Here are the regs in full in English
Read at source in Spanish.
| DOF: 01/12/2021 |
REGULATION of the General Health Law on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives.In the margin a seal with the National Shield, which reads: United Mexican States.- Presidency of the Republic.ANDRÉS MANUEL LÓPEZ OBRADOR , President of the United Mexican States, in exercise of the power conferred on me by article 89, section I of the Political Constitution of the United Mexican States, and based on articles 31, 35 and 39 of the Law Organic of the Federal Public Administration, 3o., 13, 17 Bis, 96, 100, 101, 102, 194, 194 Bis, 197, 198, fraction I, 204, 222, 234, 235, 235 Bis, 244, 245, 247, 290, 310, 368, 371, 373, 376 and other related to the General Health Law, I have seen fit to issue the following
REGULATIONS OF THE GENERAL HEALTH LAW ON HEALTH CONTROL FOR THE PRODUCTION, RESEARCH AND MEDICAL USE OF CANNABIS AND ITS DERIVATIVES PHARMACOLOGICAL
TITLE ONE
GENERAL DISPOSITION
CHAPTER I
OF THE OBJECT
ARTICLE 1. The purpose of these Regulations is the regulation, control, promotion and sanitary surveillance of raw materials, pharmacological derivatives and Cannabis medicines, for production, research, manufacturing and medical purposes.
For the purposes of the previous paragraph, the Ministry of Health, through the Federal Commission for Protection against Sanitary Risks; the Secretariat of Agriculture and Rural Development, through the National Service of Agri-food Health, Safety and Quality and the National Service of Inspection and Certification of Seeds; the Ministry of Economy and the Ministry of Finance and Public Credit, through the Tax Administration Service, will exercise the powers conferred on them by the laws, regulations and other legal provisions within the scope of their competence.
The provisions of this ordinance are of public order, social interest and mandatory observance throughout the national territory and will be applied without prejudice to the provisions of the international treaties to which Mexico is a party.
The monitoring of compliance with these Regulations corresponds to the agencies referred to in the second paragraph of this article within the scope of their respective powers and in terms of the applicable legal provisions.
CHAPTER II
OF THE ENDS
ARTICLE 2. The actions regulated by this Regulation for Cannabis are those that have the following purposes:
I. Primary production for:
a ) Supply the manufacturing referred to in section V of this article;
b ) Generate raw material to carry out the investigations referred to in sections II, III and IV of this article, and
c ) Produce seed;
II. Research for health, in terms of article 3 of the Regulation of the General Health Law on Health Research;
III. Pharmacological research referred to in Chapter II of Title Three of the Regulations of the General Health Law on Research for Health;
IV. Manufacture of pharmacological derivatives and medicines, and
V. Doctors for the realization of diagnoses, preventive, therapeutic, rehabilitation and palliative care.
CHAPTER III
OF THE DEFINITIONS
ARTICLE 3. For the purposes of these Regulations, the following shall be understood as:
I. Specific Actions: Those that are required to carry out production, research, manufacturing and medical purposes;
II. Condition: Put the Cannabis in bulk into operations until it is presented as a finished product;
III. Acquire: Obtain, for consideration, Raw Material, Pharmacological Derivatives and Cannabis Medicines ;
IV. Good Laboratory Practices: Set of rules, operational procedures and practices established to ensure the quality and integrity of the activities carried out in the Quality Laboratory and of the analytical data obtained from trials or tests;
V. Seed Qualification: Procedure by which Cannabis seeds are verified, in accordance with the rules issued by SADER for that purpose, in their genetic, physical, physiological and phytosanitary quality, in accordance with the Federal Law of Production, Certification and Seed Trade and its Regulations;
SAW. Cannabinoids: Organic compounds belonging to the group of terpenophenols, among which are cannabidiol and tetrahydrocannabinol;
VII. Cannabis: Cannabis plant sativa, indica and American or marijuana, its resin, preparations and seeds;
VIII. National Catalog of Plant Varieties: The one provided for in article 3, section VII of the Federal Law of Production, Certification and Trade of Seeds;
IX. CBD: Cannabidiol and its acidic forms, a cannabinoid compound that lacks psychoactive properties ;
X. COFEPRIS: Federal Commission for the Protection against Sanitary Risks, decentralized administrative body of HEALTH;
XI. Commercialize: Distribute, for commercial speculation purposes, Cannabis Raw Material, Pharmacological Derivatives and Medicines;
XII. Consume: Use Pharmacological Derivatives and Cannabis Medications, in terms of this Regulation;
XIII. Pharmaceutical Production Quota: Maximum quantity of Cannabis in dry weight that the person holding an authorization for the production of Pharmacological Derivatives or Medicines is allowed to acquire or use ;
XIV. Primary Production Quota: Maximum number of plants and total area in square meters or hectares that the holder of a Cannabis planting authorization is allowed , during a determined period;
XV. Pharmacological Derivative: All Cannabinoids and their acid forms, the mixture or composition of these, that have some pharmacological activity, which is identified by its physical, chemical or biological actions that is not present in pharmaceutical form and that meets the conditions to be used as active ingredient of a Drug;
XVI. Prepare and Prepare: Set of actions aimed at obtaining Pharmacological Derivatives and Cannabis Medicines;
XVII. Employ or Use: Use Cannabis Raw Material, Pharmacological Derivatives and Medications ;
XVIII. Establishments: Those referred to in article 257 of the Law;
XIX. Export: Exit of Pharmacological Derivatives and Cannabis Medications, from the national territory , under the definitive export regime, in terms of the Customs Law and its Regulations;
XX. Health Promotion: Set of actions aimed at promoting the continuous improvement of the sanitary conditions of processes, products, methods, facilities, services or activities that may cause a risk to the health of the population through communication, training, coordination and concertation schemes. with the public, private and social sectors, as well as other non-regulatory measures;
XXI. Import: Entry of Raw Material, Pharmacological Derivatives and Cannabis Medicines , into the national territory, under the definitive import regime, in terms of the Customs Law and its Regulations;
XXII. Investigate: Study, under scientific criteria, Cannabis, its Pharmacological Derivatives and Cannabis Medicines for use in humans, with respect to which there is no previous experience in the country, which have not been registered by SALUD and, therefore Therefore, they are not distributed commercially, as well as registered and approved Medicines for sale, when it comes to their use with modalities, indications, doses or routes of administration different from those established, including their use in combinations;
