutes a service whose value for the user will be established in the
p.(None): fee approved by the Executive Agency through the Ministry of Health. The income from these
p.(None): concepts will enter proprietary accounts of the services, destined to the increase and
p.(None): improvement of their provision.
p.(None): ARTICLE 104. REGULATORY ADEQUACY.
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p.(None): subjected to regular inspections that apply good manufacturing practices.
p.(None): 7.5) Trademark Certificate: Document that proves the protection of the product name or
p.(None): products mentioned in the first article of this Regulation for their commercialization, extended in the
p.(None): dependency that authority
p.(None): designate.
p.(None): 7.6) Marketing certification of pharmaceutical products type World Health Organization
p.(None): (WHO), hereinafter WHO type certificate: Document issued by the health authority of the country where the
p.(None): product, at the request of the interested party in which it must be stated that: a) The producer establishment is subject to
p.(None): periodic inspections and complies with good manufacturing practices; b) You have the authorization to
p.(None): manufacture and / or distribute the product to be imported; c) That its sale is allowed in the producing country or the
p.(None): country responsible for its commercialization; d) That it describes the complete qualitative and quantitative formula. e) That your
p.(None): sale is subject to some restrictive regime or special control, when it is the
p.(None): case.
p.(None): 7.7) Risk criteria: Determination of risk factors. Risk factor is the circumstance
p.(None): related to the degree of toxicity or lack of effectiveness of a substance, product, accessory or input that
p.(None): It can cause damage to health, life and / or the environment, temporarily or permanently.
p.(None): 7.8) International non-proprietary name: Corresponds to the name of pharmaceutical active principles accepted by
p.(None): the World Health Organization (WHO) under the signs and acronyms "Common Denominations
p.(None): Internacionales "(DCI) or" International Nonproprietary Names "(INN).
p.(None): 7.9) Dental deposit: Establishment for the import, distribution and sale of materials, products and equipment
p.(None): dental.
p.(None): 7.10) Dispensation: is the act of providing one or more medications to a patient, generally in response to
p.(None): the presentation of a recipe prepared by a licensed professional.
p.(None): 7.11) Drugstore: Pharmaceutical establishment destined for importation, packaging fractionation,
p.(None): distribution and sale of pharmaceutical specialties and
p.(None): related products.
p.(None): 7.12) Distributor: Pharmaceutical establishment destined for the import, distribution and sale of products
p.(None): Over-the-counter pharmaceuticals, related products, healing materials, surgical medical equipment and instruments, and
p.(None): laboratory reagents for use
p.(None): diagnosis.
p.(None): 7.13) Pharmaceutical equivalent: Medicines containing identical amounts of identical principles
p.(None): active, for example, the same salt or ester of the active ingredient, in the same pharmaceutical forms,
p.(None): that complies with the same standards and administrators through the same channel. Pharmaceutical equivalence does not
p.(None): necessarily implies therapeutic equivalence, since the difference of excipients and / or processes of
p.(None): manufacturing, may lead to differences in stock
p.(None): of the product.
p.(None): 7.14) Pharmaceutical specialty: Medicine prepared in a laboratory and officially authorized to be dispatched
...
p.(None): Regulation in order to guarantee the efficacy, safety and quality of the medicines and pesticides subject to this
p.(None): Regulations that are registered or marketed in Guatemala. Likewise, in those high-risk products,
p.(None): therapeutic equivalence evaluations.
p.(None): ARTICLE 16. SECURITY GUARANTEES.
p.(None): Medicines and pesticides subject to these Regulations, consisting of new molecules not yet
p.(None): recognized by the texts mentioned in Article 19 and in Chapter III below of these Regulations, will be
p.(None): object of the presentation of toxicological studies that guarantee its safety in
p.(None): normal conditions of use and in the case of medicines, which are in relation to the expected duration of the
p.(None): treatments.
p.(None): These studies will comprise acute and chronic toxicity tests, terotogenicity tests, embryotoxicity, fertility,
p.(None): mutagenesis tests and when necessary carcinogenesis and in general, those others that are considered
p.(None): necessary for a correct evaluation of the safety and tolerance of a medicine or pesticide subject to this
p.(None): Regulation, under normal conditions of use and in the case of medications, also depending on the duration of the
p.(None): treatment. The excipients of the medicines with the exclusions and limitations that proceed will be regulated
p.(None): in accordance with the provisions of these Regulations.
p.(None): ARTICLE 17. GUARANTEES OF EFFECTIVENESS OF PHARMACEUTICAL SPECIALTIES.
p.(None): For pharmaceutical specialties consisting of new molecules not yet recognized in the texts cited in
p.(None): Article 19 of these Regulations, clinical studies must be submitted, the results of which demonstrate
p.(None): the pharmacological actions produced by the specialty medicinal substance or substances
p.(None): pharmaceutical and its destination in the body. Such studies should include one or more untreated control groups or
p.(None): treated with a reference product.
p.(None): ARTICLE 18. GUARANTEES OF QUALITY, PURITY AND STABILITY OF PHARMACEUTICAL SPECIALTIES.
p.(None): Every pharmaceutical specialty must have its qualitative composition perfectly established and
p.(None): quantitative, which must be consistent with the documentation presented.
p.(None): In each case, procedures defined in the pharmacopoeias must exist and be used by the manufacturer.
p.(None): indicated in article 19 of these Regulations or the procedures developed and validated by the
p.(None): manufacturer and that have been made available to the authority, which is who will make the final decision.
p.(None): The permissible limits of quantitative variability in the composition of the specialty are established
p.(None): in accordance with the provisions of the bibliographic references cited in Article 19 of these Regulations. Of the same
p.(None): The quality control methods established in the pharmacopoeias must be executed by the manufacturer.
p.(None): authorized, with reference to raw materials, products in process, groats and final products, as well as
p.(None): of packaging, labeling and packaging material where appropriate.
p.(None): The responsible laboratory must carry out tests to guarantee stability in accordance with the
p.(None): indicated storage conditions.
p.(None): The Ministry of Health, through THE DEPARTMENT, will establish the controls required of the manufacturer according to the
p.(None): referred literature, the National Health Laboratory will carry out the analytical controls.
p.(None): ARTICLE 19. PHARMACOPEAS AND TEXTS ACCEPTED FOR PHARMACEUTICAL SPECIALTIES.
...
p.(None): The following are considered related products subject to control:
p.(None): 42.1) Cosmetics, personal hygiene and home products. 42.2) Phyto and zootherapeutic products and the like.
p.(None): 42.3) Healing material and medical surgical material. 42.4) Laboratory reagents for diagnosis.
p.(None): 42.5) Materials, products and dental equipment.
p.(None): ARTICLE 43. OF MEDICINAL PLANTS AND PHYTOTHERAPEUTIC PRODUCTS.
p.(None): Plants and their mixtures in the form of extracts, lyophilisates, distillates, tinctures, cooking or any other
p.(None): Galenic preparation that is presented with therapeutic, diagnostic or preventive utility, will follow the regimen
p.(None): established in these Regulations for magisterial formulas or officinal preparations as appropriate. The
p.(None): Phytotherapeutic products must be subject to health registration as established in
p.(None): these Regulations and the corresponding procedures.
p.(None): The Minister of Health will prepare a list of plants whose sale to the public will be restricted or
p.(None): prohibited because of its toxicity.
p.(None): ARTICLE 44. OF THE APPLICATION FOR REGISTRATION.
p.(None): All the products mentioned in Article 42 of these Regulations are subject to health registration and must
p.(None): appear before THE DEPARTMENT in the corresponding format, signed by a professional responsible to
p.(None): end the specialty and with knowledge of the risk criteria, who will guarantee that the product
p.(None): offers health safety conditions for the user.
p.(None): ARTICLE 45. REGISTRATION OF PHYTO AND ZOOTHERAPEUTIC PRODUCTS.
p.(None): In the evaluation process of phyto and zootherapeutic products, the substance or mixture of
p.(None): substances by chromatographic profile or other method that allows their identification. In the case of being a product of
p.(None): Import will apply the WHO type Certificate system or equivalent certification.
p.(None): If the product has been used traditionally without proven harmful effects, when evaluating its
p.(None): Safety No restrictive regulatory action will be taken unless new evidence emerges that requires
p.(None): review the assessment of risks versus benefits. It must be accompanied by a review
p.(None): relevant bibliographic.
p.(None): For evaluation of efficacy, copies of the articles or appropriate references to the
p.(None): themselves. Research studies, if they exist, must be taken into account. When traditional usage is unknown,
p.(None): health certification from the country of origin and at least the sales authorization must be presented in
p.(None): two other countries.
p.(None): The packaging material must contain the necessary information for its correct identification and
p.(None): use. Also, you must ensure the quality of the product during its marketing period.
p.(None): For nationally manufactured products without international reference, authorized and monitored studies will be carried out
p.(None): by THE DEPARTMENT.
p.(None): ARTICLE 46. REGISTRATION OF COSMETICS, PRODUCTS OF PERSONAL HYGIENE AND HOME.
p.(None): Cosmetics, personal hygiene and household products must guarantee their safety by using materials
p.(None): bonuses accepted in internationally recognized literature.
p.(None): Its quality must adhere to the declaration of the documentation presented in the registration and information to the consumer
...
p.(None): The national pharmacovigilance program coordinated by the Ministry of Health integrates the activities that the services
p.(None): public and private health services carry out to collect and elaborate information on efficacy and
p.(None): clinical effectiveness; adverse reactions, convenience and safety of medicines.
p.(None): In this program, doctors, dentists, veterinarians, pharmacists are required to collaborate,
p.(None): nurses and other health professionals.
p.(None): ARTICLE 89. OBJECTIVE OF THE PHARMACOVIGILANCE PROGRAM.
p.(None): The national pharmacovigilance program aims to monitor the action of medicines on
p.(None): the population and provide validated information that allows regulating policies for the rational use of medicines, as well as
p.(None): of ethical promotion criteria.
p.(None): ARTICLE 90. OBLIGATION TO DECLARE OF THE HEALTHCARE PROFESSIONALS.
p.(None): Health professionals have a duty to communicate to health authorities or centers
p.(None): specialized that they designate, of therapeutic failures, adverse reactions,
p.(None): Drug interactions and drug-related illnesses that affect people or public health.
p.(None): ARTICLE 91. OF THE OBLIGATION TO DECLARE OF MANUFACTURERS AND DISTRIBUTORS.
p.(None): Manufacturers and holders of health authorizations for medicines are obliged to declare EL
p.(None): DEPARTMENT, the unexpected or toxic effects of which they are aware and that could have been caused by
p.(None): the drugs they manufacture or market.
p.(None): ARTICLE 92. OF CLINICAL TRIALS.
p.(None): For the purposes of these Regulations, a clinical trial is understood to be any experimental evaluation of a substance
p.(None): or medicine through its administration or application to human beings, oriented towards some of the
p.(None): following purposes:
p.(None): 92.1) Show its pharmacodynamic effects or collect data regarding its absorption,
p.(None): distribution, metabolism and excretion in the human body.
p.(None): 92.2) Establish its efficacy for a therapeutic, diagnostic, prophylactic indication (including vaccines) and
p.(None): determined rehabilitation.
p.(None): 92.3) Know the profile of their adverse reactions and establish their safety.
p.(None): ARTICLE 93. AUTHORIZATION OF CLINICAL TRIALS AND STUDIES OF USE OF MEDICINES.
p.(None): To be valid, clinical trials and studies of drug use with new molecules or already
p.(None): existing research protocols will be subject to the authorization of THE DEPARTMENT,
p.(None): the following requirements must also be met:
p.(None): 93.1) No phase III clinical trial may be started as long as not enough are available
p.(None): Scientific data and, in particular, from phase II pharmacological and toxicological tests that guarantee that the risks
p.(None): that implies in the person in which it is performed, they are admissible.
p.(None): 93.2) Clinical trials must be carried out under conditions of respect for the fundamental rights of the person and
p.(None): the ethical postulates that affect biomedical research in which human beings are affected, following
p.(None): for this purpose, the contents of the Declaration of Helsinki and subsequent declarations that update the aforementioned
p.(None): postulates.
p.(None): 93.3) They are also object of authorization, the studies that have like purpose the evaluation of the efficacy and
p.(None): safety of known medications.
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p.(None): these Regulations and the corresponding procedures.
p.(None): The Minister of Health will prepare a list of plants whose sale to the public will be restricted or
p.(None): prohibited because of its toxicity.
p.(None): ARTICLE 44. OF THE APPLICATION FOR REGISTRATION.
p.(None): All the products mentioned in Article 42 of these Regulations are subject to health registration and must
p.(None): appear before THE DEPARTMENT in the corresponding format, signed by a professional responsible to
p.(None): end the specialty and with knowledge of the risk criteria, who will guarantee that the product
p.(None): offers health safety conditions for the user.
p.(None): ARTICLE 45. REGISTRATION OF PHYTO AND ZOOTHERAPEUTIC PRODUCTS.
p.(None): In the evaluation process of phyto and zootherapeutic products, the substance or mixture of
p.(None): substances by chromatographic profile or other method that allows their identification. In the case of being a product of
p.(None): Import will apply the WHO type Certificate system or equivalent certification.
p.(None): If the product has been used traditionally without proven harmful effects, when evaluating its
p.(None): Safety No restrictive regulatory action will be taken unless new evidence emerges that requires
p.(None): review the assessment of risks versus benefits. It must be accompanied by a review
p.(None): relevant bibliographic.
p.(None): For evaluation of efficacy, copies of the articles or appropriate references to the
p.(None): themselves. Research studies, if they exist, must be taken into account. When traditional usage is unknown,
p.(None): health certification from the country of origin and at least the sales authorization must be presented in
p.(None): two other countries.
p.(None): The packaging material must contain the necessary information for its correct identification and
p.(None): use. Also, you must ensure the quality of the product during its marketing period.
p.(None): For nationally manufactured products without international reference, authorized and monitored studies will be carried out
p.(None): by THE DEPARTMENT.
p.(None): ARTICLE 46. REGISTRATION OF COSMETICS, PRODUCTS OF PERSONAL HYGIENE AND HOME.
p.(None): Cosmetics, personal hygiene and household products must guarantee their safety by using materials
p.(None): bonuses accepted in internationally recognized literature.
p.(None): Its quality must adhere to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to quality control and risk criteria surveillance established by EL
p.(None): DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use; should
p.(None): also ensure the quality of the product during its marketing period.
p.(None): In the case of products whose fundamental base is maintained and the change consists of pigments, dyes and aromas, it is
p.(None): It is necessary to record the different ingredients in use and it will be registered as a single product.
p.(None): ARTICLE 47. HEALING MATERIAL, MEDICAL SURGICAL MATERIALS AND PRODUCTS AND DENTAL EQUIPMENT.
p.(None): Healing materials, medical-surgical materials, and dental products and equipment must be
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p.(None): 97.1) That are not intended for the prevention or cure of pathologies that require a doctor's diagnosis or prescription,
p.(None): as well as those other pathologies determined by the Ministry of Health.
p.(None): 97.2) That are intended for the prevention, relief or treatment of minor syndromes or symptoms.
p.(None): 97.3) That are formulated with the medicinal substances expressly established by the Ministry of Health in a list
p.(None): positive, which will be updated periodically.
p.(None): 97.4) That have proven, with extensive experience, to be safe and effective for the therapeutic indication
p.(None): correspondent.
p.(None): 97.5) That in its application the parenteral route cannot be used.
p.(None): 97.6) Subject to the conditions and criteria established in the corresponding authorization by the Ministry of
p.(None): Health with respect to each pharmaceutical specialty.
p.(None): ARTICLE 98. AUTHORIZATION OF ADVERTISING MESSAGES.
p.(None): To obtain authorization for advertising messages from pharmaceutical specialties, they must
p.(None): meet the following requirements:
p.(None): 98.1) That over-the-counter medicines are promoted only in the unions authorized by the Ministry of
p.(None): Health, either in the texts of the packages, containers or leaflets. Actions, degree of relief, benefits, etc. from
p.(None): These medications must also correspond to that authorized by the Ministry of Health.
p.(None): 98.2) That expresses the duly accredited characteristics or benefits that the products and concepts have,
p.(None): omitting any expression that considers partial truths. Descriptions or images relating to events
p.(None): verifiable, must be subject to reliable and scientifically based verification, when required.
p.(None): Special care should be taken in advertising aimed at children and young people, avoiding taking advantage of their credulity or
p.(None): lack of experience.
p.(None): 98.3) That does not suggest that the use of over-the-counter medications can delay or avoid resorting to the
p.(None): medical and / or diagnostic or rehabilitation procedures.
p.(None): 98.4) That the description of the indications and actions of an over-the-counter medicine be made in
p.(None): colloquial language without using medical or technical terms that confuse or mislead the consumer.
p.(None): When technical or scientific information is required, it must be presented in a clear way, without exaggerating
p.(None): its results or implications. The amount or variety of information in the ads should not cause
p.(None): any confusion about the ultimate use, effects, and benefits of over-the-counter medications.
p.(None): 98.5) That in the content of the text, phrases or words that exaggerate the benefits of the
p.(None): Pharmaceutical specialty in question, such as wonderful, magical, infallible medicine,
p.(None): insurmountable, safe, cure, healing, healthy, snatchy, the best, the most effective, the only, the most powerful or others
p.(None): similar to these or involving unfair competition.
p.(None): 98.6) That the advertisements do not suggest the use of over-the-counter medications permanently,
p.(None): limiting itself to the authorized administration term for the competent dependency of the Ministry of Health. Remain
p.(None): excepted from this principle, products such as vitamins or mineral supplements whose administration
p.(None): It can be carried out for long periods. Also excluded are those products whose role is preventive,
p.(None): therefore, its administration can be carried out for prolonged periods.
