Regulation Of Inputs For The Health

Original Language Title: Reglamento de Insumos para la Salud

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HEALTH INPUT RULES

Published in the DOF on February 4, 1998

Last reform published in the DOF on March 14, 2014

On the sidelines a seal with the National Shield, which reads: United Mexican States.-Presidency of the Republic.

ERNESTO ZEDILLO PONCE DE LEÓN, President of the United Mexican States, in exercise of the power granted to me by part I of Article 89 of the Political Constitution of the United Mexican States and based on the Article 39 of the Organic Law of the Federal Public Administration and 60, 194, 194 bis, 197, 198, 200, 200 bis, 204, 210, 221 to 268, 286 bis, 288 to 295, 301a, 368 to 379 and 422 of the General Health Law, I have had to issue the next

HEALTH INPUT RULES

TITLE FIRST

General provisions

Single Chapter

ARTICLE 1o. The purpose of this order is to regulate the sanitary control of the Insured and the Herbalist remedies, as well as of the Facilities, activities and services related to the same.

ARTICLE 2o. For the purposes of this Regulation,

following definitions shall apply:

I. Conditioning, to the necessary operations for which a bulk product must pass in order to arrive at its presentation as a finished product;

II. Bioavailability, to the proportion of drug that is absorbed into the general circulation after the administration of a drug and the time it requires to do so;

II Bis. Analytical Certificate, to the document that endorses the results obtained in a study to determine the composition or nature of a sample, issued by the manufacturer of the product, in accordance with the provisions of the Law, the present Regulation and other applicable provisions;

III. Health condition, to the health specifications or requirements to be met by each of the Inputs, Establishments, activities and services and which are set out in the corresponding orders;

III Bis. International non-proprietary name, to the name that identifies a pharmaceutical substance or pharmaceutical active substance by a unique name that is recognized worldwide and is in the public domain;

IV. Distinctive name, in the name that the laboratory or manufacturer assigns to its proprietary medicinal products in order to distinguish it from other similar names, after approval by the health authority and registration with the competent authorities;

V. Generic name, in the name of the medicinal product, determined by means of a pre-established method, which identifies the drug or active substance recognised internationally and accepted by the health authority;

VI. Primary packaging, to the elements of the packaging system which are in direct contact with the Insumo;

VII. Secondary packaging, to the components that are part of the package in which the Insumo is marketed and are not in direct contact with it;

VII Bis 1. Clinical studies, tests performed on humans to demonstrate the quality, safety and efficacy of the medicinal products;

VII Bis 2. Biocomparability studies, tests, trials and tests that are essential to demonstrate that a biocomparable biotechnological medicinal product has the same characteristics of quality, safety and efficacy of a Biotechnological reference medicine;

VII Bis 3. Pre-clinical studies, in vitro or in animal studies to demonstrate the quality, safety and efficacy of the product and the results of which can be extrapolated to humans;

VIII. Label, marking, marking, marking or graphic image which has been written, printed, starked, marked, embossed or in hollow, engraved, adhered or sealed in any material capable of containing the Insumo including the packaging itself;

IX. Pharmacopoeia of the United Mexican States, to the document issued by the Secretariat that provides the general methods of analysis and the requirements on identity, purity and quality of drugs, additives, drugs and biological products;

X. Homeopathic Pharmacopoeia of the United Mexican States, to the document instituted by the Law and issued by the Secretariat, which comprises the names, procedures, methods and specifications for the identification, preparation or analysis of substances and homeopathic products;

X Bis. Technical information, tests, analyses, pre-clinical and clinical studies necessary, where appropriate, to demonstrate the quality, safety and efficacy required by the Secretariat for obtaining the health record;

XI. Inputs, to the Health Insured as referred to in Article 194 bis of the Law;

XII. Law, to the General Health Law;

XIII. Lot, to the specific quantity of any raw material or Insumo, which has been produced in a production cycle, under equivalent operating conditions and over a given period;

XIII Bis 1. Biocomparable biotechnological medicinal product, the non-innovative biotechnological medicinal product which proves to be biocomparable in terms of safety, quality and efficacy to the biotechnological reference medicinal product through the tests provided by the Law, This Regulation and other applicable provisions;

XIII Bis 2. Innovative biotechnological medicinal product, to the biotechnological medicinal product obtained by the health register in Mexico, as recognized by the Secretariat;

XIII Bis 3. Biotechnological reference medicinal product, the innovative biotechnological medicinal product which is used as a reference for the registration of biocomparable biotechnological medicinal products and which is recognised as such by the Secretariat. Where the innovative biotechnological medicinal product is not registered in Mexico, it may be recognised as such for a biocomparable biocomparable medicinal product previously registered with the Secretariat;

XIV. Generic medicinal product, to the pharmaceutical specialty with the same drug or active substance and pharmaceutical form, with equal concentration or potency, which uses the same route of administration and which, by means of the required regulatory tests, has checked that their pharmacopoeic specifications, dissolution profiles or their bioavailability or other parameters, as the case may be, are equivalent to those of the reference medicinal product;

XIV Bis. Reference medicinal product, to the medicinal product indicated by the Secretariat as such, which has the register of such a dependency, which is commercially available and is selected in accordance with the criteria laid down in the Rules;

XV. Novel molecule, to the substance of natural or synthetic origin, which is the active substance of a medicinal product, not previously used in the country, whose efficacy, safety and therapeutic purposes have not been fully documented in the literature scientific;

For the purposes of the New Molecules Committee, they will be classified as new molecules to those within the following categories:

a. The drug or drug that does not have a worldwide registry and is intended to be registered in Mexico (new molecular entity).

b. That drug or drug that still exists in other countries, with limited clinical experience or controversial information, has no registration in Mexico and intends to register in our country.

c. A drug that claims to make a combination that does not exist in the national market for two or more drugs.

d. A drug or drug on the market that is intended to be marketed with another therapeutic indication.

XVI. Standards, to Mexican official standards;

XVII. Secretariat, to the Secretariat of Health, and

XVIII. Third authorised, to the person authorised by the Secretariat to deliver opinions on compliance with requirements laid down by the Secretariat itself or in the relevant Rules or to carry out studies, for the purposes of formalities or health authorizations.

ARTICLE 3o. The inputs, establishments, activities and services covered by this Regulation refer to those for human use and consumption, except where it expressly refers to others.

ARTICLE 4. The Secretariat, within the framework of the National Health System, will carry out programs and campaigns for control and health promotion, in which the community, producers, health professionals and service providers will be invited to participate.

ARTICLE 5o. The popular action referred to in Article 60 of the Law may be exercised by any person, for which it shall:

I. Report to the health authority the facts, in writing or in a verbal manner;

II. Point out the fact, act or omission that in your judgment represents a risk or causes harm to the health of the population, and

III. Provide the data to identify and locate the cause of the health risk or damage and, where appropriate, the persons involved.

When the complaint is made in a verbal manner, the health authority shall state that in writing, based on the statements of the complainant, who shall sign it, in order to proceed to the respective procedure. In no case will the anonymous complaint be processed.

The health authority shall inform the complainant of the attention it gives to the complaint.

ARTICLE 6o. The application and interpretation of this Regulation is the responsibility of the Secretariat, as well as the governments of the Federative Entities in their respective areas of competence, in accordance with the coordination agreements which, if necessary, subscribe.

TITLE SECOND

Inputs

Chapter I

Common Provisions

First Section

Health features and conditions

ARTICLE 7o. These are considered acts related to the process of the Insured, those that have the following purposes:

I. Physicians: Those that are performed for diagnostic, preventive, therapeutic or rehabilitation purposes;

II. Scientists: Those destined for research;

III. Industrial: Those intended for the production of Insured or its raw materials, and

IV. Health policy: Those who for reasons of therapeutic and collective benefit are determined by the Secretariat or by the General Health Council.

ARTICLE 8o. The Secretariat shall determine the characteristics to be collected by a product to be considered as a medicinal product or other Insumo in the United Mexican Pharmacopoeia or in the corresponding Rules.

Also, the quality specifications of the additives, drugs and drugs and the procedures for evaluating them, will be those indicated in the current edition, at the time of the evaluation, of the United States Pharmacopoeia. Mexicans and their supplements. Where the information is not available, pharmacopoeas may be used from other countries whose analysis procedures are carried out in accordance with specifications of specialised bodies or other recognised scientific literature. internationally.

ARTICLE 9o. The Rules issued by the Secretariat, in accordance with the nature of the Insumo, shall establish the microbiological, toxicological or health risk specifications, as well as the health techniques of production to ensure such specifications. and the appropriate sampling, testing and analysis methods.

ARTICLE 10. Manufacturers of medicinal products shall analyse, identify, store, manage and control the drugs and additives they use in order to ensure that they comply with the health conditions of identity, purity, safety, quality, stability, sterility and, where appropriate, pyrogenicity, and which are without alteration, adulteration or contamination.

ARTICLE 11. The batches of the Insured shall be identified in accordance with the provisions of the relevant Rules and in relation to the date of manufacture of such products.

ARTICLE 12. In the production of new batches of medicinal products, no remaining batch of other batches should be used.

ARTICLE 13. The water used in the manufacture, manufacture, mixing or conditioning of the Insured shall be potable, except for those cases in which it is established in this Regulation, in the Pharmacopoeia of the United Mexican States or in the Standard It must be purified, distilled or otherwise.

ARTICLE 14. The materials, equipment, utensils, raw materials and packaging used in the manufacture of the Insured referred to in this Regulation must be harmless and resistant to corrosion and must not contain toxic substances, with the exception of flag in the corresponding Rules.

ARTICLE 15. The Establishments which are intended for the manufacture of the Insured shall bear the analytical control thereof. Such control shall include:

I. The specifications and techniques for analysing each of the components used in the process, including sampling of the batch and finished product;

II. Methods for checking identity, purity, sterility and apirogenicity, when required;

III. Validation of the techniques used;

IV. The storage of retention samples in sufficient quantity for two full analyses of each batch processed, one year after the expiry date thereof, and

V. The other characteristics and requirements of the corresponding Standard.

A year after the product expiry date must be kept, in accordance with the relevant Standard.

ARTICLE 16. The specifications, analytical techniques and all the documents used in the manufacture and marketing of the Insured must be in Spanish.

ARTICLE 17. The following shall be observed in the transport of the Insured:

I. For no reason may vehicles intended for the transport of pesticides, plant nutrients, toxic and dangerous substances or grooming products with corrosive action be used;

II. When using public means of transport, the Insured shall be packed and packed in such a way that they meet the environmental conditions necessary for their properties to be preserved;

III. The cooling chambers shall have graphic control of the temperature and their doors shall remain open for the minimum time required to remove or introduce a medicinal product;

IV. The biological products shall be kept at the pharmacopoeic cooling temperature or the temperature set on the product label;

V. The means of transport must meet the safety requirements and conditions laid down and its operators must be able to apply emergency measures to eventualities and accidents. To this end, the Secretariat shall coordinate with the Secretariat for Communications and Transport and other competent authorities, and

VI. The means of transport used for the transport and distribution of the raw material or finished product, shall be constructed with corrosion-resistant, smooth, waterproof, non-toxic materials and which can be easily cleaned. All vehicles shall be kept always clean and in good condition. The equipment that is installed in them will ensure the preservation of the products and prevent the entry and proliferation of pests or their contamination.

Section Second

Packaging and tagging

ARTICLE 18. The physical, chemical and toxicity characteristics for each type of packaging material and the substances used to cover the packaging of the medicinal products shall be determined by the relevant standard.

ARTICLE 19. Packaging that has contained medicinal products may not be used again.

ARTICLE 20. The packaging system and the containers of the Insumas must prevent leakage that can cause damage to health or to contaminate the Insumo chemical or microbiologically.

ARTICLE 21. The packaging of the medicinal products must have systems of closure, which make it clear to the user that they have not been opened prior to their purchase and prevent accidental manipulation by the children, as established in the Pharmacopoeia of the United Mexican States or the corresponding Standard.

ARTICLE 22. Only the substances or products authorised by the Secretariat shall be used as propellants in the aerosol packaging.

ARTICLE 23. The Distinctive Denomination of the Insured, in addition to complying with the provisions of Article 225 of the Law, when used shall be subject to the following:

I. The Distinctive Denomination of two or more Insured, when orthographic or phonetically similar, shall be differentiated by at least three letters of each word;

II. The same Distinctive Denomination of another medicinal product with an existing health record, revoked or pending registration, must not be used, and

III. Only the same Distinctive Denomination may be used in different pharmaceutical forms or different doses with the same active substance and registered by the same laboratory.

ARTICLE 24. Labels shall contain at least the following health information and gather the characteristics and requirements set out in the corresponding Standard:

I. The Generic Naming;

II. The distinguishing name; in the case of Generic Medicines, their inclusion shall be optional;

III. The declaration of active ingredients;

IV. The identification and address of the manufacturer and, where applicable, of the distributor;

V. The instructions for storage;

VI. The expiration date;

VII. The batch number;

VIII. The dose and route of administration;

IX. The precautious legends, including their risk of use in pregnancy;

X. The warning legends;

XI. Repealed.

XII. The specifications of the living organism used for the preparation of the medicinal product and the name of the disease to which it is intended, in accordance with the accepted international nomenclature, in the case of medicinal products of biological origin immunological action.

When the information is expressed in other languages, from the country of origin it must also appear in Spanish language, at least, with the same size and typographical proportionality, according to the corresponding Standard.

ARTICLE 24-a. In addition to the provisions of the previous article, the labels of biotechnological medicinal products should include the following information:

I. Name or social name or name of the manufacturer and country of origin of the biopharmaceutical;

II. The place of the primary packaging of the biotechnological medicinal product, and

III. If applicable, name or social reason or name of the importer.

Innovative biotechnological medicinal products must include in their label the acronym M.B. Biocomparable biotechnological medicinal products must include in their labels the acronym M.B.B. In both cases, they shall include in their labels the International Denomination, irrespective of the distinguishing name.

ARTICLE 25. When labels contain the generic and distinctive names of the medicinal products, they must be printed in a proportion such that the size of one is at least one third of the other, measured in points of the same typography or, in its defect, in helvetic letter.

ARTICLE 26. The labelling of medicinal products intended exclusively for public health and social security institutions shall be subject to the specific provisions to be issued.

ARTICLE 27. The labelling of products whose process is carried out on the national territory and intended exclusively for export purposes shall not be subject to the provisions of this Regulation.

Third Section

Prescription

ARTICLE 28. The prescription is the document containing, among other things, the prescription of one or more medications and may be issued by:

I. Physicians;

II. Homeopaths;

III. Dental surgeons;

IV. Veterinary doctors, in the area of their competence;

V. Social service interns, from any of the previous races, and

VI. Nurses and midwives.

The professionals referred to in this Article shall have professional cedula issued by the competent educational authorities. Interns, nurses and midwives may be required to comply with specifications to be determined by the Secretariat.