XXIII. Quality Control Laboratory: The one authorized by COFEPRIS to carry out the analytical tests required for the follow-up and control necessary during the different stages of the Cannabis process, from its Importation and sowing, to the obtaining of final products ;
XXIV. Law: General Health Law;
XXV. Control Books: Compilation of graphic records obtained by any authorized system, as long as they contain the necessary data for the control of Raw Material, Pharmacological Derivatives and Cannabis Medications and comply with the provisions of article 159 of the Health Supplies Regulation and the Pharmacopoeia of the United Mexican States;
XXVI. Raw Material: Seeds, seedlings, propagative plant material, stems, leaves or inflorescences of Cannabis, necessary for the preparation of Pharmacological Derivatives or Medicines;
XXVII. Medications: Substances or mixtures of substances provided for in article 221, section I of the Law;
XXVIII. Medical Prescription: Act by which a health professional, authorized in terms of the provisions of the Law and this Regulation, indicates the use of Pharmacological Derivatives and Cannabis Medications;
XXIX. Pharmaceutical Production: Operations involved in the processing of Cannabis to transform it into Pharmacological Derivatives or Medications;
XXX. Primary Production: Process of Cannabis in the field, which includes the preparation of the land, sowing, development of the crop, harvest and packaging;
XXXI. Research Protocol: Document that describes the proposal for an investigation that involves the use of Cannabis in order to obtain its Pharmacological Derivatives that are intended for Pharmaceutical Production;
XXXII. SADER: Secretariat of Agriculture and Rural Development;
XXXIII. HEALTH: Ministry of Health;
XXXIV. SAT: Tax Administration Service;
XXXV. SE: Ministry of Economy;
XXXVI. SENASICA: National Service of Agrifood Health, Safety and Quality, a decentralized administrative body of SADER;
XXXVII. Quality Management System: Mechanism through which the Quality Control Laboratory complies with the provisions of article 8. of the Health Supplies Regulation and controls activities associated with quality;
XXXVIII. Permitted Confined Site: Physical space where the Primary Production of Cannabis is located and its commercialization is carried out, provided that in carrying out such activities barriers are used, in order to effectively limit its contact with the population and the environment;
XXXIX. SNICS: National Seed Inspection and Certification Service, a decentralized administrative body of SADER;
XL. Test: Submit to the seed and plant of Cannabis and its Pharmacological Derivatives, to a verification and test control carried out by the competent authorities, which includes varietal description, safety analysis and any other analysis that is determined;
XLI. THC: Tetrahydrocannabinol and its acid form, Cannabinoid compound with psychoactive properties ;
XLII. Transport: Transfer from one place to another Raw Material, Pharmacological Derivatives or Medicines of Cannabis through the process of custody and custody established in article 46 of the Regulation of Health Supplies, the Pharmacopoeia of the United Mexican States and other applicable legal provisions ;
XLIII. Traceability: System that allows identifying the origin and the different stages of the evolution process of products related to Cannabis, for the purposes of production, research, manufacture and distribution; which contains the unified information of all activities for greater control and monitoring capacity by the competent authorities , and
XLIV. Sanitary Surveillance: Set of evaluation, verification and supervision actions of compliance with the legal provisions that must be observed in the processes, products, methods, facilities, services or activities related to the matters within the competence of COFEPRIS.
CHAPTER IV
OF THE COMPETITION
ARTICLE 4. In the absence of an express provision in this Regulation, each authority will be subject to the applicable legal systems within the scope of its competence, except in the terms and terms to which the provisions of the Federal Law of Procedure will be applied in a supplementary manner. Administrative.
ARTICLE 5. The application and interpretation of these Regulations corresponds to the agencies, in their respective areas of competence, in accordance with the provisions of the Law and these Regulations.
ARTICLE 6. The implementation and administration of the Traceability System will be in charge of COFEPRIS. To carry out the identification process, the requirements requested by each of the authorities, in their respective field of competence, must be met , in order to grant the authorizations referred to in this Regulation, which will be an essential requirement to continue with the corresponding procedure .
The Traceability System will be operated using specialized technological tools, implementing a single, comprehensive control and inspection system, of a public nature that allows a safe control of packaged or finished Cannabis products.
ARTICLE 7. For the purposes of these Regulations, it corresponds to:
I. SENASICA, regulate and promote the health of Cannabis, as well as the application, verification and certification of the systems for reducing risks of physical, chemical and microbiological contamination in Primary Production, in accordance with the provisions of the Federal Health Law Vegetable and other applicable legal provisions;
II. SNICS, regulate the production of certified seeds, the qualification of seeds and the commercialization and circulation of all Cannabis seeds, in accordance with the provisions of the Federal Law of Production, Certification and Trade of Seeds and other applicable legal provisions;
III. COFEPRIS, the regulation, control and health promotion related to the research, manufacturing and medical purposes of Cannabis, its Pharmacological Derivatives and Medications, as well as the control and monitoring in the Testing and Traceability, in accordance with the provisions of the General Law of Health and other applicable legal provisions;
IV. SAT, verify compliance with the legal provisions applicable to Import and Export, and
V. SE, intervene, according to its attributions, in the determination of the tariffs that should correspond to the Import and Export.
SECOND TITLE
LABORATORIES OF QUALITY CONTROL
ARTICLE 8. Each person holding a sanitary registry, in terms of article 260 of the Law, must have an independent Quality Control Laboratory and under the authority of a qualified person in accordance with the procedures established in its Quality Management System, with the academic training and experience required.
The activities of the Quality Management System must include the organization, documentation and procedures that guarantee that the tests are carried out in compliance with Good Laboratory Practices , as well as good manufacturing practices in accordance with the corresponding methods and specifications , so that the Cannabis supplies and products are not released for use or sale until their quality has been evaluated.