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): 7.29) Medical prescription product: It is authorized to be marketed under the protection of a medical prescription.
p.(None): 7.30) Product in process: It is the one that is in some of the intermediate phases of its process
p.(None): manufacturing, which precedes the form
p.(None): definitive pharmaceutical.
p.(None): 7.31) Pharmaceutical product manufactured under contract: It is the one manufactured inside or outside the country by third parties.
p.(None): 7.32) Homeopathic products: They are pharmaceutical products that use microdoses of plant extracts, minerals.
p.(None): and
p.(None): animals.
p.(None): 7.33) Master product: it is the pharmaceutical product that is prepared according to master formulas
p.(None): prescribed by professionals
p.(None): doctors.
p.(None): 7.34) Official product: it is the pharmaceutical product elaborated in the pharmacies and laboratories according to the pharmacopoeia
p.(None): official.
p.(None): 7.35) Finished product: The one in its final container, labeled and ready to be distributed and
p.(None): marketed in accordance with
p.(None): current legislation.
p.(None): 7.42) New product: It is one that contains a chemical entity that has not been previously approved in the
p.(None): country.
p.(None): 7.36) Radiopharmaceuticals. Any product prepared for use for therapeutic or diagnostic purposes that contains
p.(None): one or more radionuclides (isotopes
p.(None): radioactive).
p.(None): 7.37) Prescription: Order signed by doctors or dentists, so that a quantity of any
p.(None): medication or mixture of them is dispatched as indicated by the professional who extends it. The recipes
p.(None): they are distinguished in: simple or ordinary medical prescription, prescription that protects a product of restricted sale
p.(None): and official checkbook recipe for
p.(None): narcotics
p.(None): 7.38) Responsible for the sanitary registry of reference: It is the professional Pharmaceutical Chemist responsible for
p.(None): registration of pharmaceutical products and pesticides for use
p.(None): domestic.
p.(None): 7.39) Responsible for health registration: is the professional responsible for product registration
p.(None): mentioned in Article 169 of the Code
p.(None): of health.
p.(None): 7.40) Sale of medicine: It is any establishment destined to the sale of pharmaceutical products to the public
p.(None): in a limited way according to lists provided by the agency
p.(None): competent.
p.(None): 7.41) Social sales of medicines: These are self-financing pharmaceutical service establishments,
p.(None): where basic medicines and healing materials are stored and sold, which are located both in
p.(None): urban centers as well as rural areas, which are managed by an organized community group,
p.(None): religious entities, non-governmental organizations, health service providers and administrators
p.(None): of health services that work in close coordination with the Ministry of Health, so that there is availability
p.(None): permanent basic medicine.
p.(None): * Added the definition "New Product" by Article 1 of Government Agreement Number 351-2006 on 00- 00-0000
p.(None): TITLE II
p.(None): PHARMACEUTICAL AND OTHER RELATED PRODUCTS CHAPTER I
p.(None): CLASSIFICATION
p.(None): ARTICLE 8. PHARMACEUTICAL PRODUCTS OR MEDICINES.
p.(None): The following are recognized as drugs or pharmaceuticals:
p.(None): 8.1) Pharmaceutical specialties; 8.2) Biological products;
p.(None): 8.3) Homeopathic products, 8.4) Radiopharmaceuticals;
p.(None): 8.5) The magisterial formulas;
p.(None): 8.6) The preparations or official forms; 8.7) Medicines in bulk.
...
p.(None): of these Regulations and article 177 of Decree 57-2000 of the Congress of the Republic.
p.(None): * Amended by Article 10 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 41. ON THE ADVERTISING OF PESTICIDES OF DOMESTIC USE AND PESTICIDES OF USE OF PUBLIC HEALTH PROGRAMS.
p.(None): Before presenting advertising for a product in any media, the interested party must obtain the
p.(None): authorization of THE DEPARTMENT in accordance with the specific rules and procedures established.
p.(None): CHAPTER IV
p.(None): OF RELATED PRODUCTS PURPOSE OF CONTROL
p.(None): ARTICLE 42. OF THE CLASSIFICATION.
p.(None): The following are considered related products subject to control:
p.(None): 42.1) Cosmetics, personal hygiene and home products. 42.2) Phyto and zootherapeutic products and the like.
p.(None): 42.3) Healing material and medical surgical material. 42.4) Laboratory reagents for diagnosis.
p.(None): 42.5) Materials, products and dental equipment.
p.(None): ARTICLE 43. OF MEDICINAL PLANTS AND PHYTOTHERAPEUTIC PRODUCTS.
p.(None): Plants and their mixtures in the form of extracts, lyophilisates, distillates, tinctures, cooking or any other
p.(None): Galenic preparation that is presented with therapeutic, diagnostic or preventive utility, will follow the regimen
p.(None): established in these Regulations for magisterial formulas or officinal preparations as appropriate. The
p.(None): Phytotherapeutic products must be subject to health registration as established in
p.(None): these Regulations and the corresponding procedures.
p.(None): The Minister of Health will prepare a list of plants whose sale to the public will be restricted or
p.(None): prohibited because of its toxicity.
p.(None): ARTICLE 44. OF THE APPLICATION FOR REGISTRATION.
p.(None): All the products mentioned in Article 42 of these Regulations are subject to health registration and must
p.(None): appear before THE DEPARTMENT in the corresponding format, signed by a professional responsible to
p.(None): end the specialty and with knowledge of the risk criteria, who will guarantee that the product
p.(None): offers health safety conditions for the user.
p.(None): ARTICLE 45. REGISTRATION OF PHYTO AND ZOOTHERAPEUTIC PRODUCTS.
p.(None): In the evaluation process of phyto and zootherapeutic products, the substance or mixture of
p.(None): substances by chromatographic profile or other method that allows their identification. In the case of being a product of
p.(None): Import will apply the WHO type Certificate system or equivalent certification.
p.(None): If the product has been used traditionally without proven harmful effects, when evaluating its
p.(None): Safety No restrictive regulatory action will be taken unless new evidence emerges that requires
p.(None): review the assessment of risks versus benefits. It must be accompanied by a review
p.(None): relevant bibliographic.
p.(None): For evaluation of efficacy, copies of the articles or appropriate references to the
p.(None): themselves. Research studies, if they exist, must be taken into account. When traditional usage is unknown,
p.(None): health certification from the country of origin and at least the sales authorization must be presented in
p.(None): two other countries.
p.(None): The packaging material must contain the necessary information for its correct identification and
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): regulatory authority, Drug Information of the United States Pharmacopeia (USPDI);
p.(None): Martindale and recognized pharmacologies.
p.(None): ARTICLE 20. IDENTIFICATION GUARANTEES FOR PHARMACEUTICAL SPECIALTIES.
p.(None): a) Name of the pharmaceutical specialties. A pharmaceutical specialty may be designated with a name of
p.(None): trademark or with an international common name. When it is a trademark it cannot be confused
p.(None): with an international common name, nor mislead about the therapeutic properties of
p.(None): nature of the specialty.
p.(None): On packaging, containers and labels, as well as in the written advertising of a pharmaceutical specialty that only
p.(None): has an active ingredient, the international non-proprietary name must necessarily appear in characters
p.(None): readable, along with the trademark. In the monograph and in the prospectus the name must appear
p.(None): clearly highlighted international common of other medicinal substances contained in the specialty
p.(None): pharmaceutical.
p.(None): b) Declaration of the composition: In the application for sanitary registration of reference and in the monograph of the
p.(None): pharmaceutical specialties, must include identification data, qualitative composition
p.(None): and exact and complete quantitative, including in addition to the active ingredients all the excipients.
p.(None): ARTICLE 21. GUARANTEES OF INFORMATION.
p.(None): The holder of the pharmaceutical or pesticide specialty subject to these Regulations must provide written information
p.(None): enough about its identification, indications and precautions to observe in its use. Texts must be submitted
p.(None): In Spanish language. Said written information must be recorded on the packaging, container, package leaflet and
p.(None): monograph with the length and by minors that correspond to each of these elements according to their nature.
p.(None): The packaging must include the data of the specialty, manufacturer, route of administration, batch number, date
p.(None): expiration. In the case of pesticides, method of use, content, batch number, expiration date, precautions
p.(None): of conservation and dispensing conditions.
p.(None): Sufficient information will be provided on the product packaging to the users on the identification of the
p.(None): specialty, reference health registration number, instructions for administration, use and
p.(None): conservation, as well as the adverse effects, interactions, contraindications and other data determined by the
p.(None): designated unit, in order to promote its correct use and the observance of the prescribed treatment, as well as
p.(None): measures to follow in case of poisoning.
p.(None): The product label should not give rise to any kind of doubt.
p.(None): The information to the patient and the monograph, especially that referring to
p.(None): indications, contraindications, adverse effects and particular precautions in its use, must be consistent with
p.(None): the results of pharmacological, toxicological and clinical studies and with the present state of
p.(None): scientific knowledge. It should also reflect the experience gained with the pharmaceutical specialty
p.(None): from the beginning of its commercialization.
p.(None): The monograph will summarize the essential scientific information on the pharmaceutical specialty to which it refers and may
p.(None): be disclosed to practicing physicians by the holder of the authorization. The monograph will fit a model
p.(None): uniform and it shall contain sufficient data on the identification of the specialty and its owner, as well as the
...
p.(None): positive, which will be updated periodically.
p.(None): 97.4) That have proven, with extensive experience, to be safe and effective for the therapeutic indication
p.(None): correspondent.
p.(None): 97.5) That in its application the parenteral route cannot be used.
p.(None): 97.6) Subject to the conditions and criteria established in the corresponding authorization by the Ministry of
p.(None): Health with respect to each pharmaceutical specialty.
p.(None): ARTICLE 98. AUTHORIZATION OF ADVERTISING MESSAGES.
p.(None): To obtain authorization for advertising messages from pharmaceutical specialties, they must
p.(None): meet the following requirements:
p.(None): 98.1) That over-the-counter medicines are promoted only in the unions authorized by the Ministry of
p.(None): Health, either in the texts of the packages, containers or leaflets. Actions, degree of relief, benefits, etc. from
p.(None): These medications must also correspond to that authorized by the Ministry of Health.
p.(None): 98.2) That expresses the duly accredited characteristics or benefits that the products and concepts have,
p.(None): omitting any expression that considers partial truths. Descriptions or images relating to events
p.(None): verifiable, must be subject to reliable and scientifically based verification, when required.
p.(None): Special care should be taken in advertising aimed at children and young people, avoiding taking advantage of their credulity or
p.(None): lack of experience.
p.(None): 98.3) That does not suggest that the use of over-the-counter medications can delay or avoid resorting to the
p.(None): medical and / or diagnostic or rehabilitation procedures.
p.(None): 98.4) That the description of the indications and actions of an over-the-counter medicine be made in
p.(None): colloquial language without using medical or technical terms that confuse or mislead the consumer.
p.(None): When technical or scientific information is required, it must be presented in a clear way, without exaggerating
p.(None): its results or implications. The amount or variety of information in the ads should not cause
p.(None): any confusion about the ultimate use, effects, and benefits of over-the-counter medications.
p.(None): 98.5) That in the content of the text, phrases or words that exaggerate the benefits of the
p.(None): Pharmaceutical specialty in question, such as wonderful, magical, infallible medicine,
p.(None): insurmountable, safe, cure, healing, healthy, snatchy, the best, the most effective, the only, the most powerful or others
p.(None): similar to these or involving unfair competition.
p.(None): 98.6) That the advertisements do not suggest the use of over-the-counter medications permanently,
p.(None): limiting itself to the authorized administration term for the competent dependency of the Ministry of Health. Remain
p.(None): excepted from this principle, products such as vitamins or mineral supplements whose administration
p.(None): It can be carried out for long periods. Also excluded are those products whose role is preventive,
p.(None): therefore, its administration can be carried out for prolonged periods.
p.(None): 98.7) That the arguments that are raised regarding a product, are based on clinical studies or
p.(None): Statistics designed and executed in accordance with generally accepted scientific principles or standards.
p.(None): 98.8) That testimonial arguments of notorious persons or entities are not used in teaching,
p.(None): research or health sciences that may induce consumption; and also the fact that the
p.(None): medicine is authorized by the health authorities of any country or is being controlled or analyzed
...
Social / Marital Status
Searching for indicator single:
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p.(None): relevant bibliographic.
p.(None): For evaluation of efficacy, copies of the articles or appropriate references to the
p.(None): themselves. Research studies, if they exist, must be taken into account. When traditional usage is unknown,
p.(None): health certification from the country of origin and at least the sales authorization must be presented in
p.(None): two other countries.
p.(None): The packaging material must contain the necessary information for its correct identification and
p.(None): use. Also, you must ensure the quality of the product during its marketing period.
p.(None): For nationally manufactured products without international reference, authorized and monitored studies will be carried out
p.(None): by THE DEPARTMENT.
p.(None): ARTICLE 46. REGISTRATION OF COSMETICS, PRODUCTS OF PERSONAL HYGIENE AND HOME.
p.(None): Cosmetics, personal hygiene and household products must guarantee their safety by using materials
p.(None): bonuses accepted in internationally recognized literature.
p.(None): Its quality must adhere to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to quality control and risk criteria surveillance established by EL
p.(None): DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use; should
p.(None): also ensure the quality of the product during its marketing period.
p.(None): In the case of products whose fundamental base is maintained and the change consists of pigments, dyes and aromas, it is
p.(None): It is necessary to record the different ingredients in use and it will be registered as a single product.
p.(None): ARTICLE 47. HEALING MATERIAL, MEDICAL SURGICAL MATERIALS AND PRODUCTS AND DENTAL EQUIPMENT.
p.(None): Healing materials, medical-surgical materials, and dental products and equipment must be
p.(None): manufactured under safety and quality standards, using international standards recognized by
p.(None): organizations such as the Food and Drug Administration of the United States of America (FDA) and the
p.(None): European Union (EU).
p.(None): Its quality must conform to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to the risk criteria surveillance control established by EL
p.(None): DEPARTMENT.
p.(None): All those products or supplies that are of invasive use are analyzed, understanding by
p.(None): invasive those products that break a natural barrier (for example, skin and mucosa) of the organism and which
p.(None): can cause a health risk, requiring qualitative, quantitative and
p.(None): microbiographical, as the case may be. These analyzes will be carried out by the National Health Laboratory.
p.(None): The packaging material must contain the necessary information for its correct identification and use.
p.(None): It must also ensure the quality and stability of the product during its marketing period.
p.(None): ARTICLE 48. REGISTRATION OF LABORATORY REAGENTS FOR DIAGNOSIS.
p.(None): Laboratory reagents for diagnosis must guarantee accurate results through their use and
p.(None): reliable on the corresponding tests.
p.(None): The registration will be by test, its quality must conform to the declaration of the documentation indicating all the
...
p.(None): and sealed by the technical director of the establishment, and must appear on the invoices attached to these
p.(None): documents the corresponding registration or registration number (s).