ARTICLE 29. The medical prescription must contain the full name and address and the professional ID number of the person who prescribes, as well as the date and signature of the issuer.

ARTICLE 30. The issuer of the prescription when prescribing, will indicate the dose, presentation, route of administration, frequency and duration of treatment.

ARTICLE 31. The issuer of the prescription will prescribe the drugs in accordance with the following:

I. In the case of Generic Medicines, the General Name must be recorded and if you wish, you may indicate the distinguishing name of your preference;

i Bis. In the case of biotechnological medicinal products, the International Non-proprietary Name shall be noted, and optionally the distinguishing name;

II. In other cases it may express the distinctive name or together the generic and distinctive names;

When the prescription is expressed in the Distinctive Denomination of the medicinal product, its sale or supply must conform precisely to this name and may only be replaced when expressly authorized by the person who prescribes it.

The sale and supply of biotechnological medicines should be in line with the prescription of the prescription.

ARTICLE 32. The prescription in the public institutions will be adjusted to what is indicated in each of them, with the use in all cases only the generic names of the medications included in the Basic Table of Insured for the first level or in the Catalog of Insured for the second and third level. Other medicinal products may be prescribed by derogation and with the appropriate authorisation.

Section Fourth

Selling or provisioning

ARTICLE 33. Medicinal products which present on their labels or packages the legend indicating that medical prescription is required for their sale or supply may only be sold with this condition.

ARTICLE 34. Medicinal products presented as a medical sample, original of a gift and intended for the exclusive use of public health and social security institutions shall not be sold to the public.

ARTICLE 35. In the form of free access, the medicinal products which are required for a special prescription or a prescription may not be sold in the free access mode.

Fifth Section

Research and suspending activities

ARTICLE 36. The suspension of production or placing on the market of Insured shall be communicated to the competent health authority within a period not exceeding 30 working days from the date on which it was made, in writing in which the causes that cause it.

The restart of production or marketing must also be communicated in writing to the Secretariat within ten days after it occurs.

The Secretariat reserves the right to continue, due to the social interest, when the production or marketing of the Insured is suspended.

ARTICLE 37. Where the Secretariat has evidence that an Insumo lacks security, efficacy, purity or stability, it shall implement the security measures provided for in the Law and, if necessary, revoke its registration, which shall notify the holder of the registration so that set out what is right for you. Where the latter satisfies the security and efficiency requirements laid down by the Secretariat, it may request the suspension of security measures, provided that the registration has not been revoked.

ARTICLE 38. Adverse reactions of the medicinal products or other Insulin that occur during the marketing or use of the medicinal products, those reported by health professionals, those published in the scientific literature and those reported by the organisms International health care must be made of the Secretariat's immediate knowledge by the registry holder, by the distributors or marketers of the Insured.

ARTICLE 39. Research in the field of drugs, including those that are or contain narcotic drugs and psychotropic drugs, will be subject to the provisions of Title V of the Law and the Regulation of the General Law on Health in the Field of Research for the Health.

Sixth Section

Destruction of Inputs

ARTICLE 40. The destruction of the Insured or containing narcotic drugs or psychotropic substances must be reported to the Secretariat and be carried out in the presence of a health verifier, who finds that they are destroyed.

In case the verification is not carried out within ten days of the date of filing, the applicant may perform the destruction with the presence of a Third Authorized by the Secretariat for such effect.

ARTICLE 41. Inputs that are or contain antineoplastic, hormones, beta-lactam, cephalosforinic, immunodepressants, blood products, viral biologics and microbial biologics, before their final disposal must be inactivated, except if they are incinerated, in such a way that they do not give rise to health risk. Hazardous waste must be treated in accordance with the relevant Standard.

ARTICLE 42. The destruction or inactivation of the Insured will be done in accordance with the corresponding Standard and, in all cases, the costs that originate will be assumed by the Establishment that has them in possession.

Chapter II

Biological and blood products

ARTICLE 43. For the distribution or sale of products of biological origin and blood products of domestic or foreign manufacture, each batch is required to be previously authorized based on the analytical results issued by the Secretariat or by a Third Party. Authorised, in accordance with the applicable legal provisions, with the exception of products from bacterial lysates and microbial preparations for oral non-immunological use.

In order to obtain the authorization mentioned in the previous paragraph, the applicant must make his request by means of the format that the Secretariat will issue for this purpose and published in the Official Journal of the Federation, which will have ten days to resolve the request, once the results of the lab are received.

The Federal Commission for the Protection of Health Risks may authorize the distribution or sale of the products referred to in this article in a simplified manner, based on the guidelines to the effect of the Secretariat, in terms of the applicable legal provisions, in which aspects should be considered that will minimize the risk to health, and which should be published in the Official Journal of the Federation.

Chapter III

Narcotic and psychotropic

ARTICLE 44. The production, manufacture, manufacture, preparation, mixing, conditioning, packaging, handling, storage, marketing, import, export, medical prescription, supply, possession, transport, employment, use, consumption and, in In general, any act relating to narcotic drugs and psychotropic substances, with the exception of those without therapeutic value and are used in the industry, can only be carried out for medical and scientific purposes, subject to authorisation by the Secretariat.

ARTICLE 45. The holding and custody of raw materials or medicinal products that are or contain narcotic drugs or psychotropic drugs, is the responsibility of the person who owns them, the same as the official documents that check their legitimate tenure, which must be keep for a period of three years.

ARTICLE 46. Public and private establishments intended for processing, importing, exporting or using narcotic drugs or psychotropic substances for human use shall have control books authorised by the Secretariat and with a security system for their keeping and custody.

For the purposes of this Regulation, control books shall mean the compilation of graphic records obtained by any authorised system, provided that they contain the data necessary for the control of narcotic drugs. and psychotropic.

ARTICLE 47. The manufacture of batches of raw materials or narcotic drugs or psychotropic drugs, intended for health registration, to be marketed or for scientific purposes, shall be recorded in the control book authorised by the Secretariat and signed by the person responsible for the applicant's laboratory or institution, including, as appropriate, the following data:

I. The name of the raw material;

II. The batch number;

III. The provenance;

IV. The amount to use and balance sheet;

V. The usage and destination that will be given to it, and

VI. The summary of the process.

The Secretariat will be able to verify through a visit order, the declared operations and data, which will be settled in the corresponding control book, with the exception of the stated in the section VI of this article.

ARTICLE 48. The manufacture of raw materials or veterinary medicinal products containing narcotic drugs or psychotropic substances shall be subject to control by the Secretariat and other agencies of the Federal Executive.

ARTICLE 49. Producers who regularly require raw materials or medicinal products which are or contain narcotic drugs and psychotropic substances shall inform the Secretariat, during the months of January to May, of a forecast of the quantities they will demand. during the following year.

ARTICLE 50. They may only prescribe medicinal products which can only be purchased with a special prescription or a prescription which must be retained by the pharmacy which can be dispensed with or with a prescription for up to three times, the professionals listed below. mention, provided that they have professional qualifications issued by the competent educational authorities:

I. Physicians;

II. Homeopaths;

III. Dental surgeons, for dental cases, and

IV. Veterinary doctors, when prescribed for use in animals.

ARTICLE 51. Professionals interested in obtaining the bar code for special prescription drugs, shall submit a request in the format that the Secretariat may authorize, accompanied by the following documentation:

I. Certified copy of the professional cedula, which accredits them as professionals in any of the branches referred to in the previous article;

II. Official identification copy, and

III. Written in original and two copies, in letterhead and signed by the director of the institution, in the case of hospital institutions, in which the designation of the professionals responsible for the prescription is specified.

The Secretariat or the State Health Authorities shall register the applicant professional and shall assign a certain amount of keys to the applicant professional within a period of five days in the case of the first application and a day in the subsequent. In the latter case only the request will be submitted.

ARTICLE 52. Professionals authorised in accordance with the foregoing Article shall prescribe the medicinal products in special prescriptions, in original and copy, which shall contain the following particulars:

I. The number of folio and the key expressed in bar code with the identification of the physician;

II. The name, address, number of professional cedula, specialty, if any, and autograph signature of the physician;

III. The number of days of prescription for the treatment, presentation and dosing of the medicinal product;

IV. The prescription date, and

V. The name, address and diagnosis of the patient.

The authorized physician will print the special prescription, at the time and with the specifications that the Secretariat points out.

ARTICLE 53. The loss or theft of special prescription drugs should be communicated immediately to the Secretariat, accompanying a copy of the minutes raised with the Federal Public Ministry.

ARTICLE 54. The possession of medicinal products containing narcotic drugs or psychotropic substances shall be credited, where required by the authorities concerned, with the copy of the special recipe containing the barcode and the autograph signature of the professional that extends it or with the corresponding invoice.

ARTICLE 55. Foreigners who enter the country and require them for the treatment of drugs containing narcotic drugs or psychotropic substances, will prove the possession of these drugs through the presentation to the corresponding customs office of the prescription. medical or permit issued by the competent authority of the country from which they come.

ARTICLE 56. Vessels or aircraft with Mexican registration for domestic or international transport may carry medicinal products containing narcotic drugs or psychotropic substances for the provision of first aid or for urgent cases during the trip, in the amount indicated by the Secretariat.

The management and supply of the medicines used during the trip shall be made under the responsibility of the captains of the vessels or aircraft.

ARTICLE 57. Medicinal products which are or contain narcotic drugs or psychotropic substances may not be presented in the form of a medical sample or original gift.

ARTICLE 58. The factories or laboratories which process or store the medicinal products referred to in Article 44 of this Regulation may only sell them to the establishments which have a health licence which accredits them, is the case, such as hospital units, warehouses for the deposit and distribution of medicinal products and biological or blood products for human use, drogueries, pharmacies or boticas authorized to supply the public with drugs and psychotropic.

ARTICLE 59. The import, export and marketing of raw materials and medicinal products which are or contain narcotic drugs and psychotropic substances may not be carried out by post.

ARTICLE 60. The owners or the persons responsible for establishments involved in the process, import and export of medicinal products which are or contain narcotic drugs or psychotropic substances shall give immediate notice in writing to the Secretariat of involving extraordinary volume, significant disappearance or any circumstances in which there are reasonable grounds to consider that there may have been diversion of such substances.

Chapter IV

Vitamin Medicines

ARTICLE 61. Vitaminic medicinal product is considered as a product which contains only vitamins or minerals such as mono or polydrugs, alone or in association, indicated for preventing or treating disorders due to inadequacies thereof. Presentation is in pharmaceutical form.

The corresponding rules will determine the recommended daily intake, maximum doses of vitamins and minerals, and other specifications.

ARTICLE 62. Vitaminic Medicines must have a health record and for sale it will not be required for a prescription when none of its components rebase the following daily doses:

V i t a m i n a s D o s i s

Vitamin A/Retinol 2400 µ g

Ac. Folic 2000 µ g

Beta Carotene 150 mg

Biotin 1000 µ g

Vit B1/Tiamine 150 mg

Vit B2/Riboflavin 170 mg

Vit B3/Niacin 500 mg

Vit B5/Ac. Pantothenic 550 mg

Vit B6/Piridoxin 250 mg

Vit B12/

Cyanocabalamin 1000 µ g

Vit C/Ac. Ascorbic 2000 mg

Vit D 50 µ g

Vit E/d-a-Tocoferol 1000 mg

Vit K 65 µ g

M i n e r a l e s D o s i s

Calcium 2000 mg

Copper 10 mg

Chromium 500 µ g

Fluor 5.0 mg

Phosphorus 2000 mg

Iron 75 mg

Magnesium 1000 mg

Manganese 10 mg

Molybdenum 350 µ g

Selenium 200 µ g

Iodine 500 µ g

Zinc 50 mg

Vitamin or mineral medicinal products with doses higher than those mentioned in this article, as well as those administered parenteral, regardless of their concentration, will require for sale of a prescription that may be given as many times as prescribed by the prescribing physician.

Chapter V

homeopathic medicines

ARTICLE 63. The stability tests of homeopathic medicinal products shall be measured by physical appearance parameters and microbiological tests, in the case of products whose pharmaceutical form is ointment or ointment, otic, ophthalmic and other solutions which are authorised by the Secretariat. They shall be presented on the manufacturer's letterhead and signed by the health officer of the Establishment.

ARTICLE 64. In the formulation of a homeopathic medicinal product, procaine, ephedrine, yohimbine, chaparral, germanium, animal or human hormones or other substances having hormonal or anti-hormonal activity may not be included.

The use of narcotic or psychotropic substances in these drugs will only be allowed when they are diluted and dynamized.

ARTICLE 65. Homeopathic medicinal products may be sold in establishments other than pharmacies.

Chapter VI

herbal medicines

ARTICLE 66. Herbal medicinal products, in addition to containing plant material, may be added in their formulation excipients and additives.

ARTICLE 67. Herbalist drugs are not considered to be associated with isolated and chemically defined active substances, nor those proposed as injectable.

ARTICLE 68. The formulation of a herbal medicinal product may not include narcotic or psychotropic substances of synthetic origin, or mixtures with allopathic medicinal products, procaine, ephedrine, yohimbine, chaparral, germanium, animal hormones or human or other substances that contain hormonal or anti-hormonal activity or any other that poses a health risk.

ARTICLE 69. When it is not possible to include the information indicated for the Label by the size of the Primary Pack, only the following will be settled:

I. The Distinctive Denomination;

II. The pharmaceutical form;

III. The dose and route of administration;

IV. The contraindications, when they exist;

V. The conservation legend, if any;

VI. The number of Lote;

VII. The expiration date, and

VIII. The alphanumeric key of the record.

ARTICLE 70. When it is not possible to include the information indicated for the Label by the size of the Secondary Pack, only the following will be settled:

I. The formula that expresses the Latin botanical names by gender and species, and excipient or vehicle, as the case may be;

II. The Distinctive Denomination;

III. The pharmaceutical form;

IV. The therapeutic indication;

V. The dose, route of administration and mode of use;

VI. The adverse reactions;

VII. Precautions and contraindications where they exist;

VIII. Use in pregnancy and breast-feeding;

IX. Pediatric use;

X. The expiration date, if any, and

XI. The alphanumeric key of the record.

ARTICLE 71. The sale and supply of herbal medicines that are neither narcotic nor psychotropic, may be made in Establishments other than pharmacies.

Chapter VII

Generic Medicines

ARTICLE 72. For the purposes of Article 376 a (I) of the Act, medicinal products intended for the generic market shall be the proprietary medicinal products which, in terms of this Regulation, are interchangeable.

ARTICLE 73. The General Health Council and the Secretariat shall, by publication in the Official Journal of the Federation, determine the interchangeability tests to be applied according to the relevant standard.

ARTICLE 74. Repealed.