ARTICLE 9. The Quality Control Laboratory must comply with the following:
I. Sanitary license, in accordance with article 258 of the Law;
II. Control books for standards and samples;
III. Personnel, areas and equipment, qualified in accordance with the procedures established in its Quality Management System;
IV. Procedures for cleaning, maintenance and operation of laboratory areas, measuring instruments and equipment, with the corresponding records;
V. Calibration program for measuring instruments used in the laboratory;
SAW. Validated analytical methods. When changes are made to the methodology, a new validation must be carried out in accordance with the procedures established in its Quality Management System ;
VII. Specifications, sampling procedures, test procedures and records, analytical certificates and, where appropriate, records of environmental monitoring;
VIII. Sample containers, with an identification that indicates, at least: the name, the lot number, the sampling date, the storage conditions and the containers from which the samples have been taken;
IX. Retention samples of each batch of finished product; keep them at least one year after the expiration date of the drug in its final packaging, and store them under the conditions indicated on the label;
X. Retention samples of Raw Materials; keep them at least one year after the expiration date of the last batch of product in which it was used, and store them according to the conditions indicated on the label;
XI. Retention samples of primary packaging materials and those that contribute to the integrity of the product, and keep them for the same time as the expiration date of the last batch of product in which they were used;
XII. Intermediate product or bulk product retention sample, when any manufacturing stage is performed in a facility other than the drug manufacturing site;
XIII. Sample of retention of the materials used in the packaging, when the site of primary or secondary packaging, declared in the health registry, is different from the site of manufacture of the Drug;
XIV. Records of test results, which must contain, at least, the following:
a ) Name of the product, presentation and, where appropriate, the concentration;
b ) Lot number;
c ) Name of the manufacturer or supplier;
d ) References of the specifications and analytical methods;
e ) Results of the tests, including observations, calculations and printouts of equipment outputs ;
f ) Date of the tests;
g ) Initials or names of the persons who carried out the tests;
h ) Initials or names of the persons who supervised the tests and calculations, and
i ) Description of the procedures for handling and storage of reagents, solutions, strains and culture media used in the laboratory;
XV. Where appropriate, acquire animals for laboratory tests, in the analysis of Raw Materials or products, from suppliers that meet the requirements established in the applicable legal provisions .
Said animals must be identified from their entry, and the records of their reception, history of use and final disposal must be kept ;
XVI. Carry out the control tests in process, in accordance with the methods approved in accordance with article 8 of the Regulation of Health Supplies, the Pharmacopeia of the United Mexican States and its Quality Management System;
XVII. Establish a procedure that indicates the actions to be followed in the event that analytical results are obtained outside of specifications;
XVIII. Investigations and conclusions of analytical results out of specifications must be approved by the health manager;
XIX. Sampling must be performed and recorded in accordance with written and approved procedures that include:
a ) The sampling method;
b ) The equipment to be used;
c ) The amount of sample to be taken;
d ) Instructions for the possible subdivision of the sample;
e ) The type and conditions of the container to be used for the sample;
f ) The identification of the sampled containers;
g ) Any special precautions likely to be taken into account, especially in relation to the sampling of sterile or harmful materials;
h ) The storage conditions, and
i ) Cleaning and storage instructions for sampling equipment;
XX. Types of transfer of analytical methods, among which should be found:
a ) That of the analytical development unit, to the Quality Control Laboratory;
b ) That of the development unit or the Quality Control Laboratory of a foreign plant , a subsidiary in Mexico, and
c ) That of a person who is the holder of the record, a maquiladora;
XXI. The analytical transfer must have the following factors:
a ) The receiving unit must have facilities, equipment, instruments and qualified personnel , in accordance with the provisions of its Quality Management System, for the methods to be transferred, and
b ) The protocols and analytical methodologies of the methods to be transferred, and
XXII. The transfer protocol must include, at least:
a ) Description of the test to be performed and the relevant analytical methods transferred;
b ) Identification of any additional requirements;
c ) Identification of the reference standards and the samples to be analyzed;
d ) Description and identification of any special conditions of transport and conservation of the products, standards and reagents to be used, and
e ) The acceptance criteria, which must be based on the current validation study of the methodology in accordance with the procedures established in its Management System of Quality.
ARTICLE 10. COFEPRIS may, at any time and in terms of Title Seventeen of the Law, carry out the Sanitary Verification and visits to the Quality Control Laboratories and their Quality Management System , personnel and generated results, to verify operating conditions, infrastructure, procedure and analytical tests.
COFEPRIS may order the suspension of operations and analytical tests that the Quality Control Laboratories develop in the process they control, when continuing with them puts people’s health in danger, without prejudice to imposing the corresponding sanctions, of according to the seriousness of the infractions committed, in terms of Chapter II of Title Eighteen of the Law.
TITLE THREE
OF THE END OF CANNABIS
CHAPTER I
INVESTIGATION
ARTICLE 11. Those interested in carrying out the investigations referred to in this Chapter must obtain, from COFEPRIS, the authorization of the Investigation Protocol.
For the purposes of the previous paragraph, the interested parties must submit their request in writing, attaching, in addition to the requirements established in Title Five of the Law and other applicable legal provisions, the following documentation and data:
I. The amount of Raw Material, Pharmacological Derivatives or Cannabis Medications, for the
investigation Development;
II. The document that proves the origin of the material object of the Investigation Protocol;
III. The document stating compliance with the Tested and Traceability, from origin to final disposal, in accordance with the provisions issued by the competent authority, and
IV. The Investigation Protocol.
ARTICLE 12. The Investigation Protocol shall include, in addition to the requirements established in the Fifth Title of the Law, in the Regulations of the General Health Law on Health Research Matters , and in the other applicable legal provisions; a section in which the following is determined:
I. The procedure for obtaining the Raw Material, and Pharmacological Derivatives that will be used in the execution of the Research Protocol;
II. The method of destruction of waste or surplus substances that will not be used in the Research Protocol, and
III. Compliance with Traceability, from origin to final disposal, in accordance with the provisions issued by the competent authority.
ARTICLE 13. Any investigation in human beings related to the subject matter of this Regulation, must comply with the requirements established in articles 41 Bis and 98 of the Law, in the Regulation of the General Health Law on Health Research Matters , and in the other applicable legal provisions, as well as internationally recognized good clinical practices.