p.(None): ARTICLE 55. IMPORT OF NON-EXISTING MEDICINES IN THE COUNTRY.
p.(None): Import and manufacture of medicines or pharmaceutical specialties in number is allowed
p.(None): limited, in the following cases:
p.(None): 55.1) For registration purposes.
p.(None): 55.2) For emergency cases, of products that do not exist in the country.
p.(None): 55.3) For the execution of clinical trials, for which the interested party must previously meet the requirements
p.(None): established in articles 93 and 94 of these Regulations.
p.(None): THE DEPARTMENT must establish the requirements for the approval of these cases, for the best
p.(None): application of this article.
p.(None): ARTICLE 56. OF THE IMPORT, MANUFACTURE AND DISTRIBUTION OF MEDICAL SAMPLES.
p.(None): The importation or manufacture of medicines or pharmaceutical specialties in the form of
p.(None): samples, in order to carry out promotion exclusively within the medical union, so
p.(None): free. The foregoing does not apply to medicines or pharmaceutical specialties that contain
p.(None): narcotic and psychotropic.
p.(None): The Ministry of Health must establish the procedures for the authorization and distribution of said
p.(None): samples.
p.(None): TITLE III
p.(None): NARCOTIC DRUGS, PSYCHOTROPICS AND PRECURSORS. SOLE CHAPTER
p.(None): ARTICLE 57. OF THE CLASSIFICATION OF NARCOTICS AND PSYCHOTROPICS.
p.(None): The narcotic and psychotropic drugs referred to in this Regulation are those listed in the
p.(None): Single Convention on Narcotic Drugs of 1961, in the Convention on Psychotropic Substances of 1971 and in the
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and others
p.(None): substances considered as such by the laws of the country and by the provisions dictated by the
p.(None): health authorities.
p.(None): ARTICLE 58. OF THE IMPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only laboratories and drugstores can import raw materials for the manufacture of
p.(None): narcotic and psychotropic drugs, or import them already finished for distribution, in accordance with the
p.(None): previously authorized fees. Regarding the raw materials that constitute precursors, the provisions of
p.(None): the Specific Precursor Regulation.
p.(None): The drugstores and laboratories must request and obtain from THE DEPARTMENT, authorization to import drugs,
p.(None): narcotic and psychotropic drugs and present the balance referred to in the following paragraph, except in the case of
p.(None): first import request. The import authorization request will be made through a form
p.(None): provided by the aforementioned agency.
p.(None): The import or export request must accompany the balance of imports,
p.(None): productions, products in process, existence of inventory and exports, if that were the case. East
p.(None): Balance must be presented under affidavit of the legal representative and the pharmaceutical technical director
p.(None): responsable.
p.(None): If for any reason the importer does not receive the narcotic drugs in the authorized quantities,
p.(None): must inform the health authorities and provide the necessary means of proof to
p.(None): justify the loss or missing. All without prejudice to any other explanation that the competent authority
p.(None): could demand.
...
p.(None): prejudice of the sanctions that may correspond by virtue of crime or fault.
p.(None): However, when it comes to any prescription that must be formulated in the official recipe book, prior
p.(None): their offices will have to be authorized by THE DEPARTMENT. When it's business hours, pharmacies are
p.(None): obliged to send the original recipes within twenty-four hours after their dispatch, for their
p.(None): authorization and registration.
p.(None): ARTICLE 62. ON THE USE AND PRESCRIPTION OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only duly registered medical, dental and veterinary university professionals
p.(None): authorized for this purpose by THE DEPARTMENT, they may apply the drugs contained in their respective patients
p.(None): the instruments referred to in Article 57 of these Regulations.
p.(None): Narcotic and psychotropic prescriptions should only be made for therapeutic purposes,
p.(None): using the registered pharmaceutical specialties, or official and master formulas, in the
p.(None): maximum concentrations set by THE DEPARTMENT.
p.(None): The recipes for narcotic products issued by the professionals mentioned in this article must bear the
p.(None): issue date, name and address of the patient, name, signature, number of active member and stamp registered by the
p.(None): professional before THE DEPARTMENT. The name of the prescribed drug, the amount in
p.(None): numbers and letters. Psychotropic and narcotic prescriptions will not be dispensed to minors.
p.(None): ARTICLE 63. OF THE FORM FOR THE EXTENSION OF PRESCRIPTIONS OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): An official form is established for the prescription of products that contain any of the contemplated substances
p.(None): in list I of the 1961 Single Convention on Narcotic Drugs, in the Substances Convention
p.(None): Psychotropic of 1971 and in the United Nations Convention against Illicit Traffic in
p.(None): Narcotic Drugs and Psychotropic Substances.
p.(None): These recipes will be provided to physicians by THE DEPARTMENT, at cost price; will have a special format
p.(None): and they will contain the data that is necessary for said dependency.
p.(None): Pharmacies will dispense prescriptions that are formulated in the official recipe book and authorized by EL
p.(None): DEPARTMENT. Otherwise, the dispatch of such medications is considered as illegal supply of
p.(None): narcotics and sanctioned as such.
p.(None): In case of loss or removal of a recipe book, the doctor is obliged to immediately report it to EL
p.(None): DEPARTMENT so that this office makes it known to all technical directors of pharmacies
p.(None): in order to avoid its fraudulent use.
p.(None): ARTICLE 64. OF THE AUTHORIZED FEES FOR DISPATCH.
p.(None): THE DEPARTMENT must formulate the list of narcotic and psychotropic products, with the dose allowed for
p.(None): twenty-four (24) hours.
p.(None): However, it is allowed that professionals in legal practice can prescribe and pharmacies
p.(None): Dispense higher doses, provided that its application is directly controlled by the physician and
p.(None): authorized by THE DEPARTMENT, the treating doctor being responsible for the misuse of his
p.(None): prescription is made.
p.(None): It is also the doctor's obligation when he has to administer narcotic drugs for periods of more than eight days,
p.(None): inform THE DEPARTMENT of the diagnosis and the dose to be used daily and request the corresponding weekly fee
p.(None): or biweekly, depending on the case, which will be submitted to the agency's consideration
...
Social / Property Ownership
Searching for indicator home:
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p.(None): for marketing in that other territory, except when the information is also presented to the
p.(None): Department.
p.(None): * Added the third paragraph by Article 9 of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 40. * SIMPLIFIED PROCEDURES FOR THE SANITARY REGISTRY OF REFERENCE OF PESTICIDES FOR DOMESTIC USE AND
p.(None): FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): In the case of products sufficiently evaluated by the United Nations Organization for the
p.(None): Agriculture and Food (FAO), the World Health Organization (WHO), the European Union (EU), EL
p.(None): DEPARTMENT may simplify the sanitary registration procedure and specify the documents
p.(None): necessary for this purpose, provided that these procedures meet the requirements to protect the
p.(None): undisclosed information or data from unfair commercial uses and disclosure under Articles 37, 38 and 39
p.(None): of these Regulations and article 177 of Decree 57-2000 of the Congress of the Republic.
p.(None): * Amended by Article 10 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 41. ON THE ADVERTISING OF PESTICIDES OF DOMESTIC USE AND PESTICIDES OF USE OF PUBLIC HEALTH PROGRAMS.
p.(None): Before presenting advertising for a product in any media, the interested party must obtain the
p.(None): authorization of THE DEPARTMENT in accordance with the specific rules and procedures established.
p.(None): CHAPTER IV
p.(None): OF RELATED PRODUCTS PURPOSE OF CONTROL
p.(None): ARTICLE 42. OF THE CLASSIFICATION.
p.(None): The following are considered related products subject to control:
p.(None): 42.1) Cosmetics, personal hygiene and home products. 42.2) Phyto and zootherapeutic products and the like.
p.(None): 42.3) Healing material and medical surgical material. 42.4) Laboratory reagents for diagnosis.
p.(None): 42.5) Materials, products and dental equipment.
p.(None): ARTICLE 43. OF MEDICINAL PLANTS AND PHYTOTHERAPEUTIC PRODUCTS.
p.(None): Plants and their mixtures in the form of extracts, lyophilisates, distillates, tinctures, cooking or any other
p.(None): Galenic preparation that is presented with therapeutic, diagnostic or preventive utility, will follow the regimen
p.(None): established in these Regulations for magisterial formulas or officinal preparations as appropriate. The
p.(None): Phytotherapeutic products must be subject to health registration as established in
p.(None): these Regulations and the corresponding procedures.
p.(None): The Minister of Health will prepare a list of plants whose sale to the public will be restricted or
p.(None): prohibited because of its toxicity.
p.(None): ARTICLE 44. OF THE APPLICATION FOR REGISTRATION.
p.(None): All the products mentioned in Article 42 of these Regulations are subject to health registration and must
p.(None): appear before THE DEPARTMENT in the corresponding format, signed by a professional responsible to
p.(None): end the specialty and with knowledge of the risk criteria, who will guarantee that the product
p.(None): offers health safety conditions for the user.
p.(None): ARTICLE 45. REGISTRATION OF PHYTO AND ZOOTHERAPEUTIC PRODUCTS.
p.(None): In the evaluation process of phyto and zootherapeutic products, the substance or mixture of
p.(None): substances by chromatographic profile or other method that allows their identification. In the case of being a product of
p.(None): Import will apply the WHO type Certificate system or equivalent certification.
p.(None): If the product has been used traditionally without proven harmful effects, when evaluating its
p.(None): Safety No restrictive regulatory action will be taken unless new evidence emerges that requires
p.(None): review the assessment of risks versus benefits. It must be accompanied by a review
p.(None): relevant bibliographic.
p.(None): For evaluation of efficacy, copies of the articles or appropriate references to the
p.(None): themselves. Research studies, if they exist, must be taken into account. When traditional usage is unknown,
p.(None): health certification from the country of origin and at least the sales authorization must be presented in
p.(None): two other countries.
p.(None): The packaging material must contain the necessary information for its correct identification and
p.(None): use. Also, you must ensure the quality of the product during its marketing period.
p.(None): For nationally manufactured products without international reference, authorized and monitored studies will be carried out
p.(None): by THE DEPARTMENT.
p.(None): ARTICLE 46. REGISTRATION OF COSMETICS, PRODUCTS OF PERSONAL HYGIENE AND HOME.
p.(None): Cosmetics, personal hygiene and household products must guarantee their safety by using materials
p.(None): bonuses accepted in internationally recognized literature.
p.(None): Its quality must adhere to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to quality control and risk criteria surveillance established by EL
p.(None): DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use; should
p.(None): also ensure the quality of the product during its marketing period.
p.(None): In the case of products whose fundamental base is maintained and the change consists of pigments, dyes and aromas, it is
p.(None): It is necessary to record the different ingredients in use and it will be registered as a single product.
p.(None): ARTICLE 47. HEALING MATERIAL, MEDICAL SURGICAL MATERIALS AND PRODUCTS AND DENTAL EQUIPMENT.
p.(None): Healing materials, medical-surgical materials, and dental products and equipment must be
p.(None): manufactured under safety and quality standards, using international standards recognized by
p.(None): organizations such as the Food and Drug Administration of the United States of America (FDA) and the
p.(None): European Union (EU).
p.(None): Its quality must conform to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to the risk criteria surveillance control established by EL
p.(None): DEPARTMENT.
p.(None): All those products or supplies that are of invasive use are analyzed, understanding by
...
Social / Religion
Searching for indicator religious:
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p.(None): marketed in accordance with
p.(None): current legislation.
p.(None): 7.42) New product: It is one that contains a chemical entity that has not been previously approved in the
p.(None): country.
p.(None): 7.36) Radiopharmaceuticals. Any product prepared for use for therapeutic or diagnostic purposes that contains
p.(None): one or more radionuclides (isotopes
p.(None): radioactive).
p.(None): 7.37) Prescription: Order signed by doctors or dentists, so that a quantity of any
p.(None): medication or mixture of them is dispatched as indicated by the professional who extends it. The recipes
p.(None): they are distinguished in: simple or ordinary medical prescription, prescription that protects a product of restricted sale
p.(None): and official checkbook recipe for
p.(None): narcotics
p.(None): 7.38) Responsible for the sanitary registry of reference: It is the professional Pharmaceutical Chemist responsible for
p.(None): registration of pharmaceutical products and pesticides for use
p.(None): domestic.
p.(None): 7.39) Responsible for health registration: is the professional responsible for product registration
p.(None): mentioned in Article 169 of the Code
p.(None): of health.
p.(None): 7.40) Sale of medicine: It is any establishment destined to the sale of pharmaceutical products to the public
p.(None): in a limited way according to lists provided by the agency
p.(None): competent.
p.(None): 7.41) Social sales of medicines: These are self-financing pharmaceutical service establishments,
p.(None): where basic medicines and healing materials are stored and sold, which are located both in
p.(None): urban centers as well as rural areas, which are managed by an organized community group,
p.(None): religious entities, non-governmental organizations, health service providers and administrators
p.(None): of health services that work in close coordination with the Ministry of Health, so that there is availability
p.(None): permanent basic medicine.
p.(None): * Added the definition "New Product" by Article 1 of Government Agreement Number 351-2006 on 00- 00-0000
p.(None): TITLE II
p.(None): PHARMACEUTICAL AND OTHER RELATED PRODUCTS CHAPTER I
p.(None): CLASSIFICATION
p.(None): ARTICLE 8. PHARMACEUTICAL PRODUCTS OR MEDICINES.
p.(None): The following are recognized as drugs or pharmaceuticals:
p.(None): 8.1) Pharmaceutical specialties; 8.2) Biological products;
p.(None): 8.3) Homeopathic products, 8.4) Radiopharmaceuticals;
p.(None): 8.5) The magisterial formulas;
p.(None): 8.6) The preparations or official forms; 8.7) Medicines in bulk.
p.(None): ARTICLE 9. RELATED PRODUCTS.
p.(None): Related products that are subject to control are considered cosmetics, personal hygiene products, household hygiene,
p.(None): phyto and zootherapeutics, healing and medical surgical materials, laboratory reagents for diagnostic use and
p.(None): materials, household pesticides, pesticides used in health programs, products and equipment
p.(None): dental.
p.(None): CHAPTER II
p.(None): OF THE REFERENCE SANITARY REGISTRY
p.(None): ARTICLE 10. OF THE REFERENCE SANITARY REGISTRY.
p.(None): Pharmaceutical specialties, biological products, radiopharmaceuticals and homeopathic products described in
p.(None): Article 8 of these Regulations, household pesticides and pesticides for use in programs of
p.(None): public health, must be submitted to the sanitary registration procedure of reference, granted by EL
p.(None): DEPARTMENT in the form and conditions established below. For this it is necessary that the laboratory
p.(None): manufacturer is authorized in accordance with this Regulation. In the case of imported products, the manufacturer that
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): new:
p.(None): 13.1.1. Document accrediting the legal representation granted by the owner to the natural or legal person
p.(None): responsible for the product to register; as well as the document that proves the legal representation of the
p.(None): responsible for the product to register (original or legalized photocopy of
p.(None): document).
p.(None): 13.1.2. Registration application signed and sealed by the Pharmaceutical Chemist
p.(None): responsable.
p.(None): 13.1.3. Qualitative-quantitative formula complete with the signature and seal of the responsible Chemist-Pharmacist.
p.(None): 13.1.4. Simple photocopy of the monograph
p.(None): of the product.
p.(None): 13.1.5. Validated analytical methodology of the product, for non-pharmacopoeic products, according to the
p.(None): regulation
p.(None): valid.
p.(None): 13.1.6. Specifications of the
p.(None): product.
p.(None): 13.1.7. Labeling of the primary and secondary packaging / packaging or your project, containing information
p.(None): according to the Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use,
p.(None): approved by resolution
p.(None): I START.
p.(None): 13.1.8. Mandatory prospectus, or your project, in over-the-counter products, when the required information is not
p.(None): find in the primary packaging / packaging or
p.(None): secondary.
p.(None): 13.1.9. Manufacturing contract for third parties indicating whether the applicant was manufactured by a third party
p.(None): the product, in accordance with the provisions of article 78 hereof
p.(None): Regulation.
p.(None): 13.1.10. Certificate authorizing the marketing of a pharmaceutical product, in accordance with the unique format of
p.(None): pharmaceutical product certificate to be marketed within the Customs Union, approved by
p.(None): COMIECO resolution, or equivalent document for products manufactured outside the territory of the States Parties
p.(None): (original or authenticated photocopy of the document) This certificate will be issued by the country's regulatory authority
p.(None): of origin or provenance, and will be valid for two years after its issue date.
p.(None): 13.1.11. Stability study in accordance with the Central American Technical Regulations for Stability Studies of
p.(None): Pharmaceutical Products for Human Use, approved by COMIECO resolution.
p.(None): 13.1.12. In addition to the certificate required in 13.1.10 one of the
p.(None): following:
p.(None): a) Written consent of the person who obtained the approval in another
p.(None): country; or
p.(None): b) Evidence that the approval in the other country became effective more than five (5)
p.(None): years.
p.(None): Additionally, if any other data, study or sufficient information is submitted to demonstrate the safety and
p.(None): efficacy of the pharmaceutical product as provided in this chapter, in particular in articles 15 to 19 of the
p.(None): Governmental Agreement 712-99, they must be accompanied by the written consent of the generator
p.(None): of the data, studies or
p.(None): information.
p.(None): 13.1.13. Raw material standards for products, with their corresponding certificate of analysis.
p.(None): 13.1.14. Original samples, according to the harmonized quantity, for the National Health Laboratory to carry out the
p.(None): analysis
p.(None): relevant.
p.(None): 13.1.15. Proof of payment for the right to process health registration, analysis and
p.(None): control.