ARTICLE 75. Repealed.

ARTICLE 76. Repealed.

ARTICLE 77. Repealed.

ARTICLE 78. Repealed.

ARTICLE 79. Repealed.

ARTICLE 80. Repealed.

Chapter VIII

Biotechnologic Medicines

ARTICLE 81. For the purposes of this Regulation, any substance which has been produced by molecular biotechnology, which has pharmacological activity, which is identified by its physical, chemical and biological properties and which meets the criteria, is considered to be a bio-product. conditions to be used as an active substance in a biotechnological medicinal product.

Likewise, biotechnological medicinal product is understood to be any substance that has been produced by molecular biotechnology, which has a therapeutic, preventive or rehabilitation effect, which is present in the pharmaceutical form, which is identify as such by its pharmacological activity and physical, chemical and biological properties.

Biopharmaceuticals and biotech drugs may be:

I. Recombinant proteins: The proteins produced by any biological entity prokariote or eukaryotic which is introduced to it by genetic engineering techniques, a sequence of deoxyribonucleic acid that encodes them;

II. Monoclonal antibodies: The intact immunoglobulins produced by hybridomas, immunoconjugates, immunoglobulins fragments and recombinant proteins derived from immunoglobulins;

III. Synthetic peptides: peptides consisting of less than 40 amino acids produced by molecular biotechnology techniques;

IV. Synthetic or plasmids nucleic acids: nucleic acids obtained from natural plasmids or modified by genetic engineering techniques, and

V. Other than, where appropriate, determined by agreement by the Secretariat, in accordance with technical and scientific progress.

ARTICLE 81-bis. The pharmacovigilance of biotechnological medicinal products shall be carried out in accordance with the relevant standard. Such pharmacovigilance should allow for a clear identification of the biotechnological medicinal product, specifically referring to its manufacturer, the International Denomination, the distinguishing name and the batch number. In addition, this pharmacovigilance should facilitate the identification of the biotechnological therapies administered at all stages of treatment.

Chapter IX

Other Inputs

ARTICLE 82. Medical equipment, prostheses, orthotheses, functional aids, diagnostic agents, medical devices, surgical materials, healing products, hygienic products and other medical devices, require for their production, sale and distribution. Health record.

Establishments in which the process of the Inputs referred to in the preceding paragraph is carried out shall be required to present a working notice, with the exception of those dedicated to the process of radiation sources of medical use, which require a license issued in a coordinated manner with the National Nuclear Safety and Safeguards Commission.

ARTICLE 83. The Secretariat shall classify for the purposes of registration the Insured referred to in the previous Article, in accordance with the risk involved in its use, as follows:

CLASS I. Known as the Insured in medical practice and their safety and efficacy are checked and generally not introduced into the body;

CLASS II. Those Inputs known in medical practice and which may have variations in the material they are made with or in their concentration and, generally, are introduced to the body by remaining less than thirty days, and

CLASS III. Those new or newly accepted inputs in medical practice, or that are introduced into the body and remain in the body for more than thirty days.

ARTICLE 84. The new models of the Health Inputs referred to in this Chapter, of the same production line and manufacturer, if they have technological advances, will require new registration of the Secretariat.

ARTICLE 85. Where it is necessary, according to its nature, to verify the stability of the Insured as referred to in the previous Article, it shall be met with the corresponding Standard for these products.

ARTICLE 86. Ethyl alcohol at the concentration 96º G.L. requires registration with the Secretariat as a healing material and comply with what is established by the corresponding Standard.

ARTICLE 87. The catalogues of the Insured referred to in this Chapter, as well as the promotional information contained in the medical or printed journals addressed to health professionals, are medical means of dissemination and the company responsible for the The above publications shall give the relevant notice to the Secretariat.

THIRD TITLE

Herbal Remedies

Single Chapter

ARTICLE 88. Herbalist is considered to be the preparation of medicinal plants, or their parts, individual or combined and their derivatives, presented in a pharmaceutical form, which is attributed to them by popular or traditional knowledge, the relief for some symptoms participants or isolates of a disease.

Herbal Remedies will not contain in their formulation narcotic or psychotropic substances or any other type of allopathic drug or other substances that generate hormonal activity, antihormonal or any other substance in concentrations that pose a risk to health.

ARTICLE 89. The plants used as raw materials for making Herbalist Remedios must be subjected to treatments to kill the microbial flora that accompanies them, according to the rules that are issued in this respect or with the specifications. relevant international.

ARTICLE 90. The manufacture of Herbalist Remedies must be carried out under conditions that prevent the microbiological contamination of their ingredients.

ARTICLE 91. In order to carry out the production of the Herbalist Remedies of national manufacture, application must be submitted to the Secretariat, for which it will be required:

I. Have the factory or laboratory spin of Herbalist Remedios for human use, which has laboratory of internal or external control and warning of operation;

II. The notification by product, specifying each of the ingredients of its composition or formula;

III. The certificate of microbiological analysis and the absence of toxic waste;

IV. The description of the process, which must comply with good manufacturing practices;

V. Count with health officer;

VI. Information about the identity of the components;

VII. The scientific and popular name of the plant or plants used;

VIII. The formula;

IX. The indications and time for use, and

X. The tag projects.

ARTICLE 92. The Secretariat when approving the documentation referred to in the previous Article shall, within a maximum of 20 days, assign an alphanumeric control key, which shall be expressed in the product packaging. In case of failure to resolve within the prescribed period the application shall be understood.

ARTICLE 93. To perform the distribution of Herbalist Remedios, it must be counted with a warning of operation, which must correspond to the rotation of warehouse of deposit or distribution, and with health officer.

ARTICLE 94. In order to obtain the alphanumeric key for Foreign-made Herbalist Remedies, in addition to the requirements set out in Article 91, the following documentation must be submitted:

I. The certificate of free sale issued by the health authority of the country of origin and letter of representation of the manufacturer. If the product is manufactured by the parent or subsidiary of the requesting laboratory in Mexico, no letter of representation will be required;

II. The copy of the analysis certificate issued by the company that manufactures the Herbalist Remedy, with the letterhead of its social reason and endorsed by the chemicals responsible for the foreign and national company;

III. The certificate of good manufacturing practice, and

IV. The Spanish-language and counter-label projects, if any.

ARTICLE 95. Where the Secretariat is aware that a plant or a mixture of them shows signs of toxic or cumulative effects, or any other health risk, it may prohibit the import, manufacture, storage, distribution and sale of the Herbalist remedy that contains them.

ARTICLE 96. The sale and supply to the public of the Herbalist Remedies will be freely available.

ARTICLE 97. The Herbal Remedies information for advertising and marketing purposes should be aimed at specifying the symptomatic effect and will be the same as contained in the Label. In no case can they be advertised as curative.

ARTICLE 98. The provisions relating to the Labels, Envases and Transport of the Insured referred to in Chapter I of the above Title shall be applicable to the Herbalist Remedies.

TITLE FOURTH

Establishments

Chapter I

Common Provisions

ARTICLE 99. The premises and their facilities, premises and annexes, in which the process of the Insured, activities and services referred to in this Regulation are carried out, are considered to be established.

ARTICLE 100. Establishments shall comply with the provisions of this Regulation and with those laid down in the relevant Rules for their operation.

ARTICLE 101. The Establishments must be provided with drinking water, in sufficient quantity and pressure to meet the needs of the persons in them, and must have excreta disposal services connected to the network of drainage, without prejudice to the fulfilment of other obligations which, where appropriate, impose other relevant dependencies. For health purposes, non-drinking water intake must be identified by means of a marking to be established: non-drinking water, not drinking water.

When the Establishment has air conditioning systems, in which there is contact with water, the water must be potable.

ARTICLE 102. The Establishments, in accordance with the provisions of the relevant Rules, shall meet the following requirements:

I. The construction elements exposed to the exterior will be resistant to the environment and the harmful fauna;

II. Warehouses must ensure the proper conservation and management of the Insured, in order to avoid contamination, alteration or adulteration;

III. Drinking water tanks shall be covered with harmless impermeable material, with smooth inner surfaces, fitted with lids and with appropriate protective systems to prevent contamination or water disturbance;

IV. The areas of office, laboratories, dining room, health services, reception, production, distribution or any other area required by the process must be separated;

V. Be provided with sufficient illumination, either natural or artificial, appropriate to the nature of the work, as well as adequate ventilation for continuous air renewal and to avoid excessive heat, condensation of steam and dust, and

VI. Wall, floor and ceiling finishes, within the areas of manufacture, operation and storage, shall meet the requirements of texture, ease of cleanliness and impermeability.

ARTICLE 103. The owners of the Establishments must comply with the criteria of good hygiene practices in the prevention and control of the harmful fauna.

ARTICLE 104. The owners of the Establishments shall take care of the preservation, grooming, good condition and maintenance of the same, as well as of the equipment and utensils, which will be suitable for the activity that is performed or services that are provided according to the Corresponding rule.

ARTICLE 105. In order to protect the health and safety of workers involved in the process of the Insured, as well as in the activities and services covered by this Regulation, the dress which the effect is used must comply with the requirements set out in this Regulation and in the relevant Rules.

ARTICLE 106. When the process of the Inputs requires systems for temperature and relative humidity control, they shall have instruments or devices to record and control the corresponding parameters.

ARTICLE 107. In the Establishments dedicated to the process of the Insured, there may be no additives, raw materials or substances, when their use in the manufacture of the Insured is not justified.

ARTICLE 108. Where the holder of a health licence or he who operates under a notice of operation intends to discharge the establishment, he shall inform the Secretariat at least 30 days before the date on which he ceases to operate, unless otherwise specified. fortuitous or force majeure.

Where narcotic drugs and psychotropic substances are in existence, they shall be made available to the Secretariat together with the corresponding control books referred to in the Law, within the same time limit, updated.

Chapter II

Establishments for the Insured Process

ARTICLE 109. Establishments intended for the processing of medicinal products shall have the areas, facilities, services, equipment and standard operating procedures laid down in the relevant rules.

The packaging of medicinal products or biological products and herbal remedies must comply with the requirements laid down for the areas and operations of conditioning in the Good Standards. manufacturing practices, in order to avoid cross-contamination risks between products.

ARTICLE 110. The standard operating procedures shall contain the following information:

I. The goal;

II. The scope;

III. The responsibility;

IV. Process development, and

V. Bibliographic references.

ARTICLE 111. The procedures referred to in the previous Article shall be signed by the persons who draw up, review and be authorised by the health officer; they shall also contain a sequential number reflecting the updates perform, the date of issue or update and the date of application and comply with what is set by the corresponding Standard.

ARTICLE 112. Establishments which process penicillinics, medicinal products which are or contain hormones and antineoplastic and microbial immunostimulants or immunostimulants, with the exception of microbial lysates, must have production systems in their facilities ensuring that there is no cross-contamination.

Penicillinics, cephalosporinics, viral or bacterial biologics and blood products, must have specific and independent areas for each of them, so that there is no cross-contamination with other areas of manufacturing.

ARTICLE 113. Establishments that manufacture biopharmaceuticals and biotechnological medicinal products will require facilities according to the processes they perform and in their case have separate areas for strains or cell lines, animals or plants; in addition to giving compliance with the applicable legal provisions, including the health licence referred to in Article 198 of the Law. In the case of foreign production, they must be certified of compliance with good manufacturing practice.

For the manufacturer of biopharmaceuticals and biotechnological medicines to release a batch, it will require compliance with the applicable provisions that correspond to ensure that the product is of quality.

ARTICLE 114. Drogueries, botics and pharmacies must meet the following requirements:

I. The areas intended for the medicinal products referred to in Sections I, II, III and IV of Article 226 of the Law shall be physically separated from other Informs, by counters, display cases or shelves. Those of fractions I, II and III shall have areas and systems for their keeping and custody;

II. Pharmacies located within self-service stores must be installed in specific areas and with the independence determined by the corresponding Standard, and away from the areas of alcoholic beverages, perishable foods and any substance that puts the integrity, purity and preservation of the medicinal products at risk. The medicinal products of Sections I, II, III and IV of Article 226 of the Law must be physically separated from the free access classified as well as by counters, display cases or shelves. Those in fractions l, II and III shall have areas and systems for their keeping and custody, and

III. The others to be set out in the corresponding Standard.

They shall also submit every six months, a notice of the provisions for the sale of drugs containing narcotic drugs and comply with the provisions of Article 45 of this Regulation.

ARTICLE 115. Masterways other than psychotropic or narcotic drugs, the preparation of which is carried out at the drogeries, shall be recorded in a foliated notebook or in electronic automated systems, with the following particulars:

I. The date, indicating day, month, and year;

II. The name of the preparation;

III. The name of the doctor you prescribe;

IV. The number of professional cedula;

V. The recipe number that the drogery will allocate in a row;

VI. The formula and pharmaceutical form, and

VII. The indications, if any.

ARTICLE 116. Establishments which sell or supply medicinal products may only provide medical prescriptions which comply with the requirements laid down in this Regulation.

ARTICLE 117. The staff of a drogery, botica or pharmacy, when dispensing a special medical prescription to be retained shall, as appropriate, register in the approved control book, without prejudice to the use of automated systems for this purpose, the following: data:

I. The portfolio number of the special medical prescription and the date it was issued;

II. The name of the prescribed medication, quantity, dosage and balance;

III. The name, address and professional ID number of the physician prescribing, and

IV. The date of the drug's discharge.

ARTICLE 118. Drogueries, boticas and pharmacies will be able to market vaccines, blood products and toxoids provided they have the necessary area and equipment for their conservation.

ARTICLE 119. The owners or those responsible for the establishments intended for the process of the Insured must give immediate notice to the Secretariat of any health irregularities detected therein, of the potential risk to the health that it means and collaborate on the required security measures.

ARTICLE 120. The Establishments shall have a single health licence irrespective of the number of processes or product lines manufactured in them. New health leave will be required in the case of new Establishments at different domicile. When they diversify their production lines to medicines with different health requirements, they must update the health licence for the extension of a new production line.

Chapter III

Health responders

ARTICLE 121. The health officials of the factories or laboratories of medicinal products and biological products for human use and of the factories or laboratories of raw materials for the manufacture of medicinal products or biological products for human use shall have the The following obligations:

I. Monitor that the manufacturing process of the Inputs is in accordance with the requirements set out in the corresponding Standard;

II. To authorise in writing the standard operating procedures;

III. Establish and monitor the implementation of procedures for the release of raw materials, medicinal products in the process and finished products;

IV. To authorise in writing procedures linked to the processing of drugs and medicinal products that are or contain narcotic drugs or psychotropic drugs, and

V. To be present during verification visits to the Secretariat or to designate, in writing, who will be represented in them, in case of absence.