ARTICLE 14. For the purposes of this Regulation, research in human beings has as its principle the protection of health, which is why the people who participate in the processes and related studies must be treated with dignity and respect for human rights. The persons authorized to carry out the investigations provided for in this article must submit a report to COFEPRIS detailing the actions and ways of showing respect to the participants, in adherence to internationally recognized good clinical practices .
ARTICLE 15. Researchers must certify, before the corresponding Research Ethics Committee , that they comply with the provisions of the Regulations of the General Health Law on Research for Health, as well as with the following:
I. Have a professional license of the specialty in the field and the matter of the investigation to develop;
II. Be trained for the investigation depending on the protocol to be carried out, for which they will present the documentation that accredits it, and
III. Once the clinical trials have been authorized, register on the platform of the National Registry of Clinical Trials.
ARTICLE 16. HEALTH, in coordination with the public, social and private establishments that carry out health research, as well as the educational authorities, in their respective field of competence, will carry out and update the national research inventory, in terms of the legal provisions applicable.
ARTICLE 17. For the purposes of the previous article, COFEPRIS must keep and update annually, the national inventory of research carried out in the country on Cannabis, which will contain the registry of:
I. The centers where research is carried out;
II. The researchers;
III. The scientific publications of the researchers, and
IV. The follow-up reports to the investigation.
ARTICLE 18. For the purposes of Cannabis research, the provisions of Title Five of the Law, in the Regulations of the General Health Law on Research for Health, and in these Regulations will be followed.
CHAPTER II
OF THE PRODUCTION
ARTICLE 19. The permission to plant Cannabis for the research and manufacturing purposes referred to in sections II, III and IV of Article 2 of these Regulations, must be processed before SENASICA, for which the authorization must be attached. of the Research Protocol, in accordance with the provisions of article 11 of these Regulations, or the health registry for the Drug that is intended to be produced.
ARTICLE 20. Permits for the planting of authorized Cannabis species or varieties will be granted for planting, cultivation and harvesting activities, as well as for health research, and for the manufacture of Pharmacological Derivatives and Medications.
The activities of planting, cultivation, harvesting and production of Cannabis must be carried out in a Permitted Confined Site .
ARTICLE 21. To apply to SENASICA for a permit to plant authorized Cannabis species or varieties , the interested party must submit:
I. Written request in original and simple copy, for each Permitted Confined Planting Site, which must contain:
a ) Name or denomination or business name of the applicant, federal registry of taxpayers and, where appropriate, name of the legal representative;
b ) Address of the interested party, as well as address to hear and receive notifications and the name of the person or persons authorized to receive them, indicating an email address to receive communications;
c ) Indicate the use of the Raw Material.
For the purposes of the previous paragraph, planting will only be allowed for the manufacture of Pharmacological Derivatives and Medications, as well as for their use in research, as long as it coincides with the provisions of the Research Protocol authorized by COFEPRIS;
d ) Amount of seed to be sown, variety and origin of the seed, as well as the sowing density according to the size of the production site and the conditions for which it is authorized;
e ) Estimated amount of harvest, specifying the amount of inflorescences and plant residues ;
f ) Control Book;
g ) Schedule in which the agronomic practices and number of sowings per cycle are indicated;
h ) Location map of the Permitted Confined Planting Site, indicating location in geographical coordinates of the Universal Transverse Mercator Coordinate System , in which the physical barriers used are indicated in order to effectively limit its contact with the population and with environment;
i ) Description of the reproductive or multiplicative biology of the material, life cycle with special emphasis on self-crosses, pollination, habitat, wild species and their distribution , mechanisms and frequency of self-crosses with members of the species;
j ) Procedure for containment or confinement measures to be implemented
to prevent the contamination, escape and dissemination of authorized species or varieties of Cannabis for its production and research for health and production of Pharmacological Derivatives and Medicines;
k ) Method of destruction of plant residues that guarantees the total elimination of these, as well as cleaning of agricultural equipment and machinery;
l ) Place and date of the request;
m ) Signature of the interested party or legal representative, and
n ) Contract signed, if applicable, between the agricultural producer who will carry out the sowing and the institution or laboratory that has the Research Protocol authorized by COFEPRIS;
II. A clear identification of the information provided that is considered confidential;
III. Certified copy of the sanitary license, indicating the purpose of the investigation or manufacture;
IV. In the event that the seed is imported, a legalized or apostilled document of the authorizations or official documentation that proves that the species and variety of Cannabis correspond to those authorized according to the legislation of the country of origin, being able to present, among others, the certificate within the framework of the Organization for Economic Cooperation and Development system, the certificate issued by the competent authority of the exporting country, or the document that supports the authorized seed variety;
V. Copy of the SNICS label of certified seed, in the case of national production;
SAW. Characterization of the species and variety of Cannabis;
VII. Research Protocol authorized by COFEPRIS, where the objective of sowing for health research purposes and the manufacture of Pharmacological Derivatives and Cannabis Medications is established, technically justifying the amount of seed and the area to be sown, as well as the curriculum of the researchers;
VIII. Characteristics of the facilities where cannabis is to be planted, and in particular, the following:
a ) Total area of the site where the sowing will take place;
b ) Location in geographic coordinates of the Universal Transverse Mercator Coordinate System , of the Permitted Confined Site where the Primary Production will take place ;
c ) Planting site data;
d ) Entity or states where the Permitted Confined Site will be located;
e ) Description of the Permitted Confined Site where the sowing will take place, as well as the neighboring areas, according to the dissemination characteristics of the species in question;
f ) Plan of the Permitted Confined Site;
g ) Perimeter fence;
h ) Single access door with registration and access control;
i ) Confinement area, which must have an access with a double door and a mat that allows cleaning the shoes of probable seeds or foreign material that may remain attached to the shoes;
j ) Insect-proof mesh, which must cover ventilation ducts or any other part of the greenhouse through which birds, insects or rodents could enter;
k ) Exit lock with double door, and
l ) Established perimeters, which must be far from urban areas;
IX. Procedures for monitoring activity and security measures during Primary Production to be implemented;
X. Background, where appropriate, of the sowing of the Cannabis species or variety in question in other countries , in order to identify agricultural aspects of pest management and control, as well as the establishment and design of protocols to be evaluated ;
XI. Specific instructions or recommendations for the conditioning of the harvest and storage, as well as the percentage of harvest yield, waste record and kilograms delivered to the formulator or extractor;
XII. Measures and procedures to prevent the unauthorized planting and the unforeseen dispersal of Cannabis, outside the Permitted Confined Site where the planting is intended;
XIII. Measures for the eradication of Cannabis in places other than those allowed, and development of protocols for monitoring and eliminating voluntary seedlings;
XIV. Measures for the isolation of the site where cannabis is to be planted;
XV. Cleaning methods or final disposal of planting residues within the Permitted Confined Site ;
XVI. Phytosanitary certificate of national mobilization issued by SADER and transportation license issued by COFEPRIS, of the harvest of Cannabis seeds and tops, up to the Establishment indicated by the interested party for the research and manufacture of Pharmacological Derivatives and Cannabis Medications, and
XVII. Security protocol and attention to contingencies, which guarantees that the seed, seedling and propagation material will be kept in custody until the Permitted Confined Planting Site and, where appropriate, that the necessary measures are in place to attend to various contingencies , such as theft. and diversion of use.