...
p.(None): establishment where they are prepared is responsible for their preparation with action substances and
p.(None): indication recognized in the literature. These products will be made in pharmaceutical establishments
p.(None): legally established that have the necessary means for their preparation. For these products made to
p.(None): Industrial scale requires the reference sanitary registration procedure.
p.(None): All these formulations must be perfectly identified, indicate their correct use and the name of the
p.(None): pharmacist who prepared it.
p.(None): CHAPTER III
p.(None): OF PESTICIDES FOR DOMESTIC USE
p.(None): ARTICLE 36. REGISTRATION OF PESTICIDES FOR DOMESTIC USE.
p.(None): The provisions of Chapter II of Title II of these Regulations apply to the registration of pesticides, in addition to
p.(None): established in this chapter and in the specific norms and provisions issued by EL
p.(None): DEPARTMENT.
p.(None): ARTICLE 37. *
p.(None): Conditions for the authorization of pesticides for domestic use. Sanitary registration of
p.(None): reference to a household pesticide by satisfying the following
p.(None): terms:
p.(None): 37.1) That the manufacturer or importer is registered in EL
p.(None): DEPARTMENT.
p.(None): 37.2) That the product is effective in controlling pests for which it is
p.(None): indicates.
p.(None): 37.3) That the product belongs to toxicity categories IV or V, according to the classification of the
p.(None): World Organization of the
p.(None): Health (WHO).
p.(None): 37.4) That the product is for domestic use according to the United Nations Organization for Agriculture and
p.(None): Food (FAO), the World Health Organization (WHO), the Environmental Protection Agency of the
p.(None): Government of the United States (EPA) and the European Union (EU) or, failing that, according to scientific studies
p.(None): acceptable and according to the standards established for this purpose, presented by the manufacturer.
p.(None): 37.5) That complies with the standards of the Guatemalan Standards Commission (COGUANOR), related to pesticides
p.(None): subject to this
p.(None): Regulation.
p.(None): 37.6) That meets the quality and purity requirements established by international standards such as those of the Organization
p.(None): of the Food and Agriculture United Nations (FAO), the International Pesticide Council and
p.(None): Analytic chemistry. (CIPAC) or the Environmental Protection Agency of the Government of the
p.(None): United States (EPA), when they exist for the product to be evaluated, or in its defense by those presented
p.(None): for him
p.(None): maker.
p.(None): 37.7) The Department will not allow third parties, without the consent of the people who obtained the
p.(None): prior approval in Guatemala, obtain authorization or market pesticide products for domestic use
p.(None): based on: 1) Evidence of previous marketing approvals in Guatemala; or 2) information
p.(None): Concerning the safety and efficacy that was previously presented to obtain approval to market, for
p.(None): at least ten (10) years from the date of approval, when it was granted by the competent authority, to the person
p.(None): which received approval in Guatemala.
p.(None): * Added numeral 37.7) by Article 7, of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 38. * CONDITIONS FOR THE AUTHORIZATION OF PESTICIDES FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): Authorization will be granted for the use of pesticides in public health programs, if the
p.(None): following
p.(None): terms:
p.(None): 38.1) The manufacturer or importer must be registered in EL
p.(None): DEPARTMENT.
p.(None): 38.2) The product must be effective in controlling pests for which it is
p.(None): indicates.
p.(None): 38.3) The product must in its final dilution belong to toxicity categories IV or V according to the classification of
p.(None): the World Organization of the
p.(None): Health (WHO).
p.(None): 38.4) The product must be used only by authorized personnel and
p.(None): capable.
p.(None): 38.5) The product must be of use for public health programs according to the World Organization of the
p.(None): Health (WHO), the United States Government Environmental Protection Agency (EPA) or the Union
p.(None): European (EU) or, failing that, according to scientifically acceptable studies and in accordance with established standards
p.(None): for this purpose, presented by the
p.(None): maker.
p.(None): 38.6) Comply with the standards of the Guatemalan Standards Commission (COGUANOR) related to pesticides
p.(None): subject to this
p.(None): Regulation.
p.(None): 38.7) Meet the quality and purity requirements established by international standards such as the
p.(None): Food and Agriculture Organization of the United Nations (FAO), the World Health Organization
p.(None): (WHO), the International Council for Pesticides and Analytical Chemistry (CIPAC) or the Agency for Environmental Protection
p.(None): Environment of the United States Government (EPA), when they exist for the product to be evaluated, or in
p.(None): its defect by those presented by the manufacturer.
p.(None): 38.8) The Department will not allow third parties, without the consent of the people who obtained the
p.(None): prior approval in Guatemala, obtain authorization or market pesticide products for domestic use
p.(None): based on: 1) Evidence of previous marketing approvals in Guatemala; or 2) information
p.(None): Concerning the safety and efficacy that was previously presented to obtain approval to market, for
p.(None): at least ten (10) years from the date of approval, when it was granted by the competent authority, to the person
p.(None): which received approval in Guatemala.
p.(None): * Added numeral 38.8) by Article 8, of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 39. * SCIENTIFIC INFORMATION.
p.(None): For the purposes of establishing the identity, quality, concentration, purity and stability of the
...
p.(None): of pesticide products, based on the information or the approval granted to the person who submitted the
p.(None): information, for a period of at least ten (10) years from the date of approval in the country. Refering to
p.(None): undisclosed information or other information will not be disclosed except as necessary to protect
p.(None): to the public. If the information is disclosed under these circumstances, the competent authority will not rely on such
p.(None): information or data to grant marketing approval for products to third parties other than
p.(None): authorized by the person who presented the data or information. Disclosure for such purposes does not nullify
p.(None): the right to protection of undisclosed information, granted to the owner. The competent authority will not grant
p.(None): a marketing approval based on evidence of marketing approval in another territory or
p.(None): information regarding safety and efficacy that was previously submitted for approval
p.(None): for marketing in that other territory, except when the information is also presented to the
p.(None): Department.
p.(None): * Added the third paragraph by Article 9 of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 40. * SIMPLIFIED PROCEDURES FOR THE SANITARY REGISTRY OF REFERENCE OF PESTICIDES FOR DOMESTIC USE AND
p.(None): FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): In the case of products sufficiently evaluated by the United Nations Organization for the
p.(None): Agriculture and Food (FAO), the World Health Organization (WHO), the European Union (EU), EL
p.(None): DEPARTMENT may simplify the sanitary registration procedure and specify the documents
p.(None): necessary for this purpose, provided that these procedures meet the requirements to protect the
p.(None): undisclosed information or data from unfair commercial uses and disclosure under Articles 37, 38 and 39
p.(None): of these Regulations and article 177 of Decree 57-2000 of the Congress of the Republic.
p.(None): * Amended by Article 10 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 41. ON THE ADVERTISING OF PESTICIDES OF DOMESTIC USE AND PESTICIDES OF USE OF PUBLIC HEALTH PROGRAMS.
p.(None): Before presenting advertising for a product in any media, the interested party must obtain the
p.(None): authorization of THE DEPARTMENT in accordance with the specific rules and procedures established.
p.(None): CHAPTER IV
p.(None): OF RELATED PRODUCTS PURPOSE OF CONTROL
p.(None): ARTICLE 42. OF THE CLASSIFICATION.
p.(None): The following are considered related products subject to control:
p.(None): 42.1) Cosmetics, personal hygiene and home products. 42.2) Phyto and zootherapeutic products and the like.
p.(None): 42.3) Healing material and medical surgical material. 42.4) Laboratory reagents for diagnosis.
p.(None): 42.5) Materials, products and dental equipment.
p.(None): ARTICLE 43. OF MEDICINAL PLANTS AND PHYTOTHERAPEUTIC PRODUCTS.
p.(None): Plants and their mixtures in the form of extracts, lyophilisates, distillates, tinctures, cooking or any other
p.(None): Galenic preparation that is presented with therapeutic, diagnostic or preventive utility, will follow the regimen
p.(None): established in these Regulations for magisterial formulas or officinal preparations as appropriate. The
...
p.(None): use. Also, you must ensure the quality of the product during its marketing period.
p.(None): For nationally manufactured products without international reference, authorized and monitored studies will be carried out
p.(None): by THE DEPARTMENT.
p.(None): ARTICLE 46. REGISTRATION OF COSMETICS, PRODUCTS OF PERSONAL HYGIENE AND HOME.
p.(None): Cosmetics, personal hygiene and household products must guarantee their safety by using materials
p.(None): bonuses accepted in internationally recognized literature.
p.(None): Its quality must adhere to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to quality control and risk criteria surveillance established by EL
p.(None): DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use; should
p.(None): also ensure the quality of the product during its marketing period.
p.(None): In the case of products whose fundamental base is maintained and the change consists of pigments, dyes and aromas, it is
p.(None): It is necessary to record the different ingredients in use and it will be registered as a single product.
p.(None): ARTICLE 47. HEALING MATERIAL, MEDICAL SURGICAL MATERIALS AND PRODUCTS AND DENTAL EQUIPMENT.
p.(None): Healing materials, medical-surgical materials, and dental products and equipment must be
p.(None): manufactured under safety and quality standards, using international standards recognized by
p.(None): organizations such as the Food and Drug Administration of the United States of America (FDA) and the
p.(None): European Union (EU).
p.(None): Its quality must conform to the declaration of the documentation presented in the registration and information to the consumer
p.(None): and are subject to the risk criteria surveillance control established by EL
p.(None): DEPARTMENT.
p.(None): All those products or supplies that are of invasive use are analyzed, understanding by
p.(None): invasive those products that break a natural barrier (for example, skin and mucosa) of the organism and which
p.(None): can cause a health risk, requiring qualitative, quantitative and
p.(None): microbiographical, as the case may be. These analyzes will be carried out by the National Health Laboratory.
p.(None): The packaging material must contain the necessary information for its correct identification and use.
p.(None): It must also ensure the quality and stability of the product during its marketing period.
p.(None): ARTICLE 48. REGISTRATION OF LABORATORY REAGENTS FOR DIAGNOSIS.
p.(None): Laboratory reagents for diagnosis must guarantee accurate results through their use and
p.(None): reliable on the corresponding tests.
p.(None): The registration will be by test, its quality must conform to the declaration of the documentation indicating all the
p.(None): reagents and materials involved in the test. These products are subject to surveillance control of
p.(None): risk criteria established by THE DEPARTMENT.
p.(None): The packaging material must contain the necessary information for its correct identification and use;
p.(None): Likewise, it must ensure the original quality of the product during its marketing period.
p.(None): ARTICLE 49. RENEWAL OF THE SANITARY REGISTRATION.
p.(None): The health registration can be renewed every five years at the request of the holder if they do not exist
...
p.(None): DEPARTMENT.
p.(None): ARTICLE 53. EXPORTS.
p.(None): Pharmaceuticals and other related products may be exported by laboratories, factories, drugstores and
p.(None): distributors that have their current health license.
p.(None): ARTICLE 54. OF THE POLICIES AND FORMS OF IMPORT OF PHARMACEUTICAL AND RELATED PRODUCTS.
p.(None): The customs policies and forms of importation of these products, prior to their authorization by EL
p.(None): DEPARTMENT, except for the exceptions mentioned in Article 33 of these Regulations, must be signed
p.(None): and sealed by the technical director of the establishment, and must appear on the invoices attached to these
p.(None): documents the corresponding registration or registration number (s).
p.(None): ARTICLE 55. IMPORT OF NON-EXISTING MEDICINES IN THE COUNTRY.
p.(None): Import and manufacture of medicines or pharmaceutical specialties in number is allowed
p.(None): limited, in the following cases:
p.(None): 55.1) For registration purposes.
p.(None): 55.2) For emergency cases, of products that do not exist in the country.
p.(None): 55.3) For the execution of clinical trials, for which the interested party must previously meet the requirements
p.(None): established in articles 93 and 94 of these Regulations.
p.(None): THE DEPARTMENT must establish the requirements for the approval of these cases, for the best
p.(None): application of this article.
p.(None): ARTICLE 56. OF THE IMPORT, MANUFACTURE AND DISTRIBUTION OF MEDICAL SAMPLES.
p.(None): The importation or manufacture of medicines or pharmaceutical specialties in the form of
p.(None): samples, in order to carry out promotion exclusively within the medical union, so
p.(None): free. The foregoing does not apply to medicines or pharmaceutical specialties that contain
p.(None): narcotic and psychotropic.
p.(None): The Ministry of Health must establish the procedures for the authorization and distribution of said
p.(None): samples.
p.(None): TITLE III
p.(None): NARCOTIC DRUGS, PSYCHOTROPICS AND PRECURSORS. SOLE CHAPTER
p.(None): ARTICLE 57. OF THE CLASSIFICATION OF NARCOTICS AND PSYCHOTROPICS.
p.(None): The narcotic and psychotropic drugs referred to in this Regulation are those listed in the
p.(None): Single Convention on Narcotic Drugs of 1961, in the Convention on Psychotropic Substances of 1971 and in the
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and others
p.(None): substances considered as such by the laws of the country and by the provisions dictated by the
p.(None): health authorities.
p.(None): ARTICLE 58. OF THE IMPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only laboratories and drugstores can import raw materials for the manufacture of
p.(None): narcotic and psychotropic drugs, or import them already finished for distribution, in accordance with the
p.(None): previously authorized fees. Regarding the raw materials that constitute precursors, the provisions of
p.(None): the Specific Precursor Regulation.
p.(None): The drugstores and laboratories must request and obtain from THE DEPARTMENT, authorization to import drugs,
p.(None): narcotic and psychotropic drugs and present the balance referred to in the following paragraph, except in the case of
p.(None): first import request. The import authorization request will be made through a form
p.(None): provided by the aforementioned agency.
p.(None): The import or export request must accompany the balance of imports,
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): will base on such information or data to grant approval for the marketing of products to
p.(None): third parties that are not authorized by the person who presented the data or information. Disclosure with such
p.(None): ends, does not nullify the right to protection of undisclosed information, granted to the owner.
p.(None): * Amended by Article 6 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 32. UPDATING OF THE FILE.
p.(None): The person responsible for a registry must keep the file updated, incorporating as many data, reports or
p.(None): Technological modifications impose the advances of science and the correct manufacturing and control procedures.
p.(None): These modifications must be approved by THE DEPARTMENT.
p.(None): The Ministry of Health, at any time, can request from the manufacturer of a pharmaceutical specialty all the
p.(None): information that supports the performance of quality, purity, stability, potency and other controls
p.(None): that they proceed.
p.(None): ARTICLE 33. MEDICINES OF HIGH THERAPEUTIC INTEREST.
p.(None): The Ministry of Health, to ensure the supply of medicines to its prevention and cure programs, can
p.(None): adopt special measures in relation to its manufacture in authorized laboratories or its import.
p.(None): Medication without commercial interest is understood to be that which is necessary for a specific treatment of symptoms or
p.(None): pathologies of little incidence, it does not exist in the national market or there is insufficient supply.
p.(None): ARTICLE 34. FREE SALE MEDICINES.