ARTICLE 122. The health officials of the chemical, biological, pharmaceutical or toxicology control laboratories, for the study and testing of medicinal products and raw materials or aids for sanitary regulation, shall have the following: obligations:

I. Monitor compliance with good quality control laboratory practices of the Insured and meet the requirements set out in the corresponding Standard, and

II. Comply with the requirements of fractions II, IV and V of the previous article.

ARTICLE 123. Health officials shall monitor compliance with the good storage practices of the Insured as set out in the relevant Standard.

ARTICLE 124. The health officials of the drogeries will have the following obligations:

I. Verify that the medications have sanitary registration, Lot number and expiration date;

II. Preserve the Insured in the conditions indicated on the labelling;

III. Verify, at least once a day, the operation and temperature of the refrigerator for proper storage of the medicinal products so required and keep the register per day in a foliated notebook or automatic control system;

IV. Monitor that the equipment is calibrated and the material clean;

V. Identify and store the substances used in the masterways;

VI. Prepare the master formulas and verify that they are recorded in the book for the control of prescriptions authorized by the Secretariat;

VII. To verify that in the narcotic and psychotropic control book the entries and exits of the same are settled, in accordance with the provisions of Article 117 of this Regulation, by endorsing them with their signature autograph;

VIII. Monitor that the process of preparing the Inputs, meets the requirements set out in the corresponding Standard;

IX. To authorise in writing the standard operating procedures;

X. Establish and monitor the implementation of procedures for the release of raw materials, processed medicinal products and finished products;

XI. To authorise in writing procedures linked to the processing of drugs and medicinal products that are or contain narcotic drugs or psychotropic substances;

XII. Be present during verification visits to practice the Secretariat, and

XIII. Analyze the prescription and, if necessary, request any clarification from the person who issued it.

ARTICLE 125. The health officials of pharmacies and boticas shall comply with the provisions laid down in Sections I, II, III, IV, XII and XIII of the previous Article. When they expend medicinal products which are or contain narcotic drugs or psychotropic substances, they must also observe the provisions of Article 124 (VII) of this Regulation.

ARTICLE 125-bis. The health officials of establishments intended for use in mixing centres for the preparation of nutritional and medicated parenteral mixtures shall comply with the requirements laid down in fractions I, II, III, IV, VIII, IX, XII and XIII of the Article 124 of this Regulation, as well as with the provisions laid down in the relevant Standard. Where the preparation of nutritional and medicinal parenteral mixtures is used for narcotic drugs or psychotropic substances, they shall also be required to observe the provisions of Article 124 (VII) of this Regulation.

ARTICLE 126. When health officials cease to provide their services, these or the holders of the license or the owners of the Establishments, they shall inform the Secretariat, in the format that is issued for this purpose, within ten days. after the date of the discharge, and within 30 days after that date, the owners or owners shall advise on the designation of the new person responsible.

ARTICLE 127. The Establishments will determine the schedules of the health officers autonomously, but in no case will their responsibility be modified, even if they are infringements that are committed outside the usual hours of the person responsible. or verification visits to be carried out when the person responsible is not present.

Health officials and the holders of the licenses or owners of the Establishments will be responsible for at all times, within the working hours of the Establishment, persons who may be inform the health authority about the functioning of the Establishment, in the event of a verification visit.

ARTICLE 128. In case of temporary absence greater than thirty calendar days of the health officer, this person and the owner of the license or owner of the Establishment, must notify the Secretariat of the name of the person representing the first person, who will have to have the requirements laid down by the Law and this Regulation for health officials. The health officer shall continue to be responsible for compliance with health standards by the Establishment during his/her absence.

Chapter IV

Establishments for Herbalist Remedies

ARTICLE 129. Establishments dedicated to the manufacturing, distribution and marketing of Herbalist Remedios will be subject to control and health surveillance.

ARTICLE 130. In the case of the Establishments that commercialize Herbalist Remedios, the person responsible may be the owner of the Establishment, in the terms stated in Article 261 of the Law.

Chapter V

Establishments for Mixing Centers for the Preparation of Nutritional And Nutritional Parenteral Mixtures

ARTICLE 130-bis 1. It is considered a Mixer Center, the establishment for the preparation of nutritional and nutritional parenteral mixtures authorized by the Secretariat, in accordance with the requirements laid down in the Law, this Regulation and other applicable legal provisions.

ARTICLE 130-bis 2. Preparation of nutritional and nutritional parenteral mixtures should only be performed with a prescription.

ARTICLE 130-bis 3. The Mixing Centres shall have a basic reference bibliography so that the responsible professional can establish the conditions of stability and compatibility of the mixtures.

The basic reference bibliography referred to in the preceding paragraph shall indicate, inter alia, the technical information of the product, as well as the technical information determined by the corresponding Standard.

For the purposes of this Article, compatibility conditions shall mean those that determine the possibility that a substance may be mixed with another substance and that its characteristics of quality, safety and efficacy persist.

Also, conditions of stability are defined, those that determine the time during which their characteristics of quality, safety and efficacy persist in the mix.

ARTICLE 130-bis 4. Mixing Centres which for the preparation of parenteral mixtures use cytotoxicants must have installations which comply with the specifications laid down in the relevant Standard.

TITLE FIFTH

Import and export

Chapter I

Import

ARTICLE 131. In order to import medicinal products for the purpose of marketing, the health record of the product issued by the Secretariat must first be counted. If the importer is not the holder of the registration, he must have the consent of the holder.

You may import registered Insured for your marketing, persons who have the appropriate facilities for the safe handling of the same and who guarantee the quality and pharmacovigilance control, according to the requirements set out in the corresponding Standard.

Establishments referred to in this Article shall have health leave or health notice, as appropriate, in terms of Articles 258 and 373 of the Law.

Only medicinal products whose expiry date is greater than twelve months, counted from the entry of the medicinal products into the country, except for medicinal products which have a reduced stability and thus have been imported, may be imported. authorize the Secretariat.

The importers must notify the Secretariat of the arrival of the medicinal products within five days after the customs clearance.

ARTICLE 132. The Secretariat may grant permission for the importation of raw materials or finished products which do not have a health record, only in the following cases:

I. When any contingency is present;

II. When required by health policy;

III. For purposes of scientific, recording or personal use research, or

IV. For laboratory testing.

ARTICLE 133. In the case of raw material or finished product of foreign origin, which is or contains narcotic drugs or psychotropic substances, only authorized customs will be allowed to enter the country.

ARTICLE 134. In order to receive from the customs office raw materials or medicinal products which are or contain narcotic drugs or psychotropic substances, the following must be complied with:

A. The Importer Establishment shall inform the Secretariat in writing, within a period of not more than three days, of its entry into the country, stating:

I. The number and date of the import permit;

II. The name, quantity, batch number, and expiration date of the Insumo;

III. The provenance;

IV. The conveyor company, guide number, and

V. The invoice number;

B. The importer shall submit to the health authority attached to the appropriate customs office the following documentation:

I. Copy to coal with autograph signature, from the import permit;

II. Original and copy of the invoice certified by the Mexican consul in the country of origin;

III. Copy of the manufacturer's analysis certificate;

IV. Copy of the area, land or sea guide, and

V. Customs pediment.

Once these requirements have been met, the Secretariat will immediately emphasize the Insumo as a whole.

ARTICLE 135. For the sampling of narcotic drugs or psychotropic samples and the release of the Insumo, the establishment shall, by means of the appropriate format, request the presence of a health verifier to remove the dishware. The Secretariat will have fourteen days to make the verification visit and to resolve the request.

ARTICLE 136. In order to remove the dishware from the raw material or finished product of narcotic drugs or psychotropic substances, the health verifier shall verify the batch number, the date of expiry, the quantity and the name of the material to be released on the basis of the satisfactory analytical results and to establish in the minutes and in the control book the number and date of the import permit. Such actions shall be carried out in the presence of the owner or the health officer of the Establishment.

ARTICLE 137. Where the approved customs office has an area for the reception of narcotic drugs and psychotropic substances, which meets the characteristics and requirements of the Secretariat and the other competent authorities, it shall not be required to present the the report referred to in Article 134, and the sampling and verification of data referred to in Articles 135 and 136 of this Regulation shall be carried out in the area referred to in this paragraph, with the exception of the results analytical.

To authorize the use or marketing of the Insured referred to in the preceding paragraph, the owner or the health officer of the Establishment must present the certificate of the corresponding analysis carried out by the own lab or by an Authorized Third Party.

ARTICLE 138. For the import of foreign-made biologics and blood products, the authorisation of the Secretariat and, where appropriate, the application of the product's anger in writing shall be required.

For the removal of dishware, conditioning and sampling, the establishment must ask the Secretariat for the presence of a health verifier. All these acts must be recorded in the verification report in the presence of the health officer of the establishment. The distribution or sale of the products referred to in this Article may be effected once the products referred to in Articles 43 and 201 of this Regulation are complied with.

ARTICLE 138-bis. For the release of biotechnological import medicinal products it is necessary to have the analytical certificate of the manufacturer and the importer must have the analytical results in accordance with the requirements laid down in the Pharmacopoeia Mexican United States and its supplements, or where there is no relevant information in it, with the requirements of the Pharmacopeas of other countries. The corresponding analyses may be carried out in your quality control laboratory or by any laboratory with a Certificate of Good Manufacturing Practice issued by the Secretariat. If the tests are carried out abroad, the maintenance of the system of closing and temperature control must be established.

ARTICLE 139. The Secretariat shall require the analytical certificates of the import of the Inputs to be endorsed by the health officer or the equivalent of the manufacturer's laboratory and the health officer of the laboratory requesting the registration.

ARTICLE 140. Only the import of Herbalist Remedios with a sanitary permit for placing on the market will be permitted to establishments that have a warning of operation.

ARTICLE 141. Establishments that import used equipment shall have control books or electronic automated systems and shall use a page for each medical equipment for the recording of the following data:

I. The name of the imported appliance;

II. The brand;

III. The number of import health authorization;

IV. The date of entry;

V. Tests for proper operation;

VI. The name of the acquirer;

VII. The invoice number;

VIII. The sales date, and

IX. The guarantee of effectiveness.

ARTICLE 142. Import inputs that are in transit in the country do not require registration in Mexico and for no reason may be marketed within the national territory.

ARTICLE 143. The importer shall inform, at the request of the Secretariat, the destination of the products or raw materials which are the subject of the import.

ARTICLE 144. The Secretariat may, at all times, verify the identity and health status of the import products and raw materials, and may apply the security measures provided for in the Act and this Regulation.

ARTICLE 145. The products or raw materials which, requiring prior sanitary authorization of importation, are introduced into the country without this permit, shall be considered illegally interned. The Secretariat shall apply the relevant security and sanctions measures and shall inform the competent authorities of this fact.

ARTICLE 146. Without prejudice to other arrangements, importers shall retain the prior health authorisations for imports of the Insured products covered by this Regulation, at least for three years and in the case of sources of radiation for medical use, for the lifetime of the medical use, and shall be required to display it to the health authority when required.

ARTICLE 147. The imports of the Insured foreign diplomatic personnel accredited in the country through their embassies, will be governed by international reciprocity, without prejudice to the powers of the Secretariat to identify the Insured objects. of the import. In the event that they involve a health risk, due to health failures that endanger the health of the population, the Secretariat shall adopt the security measures provided for in the Law and in this Regulation.

ARTICLE 148. The importation of Insured whose use or consumption has been prohibited for health reasons in their country of origin or on the recommendation of specialised international bodies shall not be authorised.

ARTICLE 149. In the case of a national or international health alert, the Secretariat shall take the necessary measures to prevent the importation, distribution or marketing of products, raw materials and other ingredients involved in the preparation of such products. can cause harm to health. Those measures shall be published in the Official Journal of the Federation.

Chapter II

Export

ARTICLE 150. In order to obtain the certificate of export of the Insured, an application must be submitted in the official format to which the original of the letter of acceptance of the final importer is annexed in letterhead paper. The Secretariat will have five days to resolve the request.

In the case of allopathic medicinal products and raw materials and additives that are involved in their preparation and which are neither narcotic or psychotropic, the Secretariat will have to resolve the application ten days. In case of failure to do so within that period the application shall be understood.

ARTICLE 151. The person concerned shall give notice to the Secretariat of the date on which the export is intended to carry out an export permit for narcotic and psychotropic export, in order to designate a health verifier to release the record:

I. That the Insumo corresponds to the authorized, corroborating numbers and dates of export and import permits, product name, lot number, expiration date and quantity;

II. The name of the carrier, and

III. That the Insumo became angry, sealed and lacerated.

The above data must be entered in the control book authorized by the Secretariat, in the presence of the health officer of the Establishment.

ARTICLE 152. Where the importing country rejects, for health reasons, an export of the finished product or product, the exporter and, where appropriate, the manufacturer shall inform the Secretariat of this fact within a period not exceeding five days, providing the following data:

I. The identification;

II. The quantity;

III. The presentation;

IV. The number of Lot and Item;

V. The expiration date;

VI. The date of export;

VII. The name of the manufacturer or exporter;

VIII. The cause of the rejection, and

IX. The analytical certification and analytical method used.

In case the exporter decides to re-enter the country, his or her finished products or products must apply for import permits.

The health authority shall determine the final destination of the Insured and the products referred to in this Article at the time the exporter presents the opinion on the evidence requested by that authority, which shall be carried out by authorised laboratories.

In cases where the destruction proceeds, the corresponding expenditure shall be borne by the exporter.

ARTICLE 152-bis. The formalities for the import and export of the health inputs referred to in this Regulation may be submitted by electronic means.

Applicants who opt for electronic means in the proceedings referred to in the preceding paragraph shall submit the same information and documentation as they do under this Regulation and other applicable legal provisions requires the corresponding processing. Such information and documentation shall be submitted by such electronic means.

The procedures performed by electronic means will be substantial and will be resolved by the same means, so the notifications made to the applicant regarding the requirements, actions, resolutions, exhibition, conservation or submission of authorisations or documents to be submitted by the competent authority to the competent authority and, in general, any administrative act resulting from such formalities, shall be verified by electronic means, in accordance with the legal provisions applicable.

TITLE SIXTH

Authorizations and Warnings

Chapter I

Common Provisions

ARTICLE 153. Health authorisations shall be requested in the official formats provided by the competent authority, which shall be accompanied by the documents referred to in this Regulation.

The documents accompanying the applications must be drawn up in Spanish, and if not, they must attach to them their respective translation into Spanish, endorsed with the signature of the health officer.

Documents issued by authorities in other countries must be supported or legalized and translated by expert translators.

ARTICLE 154. Where this Regulation does not specify an express time limit for resolving an application, the Secretariat shall have 40 days to that effect.

In all cases, the time limits shall be counted from the day following the receipt of the duly requested health authorization request.