Once the application is favorably ruled, SENASICA will integrate the National Registry of Cannabis Sowing Permits for research and manufacturing purposes.
Pesticides used in the control of pests that affect the Cannabis genus must have a sanitary registration for the specific crop and pest, in addition to having the maximum residue limit, established by the competent authority.
In Primary Production, phytosanitary measures must be observed, including the proper use of phytosanitary inputs, established by SENASICA for this purpose.
The person holding the permit must allow the practice of inspections by personnel duly authorized by SADER, SENASICA or SNICS, as appropriate, to verify and verify compliance with the legal provisions applicable to Primary Production activities and facilities. Likewise, it must allow the use of digital applications in real time, for taking pictures and sending data by authorized personnel.
ARTICLE 22. SENASICA will issue its resolution, founded and motivated, after analyzing the information and documentation provided by the interested party. In your resolution you may:
I. Issue the permit for the planting of Cannabis for use in research for health and the manufacture of Pharmacological Derivatives and Cannabis Medications, being able to establish, among others, additional monitoring, control, prevention and phytosanitary measures to those that were proposed by the interested party in the permit application, or
II. Deny permission in the following cases:
a ) When the request does not comply with the provisions of this Regulation, or
b ) When the information provided by the interested party, including that relating to the possible risks that the cultivation of Cannabis could cause, is false, it is
incomplete, insufficient or inconsistent.
ARTICLE 23. The laboratory and research center holding the permit will be obliged to observe and comply with the Traceability, prevention, control and phytosanitary measures established in the permit, as well as the provisions of this Regulation and other applicable legal provisions.
ARTICLE 24. SENASICA, through a well-founded and motivated resolution that must be notified personally, may modify the monitoring, control, prevention and phytosanitary measures established in the permit or require the implementation of new measures, as well as suspend or revoke said permit. , after a hearing granted to the permit holder, when he has technical and scientific evidence on phytosanitary matters . The foregoing must be established in the permits that are issued.
ARTICLE 25. SENASICA, at any time and based on new scientific or technical information on phytosanitary matters regarding Cannabis, may review the permits granted and, where appropriate, suspend their effects or revoke said permits, when a change in the circumstances under which the permit was granted or there is additional scientific or technical information that could modify the conditions, limitations or requirements of the permit. The permit review will be carried out according to the following procedure:
I. SENASICA will notify the permit holder of the start of the review procedure, having to establish and justify the causes that gave rise to the procedure;
II. The holder of the permit will have fifteen business days, counted from the day after the notification of the start of the procedure takes effect, to express what is appropriate to their right and present any element of conviction that has the character of evidence;
III. Once the statements and evidence from the permit holder have been received, or without them, SENASICA will begin the evaluation process and will compare the information, in order to issue the corresponding resolution;
IV. The resolution that falls to the review of the permit may:
a ) Confirm the terms in which it was granted;
b ) Modify the conditions under which it was granted;
c ) Suspend its effects, or
d ) Revoke it, and
V. SENASICA will have sixty business days to issue the respective resolution, which must be notified by official letter to COFEPRIS and personally to the holder of the permit subject to the review, except in the case of subsection a) of section IV of this article, in which only the permit holder will be notified personally.
CHAPTER III
OF MEDICAL PURPOSES
ARTICLE 26. For the prescription of Cannabis Medications, the provisions of Article 240 of the Law and these Regulations must be observed .
ARTICLE 27. Professionals interested in obtaining the barcode for the special prescription recipes for Cannabis Medications will submit an application in the format issued by COFEPRIS for this purpose, accompanied by the following documentation:
I. Certified copy of the professional license that accredits them as professionals in any of the branches referred to in article 240 of the Law;
II. Copy of official identification, and
III. Written document in which the appointment of the professionals responsible for the prescription is specified ; in original and two copies, on letterhead, and signed by the director of the institution in the case of hospital institutions.
COFEPRIS or the state health authorities will register the requesting professional and assign a certain number of codes in a barcode, within a period of five business days in the case of the first request, and one day in subsequent requests. In the latter case, only the application will be submitted.
ARTICLE 28. The professionals authorized in accordance with the previous article, will prescribe the Cannabis Medications in special recipe books, in original and copy, which will contain the following data:
I. The folio number and the code expressed in a barcode;
II. The name, federal taxpayer registry, tax address, professional and specialty identification number and autograph signature of the authorized professional;
III. The number of days of prescription of the treatment, presentation and dosage of the Cannabis Drug ;
IV. The prescription date, and
V. The name, address, diagnosis and the unique population registry key of the patient.
The authorized professional will print the special recipe books, at the time and with the specifications provided by the HEALTH.
ARTICLE 29. The loss or theft of the special prescription books to prescribe Cannabis Medications, must be communicated immediately to the HEALTH and COFEPRIS, accompanying a copy of the act drawn up by the Agent of the corresponding Public Ministry.