p.(None): Pharmaceutical specialties may be authorized under the over-the-counter modality when:
p.(None): 34.1) Be effective and safe to be self-medicated in the relief of symptoms of minor problems and
p.(None): used for short times.
p.(None): 34.2) Are pharmaceutical forms of easy handling, storage and that are not administered by
p.(None): parenteral.
p.(None): 34.3) Its therapeutic dosage is low risk.
p.(None): 34.4) They are monopharmaceuticals or associations with a risk / benefit index based on acceptable bibliographies.
p.(None): 34.5) They are not intended for the prevention or cure of pathologies that require diagnosis or prescription
p.(None): optional, as well as those other pathologies determined by the Ministry of Health.
p.(None): 34.6) Are intended for the prevention, relief or treatment of minor syndromes or symptoms.
p.(None): 34.7) They are formulated with the medicinal substances expressly established by the Ministry of Health in a list
p.(None): positive, which will be updated periodically.
p.(None): 34.8) Have proven, with extensive experience, to be safe and effective for the therapeutic indication
p.(None): correspondent.
p.(None): ARTICLE 35. REQUIREMENTS OF THE OFFICIAL AND MAGISTRAL FORMS.
p.(None): The magisterial and officinal formulas are not subject to control, but the technical director of the
p.(None): establishment where they are prepared is responsible for their preparation with action substances and
p.(None): indication recognized in the literature. These products will be made in pharmaceutical establishments
p.(None): legally established that have the necessary means for their preparation. For these products made to
p.(None): Industrial scale requires the reference sanitary registration procedure.
p.(None): All these formulations must be perfectly identified, indicate their correct use and the name of the
p.(None): pharmacist who prepared it.
p.(None): CHAPTER III
p.(None): OF PESTICIDES FOR DOMESTIC USE
p.(None): ARTICLE 36. REGISTRATION OF PESTICIDES FOR DOMESTIC USE.
p.(None): The provisions of Chapter II of Title II of these Regulations apply to the registration of pesticides, in addition to
p.(None): established in this chapter and in the specific norms and provisions issued by EL
p.(None): DEPARTMENT.
p.(None): ARTICLE 37. *
p.(None): Conditions for the authorization of pesticides for domestic use. Sanitary registration of
p.(None): reference to a household pesticide by satisfying the following
p.(None): terms:
p.(None): 37.1) That the manufacturer or importer is registered in EL
p.(None): DEPARTMENT.
p.(None): 37.2) That the product is effective in controlling pests for which it is
p.(None): indicates.
...
p.(None): The prescription is the document that supports the dispensation under medical prescription and is valid for the entire territory
p.(None): national.
p.(None): Prescriptions and hospital dispensing orders must be written in Spanish and contain basic information.
p.(None): identification of the prescriber, patient and medications.
p.(None): In prescriptions and orders, the doctor must include the pertinent warnings for the pharmacist and
p.(None): the instructions for the best observance of the treatment.
p.(None): The Ministry of Health may regulate on a basic basis the provisions of the preceding paragraphs and establish the
p.(None): requirement of other requirements that, because they affect public health or the health system, must be
p.(None): of general application in prescriptions or hospital orders.
p.(None): At the discretion of the doctor and in order to favor his patient with the Accessibility Program
p.(None): of medicines (PROAM), you can include the technical name of the medicine (Common Name
p.(None): International). Only under this criterion will the recipe be dispensed in the Program's distribution network.
p.(None): of drug accessibility.
p.(None): CHAPTER II
p.(None): ADVERTISING, PROMOTION AND INFORMATION ON MEDICINES
p.(None): ARTICLE 97. ADVERTISING OF PHARMACEUTICAL SPECIALTIES.
p.(None): The Ministry of Health must determine the pharmaceutical specialties that may be the subject of advertising directed at
p.(None): the population when they comply; at least the following requirements:
p.(None): 97.1) That are not intended for the prevention or cure of pathologies that require a doctor's diagnosis or prescription,
p.(None): as well as those other pathologies determined by the Ministry of Health.
p.(None): 97.2) That are intended for the prevention, relief or treatment of minor syndromes or symptoms.
p.(None): 97.3) That are formulated with the medicinal substances expressly established by the Ministry of Health in a list
p.(None): positive, which will be updated periodically.
p.(None): 97.4) That have proven, with extensive experience, to be safe and effective for the therapeutic indication
p.(None): correspondent.
p.(None): 97.5) That in its application the parenteral route cannot be used.
p.(None): 97.6) Subject to the conditions and criteria established in the corresponding authorization by the Ministry of
p.(None): Health with respect to each pharmaceutical specialty.
p.(None): ARTICLE 98. AUTHORIZATION OF ADVERTISING MESSAGES.
p.(None): To obtain authorization for advertising messages from pharmaceutical specialties, they must
p.(None): meet the following requirements:
p.(None): 98.1) That over-the-counter medicines are promoted only in the unions authorized by the Ministry of
p.(None): Health, either in the texts of the packages, containers or leaflets. Actions, degree of relief, benefits, etc. from
p.(None): These medications must also correspond to that authorized by the Ministry of Health.
p.(None): 98.2) That expresses the duly accredited characteristics or benefits that the products and concepts have,
p.(None): omitting any expression that considers partial truths. Descriptions or images relating to events
p.(None): verifiable, must be subject to reliable and scientifically based verification, when required.
p.(None): Special care should be taken in advertising aimed at children and young people, avoiding taking advantage of their credulity or
p.(None): lack of experience.
p.(None): 98.3) That does not suggest that the use of over-the-counter medications can delay or avoid resorting to the
p.(None): medical and / or diagnostic or rehabilitation procedures.
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Social / education
Searching for indicator educational:
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p.(None): All state health institutions are obliged to use in the selection, supply and
p.(None): prescription of medicines the international common name.
p.(None): ARTICLE 101. SUPPORT STRUCTURES FOR THE RATIONAL USE OF MEDICINES IN HOSPITALS.
p.(None): Without prejudice to the responsibility that all health professionals have in the rational use of
p.(None): medicines, hospitals must have a hospital pharmacy service or units, directed by
p.(None): Pharmaceutical Chemists.
p.(None): To achieve the rational use of medications, the hospital pharmacy units or services will carry out the
p.(None): following functions:
p.(None): 101.1) Guarantee and assume technical responsibility for the acquisition, quality, correct conservation,
p.(None): coverage of needs, custody, preparation of magisterial formulas or official preparations and
p.(None): dispensing of the necessary drugs for in-hospital activities and those for treatment
p.(None): out-of-hospital requiring special surveillance, supervision or control.
p.(None): 101.2) Establish an effective and safe medicine distribution system, take measures to
p.(None): guarantee its correct administration and ensure compliance with drug legislation
p.(None): and psychotropic or any other medication that requires special control.
p.(None): 101.3) Being part of the hospital commissions where their knowledge can be useful for
p.(None): selection and scientific evaluation of medicines and their use.
p.(None): 101.4) Establish a medicine information service for all hospital personnel, a system of
p.(None): in-hospital pharmacovigilance, systematic studies of drug use and activities of
p.(None): clinical pharmacokinetics.
p.(None): 101.5) Carry out educational activities on aspects of its competence aimed at health personnel of the
p.(None): hospital and patients.
p.(None): 101.6) Carry out own research work or in collaboration with other units or services and participate in
p.(None): clinical trials with medications in accordance with the provisions of Title V of these Regulations.
p.(None): 101.7) Carry out as many functions as may lead to better use and control of medications.
p.(None): ARTICLE 102. HOSPITAL PHARMACY.
p.(None): Hospitals with twenty (20) or more beds must have a hospital pharmacy service under the
p.(None): ownership and responsibility of a pharmaceutical technical director, preferably with a specialty in pharmacy
p.(None): hospitable.
p.(None): The Ministry of Health must develop the regulations in the following aspects:
p.(None): 102.1) Establishment of requirements for its proper functioning, in accordance with the established functions. 102.2) That the
p.(None): performances are provided with the presence and professional performance of the pharmacist or pharmacists necessary for a correct
p.(None): assistance.
p.(None): TITLE VII FINAL AND TRANSITORY PROVISIONS
p.(None): SOLE CHAPTER
p.(None): ARTICLE 103. COST OF SERVICES.
p.(None): The granting of the sanitary registry of reference and the authorization or sanitary license, as well as other
p.(None): authorizations, certifications and registrations, constitutes a service whose value for the user will be established in the
p.(None): fee approved by the Executive Agency through the Ministry of Health. The income from these
p.(None): concepts will enter proprietary accounts of the services, destined to the increase and
p.(None): improvement of their provision.
p.(None): ARTICLE 104. REGULATORY ADEQUACY.
p.(None): The owners or legal representatives and technical directors of the pharmaceutical establishments that
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Social / philosophical differences/differences of opinion
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p.(None): pharmaceutical specialties or pesticides subject to this Regulation and must be known by the
p.(None): DEPARTMENT:
p.(None): In products with active ingredients recognized in the texts cited in Article 19 or in Chapter III of
p.(None): this Title, the presentation of monograph can be omitted and in these cases the information is taken as monograph
p.(None): published described.
p.(None): ARTICLE 22. GUARANTEES IN PREVENTION OF ACCIDENTS.
p.(None): Medications must be developed and presented in a way that ensures reasonable prevention in
p.(None): accidents, especially related to childhood and people with reduced capacity.
p.(None): In particular, efforts will be made to ensure that pharmaceutical specialties have security closures or
p.(None): materials that are sufficiently resistant to opening and allow for quick and easy identification.
p.(None): The containers will carry a security seal that guarantees the user that the pharmaceutical specialty is of first use.
p.(None): ARTICLE 23. PROCESSING.
p.(None): In accordance with the provisions of these Regulations, the Ministry of Health will establish the procedure to obtain
p.(None): the authorization of sanitary registration of reference of the medicines and pesticides subject to this Regulation,
p.(None): including the deadlines within which requests must be resolved. The Ministry of Health may
p.(None): require the applicant to provide documentation, studies, data or additional information.
p.(None): Once any requirement has been formulated, the period set for the
p.(None): procedure in question, until it is attended.
p.(None): In the evaluation procedure, the Ministry of Health, in agreement with the applicant, may require the
p.(None): advice and opinion of qualified experts.
p.(None): In the authorization procedure, the medicine will be subject to quality control carried out by the
p.(None): National Health Laboratory, which will carry out the necessary analyzes and experimental checks
p.(None): to determine if the product complies with the quality, purity, stability and other guarantees that may be filled.
p.(None): the previous requirements and granted the corresponding authorization, THE DEPARTMENT will grant the sanitary registry
p.(None): of reference of the product and the corresponding certification will be issued.
p.(None): ARTICLE 24. * DENIAL OF THE APPLICATION FOR A REFERENCE SANITARY REGISTRY.
p.(None): The application for reference health registration of a product will be denied when one or more are presented
p.(None): of the following
p.(None): situations:
p.(None): 24.1) That the inconsistency of the documents with the result is deduced from their study
p.(None): analytical.
p.(None): 24.2) That lacks therapeutic efficacy or safety according to the literature of
p.(None): reference.
p.(None): 24.3) That its therapeutic efficacy or safety have not been sufficiently proven by the applicant in the
p.(None): case of products with active ingredients
p.(None): new.
p.(None): 24.4) That does not have the quantitative or qualitative composition
p.(None): declared.
p.(None): 24.5) That its composition is not stable under normal conditions of
p.(None): use.
p.(None): 24.6) That the studies and investigations presented in support of the application are incomplete,
p.(None): insufficient or imperfect to demonstrate the safety, efficacy and quality of the product, according to the literature of
p.(None): reference.
p.(None): 24.7) That the manufacturer or distributor does not possess the sanitary license referred to in this Regulation.
p.(None): 24.8) That the identification guarantees established in Article 19 of these Regulations are not complied with.
...
General/Other / Other Country
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p.(None): according to the Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use,
p.(None): approved by resolution
p.(None): I START.
p.(None): 13.1.8. Mandatory prospectus, or your project, in over-the-counter products, when the required information is not
p.(None): find in the primary packaging / packaging or
p.(None): secondary.
p.(None): 13.1.9. Manufacturing contract for third parties indicating whether the applicant was manufactured by a third party
p.(None): the product, in accordance with the provisions of article 78 hereof
p.(None): Regulation.
p.(None): 13.1.10. Certificate authorizing the marketing of a pharmaceutical product, in accordance with the unique format of
p.(None): pharmaceutical product certificate to be marketed within the Customs Union, approved by
p.(None): COMIECO resolution, or equivalent document for products manufactured outside the territory of the States Parties
p.(None): (original or authenticated photocopy of the document) This certificate will be issued by the country's regulatory authority
p.(None): of origin or provenance, and will be valid for two years after its issue date.
p.(None): 13.1.11. Stability study in accordance with the Central American Technical Regulations for Stability Studies of
p.(None): Pharmaceutical Products for Human Use, approved by COMIECO resolution.
p.(None): 13.1.12. In addition to the certificate required in 13.1.10 one of the
p.(None): following:
p.(None): a) Written consent of the person who obtained the approval in another
p.(None): country; or
p.(None): b) Evidence that the approval in the other country became effective more than five (5)
p.(None): years.
p.(None): Additionally, if any other data, study or sufficient information is submitted to demonstrate the safety and
p.(None): efficacy of the pharmaceutical product as provided in this chapter, in particular in articles 15 to 19 of the
p.(None): Governmental Agreement 712-99, they must be accompanied by the written consent of the generator
p.(None): of the data, studies or
p.(None): information.
p.(None): 13.1.13. Raw material standards for products, with their corresponding certificate of analysis.
p.(None): 13.1.14. Original samples, according to the harmonized quantity, for the National Health Laboratory to carry out the
p.(None): analysis
p.(None): relevant.
p.(None): 13.1.15. Proof of payment for the right to process health registration, analysis and
p.(None): control.
p.(None): 13.1.16. Certificate of Good Manufacturing Practices of Manufacturers Laboratories specifying the authorization
p.(None): by pharmaceutical form and type of product, issued by the competent authority of the country or countries in
p.(None): where the manufacturing process takes place; valid for not more than two years after
p.(None): your date
p.(None): issue.
p.(None): 13.1.17. Summary manufacturing protocol for biological products (vaccines, biotechnology and blood derivatives).
p.(None): 13.1.18. Depending on the case, one of the
p.(None): following:
p.(None): a) Sworn statement that there is one or more patents in force in Guatemala that covers the product or its
p.(None): uses, identifying such patent or patents and their expiration date and establishing: 1) that the person who
p.(None): applies for marketing approval is the owner of the patent or patents; or 2) that the person requesting the
...