ARTICLE 155. Time-limits shall be suspended where the Secretariat requires the applicant, in an express and written form, with documents, clarifications or missing information, and shall resume the day after the individual has delivered such information, documents or documents. the relevant clarifications. In case of not being provided in the term to be granted to the effect, the application shall be such as not to be filed.

ARTICLE 156. The Secretariat may require, in writing, additional or missing information within a time limit which shall be equal to one third of the period granted for the purpose of resolving the application, where the latter is of a two-thirds administrative nature. parts, where it is of a technical nature.

If the time limits set forth in the previous paragraph elapse, the Secretariat will not be able to deny the authorization for lack of information. In case applications consider active ingredients or therapeutic indications not known in the United Mexican States, the authority may request additional technical information at any time.

ARTICLE 157. The health authorizations granted in the terms of this Regulation may be reviewed by the Secretariat or the States at any time, in accordance with the requirements of the Law and this Regulation.

When of the review made, the Secretariat determines that the holder does not comply with any provision established in the Law or in this Regulation, will notify the person concerned to be, within a period of not more than 15 days, counted to from the date of the notification, express what is at its right. After that period, there is, or does not exist, the person concerned, the Secretariat shall determine what is appropriate.

ARTICLE 158. In the activities, Establishments, Insured and Services covered by this Regulation, the health control card referred to in Article 377 of the Law shall not be required.

ARTICLE 159. In order to obtain the authorization of the narcotic and psychotropic control books, it is required to submit an application in the official format, which will be attached to the foliated librettas legal size with fillings that prevents the separation of the leaves, with product-delimited separations, in order to bring the control and balance of raw materials and medicinal products, as the case may be, according to the following:

I. Medicines that can only be purchased with a prescription or special permission;

II. Medications that require medical prescription to be retained in the pharmacy that is in the groove;

III. Medicines that can only be purchased with a prescription that can be dispensed up to three times, and

IV. Raw materials including narcotic drugs or psychotropic substances.

The Secretariat will respond in one day.

ARTICLE 160. The maximum validity of import and export authorisations shall be one hundred and eighty days, which may be extended for an equal period, provided that the conditions under which they were granted do not change.

ARTICLE 161. Documents originating in a foreign country which are submitted on the occasion of the importation or registration of the Insured referred to in this Regulation shall meet the following requirements:

I. Copies of invoices for medical equipment used or rebuilt shall be certified and clearly express that they are used equipment;

II. Certificates of analysis of products containing blood products shall be endorsed by the regulatory entity of the country of origin, and

III. Letters of representation shall be authenticated by the legal proceedings in the country of origin. These letters must be presented in Spanish or in another language, with their translation, carried out by a translator.

ARTICLE 161-a. The Secretariat may issue provisions of a general nature which are intended to recognise that the requirements, tests, evaluation procedures and other requirements requested by the foreign health authorities to enable them to be respective countries the sale, distribution and use of the Insured referred to in this Regulation are equivalent to those which the Law, this Regulation and other applicable provisions require in order to ensure the quality, safety and efficacy that they must satisfy such Insured, to obtain their sanitary registration in the country.

Chapter II

Licenses

ARTICLE 162. In order to obtain the health licence, the application shall be submitted in the official format, specifying the health requirements for the operation of the type of establishment for which the licence is requested, which shall be annexed, exclusively, Federal Taxpayer Register issued by the Secretariat of Finance and Public Credit. The Secretariat will have sixty days to resolve the license application. In case of failure to do so within that period the application shall be understood.

When the applicant submits certification of compliance with the requirements of operation issued by a Third Authorised by the Secretariat, the latter shall have a period of ten days to resolve the licence application. In case of failure to do so within that period the application shall be understood.

ARTICLE 163. The health authority, for the granting of the health license, may carry out verification visits to verify that the Establishments comply with the requirements of the Law, this Regulation and the corresponding Rules, as well as with what was stated in your request.

ARTICLE 164. Licences for establishments using radiation sources for medical use, as well as for those responsible for the operation and operation of such radiation sources, shall be subject, as appropriate, to the provisions of the Regulation. of the General Health Law on Health Control of Environmental Health, without prejudice to the privileges of other agencies.

Chapter III

Records

ARTICLE 165. The Secretariat, when granting the sanitary registration to the Insured, will identify them by assigning an alphanumeric key and the acronym SSA, which the registry holder will express in the labelling of the products, as established by the Standard corresponding.

ARTICLE 166. Requests for health registration of allopathic medicinal products shall be resolved by the Secretariat, in accordance with the following:

I. In the case of medicinal products containing active ingredients and therapeutic indications already registered in the United Mexican States, the resolution shall be issued within a maximum period of one hundred and eighty calendar days;

II. In the case of medicinal products whose active ingredients are not registered in the United Mexican States, but are registered and sold freely in their country of origin, the decision shall be issued within a maximum of two hundred forty calendar days, and

III. In the case of medicinal products with new molecules, prior to the application for sanitary registration, a technical meeting shall be held between the applicant and the New Molecules Committee of the Federal Commission for the Protection against Health Risks. Once the health registration application is submitted, the resolution shall be issued within a maximum period of 180 calendar days.

The New Molecules Committee will be composed of the Commissioner for Health Authorization, the Executive Director of Product Authorisation and Establishments, the Director of the National Pharmacovigilance Centre, and representatives of academic associations.

When the last day of the deadline is indeft, it shall be deemed to be extended until the following working day.

If the applicant submits a favourable technical report issued by an institution recognised as Third Authorised by the Secretariat, the time limits shall be halved.

ARTICLE 167. To obtain the health record of an allopathic medicinal product, it must be presented exclusively:

I. Technical and scientific information demonstrating:

a. The identity and purity of its components in accordance with what is established by the United Mexican Pharmacopoeia and its supplements;

b. The stability of the finished product in accordance with the relevant Standards;

c. Therapeutic efficacy and safety in accordance with the relevant scientific information;

II. The information to prescribe, in its broad and reduced versions, and (sic)

III. The tag project;

IV. The point made in Article 167-bis of this Regulation;

V. For Generic Medicinal Products, instead of the information referred to in section 1 (c), the report of the interchangeability tests in accordance with the relevant Standards and other applicable provisions, and

VI. Identification of the origin and certificate of good manufacturing practice of the drug issued by the Secretariat or by the competent authority of the country of origin.

In case the applicant submits the certificate of the competent authority of the country of origin, and it comes from countries with which the Secretariat has no agreements of recognition in the field of good practice of manufacture, the Secretariat shall verify compliance with good manufacturing practice and the production process of the medicinal product, as well as the certification of its active substances, in accordance with the relevant Standards. If appropriate, the Secretariat shall, within a period not exceeding 20 working days, fix the date on which the Secretariat or its authorized third parties shall verify compliance with good manufacturing practice and the production process of the medicinal product. as the certification of its active principles in the terms provided for in the Law and other applicable provisions. If this check is not carried out on the scheduled date for reasons attributable to the Secretariat, it shall be rescheduled as a priority.

The certification of good manufacturing practices will be in effect for thirty months.

As provided for in Article 391 bis of the Act, the Secretariat may issue certificates on the basis of information, fact-checking or technical recommendations provided by authorized third parties.

For the granting of the sanitary registration referred to in this article, the Secretariat shall verify compliance with good manufacturing practices and the production process of the medicinal product, as well as the certification of its active principles, in accordance with the relevant rules.

When in the United Mexican Pharmacopoeia and its supplements there is no relevant information, the information of pharmacopoeas of other countries whose analysis procedures are performed according to specifications and recommendations of specialised bodies or other sources of international scientific information.

ARTICLE 167-bis. The applicant for the registration of an allopathic medicinal product shall attach to the application the documentation showing that he is the holder of the patent of the active substance or ingredient or which has the corresponding licence, both of which are registered in the Mexican Institute of Industrial Property.

Alternatively, and according to the list of products established in Article 47a of the Regulation of the Law of Industrial Property, may manifest, under protest of truth, that it complies with the applicable provisions in the case of patents in respect of the active substance or ingredient covered by the application. In this case, the Secretariat shall immediately request the technical cooperation of the Mexican Industrial Property Institute so that, within the scope of its competence, it shall determine at the latest within ten working days after the receipt of the request, if existing patent rights are invoked. If the Mexican Institute of Industrial Property concludes that there are patents in force on the active substance or ingredient of which the applicant is not a holder or a licensee, it shall inform the Secretariat that it will prevent the applicant for the purpose of proving that he holds the patent or that he has the respective license, within the time limit determined by the Secretariat and which may not be less than five working days from which the notification. Where the applicant does not remedy the omission, the Secretariat shall discard the application and inform the applicant of the reasons for this determination so that, where appropriate, the applicant shall address them to the competent authority. The lack of response from the Mexican Institute of Industrial Property within the stated period will be understood in a favorable sense to the applicant.

Without prejudice to the above two paragraphs, registration of a generic in respect of a medicinal product whose active substance or ingredient is protected by a patent may be requested for the purpose of carrying out the studies, trials and experimental production in the three years preceding the expiry of the patent. In this case, the health record shall be granted only upon completion of the patent.

The information referred to in Articles 167 and 167 bis of this Regulation that is confidential or reserved in accordance with the international treaties of which Mexico is a party and with the other applicable legal provisions, shall be protected against any disclosure to other individuals.

ARTICLE 168. In order to be the holder of the health registration of a medicinal product, it is necessary to have a factory or laboratory health license for medicinal products or biological products for human use. In the case of foreign manufacturers, it is required to have a license, certificate or document that proves that the company has the permission to manufacture medicines, issued by the competent authority of the country of origin.

ARTICLE 169. In order to be the holder of the health registration of vaccines and blood products in addition to complying with all applicable provisions for allopathic medicinal products, the relevant rules for biological and blood products shall be complied with.

ARTICLE 170. In order to obtain the health registration of allopathic foreign-made medicinal products, in addition to complying with Article 167, fractions I to V of this Regulation, the following documents shall be annexed to the application:

I. The certificate of free sale or equivalent issued by the relevant authority of the country of origin;

For medicinal products containing new molecular entities that have not been placed on the market in any other country for not having the corresponding sanitary registration and which are intended to be registered in Mexico, the certificate to referred to in the preceding paragraph, may be replaced by the report of clinical studies that have the participation of Mexican population and demonstrate the safety, quality and efficacy of the product, as well as the document describing the activities and interventions designed to characterize and prevent potential Previously identified risks related to medicinal products, including measuring the effectiveness of such interventions.

II. Certificate of good manufacturing practice for the medicinal product and the medicinal product, issued by the Secretariat or by the competent authority of the country of origin.

In case the applicant submits the certificate of the competent authority of the country of origin, and it comes from countries with which the Secretariat has no agreements of recognition in the field of good practice of manufacture, the Secretariat shall verify compliance with good manufacturing practice and the production process of the medicinal product, as well as the certification of its active substances, in accordance with the relevant Standards. If appropriate, the Secretariat shall, within a period not exceeding 20 working days, fix the date on which the Secretariat or its authorized third parties shall verify compliance with good manufacturing practice and the production process of the medicinal product. as the certification of its active principles in the terms provided for in the Law and other applicable provisions. If this check is not carried out on the scheduled date for reasons attributable to the Secretariat, it shall be rescheduled as a priority.

The certification of good manufacturing practices will be done at the request of a party and will be in force for thirty months.

As provided for in Article 391 bis of the Act, the Secretariat may issue certificates on the basis of information, fact-checking or technical recommendations provided by authorized third parties, and

III. The document that accredits a legal representative with domicile in the United Mexican States.

For the granting of the sanitary registration referred to in this article, the Secretariat shall verify compliance with good manufacturing practices and the production process of the medicinal product, as well as the certification of its active principles, in accordance with the relevant rules.

ARTICLE 171. The formulas for enteral enteral feeding require health registration, for which the application will be submitted in the corresponding format, to which the following documents will be annexed:

I. Product Description;

II. Cualicuantitive formula;

III. Project of Label with precautious legends and conditions of management, conservation and storage;

IV. The instructional of use, if any;

V. The stability tests;

VI. The certificate of analysis of raw materials and finished product, their control methods and bibliographic references;

VII. The finished product specifications;

VIII. The certificate of free sale issued by the health authority or competent body of the country of origin, if the product is imported, and

IX. The letter of representation of the product, if any.

The Secretariat will have sixty days to resolve the request.

If the applicant submits a favourable opinion issued by a Third Authorised to the Secretariat, it shall authorise the registration within 15 days.

ARTICLE 172. Vitamin medicinal products shall require health registration, in order to be submitted in the appropriate format, to which the following documents shall be annexed:

I. The monograph of the finished product with methods of control, qualitative and quantitative, of all the components;

II. The conditions of handling, storage and storage;

III. The description of the Primary and Secondary Packaging and atoxicity tests;

IV. Tag projects with precautious legends;

V. The instructional of use, if any;

VI. The stability tests, according to the Standard;

VII. The certificate of analysis of the raw material and finished product, containing the physico-chemical and microbiological specifications, and

VIII. The certificate of free sale or equivalent, if the product is of import, issued by the health authority or competent body of the country of origin and letter of representation of the supplier.

The Secretariat will have forty-five days to resolve the request.

If the applicant submits a favourable opinion issued by a Third Authorised to the Secretariat, it shall authorise the registration within 15 days.

ARTICLE 173. In order to obtain the registration of homeopathic medicinal products of national manufacture, it is required to submit an application in the official format, to which the following documentation will be attached:

I. Technical and scientific information demonstrating:

a. The identity and purity of its components in accordance with what is established by the Homeopathic Pharmacopoeia of the United Mexican States and its supplements or, failing that, the homeopathic pharmacopoeias of other countries or sources of scientific information international, and

b. The stability of the finished product according to the corresponding Standard.

II. Therapeutic indications;

III. The Label projects;

IV. The pathogenesis of active substances;

V. The instructional for use, if any;

VI. The description of the manufacturing process of the medicinal product to be registered, and

VII. The text of the broad and reduced version of the information to be prescribed in the case of the medicinal products referred to in Section I to IV of Article 226 of the Law.

The Secretariat will have forty-five days to resolve the request. In case of failure to do so within that period the application shall be understood.

If the applicant submits a favourable opinion issued by a Third Authorised Party to the Secretariat, it shall authorise the registration within a maximum of 15 days.

For the granting of the sanitary registration referred to in this article, the Secretariat will verify compliance with good manufacturing practices and the production process of the drug, as well as the certification of its active principles, in accordance with the relevant rules.

ARTICLE 174. In order to obtain the registration of herbal medicines of national manufacture, it is required to submit an application in the official format, to which the following will be annexed:

I. Technical and scientific information demonstrating:

a. The identity and purity of its components according to what the special pharmacopoeias establish or, failing that, the sources of international scientific information;

b. The stability of the finished product, and

c. The taxonomic identification.