ARTICLE 30. The drugstores, pharmacies or pharmacies authorized to supply the public with Cannabis Medications must have a registry of patients, in accordance with the applicable legal provisions regarding the protection of personal data, which must contain the following data:
I. The name, age, sex, conventional or fiscal address, the diagnosis and the unique population registry key of the patient;
II. The name, fiscal address, federal taxpayer registry, professional identification number and specialty of the authorized professional, and
III. The prescription date.
ARTICLE 31. Possession of Cannabis Medications will be accredited, when required by the corresponding authorities, with the copy of the special prescription containing the barcode and the autograph signature of the authorized professional who issues it or with the corresponding invoice.
ARTICLE 32. Passengers on international trips, whether resident in the country or abroad, who require Cannabis Medications for their treatment and bring them with them, must show the corresponding medical prescription to the competent authority or, where appropriate, the permit issued by the competent authority of the country from which they come.
ARTICLE 33. Establishments that provide auxiliary services for diagnosis and treatment where Cannabis Medications are prescribed or supplied, must:
I. Have a notice of operation;
II. Have a sanitary license;
III. Have a health manager;
IV. Have Control Books;
V. Comply with good practices, clinics and the specific applicable standards;
SAW. Have specialized personnel, facilities, infrastructure, services and equipment according to the services it offers, and
VII. Facilitate the activities of the Sanitary Surveillance in charge of the competent authorities.
CHAPTER IV
OF MANUFACTURING
ARTICLE 34. The custody of Raw Material, Pharmacological Derivatives or Cannabis Medicines are the responsibility of the person who possesses them, for which they must have the documents that prove their possession in accordance with Article 54 of the Health Supplies Regulation and the Pharmacopoeia of the United Mexican States, which must be kept for a period of three years, counted from the date of issuance of the documents as concerned.
ARTICLE 35. Public and private establishments that are destined to the manufacturing process, or that import, export or use Raw Material, Pharmacological Derivatives or Cannabis Medications, will have Control Books authorized by COFEPRIS and a security system for the guardianship and custody, in terms of Article 46 of the Regulation of Health Products and Pharmacopeia United Mexican States.
ARTICLE 36. The Control Book authorized by COFEPRIS, in which the manufacture of batches of Raw Material, Pharmacological Derivatives or Cannabis Medications is registered, destined to obtain sanitary registration for commercialization or research, must be signed by the head of the laboratory or requesting institution. Likewise, it must include, as the case may be, the following data:
I. The name of the Raw Material, Pharmacological Derivatives or Cannabis Drug;
II. The batch number;
III. The amount to use and balance;
IV. Provenance;
V. The use and destination that will be given to it, and
SAW. The summary of the process.
COFEPRIS may verify, through a visit order, the operations and data recorded in the Control Book referred to in this article.
ARTICLE 37. The manufacture of Pharmacological Derivatives or Cannabis Medications will be subject to the control determined in coordination by COFEPRIS and the other authorities of the Federal Public Administration referred to in article 7 of this Regulation.
ARTICLE 38. Producers who regularly need Raw Materials, Pharmacological Derivatives or Cannabis Medications, will notify COFEPRIS, during the months of January to May, a forecast of the quantities they will demand during the following year.
ARTICLE 39. Cannabis Medications may not be presented in the form of a medical sample or an original gift.
ARTICLE 40. The factories or laboratories that process, or stores that sell, materials premiums, or derivatives Pharmacological Drug Cannabis may only sell them to establishments that have that accredits health license, as applicable, as warehouses deposit and distribution of drugs and biological products or blood products for human use, drug stores, pharmacies or pharmacies authorized to supply them to the public, in accordance with article 257 of the Law.
ARTICLE 41. The owners of the Raw Materials, Pharmacological Derivatives or Cannabis Medications , as well as those responsible for carrying out the Specific Actions indicated in this Regulation, and other actions that they carry out in compliance with other applicable legal provisions, must give notice in writing to COFEPRIS and other corresponding authorities, regarding their disappearance , in order to avoid the diversion of said substances.
ARTICLE 42. The use of Cannabis in homeopathic medicines will only be allowed when they are presented diluted and dynamized.
ARTICLE 43. Cannabis of natural or synthetic origin may not be included in the formulation of an herbal remedy .
ARTICLE 44. The manufacture of Pharmacological Derivatives and Cannabis Medications will be subject to what is established in Chapter IV of Title Twelfth of the Law, in the Regulation of Health Supplies , and in this Regulation.
CHAPTER V
OF DESTRUCTION
ARTICLE 45. The destruction of Raw Materials, Pharmacological Derivatives or Cannabis Medications must be communicated to COFEPRIS and carried out in the presence of a sanitary verifier, who will verify that they are destroyed.
ARTICLE 46. The destruction of Raw Materials, Pharmacological Derivatives or Cannabis Medications , will be carried out in accordance with the Sixth Section of Chapter I of the Second Title of the Regulation of Health Supplies and other applicable legal provisions.
TITLE FOUR
OF IMPORT AND EXPORT
CHAPTER I
GENERAL CONSIDERATIONS
ARTICLE 47. For the purposes regulated in this Regulation, the following may be imported:
I. Raw Material;
II. Pharmacological derivatives, or
III. Cannabis Medications.
ARTICLE 48. For the purposes regulated in this Regulation, the following may be exported:
I. Pharmacological Derivatives, and
II. Cannabis Medications.
ARTICLE 49. For the Import and Export of Raw Material, Pharmacological Derivatives and Cannabis Medicines, as the case may be, there must be a prior sanitary permit for Import or Export, granted by SADER or COFEPRIS, within the scope of their attributions. .
ARTICLE 50. In the case of Raw Material, Pharmacological Derivatives or Cannabis Medicines of foreign origin, they will only be allowed to be dispatched by the authorized customs offices determined by the competent authority, in terms of the applicable legal provisions.
ARTICLE 51. The Import or Export, as the case may be, of Raw Material, Pharmacological Derivatives or Cannabis Medications, may not be carried out, in any case, by post, using the services of courier or parcel companies, or in the other assumptions indicated by the regulations of the matter that regulate customs clearance.
ARTICLE 52. The Importation, into national territory, of Raw Material or products that contain them, Pharmacological Derivatives and Cannabis Medications will not be allowed , in cases where they are prohibited in the country of origin or not allowed for their Importation of compliance with applicable regulations .