General/Other / Public Emergency
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p.(None): established.
p.(None): For vaccine imports, the batch release certificate must be attached to the invoices.
p.(None): issued by the health authority of the producing country, summary batch production protocol and protocol
p.(None): summary of batch quality control. These products upon entering the country must have at least eighty
p.(None): percent (80%) of its validity period.
p.(None): The customs authorities of the Republic will only allow the import of the products listed in the
p.(None): Article 1 of these Regulations, which are duly registered or registered as appropriate. To comply with
p.(None): above, customs policies and forms must be previously submitted, for authorization, to EL
p.(None): DEPARTMENT.
p.(None): ARTICLE 53. EXPORTS.
p.(None): Pharmaceuticals and other related products may be exported by laboratories, factories, drugstores and
p.(None): distributors that have their current health license.
p.(None): ARTICLE 54. OF THE POLICIES AND FORMS OF IMPORT OF PHARMACEUTICAL AND RELATED PRODUCTS.
p.(None): The customs policies and forms of importation of these products, prior to their authorization by EL
p.(None): DEPARTMENT, except for the exceptions mentioned in Article 33 of these Regulations, must be signed
p.(None): and sealed by the technical director of the establishment, and must appear on the invoices attached to these
p.(None): documents the corresponding registration or registration number (s).
p.(None): ARTICLE 55. IMPORT OF NON-EXISTING MEDICINES IN THE COUNTRY.
p.(None): Import and manufacture of medicines or pharmaceutical specialties in number is allowed
p.(None): limited, in the following cases:
p.(None): 55.1) For registration purposes.
p.(None): 55.2) For emergency cases, of products that do not exist in the country.
p.(None): 55.3) For the execution of clinical trials, for which the interested party must previously meet the requirements
p.(None): established in articles 93 and 94 of these Regulations.
p.(None): THE DEPARTMENT must establish the requirements for the approval of these cases, for the best
p.(None): application of this article.
p.(None): ARTICLE 56. OF THE IMPORT, MANUFACTURE AND DISTRIBUTION OF MEDICAL SAMPLES.
p.(None): The importation or manufacture of medicines or pharmaceutical specialties in the form of
p.(None): samples, in order to carry out promotion exclusively within the medical union, so
p.(None): free. The foregoing does not apply to medicines or pharmaceutical specialties that contain
p.(None): narcotic and psychotropic.
p.(None): The Ministry of Health must establish the procedures for the authorization and distribution of said
p.(None): samples.
p.(None): TITLE III
p.(None): NARCOTIC DRUGS, PSYCHOTROPICS AND PRECURSORS. SOLE CHAPTER
p.(None): ARTICLE 57. OF THE CLASSIFICATION OF NARCOTICS AND PSYCHOTROPICS.
p.(None): The narcotic and psychotropic drugs referred to in this Regulation are those listed in the
p.(None): Single Convention on Narcotic Drugs of 1961, in the Convention on Psychotropic Substances of 1971 and in the
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and others
p.(None): substances considered as such by the laws of the country and by the provisions dictated by the
p.(None): health authorities.
p.(None): ARTICLE 58. OF THE IMPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only laboratories and drugstores can import raw materials for the manufacture of
...
p.(None): Dispense higher doses, provided that its application is directly controlled by the physician and
p.(None): authorized by THE DEPARTMENT, the treating doctor being responsible for the misuse of his
p.(None): prescription is made.
p.(None): It is also the doctor's obligation when he has to administer narcotic drugs for periods of more than eight days,
p.(None): inform THE DEPARTMENT of the diagnosis and the dose to be used daily and request the corresponding weekly fee
p.(None): or biweekly, depending on the case, which will be submitted to the agency's consideration
p.(None): mentioned, which in consultation can authorize or deny it.
p.(None): In the case of people who have become accustomed to the use of narcotic drugs, treating doctors
p.(None): They must inform THE DEPARTMENT and they will proceed in the manner indicated in the previous paragraph.
p.(None): The prescriptions for the taxicómanos must be extended in the official form by a doctor of the Health Center
p.(None): respective, the number and date of the agreement by which the designated agency authorized the
p.(None): share. These recipes will be delivered personally to the interested party weekly, biweekly or monthly,
p.(None): according to the case, and will be signed and sealed by the head of said agency.
p.(None): Doctors are obliged to inform THE DEPARTMENT when they stop assisting these patients, or their
p.(None): death, if applicable, within the following thirty (30) days, in order to proceed with the
p.(None): cancellation of the quota that they have authorized.
p.(None): ARTICLE 65. OF THE CONTROLS IN HEALTHCARE HOUSES, SANATORIES AND HOSPITALS.
p.(None): Health houses, sanitariums and hospitals that do not have pharmacies served by doctors, can
p.(None): keep in their emergency kits, quantities of narcotic drugs and psychotropic drugs for use
p.(None): Therapeutic exclusively, provided they meet the following requirements:
p.(None): 65.1) Be duly registered in THE DEPARTMENT.
p.(None): 65.2) Request a monthly fee from the DEPARTMENT for psychotropic and narcotic drugs.
p.(None): 65.3) Send monthly to THE DEPARTMENT, under sworn declaration of the director of the establishment or the professional
p.(None): responsible pharmacist, the balance of entries and exits, during the first ten days of each month. In said
p.(None): Form must detail the name of the patient and the prescriber. All this information must have
p.(None): sustenance in the recipes and is under the responsibility of the director of the health establishment or the professional
p.(None): pharmacist, which must be placed in view of THE DEPARTMENT when required.
p.(None): 65.4) Keep for two years the original prescriptions in which these medications are prescribed as well as the invoices
p.(None): with which its acquisition is verified.
p.(None): 65.5) Only the medical director of the establishment, who must be registered as such in the Ministry of Health,
p.(None): may sign the purchase requests, in the form set by these Regulations, being obliged to comply with all
p.(None): the current provisions and those issued on narcotic drugs and psychotropics, being responsible,
p.(None): in addition, the misuse of authorized narcotic drugs and psychotropics; and ,
p.(None): 65.6) In establishments where there is a pharmacy with a technical director, he will be responsible for compliance
p.(None): the mentioned requirements.
p.(None): ARTICLE 66. OF THE INSPECTIONS OF CONTROL OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): THE DEPARTMENT must carry out periodic inspections, or when it deems appropriate,
p.(None): authorized health establishments and pharmacists, in order to verify the use of psychotropics and
p.(None): narcotics
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General/Other / Relationship to Authority
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p.(None): organized that relate to medications.
p.(None): The requested documents must meet all the requirements established in the current legal order
p.(None): in order to be valid in the country, mainly when they are of foreign origin.
p.(None): ARTICLE 5. INSPECTIONS.
p.(None): THE DEPARTMENT may carry out the inspections it deems necessary to establishments under control, with
p.(None): in order to verify compliance with these Regulations. These inspections will be carried out during
p.(None): operation of the establishments subject to inspection. The owner or person responsible must allow
p.(None): authorized officials or inspectors carry out the relevant sanitary inspections. THE DEPARTMENT may,
p.(None): Likewise, implement self-evaluation and statistical verification procedures.
p.(None): ARTICLE 6. PREVENTIVE MEASURES.
p.(None): To guarantee the effectiveness of the inspection and, where appropriate, the probable confiscation of substances or products that
p.(None): represent a health risk, the official or employee who performs the inspection may
p.(None): order, by means of minutes, the immobilization of these, being able to also seal the packages,
p.(None): boxes, containers, enclosures or establishments so that the continuation of the inspection is not impeded nor
p.(None): the effectiveness of the sanctions that may be derived from it are impaired.
p.(None): ARTICLE 7. * DEFINITIONS.
p.(None): For the purposes of these Regulations,
p.(None): understand by:
p.(None): 7.1) Pharmacy assistant: He is the person responsible for the sales of medicines, duly recognized and authorized
p.(None): in accordance with the specific regulations issued by the corresponding authority.
p.(None): 7.2) Rural medicine cabinet: Medicine sales service for dispersed populations which will be in charge of a
p.(None): community organized group coordinated by a social medicine sale. The person in charge of
p.(None): rural medicine cabinet is a promoter or guardian of
p.(None): Health.
p.(None): 7.3) Good manufacturing practices: Installation conditions and established procedures for all
p.(None): production processes and control of the products mentioned in Article 1 of these Regulations, in order to
p.(None): guarantee its uniform quality, within the internationally accepted and valid limits for each
p.(None): one of
p.(None): they.
p.(None): 7.4) Certificate of good manufacturing practices: Document issued by the competent authority of the country where
p.(None): the manufacturer is located, indicating that the facilities where the products are manufactured are
p.(None): subjected to regular inspections that apply good manufacturing practices.
p.(None): 7.5) Trademark Certificate: Document that proves the protection of the product name or
p.(None): products mentioned in the first article of this Regulation for their commercialization, extended in the
p.(None): dependency that authority
p.(None): designate.
p.(None): 7.6) Marketing certification of pharmaceutical products type World Health Organization
p.(None): (WHO), hereinafter WHO type certificate: Document issued by the health authority of the country where the
p.(None): product, at the request of the interested party in which it must be stated that: a) The producer establishment is subject to
p.(None): periodic inspections and complies with good manufacturing practices; b) You have the authorization to
p.(None): manufacture and / or distribute the product to be imported; c) That its sale is allowed in the producing country or the
p.(None): country responsible for its commercialization; d) That it describes the complete qualitative and quantitative formula. e) That your
p.(None): sale is subject to some restrictive regime or special control, when it is the
p.(None): case.
p.(None): 7.7) Risk criteria: Determination of risk factors. Risk factor is the circumstance
p.(None): related to the degree of toxicity or lack of effectiveness of a substance, product, accessory or input that
p.(None): It can cause damage to health, life and / or the environment, temporarily or permanently.
p.(None): 7.8) International non-proprietary name: Corresponds to the name of pharmaceutical active principles accepted by
p.(None): the World Health Organization (WHO) under the signs and acronyms "Common Denominations
p.(None): Internacionales "(DCI) or" International Nonproprietary Names "(INN).
p.(None): 7.9) Dental deposit: Establishment for the import, distribution and sale of materials, products and equipment
p.(None): dental.
p.(None): 7.10) Dispensation: is the act of providing one or more medications to a patient, generally in response to
p.(None): the presentation of a recipe prepared by a licensed professional.
...
p.(None): necessarily implies therapeutic equivalence, since the difference of excipients and / or processes of
p.(None): manufacturing, may lead to differences in stock
p.(None): of the product.
p.(None): 7.14) Pharmaceutical specialty: Medicine prepared in a laboratory and officially authorized to be dispatched
p.(None): with a commercial name or International Nonproprietary Name.
p.(None): 7.15) Evaluation of a pharmaceutical specialty: Systematic studies of the physicochemical properties,
p.(None): pharmacological, clinical, toxicological and teratological and biological, in order to determine its quality, efficacy and
p.(None): security to be used in beings
p.(None): humans.
p.(None): 7.16) Pharmacy: It is the pharmaceutical establishment where medicines and products are stored and sold.
p.(None): related, which are classified by their location and type of products they dispense.
p.(None): 7.17) State and municipal pharmacies: they are pharmaceutical establishments that have resources
p.(None): state or municipal, decentralized administration, self-financing and sustainable, where they are stored and
p.(None): They sell basic medicines of guaranteed quality at affordable prices for the population. Pharmacies
p.(None): State agencies will function under the responsibility of the Ministry of Health. The municipal pharmacies will be
p.(None): under the responsibility of their respective municipality. Both establishments will operate in accordance
p.(None): to the regulations established by the Ministry of
p.(None): Health.
p.(None): 7.18) Expiration date: the one indicated by the month and calendar year, up to which it can be expected that
p.(None): the pharmaceutical product can be consumed with the guarantee of
p.(None): maker.
p.(None): 7.19) Health registration: Act by which a product is registered with the health authority after evaluating
p.(None): the documentation presented according to established requirements and the analysis of the product according to
p.(None): criterion of
p.(None): risk.
p.(None): 7.20) Health license: It is the authorization to operate a pharmaceutical or related establishment, issued by the
p.(None): dependence
p.(None): competent.
p.(None): 7.21) Lot: Fixed quantity of a uniform product, manufactured with a particular manufacturing process.
p.(None): 7.22) Monograph: It is the technical and scientific information of a
p.(None): product.
p.(None): 7.23) Medical sample: Pharmaceutical product that has a valid health registration and authorization or registration,
p.(None): intended for direct, exclusive and free distribution to medical professionals.
p.(None): 7.24) Pesticides for domestic use: Pesticide that according to the toxicological classification of the World Organization
p.(None): Health (WHO), belongs to categories IV and V and that, due to its characteristics, can be used
p.(None): inside homes without causing risks to people and pets when used correctly.
p.(None): 7.25) Pesticides for use in public health programs: Pesticide that after the
p.(None): recommended dilution and according to the toxicological classification of the World Health Organization
p.(None): (WHO), belongs to categories IV or V and that due to its characteristics can be used in public health programs
p.(None): by authorized personnel and
p.(None): capable.
p.(None): 7.26) Bulk product: The one that is in its final pharmaceutical form (ampoules, tablets,
p.(None): dragees, within others) or in their primary packaging (labeled vial-ampoules, solid dosage forms,
p.(None): divided and labeled in sheets of cellophane, aluminum or other material) and that has not yet been
p.(None): conditioning in the final distribution packages and
p.(None): commercialization.
...
p.(None): permanent basic medicine.
p.(None): * Added the definition "New Product" by Article 1 of Government Agreement Number 351-2006 on 00- 00-0000
p.(None): TITLE II
p.(None): PHARMACEUTICAL AND OTHER RELATED PRODUCTS CHAPTER I
p.(None): CLASSIFICATION
p.(None): ARTICLE 8. PHARMACEUTICAL PRODUCTS OR MEDICINES.
p.(None): The following are recognized as drugs or pharmaceuticals:
p.(None): 8.1) Pharmaceutical specialties; 8.2) Biological products;
p.(None): 8.3) Homeopathic products, 8.4) Radiopharmaceuticals;
p.(None): 8.5) The magisterial formulas;
p.(None): 8.6) The preparations or official forms; 8.7) Medicines in bulk.
p.(None): ARTICLE 9. RELATED PRODUCTS.
p.(None): Related products that are subject to control are considered cosmetics, personal hygiene products, household hygiene,
p.(None): phyto and zootherapeutics, healing and medical surgical materials, laboratory reagents for diagnostic use and
p.(None): materials, household pesticides, pesticides used in health programs, products and equipment
p.(None): dental.
p.(None): CHAPTER II
p.(None): OF THE REFERENCE SANITARY REGISTRY
p.(None): ARTICLE 10. OF THE REFERENCE SANITARY REGISTRY.
p.(None): Pharmaceutical specialties, biological products, radiopharmaceuticals and homeopathic products described in
p.(None): Article 8 of these Regulations, household pesticides and pesticides for use in programs of
p.(None): public health, must be submitted to the sanitary registration procedure of reference, granted by EL
p.(None): DEPARTMENT in the form and conditions established below. For this it is necessary that the laboratory
p.(None): manufacturer is authorized in accordance with this Regulation. In the case of imported products, the manufacturer that
p.(None): produces them must be authorized by the corresponding authority and comply with the health laws of the country of
p.(None): origin.
p.(None): ARTICLE 11. APPLICATION FOR A REFERENCE SANITARY REGISTRY.
p.(None): Applications for a sanitary registration of pharmaceutical specialties must be submitted to EL
p.(None): DEPARTMENT in special format provided by it, with the name and signature of the
p.(None): pharmacist responsible for registration. The requirements for the sanitary reference register for pesticides for use
p.(None): domestic and for use in public health programs, are detailed in chapter III of this Title, without omitting
p.(None): those indicated in this chapter.
p.(None): ARTICLE 12. PRODUCTS UNDER LICENSE.
p.(None): When it comes to registering, manufacturing or distributing a licensed product, it must be proven that the
p.(None): authorization of the owner of the same, where it is indicated that the legal representative is authorized for such purpose.
p.(None): In addition to authorization, it must be proven that the representative has been given a mandate with sufficient powers
p.(None): to manage before the health authority and to answer for any damage caused by the
p.(None): manufactured and distributed products.
p.(None): ARTICLE 13. * NECESSARY DOCUMENTATION FOR SANITARY REGISTRATION OF REFERENCE AND SANITARY REGISTRATION OF PRODUCTS
p.(None): IMPORTED.
p.(None): To obtain the marketing authorization for pharmaceutical products, you must comply with the
p.(None): following:
p.(None): 13.1. To grant the marketing authorization of a product
p.(None): new:
p.(None): 13.1.1. Document accrediting the legal representation granted by the owner to the natural or legal person
p.(None): responsible for the product to register; as well as the document that proves the legal representation of the
p.(None): responsible for the product to register (original or legalized photocopy of
p.(None): document).
p.(None): 13.1.2. Registration application signed and sealed by the Pharmaceutical Chemist
p.(None): responsable.
p.(None): 13.1.3. Qualitative-quantitative formula complete with the signature and seal of the responsible Chemist-Pharmacist.
p.(None): 13.1.4. Simple photocopy of the monograph
p.(None): of the product.
p.(None): 13.1.5. Validated analytical methodology of the product, for non-pharmacopoeic products, according to the
p.(None): regulation
p.(None): valid.
p.(None): 13.1.6. Specifications of the
p.(None): product.
p.(None): 13.1.7. Labeling of the primary and secondary packaging / packaging or your project, containing information
p.(None): according to the Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use,
p.(None): approved by resolution
p.(None): I START.
p.(None): 13.1.8. Mandatory prospectus, or your project, in over-the-counter products, when the required information is not
p.(None): find in the primary packaging / packaging or
p.(None): secondary.
p.(None): 13.1.9. Manufacturing contract for third parties indicating whether the applicant was manufactured by a third party
p.(None): the product, in accordance with the provisions of article 78 hereof
p.(None): Regulation.