II. Therapeutic indications;

III. The Label projects;

IV. The instructional for its use, and

V. The description of the manufacturing process of the product to be registered.

The Secretariat will have forty-five days to resolve the request.

If the applicant submits a favourable opinion issued by a Third Authorised to the Secretariat, it shall grant the registration within a period of 15 days.

For the granting of the sanitary registration referred to in this article, the Secretariat will verify compliance with good manufacturing practices and the production process of the drug, as well as the certification of its active principles, in accordance with the relevant rules.

ARTICLE 175. In order to obtain the sanitary registration of homeopathic medicinal products and foreign-made herbalists, in addition to the requirements set out in Articles 173 and 174 of this Regulation, the following documentation shall be submitted:

I. The certificate of free sale issued by the competent authority of the country of origin;

II. The certificate of analysis issued by the manufacturer of the medicinal product, on paper letterhead and endorsed by the health officials of foreign and domestic companies, and

III. The manufacturer's letter of representation, only when the laboratory that manufactures it abroad is not a subsidiary or parent of the laboratory requesting the registration.

The Secretariat will resolve applications within the time limits set out in Articles 173 and 174 of this Regulation, as the case may be.

For the granting of the sanitary registration referred to in this article, the Secretariat shall verify that the good manufacturing practices and the production process of the medicinal product are complied with, as well as the certification of their active principles, in accordance with the relevant rules, through the licence, certificate or document issued by the competent authority of the country of origin for such purposes.

ARTICLE 176. Any change of domestic to foreign manufacture of a medicinal product shall change the conditions of the registration and must comply with the conditions specified in the previous article.

To authorize foreign-to-domestic manufacturing of any registered medicinal products, the application shall be submitted in the official format and shall be complied with in accordance with Articles 167, 173 and 174 of this Regulation, the medicinal product concerned.

ARTICLE 177. In order to obtain the sanitary registration of innovative biotechnological medicines, it is required to submit an application in the official format, which for this purpose is published in the Official Journal of the Federation, to which the documentary information will be annexed. next:

I. The monograph of the biopharmaceutical, composition and formula;

II. The origin and history of the master cell bank, the gene, the construction of the vector-host expression system for the protein of interest and the relevant characterization of the genotype and phenotype;

III. The summary of the process of manufacture of the biopharmaceutical: cell strain or cell line, fermentation, separation and purification, as well as the flow diagram corresponding to that process;

IV. Analytical methods: physical, chemical and biological for raw materials and biopharmaceuticals, as well as the validation report of their results, carried out by the manufacturer, for cases in which they are not pharmacopoeic methods;

V. The report of the validation of the manufacturing process, performed by the manufacturer;

VI. The monograph of the medicinal product including the International Common Name, pharmaceutical form, qualitative and quantitative specifications;

VII. The manufacturing, formulation, filling and conditioning processes, as well as their process controls;

VIII. The corresponding label and instructional projects, as well as the specifications of the primary and secondary packaging, in accordance with the Law, this Regulation and other applicable provisions;

IX. Intensive pharmacovigilance programme, in accordance with the applicable provisions, and

X. The preclinical and clinical studies that the Secretariat points out as necessary to demonstrate the safety, efficacy and quality of the product, in accordance with the law, this Regulation and other applicable legal provisions, including the report of adverse events and immunogenicity, characterizing the immune response and assessment of the correlation between neutralising antibodies to the pharmacokinetics and pharmacodynamics of the product.

All innovative biotechnological drugs must be submitted for evaluation before the New Molecules Committee and must be studied by the Subcommittee on the Evaluation of Biotechnological Products prior to submission. of the health registration application to determine whether clinical trials are effective in demonstrating their safety, quality and efficacy.

For the case of innovative biotechnological medicinal products for foreign manufacture in addition to the above documents, they shall be annexed to those set out in Sections I, II and III of Article 170 of this Regulation.

The Secretariat shall resolve applications for the registration of innovative biotechnological medicinal products within one hundred and eighty calendar days from the day following that in which the application for registration is submitted. corresponding. The Secretariat may request missing information, for the first time, during the first hundred and twenty calendar days of the period referred to above, with the person concerned a maximum of 100 working days to reply, counted from the day following the one in which you have been notified of the respective prevention.

If the Secretariat does not issue the respective resolution within the stated time limit, the registration application shall be deemed to be resolved in a negative sense.

ARTICLE 177-bis 1. Clinical studies of innovative biotechnology drugs should be conducted in Mexico:

I. When the medicinal product is manufactured in the national territory, and

II. Where the manufacture and studies referred to have been carried out abroad and so determined by the Secretariat, on the basis of the opinion of the New Molecules Committee, after consultation with the Subcommittee on the Evaluation of Products Biotechnology.

ARTICLE 177-bis 2. In order to obtain the sanitary registration of biocomparable biotechnological medicinal products, it is necessary to submit an application in the official format, which for this purpose is published in the Official Journal of the Federation, to which Annex the documentation contained in sections I to IX of Article 177 and the preclinical and clinical studies that the Secretariat points to as biocomparability studies, immunogenicity studies and adverse event reports, and other Secretariat determines, after the opinion of the new Molecules Committee, after consultation to the Sub-Committee on the Evaluation of Biotechnological Products, which shall be made of the knowledge of the interested parties by publication in the Official Journal of the Federation.

Once a biocomparable biotechnological medicinal product has been shown to be biocomparable, the indications that the reference biotechnological medicinal product has approved will be authorised, provided that the medicinal product biocomparable biotechnological is present in the same pharmaceutical form and dose as the reference biotechnological and that these indications share the same mechanism of action or that the biocomparable biotechnological medicinal product has the same effect pharmacodynamic, either according to the published by the reference, or in his case according to the clinical experience and scientific evidence available. This is without prejudice to the international treaties of which Mexico is a party.

For the purposes of the preceding paragraph, the Secretariat shall, on the basis of the opinion of the New Molecules Committee, after consulting the Subcommittee on the Evaluation of Biotechnological Products, determine the biocomparability tests. to permit the authorisation of therapeutic indications for biocomparable biotechnological medicinal products.

Without prejudice to the above paragraphs, registration of a biocomparable medicinal product may be requested in respect of a biotechnological medicinal product protected by a patent, in order to carry out the studies, tests and corresponding experimental production, within eight years prior to the expiry of the patent. In which case, the health record shall be granted only at the end of the validity of the patent.

ARTICLE 177-bis 3. The scope of the clinical trials of biocomparability should be based on the characterization of the biopharma and biocomparable biotechnological medicinal product, and the more characterized the product and the better it is demonstrated. Physical-chemical comparability, lower clinical evidence will be required.

The dosage, dose, and route of administration of the biocomparable biotechnological medicinal product should be the same as those of the reference biotechnological medicinal product.

ARTICLE 177-bis 4. Preclinical and clinical studies, in which the applicant for the registration of biocomparable biotechnological medicinal products based on their application, shall use the relevant biotechnological reference medicinal product for the performance of the comparative and physico-chemical studies. For this purpose, you must present the following documentary information:

I. In vitro studies. These shall not be required when the Secretariat, on the basis of the opinion of the New Molecules Committee, after consultation with the Sub-Committee on the Evaluation of Biotechnological Products, determines this;

II. The reports of preclinical studies in animals including information comparing the biotechnological reference medicine and biocomparable biotechnological medicinal product. Such pre-clinical studies must be carried out on animal species relevant to the study model and must include, in accordance with the opinion of the Committee on New Molecules, after consultation with the Sub-Committee of Molecules. Assessment of Biotechnological Products, the following data:

a. Comparative reporting of the pharmacodynamic effect and relevant activity for the clinical application;

b. Comparative toxicology report in at least one repeated dose toxicity study, including toxicocytic measurements;

c. The reported duration of studies should be technically justified to allow for the detection of relevant differences in toxicity and immune responses between biocomparable biotechnological medicinal product and the biotechnological medicinal product of reference;

d. If the results of the studies mentioned are not sufficient, relevant observations should be included in the same toxicological study of repeated doses, including, local tolerability, and

e. Only reports of other toxicological studies such as pharmacological safety, reproductive toxicology, mutagenesis and carcinogenicity for the evaluation of biocomparable biotechnological medicinal products, if the results of the dose studies, will be required. repeated so require;

III. A report of comparative pharmacokinetic studies, when determined by the Secretariat, taking into account the opinion of the New Molecules Committee, after consultation with the Subcommittee on the Evaluation of Biotechnological Products, for demonstrate the pharmacokinetic biocomparability between the biocomparable biotechnological medicinal product and the reference biotechnological medicinal product in relation to the key parameters;

IV. Reports of pharmacodynamic studies with the following characteristics:

a. Markers for pharmacodynamics should be selected according to their relevance to demonstrate therapeutic efficacy of the product;

b. The pharmacodynamic effect of the biocomparable biotechnological medicinal product and the reference biotechnological medicinal product should be compared in a population where possible differences can be observed, and

c. The design and duration of the studies should be justified.

Combined pharmacokinetic and pharmacodynamic studies may provide useful information on the relationship between exposure and effect, and

V. Clinical studies of efficacy and comparative safety to demonstrate clinical similarity between the biocomparable biotechnological medicinal product and the reference biotechnological medicinal product. Such studies shall have the following characteristics:

a. The parameters and margins of clinical biocomparability should have been justified and specified prior to the performance of such studies and should be clearly indicated in the report of comparative efficacy and safety studies. present for evaluation;

b. Comply with the applicable normativity of good clinical research practices that ensure the scientific validity of the study, and

c. For those medicines where the immune response may affect the endogenous protein or its biological function, the antibody tests should be performed in the safety clinical trials, taking into account the role that the immune response may have. hypersensitivity, infusion reactions, autogenicity, and loss of efficacy.

For the purposes of the above fractions, the specific requirements for the approval of each biocomparable biotechnological medicinal product shall be determined by the Secretariat, considering, the opinion of the Committee for New Molecules, after consultation with the Subcommittee on the Evaluation of Biotechnological Products.

For the case of biocomparability studies in relation to a reference biotechnological medicinal product, the same should be used throughout the development of biocomparable biotechnological medicinal product, in order to compare quality and preclinical and clinical studies.

Once the first registration of a biocomparable biotechnological medicinal product has been granted, in respect of a molecule identified by the International Common Denomination, the listing of the requirements relating to technical information based on Those who have been granted registration must be published by the Secretariat in the Official Journal of the Federation. The same requirements shall be met in order to obtain the registration of subsequent biocomparable biocomparable medicinal products corresponding to the same International Common Name. These requirements may vary, taking into account the advances of science and technology, which, if so, will be made known by the Secretariat, by means of publication in the Official Journal of the Federation. Where in the Pharmacopoeia of the United Mexican States and in its supplements there is no relevant information, nor in national guides or monographs, the Secretariat may evaluate the biocomparability tests using the information of guides

The clinical studies of biocomparable biotechnological medicinal products must be carried out in Mexico, when determined by the Secretariat on the basis of the opinion of the New Molecules Committee, after consultation with the Subcommittee on the Evaluation of Biotechnological Products.

For biocomparable biocomparable biotechnological medicinal products for foreign manufacture in addition to the above documents, those laid down in Article 170 (I), (II) and (III) of this Regulation shall be annexed.

The Secretariat shall resolve applications for the registration of biocomparable biotechnological medicinal products within one hundred and eighty calendar days from the day following that in which the application for registration is submitted. corresponding. The Secretariat may request missing information, for the only time, within the first hundred and twenty calendar days of the period referred to above, with the person concerned a maximum of 100 working days, counted from the day following that in which has been notified of the respective prevention for its failure.

If the Secretariat does not issue the respective resolution within the stated time limit, the registration application shall be deemed to be resolved in a negative sense.

N. E. IN RELATION TO THE ENTRY INTO FORCE OF THIS ARTICLE, SEE TRANSITIONAL FIRST OF THE DECREE AMENDING THE REGULATION.

ARTICLE 177 Bis 5. An innovative biotechnological medicinal product or biocomparable biotechnological medicinal product may be approved for use in other clinical indications, provided that there is scientific justification approved by clinical studies, as determined by the the Secretariat considering the opinion of the New Molecules Committee, after consultation with the Subcommittee on the Evaluation of Biotechnological Products.

ARTICLE 178. Each batch of biomedical manufactured before being released must comply with what the United Mexican Pharmacopoeia establishes in terms of quality, purity, identity and power. Where the relevant information does not exist, the pharmacopoeas information may be used in other countries whose analysis procedures are carried out in accordance with specifications and recommendations of specialised bodies or other sources of international scientific information.

ARTICLE 179. In order to obtain the sanitary registration of the Insured referred to in Chapter IX of Title II of this Regulation, an application must be submitted in the official format, to which the following documentary information shall be annexed:

I. Scientific and technical information to demonstrate that Insumo brings together the safety and efficacy features;

II. The Spanish Language Label project, in the terms of the corresponding Standard;

III. The instructional, if applicable, for use or manual of operation in Spanish language;

IV. The description of the manufacturing process that is performed to obtain the product;

V. The description of the structure, materials, parts and functions, in the case of medical equipment;

VI. The constancy of good manufacturing practice;

VII. Laboratory tests to verify Insumo specifications;

VIII. Bibliographic references, and

IX. The other to be established by the Secretariat in the relevant Rules.

The Secretariat shall resolve the applications for registration of Class I Insured within thirty days. In case of failure to do so within that period the application shall be understood.

For the Insured classes II and III, the Secretariat shall be thirty-five and sixty days, respectively, to resolve the application.

If the applicant submits a favourable opinion issued by a Third Authorised to the Secretariat, in the sense that the Insumo complies with the conditions of safety and efficacy, the Secretariat shall authorize the registration in a period not longer than 15 days.

ARTICLE 180. For the health record of the Insured referred to in Chapter IX of Title II of this Regulation, which are foreign-made, in addition to the requirements set out in the previous Article, application shall be made in the official format, to which the following documentation shall be annexed:

I. The certificate of free sale or equivalent, issued by the health authority of the country of origin;

II. The manufacturer's letter of representation, if the product is not manufactured by the parent or factory or laboratory requesting registration in Mexico;

III. The certificate of good manufacturing practice issued by the health authority of the country of origin, and

IV. The original certificate of analysis issued by the company that makes the product, with the letterhead of its social reason and signed by the chemicals responsible for the foreign company.

The Secretariat will resolve applications within the time limits set out in Article 179 of this Regulation.

ARTICLE 181. In order to be the holder of the sanitary registration of the Insured referred to in Chapter IX of Title II of this Regulation, it is required to have a factory or laboratory operating notice of production, warehouse or distribution or conditioning established in the national territory.

ARTICLE 182. The registration of the Insured as referred to in the previous article, may be used by other distributors, prior to the authorization of the manufacturer and the Secretariat with the letter of representation of the manufacturer and the draft Label corresponding.