ARTICLE 53. Without prejudice to other legal provisions, importers must keep the Import and Export permits for Medicines containing Pharmacological Derivatives or Raw Material involved in their preparation, for a minimum period of three years and will be obliged to exhibit them at the competent authorities that require it, within the scope of their competence.
ARTICLE 54. The procedures for Importing and Exporting Raw Material or products that contain them, Molecular Complexes, Pharmacological Derivatives and Medications referred to in the
These Regulations must be submitted electronically.
Applicants must submit the information and documentation that, in accordance with these Regulations and other applicable legal provisions, the corresponding procedure requires.
The procedures carried out by electronic means will be substantiated and resolved by the same means, so that the notifications made to the applicant regarding the requirements, actions, resolutions, exhibition, conservation or presentation of authorizations or documentation that the applicant must deliver to the competent authority and, in general, any administrative act derived from said procedures will be verified and resolved electronically, in accordance with the Law, the regulations derived from it and other applicable legal provisions.
CHAPTER II
OF THE IMPORT OF RAW MATERIAL, DRUG DERIVATIVES AND MEDICINES OF CANNABIS
ARTICLE 55. HEALTH, with the prior favorable opinion of SENASICA within the scope of its competence, will issue the Raw Material Import permit in the following cases:
I. Botanical seed for sowing;
II. Seedlings for planting, and
III. Plant propagation material.
The Import permit will contain the phytosanitary requirements necessary to mitigate risks, the phytosanitary measures to be applied in origin or origin of the seed, seedling and propagative plant material, of the authorized varieties, volumes, authorized entry point to the country and other declarations that are required.
ARTICLE 56. The phytosanitary measures that are established will be those necessary to reduce the risk of introduction of pests to the country and ensure the adequate level of protection and phytosanitary condition in the national territory, for which SENASICA will take into consideration the scientific evidence, pest risk analysis and, where appropriate, international recommendations, which should consider the species, type of product, use, country of origin and country of origin.
ARTICLE 57. To obtain the import permit referred to in article 55 of this Regulation, the following requirements must be met:
I. Declare its equivalent category in accordance with what is established in the Federal Law of Seed Production, Certification and Trade, and in the rules issued by SADER for this purpose;
II. Have the phytosanitary certificate for importation or equivalent official document, in the terms of the Federal Law of Plant Health and its Regulations, for which it must comply with the phytosanitary requirements established by SENASICA.
In the cases of Importing seeds that are genetically modified organisms, the provisions of the Biosafety Law for Genetically Modified Organisms must also be complied with ;
III. Present a copy of the Research Protocol authorized by COFEPRIS, in the case of Raw Material intended for research in terms of this Regulation, and
IV. Present a copy of the current sanitary registry issued by COFEPRIS, for the manufacture of Medicines.
For the purposes of sections III and IV of this article, the conditions established in the corresponding authorizations must be met .
ARTICLE 58. Those interested in importing Raw Material for sowing must submit an application for the issuance of the phytosanitary certificate for Import, as well as the following information and documents :
I. Name or denomination or company name, federal registry of taxpayers, where appropriate, name and legal personality of the legal representative, email, address of the interested party, address to hear and receive notifications and names of the persons authorized to receive them
in terms of the Federal Law of Administrative Procedure;
II. Planting purpose, which must be for:
a ) Research, in which case they must present the authorized Research Protocol, and
b ) Manufacture of Pharmacological Derivatives and Cannabis Medications, in which case they must present the current health registration;
III. Certificate issued within the framework of the Organization for Economic Cooperation and Development System or, where appropriate, certificate issued by the competent authority of the exporting country , which covers the variety of imported seed, seedling or propagation material, and that the The interested party is authorized to research or manufacture Medicines;
IV. Class of container or packaging that will be used to import the product;
V. Amount of seed to import;
SAW. Map of the location of the Permitted Confined Site, which must contain the geographic coordinates of the Universal Transverse Mercator Coordinate System. Such information will be kept confidential for security reasons, and
VII. Certified copy of the health license issued by COFEPRIS for the production of Cannabis for research or manufacturing, in terms of this Regulation.
ARTICLE 59. Once the Importation of Raw Material is allowed, it must be mobilized to the facilities where the sowing will take place, under the guardianship, custody and responsibility procedure, which will be charged to the importer and will consist of the safeguarding of the batch or shipment of Raw Material, from the point of entry into the national territory, to the Permitted Confined Site where the sowing will take place.
The procedure care, custody and responsibility must observe the provisions of Articles 78, section II of the Regulations of the Federal Plant Health Act and 45 of the Rules of Inputs for Health.
It is strictly forbidden to move the Raw Material to a place other than the one indicated in the phytosanitary certificate for Import.
ARTICLE 60. To obtain prior permission for the Importation of Pharmacological Derivatives and Cannabis Medications, the following data and documents must be submitted:
I. Sanitary license;
II. Notice of sanitary responsible in terms of article 259 of the Law;
III. Authorized Control Books and report their annual forecasts;
IV. Copy of the Research Protocol authorized by COFEPRIS, when the Importation is for research purposes, and
V. Copy of the current sanitary registration issued by COFEPRIS, when the Importation is for the manufacture of Medicines.
For the purposes of sections IV and V of this article, the conditions established in the corresponding authorizations must be met .
ARTICLE 61. In the case of Raw Material, HEALTH, with the prior opinion of SADER, may grant permission for the Importation of the seed only for medicinal use and research, in terms of this Regulation. In the latter case, the permit will be granted upon presentation and authorization of the Research Protocol or the corresponding sanitary registry, both granted by COFEPRIS.
The seed must be presented, for customs clearance, with the corresponding permit, before the customs office determined by the competent authority, complying with the regulations and restrictions established in accordance with the tariff fractions and nomenclature that correspond to them, in terms of the applicable legal provisions.
ARTICLE 62. To obtain the permit for the Importation of seeds for manufacturing purposes in terms of this Regulation, the following must be done:
I. Declare its equivalent category, in accordance with the provisions of the Federal Seed Production, Certification and Trade Law and the rules issued by SADER for that purpose, and
II. Have the phytosanitary certificate for importation or equivalent official document, in the terms of the Federal Law on Plant Health and its Regulations, for which the phytosanitary requirements established by SENASICA must be met.