p.(None): 13.1.10. Certificate authorizing the marketing of a pharmaceutical product, in accordance with the unique format of
p.(None): pharmaceutical product certificate to be marketed within the Customs Union, approved by
p.(None): COMIECO resolution, or equivalent document for products manufactured outside the territory of the States Parties
p.(None): (original or authenticated photocopy of the document) This certificate will be issued by the country's regulatory authority
p.(None): of origin or provenance, and will be valid for two years after its issue date.
p.(None): 13.1.11. Stability study in accordance with the Central American Technical Regulations for Stability Studies of
p.(None): Pharmaceutical Products for Human Use, approved by COMIECO resolution.
p.(None): 13.1.12. In addition to the certificate required in 13.1.10 one of the
p.(None): following:
p.(None): a) Written consent of the person who obtained the approval in another
p.(None): country; or
p.(None): b) Evidence that the approval in the other country became effective more than five (5)
p.(None): years.
p.(None): Additionally, if any other data, study or sufficient information is submitted to demonstrate the safety and
p.(None): efficacy of the pharmaceutical product as provided in this chapter, in particular in articles 15 to 19 of the
p.(None): Governmental Agreement 712-99, they must be accompanied by the written consent of the generator
p.(None): of the data, studies or
p.(None): information.
p.(None): 13.1.13. Raw material standards for products, with their corresponding certificate of analysis.
p.(None): 13.1.14. Original samples, according to the harmonized quantity, for the National Health Laboratory to carry out the
p.(None): analysis
p.(None): relevant.
p.(None): 13.1.15. Proof of payment for the right to process health registration, analysis and
p.(None): control.
p.(None): 13.1.16. Certificate of Good Manufacturing Practices of Manufacturers Laboratories specifying the authorization
p.(None): by pharmaceutical form and type of product, issued by the competent authority of the country or countries in
p.(None): where the manufacturing process takes place; valid for not more than two years after
p.(None): your date
p.(None): issue.
p.(None): 13.1.17. Summary manufacturing protocol for biological products (vaccines, biotechnology and blood derivatives).
p.(None): 13.1.18. Depending on the case, one of the
p.(None): following:
p.(None): a) Sworn statement that there is one or more patents in force in Guatemala that covers the product or its
p.(None): uses, identifying such patent or patents and their expiration date and establishing: 1) that the person who
p.(None): applies for marketing approval is the owner of the patent or patents; or 2) that the person requesting the
p.(None): approval has the written authorization of the patent holder or
p.(None): patents; or
p.(None): b) Sworn statement that there is no patent or patents in force in Guatemala that covers the product or its
p.(None): applications.
p.(None): The Department will require that the aforementioned affidavits be made at least with
p.(None): reference to the patents identified under any of the cases in subsection a), as well as
p.(None): patents identified by the holder of a patent in force in Guatemala that covers the product, or its uses,
p.(None): been subject to or is subject to a marketing approval in force or pending approval in
p.(None): Guatemala or abroad. The Department will make the information of said patents identified in the subsection
p.(None): a) and in this paragraph is available to potential applicants, for such
p.(None): purpose.
p.(None): In no case will an application for marketing approval be processed unless it is
p.(None): accompanied by one of the previous statements
p.(None): sworn.
p.(None): 13.2. To grant the marketing authorization of a product,
p.(None): new:
p.(None): 13.2.1. The documentation specified in sub-section 13.1 must be presented, except in what
...
p.(None): treatments.
p.(None): These studies will comprise acute and chronic toxicity tests, terotogenicity tests, embryotoxicity, fertility,
p.(None): mutagenesis tests and when necessary carcinogenesis and in general, those others that are considered
p.(None): necessary for a correct evaluation of the safety and tolerance of a medicine or pesticide subject to this
p.(None): Regulation, under normal conditions of use and in the case of medications, also depending on the duration of the
p.(None): treatment. The excipients of the medicines with the exclusions and limitations that proceed will be regulated
p.(None): in accordance with the provisions of these Regulations.
p.(None): ARTICLE 17. GUARANTEES OF EFFECTIVENESS OF PHARMACEUTICAL SPECIALTIES.
p.(None): For pharmaceutical specialties consisting of new molecules not yet recognized in the texts cited in
p.(None): Article 19 of these Regulations, clinical studies must be submitted, the results of which demonstrate
p.(None): the pharmacological actions produced by the specialty medicinal substance or substances
p.(None): pharmaceutical and its destination in the body. Such studies should include one or more untreated control groups or
p.(None): treated with a reference product.
p.(None): ARTICLE 18. GUARANTEES OF QUALITY, PURITY AND STABILITY OF PHARMACEUTICAL SPECIALTIES.
p.(None): Every pharmaceutical specialty must have its qualitative composition perfectly established and
p.(None): quantitative, which must be consistent with the documentation presented.
p.(None): In each case, procedures defined in the pharmacopoeias must exist and be used by the manufacturer.
p.(None): indicated in article 19 of these Regulations or the procedures developed and validated by the
p.(None): manufacturer and that have been made available to the authority, which is who will make the final decision.
p.(None): The permissible limits of quantitative variability in the composition of the specialty are established
p.(None): in accordance with the provisions of the bibliographic references cited in Article 19 of these Regulations. Of the same
p.(None): The quality control methods established in the pharmacopoeias must be executed by the manufacturer.
p.(None): authorized, with reference to raw materials, products in process, groats and final products, as well as
p.(None): of packaging, labeling and packaging material where appropriate.
p.(None): The responsible laboratory must carry out tests to guarantee stability in accordance with the
p.(None): indicated storage conditions.
p.(None): The Ministry of Health, through THE DEPARTMENT, will establish the controls required of the manufacturer according to the
p.(None): referred literature, the National Health Laboratory will carry out the analytical controls.
p.(None): ARTICLE 19. PHARMACOPEAS AND TEXTS ACCEPTED FOR PHARMACEUTICAL SPECIALTIES.
p.(None): For the purposes of establishing the identity, quality, potency, purity and stability of the active ingredients and
p.(None): pharmaceutical forms of the drugs whose authorization is requested, the regulatory entity accepts the following
p.(None): bibliography and its supplements:
p.(None): 19.1) British Pharmacopoeia.
p.(None): 19.2) United States Pharmacopeia and National Form (USP / NF). 19.3) European Pharmacopoeia.
p.(None): 19.4) French Pharmacopoeia.
p.(None): 19.5) Farrmacopea helvetica.
p.(None): 19.6) International Pharmacopoeia.
p.(None): 19.7) Japanese Pharmacopeia.
p.(None): On these texts, the United States Pharmacopeia and National Form (USP / NF) has
p.(None): preeminence.
p.(None): In the case of a new pharmaceutical product that does not appear in any official text previously indicated, the entity
p.(None): Regulatory may qualify technical support information.
p.(None): For the pharmacological evaluation, base texts are considered, the pharmacological norms established by the
p.(None): regulatory authority, Drug Information of the United States Pharmacopeia (USPDI);
p.(None): Martindale and recognized pharmacologies.
p.(None): ARTICLE 20. IDENTIFICATION GUARANTEES FOR PHARMACEUTICAL SPECIALTIES.
p.(None): a) Name of the pharmaceutical specialties. A pharmaceutical specialty may be designated with a name of
p.(None): trademark or with an international common name. When it is a trademark it cannot be confused
p.(None): with an international common name, nor mislead about the therapeutic properties of
p.(None): nature of the specialty.
p.(None): On packaging, containers and labels, as well as in the written advertising of a pharmaceutical specialty that only
p.(None): has an active ingredient, the international non-proprietary name must necessarily appear in characters
p.(None): readable, along with the trademark. In the monograph and in the prospectus the name must appear
p.(None): clearly highlighted international common of other medicinal substances contained in the specialty
p.(None): pharmaceutical.
p.(None): b) Declaration of the composition: In the application for sanitary registration of reference and in the monograph of the
p.(None): pharmaceutical specialties, must include identification data, qualitative composition
p.(None): and exact and complete quantitative, including in addition to the active ingredients all the excipients.
p.(None): ARTICLE 21. GUARANTEES OF INFORMATION.
p.(None): The holder of the pharmaceutical or pesticide specialty subject to these Regulations must provide written information
p.(None): enough about its identification, indications and precautions to observe in its use. Texts must be submitted
p.(None): In Spanish language. Said written information must be recorded on the packaging, container, package leaflet and
...
p.(None): authorization, are wrong or
p.(None): false.
p.(None): 27.7) That it is shown that the studies, data and information have not been carried out or are not signed by
p.(None): professionals with technical qualities
p.(None): enough.
p.(None): 27.8) That, after warning, the rules dictated for the satisfaction of the
p.(None): guarantees of identification and information that regulates this
p.(None): Regulation.
p.(None): 27.9) That for any other justified reason it represents a foreseeable risk to people's health or safety.
p.(None): 27.10) the approval to market within the sanitary registry is incompatible with the
p.(None): requirements to protect undisclosed information, pursuant to Article 177 of Decree 57-2000 of Congress
p.(None): of the Republic. Cancellation requests will be processed applying the procedure established for
p.(None): cases of infringement of these Regulations.
p.(None): * Added numeral 27.10) by Article 4, of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 28. * SIMPLIFIED PROCEDURES FOR SUFFICIENTLY KNOWN MEDICINES.
p.(None): In the case of already known and sufficiently experienced medicines that their effectiveness, safety of use and
p.(None): adverse reactions are already known and / or appear in the scientific literature, THE DEPARTMENT will specify
p.(None): the necessary documents in printed form.
p.(None): You should also establish a simplified procedure, when the request for authorization refers to a
p.(None): pharmaceutical specialty of composition and indications similar to another already authorized, according to
p.(None): the provisions of these Regulations and whose effectiveness and safety the health authority has the
p.(None): due knowledge. The provisions of this article will apply without prejudice to observing the guarantees
p.(None): requirements prescribed in article 15 of these Regulations and comply with the obligations to protect information
p.(None): undisclosed of unfair commercial use, pursuant to Article 177 of Decree 57-2000 of the Congress of
p.(None): the Republic and article 13 of these Regulations.
p.(None): * Reformed the second paragraph by Article 5, of the Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 29. ASSOCIATIONS AT FIXED DOSE.
p.(None): In the case of medicinal substances associated with fixed doses, the presentation of evidence that the
p.(None): specialty offers advantages over the isolated use of each of its components. The associations
p.(None): recognized already experienced, must comply with all the requirements of the sanitary registry of
p.(None): simplified reference.
p.(None): ARTICLE 30. ON THE RESPONSIBILITY OF A REFERENCE SANITARY REGISTRY.
p.(None): The pharmacist is responsible for the inalterability of the quantitative and qualitative formula and the purity of the
p.(None): substances that make up the product that you have registered, responsibility that you share with the
p.(None): legal representative of the company.
p.(None): ARTICLE 31. * CONFIDENTIALITY.
p.(None): The content of the files related to the authorization and registration of the products object of this
p.(None): Regulation is confidential, provided that the data is supplied by the interested parties under guarantee of confidentiality.
p.(None): Regarding undisclosed information or other information will not be disclosed, except when
p.(None): necessary to protect the public. If the information were disclosed in these circumstances, the Department will not
...
p.(None): Health (WHO).
p.(None): 37.4) That the product is for domestic use according to the United Nations Organization for Agriculture and
p.(None): Food (FAO), the World Health Organization (WHO), the Environmental Protection Agency of the
p.(None): Government of the United States (EPA) and the European Union (EU) or, failing that, according to scientific studies
p.(None): acceptable and according to the standards established for this purpose, presented by the manufacturer.
p.(None): 37.5) That complies with the standards of the Guatemalan Standards Commission (COGUANOR), related to pesticides
p.(None): subject to this
p.(None): Regulation.
p.(None): 37.6) That meets the quality and purity requirements established by international standards such as those of the Organization
p.(None): of the Food and Agriculture United Nations (FAO), the International Pesticide Council and
p.(None): Analytic chemistry. (CIPAC) or the Environmental Protection Agency of the Government of the
p.(None): United States (EPA), when they exist for the product to be evaluated, or in its defense by those presented
p.(None): for him
p.(None): maker.
p.(None): 37.7) The Department will not allow third parties, without the consent of the people who obtained the
p.(None): prior approval in Guatemala, obtain authorization or market pesticide products for domestic use
p.(None): based on: 1) Evidence of previous marketing approvals in Guatemala; or 2) information
p.(None): Concerning the safety and efficacy that was previously presented to obtain approval to market, for
p.(None): at least ten (10) years from the date of approval, when it was granted by the competent authority, to the person
p.(None): which received approval in Guatemala.
p.(None): * Added numeral 37.7) by Article 7, of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 38. * CONDITIONS FOR THE AUTHORIZATION OF PESTICIDES FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): Authorization will be granted for the use of pesticides in public health programs, if the
p.(None): following
p.(None): terms:
p.(None): 38.1) The manufacturer or importer must be registered in EL
p.(None): DEPARTMENT.
p.(None): 38.2) The product must be effective in controlling pests for which it is
p.(None): indicates.
p.(None): 38.3) The product must in its final dilution belong to toxicity categories IV or V according to the classification of
p.(None): the World Organization of the
p.(None): Health (WHO).
p.(None): 38.4) The product must be used only by authorized personnel and
p.(None): capable.
p.(None): 38.5) The product must be of use for public health programs according to the World Organization of the
p.(None): Health (WHO), the United States Government Environmental Protection Agency (EPA) or the Union
p.(None): European (EU) or, failing that, according to scientifically acceptable studies and in accordance with established standards
p.(None): for this purpose, presented by the
p.(None): maker.
p.(None): 38.6) Comply with the standards of the Guatemalan Standards Commission (COGUANOR) related to pesticides
p.(None): subject to this
p.(None): Regulation.
p.(None): 38.7) Meet the quality and purity requirements established by international standards such as the
p.(None): Food and Agriculture Organization of the United Nations (FAO), the World Health Organization
p.(None): (WHO), the International Council for Pesticides and Analytical Chemistry (CIPAC) or the Agency for Environmental Protection
p.(None): Environment of the United States Government (EPA), when they exist for the product to be evaluated, or in
p.(None): its defect by those presented by the manufacturer.
p.(None): 38.8) The Department will not allow third parties, without the consent of the people who obtained the
p.(None): prior approval in Guatemala, obtain authorization or market pesticide products for domestic use
p.(None): based on: 1) Evidence of previous marketing approvals in Guatemala; or 2) information
p.(None): Concerning the safety and efficacy that was previously presented to obtain approval to market, for
p.(None): at least ten (10) years from the date of approval, when it was granted by the competent authority, to the person
p.(None): which received approval in Guatemala.
p.(None): * Added numeral 38.8) by Article 8, of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 39. * SCIENTIFIC INFORMATION.
p.(None): For the purposes of establishing the identity, quality, concentration, purity and stability of the
p.(None): Active principles of pesticides for domestic use whose authorization is requested, THE DEPARTMENT will accept the
p.(None): internationally recognized scientific bibliography and official standards
p.(None): nationals.
p.(None): In the case of a new product that does not appear in the scientific information accepted according to the previous paragraph, THE
p.(None): DEPARTMENT will accept the one presented by the manufacturer, as long as it is based on the criteria
p.(None): internationally recognized for such
p.(None): finish.
p.(None): The presentation of undisclosed scientific information may not be used to authorize third parties to register
p.(None): of pesticide products, based on the information or the approval granted to the person who submitted the
p.(None): information, for a period of at least ten (10) years from the date of approval in the country. Refering to
p.(None): undisclosed information or other information will not be disclosed except as necessary to protect
p.(None): to the public. If the information is disclosed under these circumstances, the competent authority will not rely on such
p.(None): information or data to grant marketing approval for products to third parties other than
p.(None): authorized by the person who presented the data or information. Disclosure for such purposes does not nullify
p.(None): the right to protection of undisclosed information, granted to the owner. The competent authority will not grant
p.(None): a marketing approval based on evidence of marketing approval in another territory or
p.(None): information regarding safety and efficacy that was previously submitted for approval
p.(None): for marketing in that other territory, except when the information is also presented to the
p.(None): Department.
p.(None): * Added the third paragraph by Article 9 of Governmental Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 40. * SIMPLIFIED PROCEDURES FOR THE SANITARY REGISTRY OF REFERENCE OF PESTICIDES FOR DOMESTIC USE AND
p.(None): FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): In the case of products sufficiently evaluated by the United Nations Organization for the
p.(None): Agriculture and Food (FAO), the World Health Organization (WHO), the European Union (EU), EL
p.(None): DEPARTMENT may simplify the sanitary registration procedure and specify the documents
p.(None): necessary for this purpose, provided that these procedures meet the requirements to protect the
p.(None): undisclosed information or data from unfair commercial uses and disclosure under Articles 37, 38 and 39
p.(None): of these Regulations and article 177 of Decree 57-2000 of the Congress of the Republic.
p.(None): * Amended by Article 10 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 41. ON THE ADVERTISING OF PESTICIDES OF DOMESTIC USE AND PESTICIDES OF USE OF PUBLIC HEALTH PROGRAMS.
p.(None): Before presenting advertising for a product in any media, the interested party must obtain the
p.(None): authorization of THE DEPARTMENT in accordance with the specific rules and procedures established.
p.(None): CHAPTER IV
p.(None): OF RELATED PRODUCTS PURPOSE OF CONTROL
p.(None): ARTICLE 42. OF THE CLASSIFICATION.