ARTICLE 183. Persons other than the holders of the register may only draw up the products registered with the authorisation of the holder, provided that they are drawn up under the same conditions as they were authorised for sale, and the following conditions are met: requirements:

I. That the establishment in which the product is drawn up has a health licence or operating notice, as laid down in this Regulation;

II. The holder of the health record shall have at all times and without any restriction the possibility of monitoring the conditions for the production of the product and, where appropriate, to establish the improvements or adjustments it deems necessary for it to be prepare under the same conditions as it was authorized, and

III. That the product label identifies the address of the working establishment and the name and address of the registrant, when the external manufacturing process is carried out continuously for more than three hundred and sixty days.

ARTICLE 184. Any modification intended to be made to the conditions under which the Insured referred to in Chapter IX of Title II of this Regulation were recorded, must be authorized in advance by the Secretariat, for which the technical, scientific and legal information, where appropriate, to justify such modification. When changes of drugs or pharmaceutical form or formulation are made, a new registration shall be required, except in the case of a reformulation indicated or agreed by the Secretariat.

In the case of a distributor change, the projects of label or counter-label, when required, will be accompanied by duplicate in Spanish. In the case of Insured with exclusive presentation for public health or social security institutions, it will be annexed to the corresponding key in the Basic Table or in the Catalogue of Insured and, in the case of sources of radiation, the corresponding license.

ARTICLE 185. In order to obtain the approval of modifications to the conditions of registration of any medicinal product, application must be submitted in the official format accompanied by the projects of Labels and, where appropriate, the text projects of the versions broad and reduced information to prescribe, as well as, where appropriate, the following:

I. The stability tests according to the corresponding Standard, for changes in manufacturing processes, primary packaging material, expiry time, and additives or excipients;

II. The written technical justification giving the need or convenience to change the primary packaging;

III. Copies of the monographs of the additives and excipients and their bibliographic references for changes in these ingredients;

IV. The method of control and specifications of the drugs and additives and finished product signed by the health officer of the Establishment, for changes in the manufacturing process, packaging or additives and excipients, and

V. The provisions of Article 176 of this Regulation for changes in domestic production to foreign or foreign-to-domestic manufacturing.

ARTICLE 186. The Secretariat shall resolve requests for amendments to the conditions for registration of any medicinal product in accordance with the following deadlines:

I. In forty-five days, in the case of modifications involving changes in the production process;

II. In 30 days, in the case of modifications to:

a. The expiration time;

b. The additives, without change in the pharmaceutical form;

c. Primary packaging;

d. The change of domestic manufacturing to foreign manufacture, without modifications in the production process;

e. Foreign manufacturing change to domestic manufacturing, without modification in the production process;

III. In 20 days, in the case of modifications to:

a. The name or address of the registrant without change in the production process;

b. The trade name of the medicinal product;

c. The name or address of the foreign manufacturer, without change in the production process;

d. The presentation and contents of the packaging;

e. The secondary packaging, and

f. The conditions of sale and supply to the public, without changes of therapeutic indication and formulation.

In case the Secretariat does not resolve within the stated deadline, the request will be understood.

When more than one modification type is requested for the record, the maximum response time will be equal to the largest of those applicable.

If the applicant submits an application for modification to the registration conditions with an opinion issued by the Secretariat, it shall be resolved within a period of 15 days.

In the case of any application for modification to the conditions for registration of homeopathic medicinal products, if the Secretariat does not resolve within the corresponding time limits the application will be understood.

ARTICLE 187. In the case of modifications to the information texts only to prescribe, in its broad and reduced versions, the Secretariat will have to resolve the request twenty days. In the event of failure to do so within that period, the application shall be understood. The applicant shall present the draft text as well as the bibliographic information which is based on the proposed amendment.

ARTICLE 188. The Secretariat shall decide on requests for amendments to the conditions for registration of the Insured referred to in Chapter IX of Title II of this Regulation within a period of 22 days. Where the Secretariat does not resolve within that period the application shall be deemed to have been made.

If the applicant submits a request for modification to the conditions of registration with a favorable opinion issued by Third Authorised by the Secretariat, it shall be resolved within a period of 15 days.

ARTICLE 189. The trade in which the modification is authorized to the conditions of registration shall contain a legend indicating that the Secretariat gives the holder of the registration a period of one hundred and twenty days to exhaust the existence of packaging materials and finished product.

In case the holder requires an extension to the period specified in the preceding paragraph, he will obtain it automatically by warning to the Secretariat, in the format that for this purpose is issued, within ten days prior to the expiry of the period to be extended. By a first notice, the period may be extended for up to 60 additional days; up to an additional forty days, by a second notice; and up to an additional twenty days by a third and final notice.

ARTICLE 190. The transfer of rights to a health record of the Insured of which this Regulation is concerned shall be communicated in writing to the Secretariat by the holder of the register, within a period not longer than 30 days from the date on which it was made. This communication shall annex the documents on which the assignment and the duplicate label projects in which the new holder is expressed shall be annexed.

For the processing of the assignment of rights referred to in the preceding paragraph, the changes to the conditions of registration shall be followed.

ARTICLE 190-bis 1. In order to obtain the extension of the health registration of medicinal products, the following shall be submitted only:

I. Proof of payment of rights, in terms of the Federal Law of Rights;

II. Number or simple copy of the health record for which the extension is requested;

III. Technical report of the interchangeability tests, where there are changes that may alter the pharmacokinetics of the medicinal product, either in the production equipment, in the quality of the components, in the acceptance criteria or in the process of production;

IV. Tags in use, instructional, as well as information to prescribe in its broad and reduced forms, previously authorized;

V. Pharmacovigilance report of the medicinal product, in the terms of applicable normativity, and

VI. For allopathic medicinal products, certificate of good manufacturing practice of the drug, issued by the Secretariat or by the competent authority of the country of origin.

In case the applicant submits the certificate of the competent authority of the country of origin, and it comes from countries with which the Secretariat has no agreements of recognition in the field of good practice of manufacture, the Secretariat shall verify compliance with good manufacturing practice and the production process of the medicinal product, as well as the certification of its active substances, in accordance with the relevant Standards. If appropriate, the Secretariat shall, within a period not exceeding 20 working days, fix the date on which the Secretariat or its authorized third parties shall verify compliance with good manufacturing practice and the production process of the medicinal product. as the certification of its active principles in the terms provided for in the Law and other applicable provisions. If this check is not carried out on the scheduled date for reasons attributable to the Secretariat, it shall be rescheduled as a priority.

As provided for in Article 391 bis of the Law, the Secretariat may issue certificates, based on information, fact-checking or technical recommendations provided by authorized third parties.

For the granting of the extension of the health record referred to in this article, the Secretariat shall verify compliance with good manufacturing practices and the production process of the medicinal product, as well as the certification of its active principles, in accordance with the relevant rules.

ARTICLE 190-bis 2. In order to obtain the extension of the sanitary registration of foreign-made medicinal products, in addition to the provisions of Article 190 Bis 1, fractions I to V, the application must be submitted exclusively the following:

I. The document that accredits a legal representative with domicile in the United Mexican States;

II. For allopathic medicinal products, a certificate of good manufacturing practice for the medicinal product and the medicinal product, issued by the Secretariat or by the competent authority of the country of origin, and

III. For herbal medicines, vitamins and homeopathic medicines, certificate of good manufacturing practice of the medicinal product, issued by the Secretariat or by the competent authority of the country of origin.

In case the applicant submits the certificate of the competent authority of the country of origin, and it comes from countries with which the Secretariat has no agreements of recognition in the field of good practice of manufacture, the Secretariat shall verify compliance with good manufacturing practice and the production process of the medicinal product, as well as the certification of its active substances, in accordance with the relevant Standards. If appropriate, the Secretariat shall, within a period not exceeding 20 working days, fix the date on which the Secretariat or its authorized third parties shall verify compliance with good manufacturing practice and the production process of the medicinal product. as the certification of its active principles in the terms provided for in the Law and other applicable provisions. If this check is not carried out on the scheduled date for reasons attributable to the Secretariat, it shall be rescheduled as a priority.

As provided for in Article 391 bis of the Law, the Secretariat may issue certificates, based on information, fact-checking or technical recommendations provided by authorized third parties.

For the granting of the extension of the health record referred to in this article, the Secretariat shall verify compliance with good manufacturing practices and the production process of the medicinal product, as well as the certification of its active principles, in accordance with the relevant rules.

ARTICLE 190-bis 3. To obtain the extension of the sanitary registration of medical equipment, prostheses, orthotheses, functional aids, diagnostic agents, dental use inputs, surgical materials, healing materials, hygienic products, and other medical devices, which are of national manufacture, shall be submitted in the following order and with the application only:

I. Proof of payment of rights, in terms of the Federal Law of Rights;

II. Number or simple copy of the health record of which the extension and its modifications are requested;

III. Tags in use, instructional or manual, previously authorized;

IV. Technosurveillance report by product, in terms of applicable normativity;

V. Certificate of analysis issued by the company making the product, with the letterhead of its social reason and signed by the health officer or its equivalent, and

VI. Certificate of good manufacturing practice of the product, issued by the Secretariat. If the applicant does not submit this Certificate, the Secretariat shall, within a period of no more than 20 working days, fix the date on which the verification visit will take place, in accordance with the procedure laid down by the Secretariat and published in the Official Journal of the Federation. If this visit is not made on the scheduled date for reasons attributable to the Secretariat, it will be rescheduled as a priority.

As provided for in Article 391 bis of the Act, the Secretariat may issue certificates on the basis of information, fact-checking or technical recommendations provided by authorized third parties.

ARTICLE 190-bis 4. To obtain the extension of the sanitary registration of medical equipment, prostheses, orthotheses, functional aids, diagnostic agents, dental use inputs, surgical materials, healing materials, hygienic products and other medical devices, which are foreign-made, in addition to the requirements of Article 190 Bis 3, fractions I to V, the following shall be submitted exclusively:

I. The document that accredits a legal representative with domicile in the United Mexican States, and

II. Certificate of good manufacturing practice of the product, issued by the Secretariat, or by the competent authority of the country of origin.

For Class I, II, and Class III products, it shall be accepted as equivalent of the certificate of Good Manufacturing Practice to the current ISO 13485 certificate or the CE mark certificate issued by an approved certification body.

Where the applicant submits the certificate of the competent authority of the country of origin and comes from countries with which the Secretariat has no recognition agreements in respect of good practice of The Secretariat may make a health visit to the establishment to check compliance with good manufacturing practice. In that case, the authority shall fix, within a period of no more than 20 working days, the date on which the verification visit will take place, in accordance with the procedure laid down by the Secretariat and published in the Official Journal of the Federation. If this visit is not made on the scheduled date for reasons attributable to the Secretariat, it will be rescheduled as a priority.

As provided for in Article 391 bis of the Act, the Secretariat may issue certificates on the basis of information, fact-checking or technical recommendations provided by authorized third parties.

ARTICLE 190-bis 5. Upon notification of the decision corresponding to the request for an extension, the registrant shall deliver to the notifier the original of the health authorisation and, where appropriate, its amendments.

In case of not having the original of the registration you must present a copy of the complaint made to the Public Ministry of the loss or theft.

ARTICLE 190-bis 6. Applications for extension as provided for in Articles 190 Bis 1, 190 Bis 2, 190 Bis 3 and 190 Bis 4 shall be submitted no later than 50 calendar days before the end of the relevant registration.

The Secretariat will resolve requests for the extension of Insured within a maximum of one hundred and fifty calendar days following the filing of the application. Where the last day of the period is not deft, it shall be extended until the following working day. If the Secretariat does not issue the respective resolution within the time limits specified in this Article, the request shall be deemed to be appropriate.

In the case of requests for extension, if the applicant submits an opinion issued by the Secretariat, the time limits shall be reduced by half.

ARTICLE 191. The review of the health record of the Insured is appropriate when:

I. Technical, scientific or clinical research indicates that the medicinal product has adverse reactions or toxic, immediate or late effects in relation to the expected benefits;

II. Where duly documented technical or scientific developments in the field determine a negative risk benefit ratio;

III. Where documented evidence of therapeutic inefficiency of the medicinal product exists, and

IV. When the international agencies recommend it.

ARTICLE 192. Prior to the revocation of the health record referred to in Articles 380 and 381 of the Law, the Secretariat may review, evaluate and request the reformulation of the medicinal product concerned.

Chapter IV

Permissions

ARTICLE 193. The Secretariat shall grant the permit for the importation of registered medicinal products or their raw materials, which require it, upon submission of the application in the official format.

ARTICLE 194. In the case of import, the Secretariat may issue the following health permits:

I. Definitive importation, for which the entry to the country of Insured of foreign origin is authorized, to remain in the national territory for unlimited time;

II. Temporary importation, authorizing the entry into the country of Insured, to remain in the country for limited time and for a specific purpose, provided that they return abroad within a period of not more than one year;

III. Import into transit, for which the entry into the country of Insured is authorized, for the transfer of one to another national customs office, for departure abroad, within a period not greater than thirty days, and

IV. For sale or temporary distribution, for which the sale or distribution of medicines exclusively for strategic purposes is authorised.

ARTICLE 195. In order to obtain the import permit for raw materials or medicinal products that are or contain narcotic drugs or psychotropic substances, the importer shall submit an application in the official format.

The Secretariat will decide on the permit within a maximum of fourteen days.

The validity of the permits will be one hundred and eighty days, which may be extended for ninety days.

ARTICLE 196. In order to obtain the import permit for medicinal products which do not have registration with the Secretariat, intended for research, laboratory tests, maquila, for special treatments in low-incidence diseases with social impact or for personal use or are donated, the importer shall submit an application in the official format, to which he shall appraise, as appropriate, the following documentation:

I. For laboratory research and testing: a copy of the approval trade of the protocol authorised by the Secretariat;

II. For maquila: copy of the corresponding authorization issued by the Secretariat of Commerce and Industrial Development;

III. For special treatments: copy of the professional ID card and identification of the treating physician;

IV. For personal use: medical prescription, including professional card number. In case of narcotic drugs, special prescription with the barcode, and

V. For donations: the donation letter and letter of acceptance of the donation and non-marketing commitment.

The Secretariat will have to resolve the request ten days. In case of failure to do so within that period, the application shall be deemed to have been made, with the exception of narcotic drugs or psychotropic substances.

ARTICLE 197. In order to obtain the purchase permit in place of raw materials or medicinal products that are or contain narcotic drugs or psychotropic drugs, intended for the production of medicinal products, for medical purposes or for scientific research, submit a request in the official format. The Secretariat shall decide on the permit within a maximum of 14 days. The permit will be valid for one hundred and eighty days.

ARTICLE 198. For the import of Herbalist Remedies the application must be submitted in the appropriate format and indicate the alphanumeric key referred to in Article 94 of this Regulation.

ARTICLE 199. For the importation of the Insured as referred to in Chapter IX of Title II of this Regulation, except for those covered by the following Article, it shall be annexed to the customs order copy of the health record of the product to be imported.

The importers of these Insured will have to notify the Secretariat in the official format, the arrival of these, within five days after the customs clearance, annexing copies of the import request and the registration of the imported products that were annexed.

ARTICLE 200. For the issue of the prior authorization of importation of heart valves, internal ortheses, pacemakers, prostheses, diagnostic reagents with radioactive isotopes, used Insured, as well as the Insured referred to in Chapter IX of the Title Second of this Regulation without registration or in the phase of experimentation for maquila, personal use, for doctors, for research or to be donated, the importer will submit an application in the official format, to which it will annex, as the case may be, the following documents:

I. For maquila: copy of the corresponding authorization issued by the Secretariat of Commerce and Industrial Development;

II. For personal use: copy of the prescription;

III. For doctors: copy of the professional card;

IV. For investigation: copy of authorized protocol approval craft, and

V. For donations: donation letter and letter of acceptance of the donation.

The Secretariat will have ten days to resolve the request. In case of failure to do so within that period the application shall be understood.

ARTICLE 201. For the importation of blood products containing blood products, a certificate of analysis shall be submitted by the regulatory entity of the country of origin. It shall be stated in that certificate that the blood donors from which the components used for the manufacture of the batch were obtained have been tested negative for the antibodies against the virus. Human immunodeficiency and Hepatitis C, as well as to detect Hepatitis B antigens and others to be established in the corresponding Norms.

ARTICLE 202. In the field of export, the Secretariat may issue the following health permits:

I. Definitive export, for which the country's exit from Insured is authorized, for unlimited time, and

II. Temporary export, authorizing the departure of the country of Insured for a specific purpose, provided that they return to the national territory in a period not longer than one year.

ARTICLE 203. In order to obtain the export permit for raw materials or medicinal products which are or contain narcotic drugs or psychotropic substances, an application shall be made in the official format, which shall be annexed to the import permit issued by the authority. health of the country of destination. The Secretariat will have fourteen days to resolve the request.

ARTICLE 204. In order to obtain the foreign-made exchange permit from the Insured States in Chapter IX of Title II of this Regulation, an application must be submitted in the official format, to which it shall be annexed by the health authority of the country concerned. Such an application shall include the indication that the company is licensed, complies with good manufacturing practice and has a letter of representation from the manufacturer.

If the product is manufactured by the parent or subsidiary of the factory or laboratory holder of the registration requesting authorization in Mexico, no letter of representation will be required.

ARTICLE 205. In order to obtain foreign-to-domestic manufacturing, an application shall be submitted in the official format, to which it shall be annexed:

I. The analytical certificate of the finished product, control method and its bibliographic references, and

II. Label projects that comply with the corresponding Standard for these products, in Spanish.

Chapter V

Notices

ARTICLE 206. The advertising directed to health professionals of the Insured referred to in this Regulation shall be made by means of a notice submitted to the Secretariat, 15 days prior to its dissemination or distribution, in the official format to which it shall be annexed. the advertising project.

ARTICLE 207. The notice referred to in the foregoing article shall be made in protest of the truth that the advertising project meets the requirements laid down in the Law, the corresponding regulations, the corresponding Rules and the Code of Ethics in matter.

Chapter VI

Healthcare certificates

ARTICLE 208. For the issue of certificates in support of export, the presentation of an opinion issued by a Third Authorised for this by the Secretariat, which establishes the conformity of processes, products, methods, shall be sufficient. facilities, services or activities with the specifications laid down in the health regulation.

In case the particular present opinion issued by the Third Authorised Party, the time limit for issuing the official certificate shall be three days. Otherwise, the time limit for the issue of such a certificate shall be 15 days, including the verification visit.

ARTICLE 209. In order to grant the certificate of free sale of the Insured, it is required to submit a request in the official format to which it will be annexed, if appropriate, copy of the last production order and the unit formula endorsed by the health officer of the Establishment. The Secretariat shall have a period of five days to issue the certificate, unless required in a format with special characteristics, in which case an additional five days shall be available.

TITLE SEVENTH

Authorized Third Parties

Single Chapter

ARTICLE 210. The Secretariat shall publish regularly calls for the authorisation of third parties referred to in Article 391 bis of the Law, which may be natural or moral persons.

The Secretariat will also form technical committees composed of experts in the specific fields, representatives of chambers and associations and, where appropriate, of the accreditation entity, which will have as their purpose technically to know requests for the granting of third-party authorizations.

ARTICLE 211. To operate as an Authorized Third it will be necessary to comply with the following:

I. Submit a request for the legal capacity of the applicant;

II. Demonstrate that the applicant has the technical, material, human and financial capacity, as well as the facilities, equipment and technology to carry out the tests, studies, verifications and other activities necessary to issue the opinions;

III. Having standard operating procedures to ensure the quality of the performance of their tasks;

IV. Not be subject to direct influence by any manufacturer, merchant or merchant moral person of the processes and products to be evaluated, and

V. Present your proposals for activities to be ruled, as well as describe the services you intend to provide and the procedures to use.

ARTICLE 212. The Secretariat shall carry out the verification visits and, in conjunction with the evaluation committee referred to in Article 210 of this Regulation, shall carry out the evaluations. they are necessary to rule on compliance with the requirements referred to in the previous Article.

If the opinion issued by the Secretariat is not favorable, a period of up to one hundred and eighty days will be granted to the applicant to correct the detected anomalies. That period may be extended for an equal period, on a single occasion, where the applicant justifies the need for this.

In case the applicant fails to correct the anomalies detected within the given time limit, the procedure will be considered abandoned and the application will be rejected.

ARTICLE 213. Authorised Third Parties shall:

I. Comply with the regulations applicable to the acts or acts in which they are involved;

II. To provide services on non-discriminatory terms and to observe other provisions in the field of economic competition;

III. Avoid the existence of conflicts of interest that may affect their performances and be excused when they exist;

IV. Immediately inform the Secretariat of any irregularities in its relationship with clients, the performance of their functions or breaches identified in the processes it evaluates;

V. Provide the Secretariat with reports on the opinions and technical recommendations it issues;

VI. Report regularly to the Secretariat on the services it provides;

VII. Assist the Secretariat in emergency cases, and

VIII. Allow the verification of their activities and provide the Secretariat with free access to their facilities, as well as provide the information required.

ARTICLE 214. The results of the tests carried out by the authorised third parties shall be recorded in an opinion to be signed, under their responsibility, by the person empowered to do so. Such opinions shall be valid before the Secretariat in accordance with the functions authorized to the third party.

ARTICLE 215. The Secretariat may, at any time, carry out verification visits, in order to verify that the conditions under which the corresponding authorisation was granted are fulfilled by the Authorized Third Parties.

ARTICLE 216. If the conditions referred to in the previous article do not persist, or the applicable legal provisions are not complied with, the Secretariat shall prevent the person concerned from failing to remedy the anomalies found and give him a period of time. up to one hundred and eighty days to correct them. Where you are at risk for health, you may temporarily suspend the activities concerned.

The lack of compliance with the corrections indicated by the Secretariat will be the cause of suspension of the authorization granted, and the Secretariat will grant you a new period of ninety days to correct the irregularities. In case of failure to comply with the instructions of the Secretariat within the latter period, the authorisation shall be revoked.

ARTICLE 217. The Secretariat shall periodically publish in the Official Journal of the Federation the relationship of the authorised third parties, as well as the suspensions and revocations.

TITLE EIGHTH

Verification, Security Measures, and Sanctions

Chapter I

Verification

ARTICLE 218. Verification visits shall be carried out in accordance with the procedure laid down in the Law and shall be:

I. Get health conditions information:

a. From the Establishment;

b. Equipment, machinery, utensils and instruments with which the process is performed;

c. Of the products, raw materials, additives and packaging material and packaging used in the manufacture of the products;

d. From the health surveillance programs of the occupational staff exposed;

e. From the operation of the process;

f. Of the forms of waste and waste disposal, and

g. Of the transport of the Insured, when required.

II. Identify health deficiencies and failures;

III. Take samples, if any;

IV. Apply or release security measures;

V. Conduct orientation, instruction and education activities of a health nature, and

VI. The others indicated by the Secretariat, in accordance with the provisions of the Law.

ARTICLE 219. It is for the health authority to verify that the establishments are conditioned for the use to which they are intended or intended to be used, in accordance with the characteristics of the process of the products, having regard to what they establish Regulation and the relevant rules.

ARTICLE 220. The allocation of the establishment or place to carry out the verification visit shall be determined by any of the following mechanisms:

I. By random selection;

II. By contingency or health alert;

III. By programmes determined by the health authority, in which case it shall be expressly stated in the relevant order of business;

IV. By denunciation of third parties, in the terms of Article 5o. of this Regulation;

V. At the request of the owner, and

VI. As a follow-up to an administrative procedure initiated by the health authority.

ARTICLE 221. The verification visit order, among other requirements, must include the telephone number of the health authority issuing it so that the owner, responsible or responsible for the establishment or the place, can make inquiries, complaints or complaints and, where appropriate, confirm the provenance of the act of verification.

ARTICLE 222. The verification record shall include the circumstances of the diligence referred to in Article 401 of the Act and shall contain at least the following:

I. The legal accreditation of the verifier to perform the function;

II. The description of the sanitary conditions of the Establishment or the place, equipment, personnel, raw materials, process, procedures and Insured;

III. The filling of the report, based on a specific verification guide for industrial, commercial or service rotation;

IV. The recording of observed health failures or deficiencies;

V. The sampling, if any, and

VI. The manifestation of what is entitled to it to the owner, responsible, responsible or occupant of the Establishment or the place.

ARTICLE 223. Where anomalies are detected during verification visits, the Secretariat shall grant a period of up to one hundred and eighty calendar days to correct them, provided that they do not involve a risk or damage to health and do not affect the Safety and quality of the Insured.

After the period referred to in the preceding paragraph, a visit shall be made to verify compliance with the corrective actions; if the corrective actions have not been completed, the Secretariat shall grant an unrenewable period of time. Ninety calendar days to correct them.

After the time limits referred to in the preceding paragraphs, a visit shall be made to verify compliance with the corrective actions; if the corrective actions have not been completed, the Secretariat shall apply the security laid down in the Act.

Chapter II

Security measures

ARTICLE 224. If the health conditions of the establishment, raw materials, process or procedure represent an important health risk, the verifiers must take immediate safety measures, with the approval or consent of the health authority from which they are dependent. In this case, it can be awarded by telephone and identified by a key.

The security measure imposed must be ratified, amended or revoked within a period not exceeding five days from the appearance of the person concerned.

ARTICLE 225. The competent health authorities may order the application of the security measures referred to in Article 404 of the Law, where in the areas, facilities, equipment or manufacturing process, the identity, purity, conservation, concentration or manufacture of the Insured; as well as for non-compliance with good manufacturing practice and, in general, where the provisions of the Law and this Regulation are in breach of a serious health risk.

Chapter III

Sanctions

ARTICLE 226. The health authority shall sanction the person in breach of the provisions of this Regulation, without prejudice to the penalties applicable to them when they constitute a crime.

ARTICLE 227. A fine of up to five hundred days of the general minimum wage in force in the economic zone concerned shall be punishable by infringement of the provisions of Articles 107, 184 and 190 of this Regulation.

ARTICLE 228. A fine of five hundred to one thousand days of the general minimum wage in force in the economic zone concerned shall be punishable by infringement of the provisions of Articles 10, 16, 101, 102, 103, 104, 105, 106, 121, 122, 123, 124, 125, 127, 181 and 206 of this Regulation.

ARTICLE 229. A fine of one thousand up to three thousand days of the general minimum wage in force in the economic zone concerned shall be punished, the infringement of the provisions of Articles 13, 15, 62, 68, 86, 88, 89, 90, 93, 111, 112, 114, 117, 135, 141 and 172 of this Regulation.

ARTICLE 230. A fine of three thousand to six thousand days of the general minimum wage in force in the economic zone concerned shall be punishable by infringement of the provisions of Articles 17, 30, 32, 33, 36, 53, 79, 116, 118, 126, 148, 152, 168, 169 and 174. of this Regulation.

ARTICLE 231. A fine of six thousand to ten thousand days of the general minimum wage in force in the economic zone concerned shall be punishable by infringement of the provisions of Articles 19, 20, 21, 22, 24, 31 last paragraph, 35, 40, 44, 45, 46, 50, 57, 59, 77, 78, 134 and 165 of this Regulation.

ARTICLE 232. Infringements not provided for in this Chapter shall be punishable by a fine of up to ten thousand days of general minimum wage in the economic zone concerned.

TRANSIENT

FIRST. This Regulation shall enter into force on the fifteenth day following its publication in the Official Journal of the Federation, with the exception of the provisions set out below, which shall enter into force within the time limits indicated, the entry into force of this instrument:

I. At eighteen months, Articles 31, fraction I and 116, and

II. Twenty-four months, Chapters I, II and IV, of Title IV only with respect to persons who import and export vitamin, homeopathic and herbal medicines, as well as Herbalist Remedies. In the meantime, such persons shall have a distribution warehouse with a working notice.

SECOND. Articles 2o, fractions III, point (b) and (b) are repealed. (r) and V; 46; 149 fractions I, points (c) and (d) and III; 151; 156; 157; 158; 167, fractions IV, V, VI and X; 181, 182 and 183; and Title Twenty-First, concerning medical, narcotic and psychotropic substances, of the General Law Regulation Health in Matter of Health Control of Activities, Establishments, Products and Services, published in the Official Journal of the Federation on January 18, 1988.

THIRD. The administrative provisions in force shall continue to apply, until such time as others are issued, except in so far as they are contrary to this Regulation.

FOURTH. In the case of administrative acts and procedures relating to the matter of this Regulation, which have been initiated or initiated before it enters into force, the person concerned may decide to continue to apply the rules in force in accordance with the procedure in force. during their initiation or by the application of this Regulation.

QUINTO. The publication in the Official Journal of the Federation, by which the General Health Council and the Secretariat shall determine the tests to be applied to treat medicinal products as interchangeable, shall be carried out, the opinion of the industry, within 45 days of the entry into force of this Regulation.

This publication shall set the time limit for the Secretariat to notify the General Health Council and the person concerned of its opinion on the application referred to in Article 77 of this Regulation.

SIXTH. The formats referred to in this Regulation shall be published in the Official Journal of the Federation within six months of the entry into force of this instrument.

Given at the Federal Executive Branch, in Mexico City, Federal District, on the three days of the month of February of a thousand nine hundred and ninety-eight.-Ernesto Zedillo Ponce de León.-Heading.-The Secretary of Health, Juan Ramon de la Fuente.-Rubrica.