...
p.(None): Harmful or unsafe under normal conditions of employment. 51.2) The product does not comply with what is authorized.
p.(None): 51.3) The quality controls established in these Regulations are not complied with. 51.4) The manufacturing laboratory does not comply
p.(None): good manufacturing practices.
p.(None): 51.5) It is demonstrated that the data and information contained in the authorization request and others
p.(None): Accompanying documents are erroneous or false.
p.(None): 51.6) After warning, continue to breach the rules issued to satisfy the guarantees of
p.(None): identification and information that regulates these Regulations.
p.(None): 51.7) For any other justified cause that supposes a foreseeable risk for people's health or safety.
p.(None): CHAPTER V
p.(None): OF IMPORTS AND EXPORTS
p.(None): ARTICLE 52. IMPORTS.
p.(None): Without prejudice to other legal or regulatory requirements, only the
p.(None): products mentioned in article 1 of these Regulations when they are registered or registered,
p.(None): as appropriate, before THE DEPARTMENT.
p.(None): Only pharmaceutical establishments and related products that are licensed may import
p.(None): current health as an importer.
p.(None): The technical director and the legal representative of the importing and / or distribution entity will guarantee the quality and
p.(None): safety of imported products.
p.(None): The bulk impotaciones must have sanitary registration or registration as the case may be, and this will be
p.(None): processed in conjunction with the final presentation to the user according to the form and procedure
p.(None): established.
p.(None): For vaccine imports, the batch release certificate must be attached to the invoices.
p.(None): issued by the health authority of the producing country, summary batch production protocol and protocol
p.(None): summary of batch quality control. These products upon entering the country must have at least eighty
p.(None): percent (80%) of its validity period.
p.(None): The customs authorities of the Republic will only allow the import of the products listed in the
p.(None): Article 1 of these Regulations, which are duly registered or registered as appropriate. To comply with
p.(None): above, customs policies and forms must be previously submitted, for authorization, to EL
p.(None): DEPARTMENT.
p.(None): ARTICLE 53. EXPORTS.
p.(None): Pharmaceuticals and other related products may be exported by laboratories, factories, drugstores and
p.(None): distributors that have their current health license.
p.(None): ARTICLE 54. OF THE POLICIES AND FORMS OF IMPORT OF PHARMACEUTICAL AND RELATED PRODUCTS.
p.(None): The customs policies and forms of importation of these products, prior to their authorization by EL
p.(None): DEPARTMENT, except for the exceptions mentioned in Article 33 of these Regulations, must be signed
p.(None): and sealed by the technical director of the establishment, and must appear on the invoices attached to these
p.(None): documents the corresponding registration or registration number (s).
p.(None): ARTICLE 55. IMPORT OF NON-EXISTING MEDICINES IN THE COUNTRY.
p.(None): Import and manufacture of medicines or pharmaceutical specialties in number is allowed
p.(None): limited, in the following cases:
p.(None): 55.1) For registration purposes.
p.(None): 55.2) For emergency cases, of products that do not exist in the country.
p.(None): 55.3) For the execution of clinical trials, for which the interested party must previously meet the requirements
p.(None): established in articles 93 and 94 of these Regulations.
...
p.(None): Single Convention on Narcotic Drugs of 1961, in the Convention on Psychotropic Substances of 1971 and in the
p.(None): United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and others
p.(None): substances considered as such by the laws of the country and by the provisions dictated by the
p.(None): health authorities.
p.(None): ARTICLE 58. OF THE IMPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Only laboratories and drugstores can import raw materials for the manufacture of
p.(None): narcotic and psychotropic drugs, or import them already finished for distribution, in accordance with the
p.(None): previously authorized fees. Regarding the raw materials that constitute precursors, the provisions of
p.(None): the Specific Precursor Regulation.
p.(None): The drugstores and laboratories must request and obtain from THE DEPARTMENT, authorization to import drugs,
p.(None): narcotic and psychotropic drugs and present the balance referred to in the following paragraph, except in the case of
p.(None): first import request. The import authorization request will be made through a form
p.(None): provided by the aforementioned agency.
p.(None): The import or export request must accompany the balance of imports,
p.(None): productions, products in process, existence of inventory and exports, if that were the case. East
p.(None): Balance must be presented under affidavit of the legal representative and the pharmaceutical technical director
p.(None): responsable.
p.(None): If for any reason the importer does not receive the narcotic drugs in the authorized quantities,
p.(None): must inform the health authorities and provide the necessary means of proof to
p.(None): justify the loss or missing. All without prejudice to any other explanation that the competent authority
p.(None): could demand.
p.(None): In the event that the importer does not comply with the aforementioned, without prejudice to criminal sanctions
p.(None): and civilians that may correspond, will be sanctioned in accordance with the Health Code.
p.(None): ARTICLE 59. OF THE CERTIFICATES OF IMPORT AND EXPORT OF NARCOTIC DRUGS AND PSYCHOTROPICS.
p.(None): Certificates authorizing the import or export of drugs, narcotic drugs and psychotropics must be
p.(None): extended by THE DEPARTMENT in original and four copies, one copy being used for:
p.(None): 59.1) THE DEPARTMENT.
p.(None): 59.2) The corresponding office of the importing or exporting country. 59.3) For the exporting house.
p.(None): 59.4) Other for the importer, and
p.(None): 59.5) For the Executive Secretary of the Commission Against Addictions and Illicit Drug Trafficking
p.(None): (SECCATID) of the Vice Presidency of the Republic.
p.(None): Any extended certificate for the import and export of drugs, narcotic drugs and psychotropics must be
p.(None): presented in the corresponding form in which the necessary documents and times of
p.(None): delivery. This certificate is valid for six months from the date it was issued, and must
p.(None): verify the respective introduction to the country, according to the corresponding customs documents.
p.(None): If for any reason the products are not entered into the country in the period of validity described in the paragraph
p.(None): above, the interested party can request an extension as long as it is accompanied by the justification
p.(None): relevant. Said extension may not exceed sixty (60) business days.
p.(None): ARTICLE 60. ABOUT THE CONTROLS TO BE CARRIED OUT BY THE PHARMACIES.
...
Orphaned Trigger Words
p.(None): 13.1.18. Depending on the case, one of the
p.(None): following:
p.(None): a) Sworn statement that there is one or more patents in force in Guatemala that covers the product or its
p.(None): uses, identifying such patent or patents and their expiration date and establishing: 1) that the person who
p.(None): applies for marketing approval is the owner of the patent or patents; or 2) that the person requesting the
p.(None): approval has the written authorization of the patent holder or
p.(None): patents; or
p.(None): b) Sworn statement that there is no patent or patents in force in Guatemala that covers the product or its
p.(None): applications.
p.(None): The Department will require that the aforementioned affidavits be made at least with
p.(None): reference to the patents identified under any of the cases in subsection a), as well as
p.(None): patents identified by the holder of a patent in force in Guatemala that covers the product, or its uses,
p.(None): been subject to or is subject to a marketing approval in force or pending approval in
p.(None): Guatemala or abroad. The Department will make the information of said patents identified in the subsection
p.(None): a) and in this paragraph is available to potential applicants, for such
p.(None): purpose.
p.(None): In no case will an application for marketing approval be processed unless it is
p.(None): accompanied by one of the previous statements
p.(None): sworn.
p.(None): 13.2. To grant the marketing authorization of a product,
p.(None): new:
p.(None): 13.2.1. The documentation specified in sub-section 13.1 must be presented, except in what
p.(None): Regarding 13.1.12, the applicant will also present evidence of prior approval for the product
p.(None): pharmacist in Guatemala, accompanied
p.(None): from:
p.(None): a) Simple copy of the written consent of the person who obtained the prior approval;
p.(None): or
p.(None): b) Proof that the marketing approval entered into force in Guatemala more than five years ago
p.(None): (5 years;
p.(None): or
p.(None): c) When the prior approval in Guatemala was based on undisclosed information concerning the
p.(None): safety and efficacy or evidence of safety and efficacy of an approved product in another territory, as expected
p.(None): in article 177 of Decree 57-2000 of the Congress of the Republic, proves that the period of
p.(None): protection stipulated in said article
p.(None): has expired.
p.(None): 13.3. To grant the marketing authorization of a product under a new pharmaceutical form,
p.(None): new indications or new
p.(None): dosage:
p.(None): 13.3.1. The documentation specified in sub-section 13.1, must be presented; Regarding 13.1.12, the
p.(None): Applicant may also submit supporting scientific literature.
p.(None): * Amended by Article 2 of Government Agreement Number 351-2006 on 00-00-0000
p.(None): ARTICLE 14: CONDITIONS FOR THE AUTHORIZATION OF SPECIALTIES FOR PHARMA CEUTICS, PESTICIDES FOR DOMESTIC USE AND
p.(None): PESTICIDES FOR USE IN PUBLIC HEALTH PROGRAMS.
p.(None): Reference sanitary registration is granted to a pharmaceutical specialty, household pesticides and
p.(None): pesticides for use in public health programs, if the product meets the following conditions:
p.(None): 14.1) It is safe, that is, when under normal conditions of use it does not produce toxic or undesirable effects
p.(None): disproportionate to the benefit it seeks.
p.(None): 14.2) In the case of a pharmaceutical specialty, which is effective in the therapeutic indications for which it is
p.(None): offers and in the case of pesticides subject to registration, be effective in controlling the pests that are reported.
p.(None): 14.3) That meets the quality and purity requirements established.
p.(None): 14.4) That it is correctly identified and accompanied by accurate information.
p.(None): 14.5) That the holder of the authorization or, where appropriate, the manufacturer, has the material resources
p.(None): and personal, the organization and sufficient operational capacity for its correct manufacture.
p.(None): ARTICLE 15. GENERAL GUARANTEES OF THE EVALUATION.
p.(None): The studies, data and information that are presented with the request for authorization of a specialty
p.(None): pharmaceutical or pesticides subject to these Regulations, for compliance with the conditions and guarantees mentioned
p.(None): in this chapter they must be foliated and endorsed with their signature by the pharmaceutical manager and the legal representative
p.(None): in Guatemala. The studies and analyzes of the medicines and pesticides subject to these Regulations shall be in accordance with the
p.(None): established good laboratory and clinical practices.
p.(None): The Ministry of Health will carry out controls in accordance with the United States Pharmacopeia of
p.(None): America (USP) and the other pharmacopoeias and texts mentioned in articles 19, 38 and 39 of this
p.(None): Regulation in order to guarantee the efficacy, safety and quality of the medicines and pesticides subject to this
p.(None): Regulations that are registered or marketed in Guatemala. Likewise, in those high-risk products,
p.(None): therapeutic equivalence evaluations.
p.(None): ARTICLE 16. SECURITY GUARANTEES.
p.(None): Medicines and pesticides subject to these Regulations, consisting of new molecules not yet
p.(None): recognized by the texts mentioned in Article 19 and in Chapter III below of these Regulations, will be
p.(None): object of the presentation of toxicological studies that guarantee its safety in
p.(None): normal conditions of use and in the case of medicines, which are in relation to the expected duration of the
p.(None): treatments.
p.(None): These studies will comprise acute and chronic toxicity tests, terotogenicity tests, embryotoxicity, fertility,
...
p.(None): THE DEPARTMENT will grant the corresponding authorization only after verifying that the requirements are met
p.(None): previously required.
p.(None): The authorization will be granted within the term to be determined in the respective procedures. This term will remain
p.(None): interrupted if THE DEPARTMENT requires compliance with additional requirements that the requirements are met
p.(None): of good manufacturing practices.
p.(None): ARTICLE 74. GOOD MANUFACTURING PRACTICES.
p.(None): Holders of a pharmaceutical laboratory authorization must comply with the good practices of
p.(None): manufacturing approved by the Ministry of Health as well as good laboratory practices. These standards should
p.(None): be periodically adapted to the state of science and technique and its control and monitoring will be done using the
p.(None): respective form.
p.(None): ARTICLE 75. MANUFACTURE OF RADIOPHARMACEUTICALS
p.(None): . Without prejudice to the other obligations that are imposed by legal or regulatory provision, the
p.(None): industrial manufacturing and registration of generators, equipment, reagents, precursors and radiopharmaceuticals has
p.(None): as a requirement the prior authorization of THE DEPARTMENT, which will be granted in accordance with the principles
p.(None): of these Regulations and according to the procedures established for this purpose.
p.(None): The authorization provided in the previous paragraph will not be required for the extemporaneous preparation of a
p.(None): radiopharmaceutical by a person qualified for application in a center or institution legally empowered to do so, if
p.(None): carried out exclusively from authorized generators, equipment, reagents and precursors and in accordance with the
p.(None): manufacturer's instructions.
p.(None): The provisions of these Regulations will not affect the legal measures on protection against radiation from
p.(None): people undergoing medical tests or treatments or for the protection of public health and workers.
p.(None): ARTICLE 76. MODIFICATION OF PHARMACEUTICAL ESTABLISHMENTS.
p.(None): Any modification of the specifications under which the authorization was granted according to the article
p.(None): 73 above, must be previously approved by THE DEPARTMENT.
p.(None): ARTICLE 77. SUSPENSION OF AUTHORIZATION.
p.(None): THE DEPARTMENT may suspend the authorization of the producing establishment for a certain category
p.(None): of products or for all of them when the requirements specified in article 73 of these Regulations are not met.
p.(None): This agency may also, without prejudice to other measures that may apply, suspend manufacturing
p.(None): of pharmaceutical specialties or the manufacturing authorization itself when obligations are breached
p.(None): established in this chapter.
p.(None): ARTICLE 78. MANUFACTURE OR QUALITY CONTROL BY THIRD PARTIES AT THE NATIONAL LEVEL.
p.(None): Manufacturers of pharmaceutical specialties may entrust manufacturing or quality control to third parties
p.(None): under contract for pharmaceutical specialties, if the following requirements are met:
p.(None): 78.1) That the contractor has a sanitary license from a manufacturer of pharmaceutical specialties or control of
p.(None): quality if that were the case.
p.(None): 78.2) Obtain from THE DEPARTMENT specific authorization for manufacturing by third parties, at the
p.(None): national.
p.(None): ARTICLE 79. ON DRUGSTORES.
p.(None): The distribution of pharmaceutical products from manufacturing laboratories to pharmacies and
p.(None): pharmacy of health establishments, can be done through drugstores.
p.(None): Drugstores must have a health license issued by THE DEPARTMENT.
p.(None): ARTICLE 80. OF THE DISTRIBUTORS.
p.(None): The distribution of over-the-counter products, cosmetics, personal and household hygiene products,
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| children | Child |
| crime | Illegal Activity |
| criminal | criminal |
| dependency | Drug Dependence |
| drug | Drug Usage |
| educational | education |
| emergency | Public Emergency |
| home | Property Ownership |
| illegal | Illegal Activity |
| impaired | Cognitive Impairment |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| other country | Other Country |
| party | political affiliation |
| political | political affiliation |
| religious | Religion |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| union | Trade Union Membership |
| usage | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| crime | ['illegal'] |
| drug | ['substance', 'usage'] |
| illegal | ['crime'] |
| party | ['political'] |
| political | ['party'] |
| substance | ['drug', 'usage'] |
| usage | ['drug', 'substance'] |
Trigger Words
capacity
consent
protect
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input