In the cases of Importation of seeds that are genetically modified organisms, the provisions of the Biosafety Law of Genetically Modified Organisms must also be complied with .
ARTICLE 63. For the Importation of Pharmacological Derivatives or Cannabis Medications, prior to and after customs clearance, the importer must:
A. Inform COFEPRIS in writing, three business days in advance, the date and the customs office through which the merchandise is to be imported, as well as the following data:
I. The number and date of the import permit;
II. The name, quantity, batch number and expiration date of the Pharmacological Derivatives or Cannabis Medications;
III. The origin and provenance;
IV. The name or denomination or company name of the carrier, and
V. The invoice number;
B. Submit to COFEPRIS, after customs clearance, the following documentation :
I. Copy of the import sanitary permit;
II. Original and copy of digital tax receipt online or equivalent document certified by the Mexican consul in the country of origin;
III. Copy of the manufacturer’s certificate of analysis;
IV. Copy of the air waybill, bill of lading or packing list, and
V. Copy of the motion.
Once the requirements set forth in this article have been satisfied, COFEPRIS will immediately bundle, in their entirety, the Pharmacological Derivatives or Cannabis Medications.
ARTICLE 64. For the taking of samples of Pharmacological Derivatives or Cannabis Medications and the release of these, the Establishment must request, through the corresponding format, the presence of a sanitary verifier who proceeds to remove the straps. COFEPRIS will have fourteen business days to carry out the verification visit and decide on the request.
ARTICLE 65. To remove the strips of Pharmacological Derivatives or Cannabis Medications, the health verifier must verify the batch number, expiration date, quantity and name of the material that is released based on the satisfactory analytical results, and establish in the minutes, and in the Control Book , the number and date of the Import permit.
These actions must be carried out in the presence of the owner or health officer of the Establishment where the merchandise is consigned.
ARTICLE 66. To remove the bandage referred to in the previous article, and that the removal meets the characteristics and requirements indicated by COFEPRIS and the other competent authorities, the health authority will carry out the sampling and verification of data referred to in this Regulation .
For this purpose, the owner or the health manager of the establishment must present the corresponding certificate of analysis carried out by an auxiliary testing laboratory in the health regulation.
The importer will not be able to dispose of the merchandise until COFEPRIS has the analytical results .
ARTICLE 67. The importer of Pharmacological Derivatives or Cannabis Medications must have adequate facilities for the safe handling of them, which guarantee the control of their quality and pharmacovigilance, in accordance with the applicable legal provisions.
ARTICLE 68. Medications that contain Pharmacological Derivatives may only be imported when the expiration date is greater than twelve months from their entry into the national territory, unless such Medications, by their nature, have reduced stability and as authorized by COFEPRIS.
ARTICLE 69. COFEPRIS will require that the analytical certificates for Medicines containing Cannabis, which are imported into the national territory, be endorsed by the health manager or equivalent of the manufacturing laboratory, and by the health manager of the laboratory requesting registration.
ARTICLE 70. At the request of COFEPRIS, whoever has imported Medications that contain Pharmacological Derivatives or Raw Materials involved in their preparation, must inform the destination that they have been given.
ARTICLE 71. When, without prior permission for Import, Medications containing Pharmacological Derivatives or Raw Material that intervene in their preparation are introduced into the national territory , the competent authorities will apply the corresponding security measures and sanctions, without prejudice to those that correspond in Criminal matters.
ARTICLE 72. In the case of the Importation of Cannabis Medications intended for personal use and medical purposes, COFEPRIS may grant the prior import sanitary permit, for which the applicant must attach to his request the medical prescription that includes the professional identification number, the product and its quantity.
Both the prior import health permit and the medical prescription referred to in the previous paragraph must be presented for dispatch.
CHAPTER III
FROM THE EXPORT OF CANNABIS DRUG DERIVATIVES AND DRUGS
ARTICLE 73. In order to obtain the Export permit for Pharmacological Derivatives and Cannabis Medications , an application must be submitted in the official format in terms of article 292 of the Law and 203 of the Health Supplies Regulation.
HEALTH will have fourteen business days to resolve the request.
ARTICLE 74. Once the Exportation of Pharmacological Derivatives and Cannabis Medications has been granted , the interested party will notify COFEPRIS of the date on which they intend to carry out the Export so that a sanitary verifier is appointed to draw up a record stating:
I. That the Pharmacological Derivatives and Cannabis Medications correspond to those authorized, for which the numbers and date of the Export permit, product name , batch number, expiration date and quantity will be confirmed ;
II. The name or denomination or company name of the carrier, and
III. That the Pharmacological Derivatives and Cannabis Medications were wrapped, sealed and sealed.
The above data must be entered in the Control Book authorized by COFEPRIS, in the presence of the health manager of the Establishment.
TITLE FIFTH
OF HEALTH CARE ESTABLISHMENTS PROVIDING CANNABIS DRUGS
ARTICLE 75. The Establishments that provide medical care services and supply Cannabis Medications, must comply, for their operation, with the provisions contained in the Regulations of the General Health Law on Health Control of Activities, Establishments, Products and Services , as well as those of the Regulations of the General Health Law on the Provision of Medical Care Services.
ARTICLE 76. In order to Prescribe Cannabis Medications in Establishments that provide health care services, the provisions of the Law, the Regulations of the General Health Law on the Provision of Health Care Services, and other provisions must be observed. applicable legal.
TITLE SIX
OF ADVERTISING AND COMMERCIALIZATION
ARTICLE 77. For the purposes of article 310 of the Law, only the advertising of Cannabis Medications that is aimed at health professionals will be authorized , therefore it is forbidden to carry out promotion and advertising aimed at the general population.
ARTICLE 78. Advertising must be limited to the bases approved by HEALTH in the sanitary registry of Cannabis Medications.
ARTICLE 79. Establishments that sell Cannabis Medications must comply with the applicable legal provisions, and have:
I. Sanitary license;
II. Health manager;
III. Control Books;
IV. Federal taxpayer registry, and
V. Acquisition permit in place, in terms of article 236 of the Law and 197 of the Health Supplies Regulation .
ARTICLE 80. COFEPRIS, at any time and in accordance with the applicable legal provisions , may carry out the Sanitary Surveillance and commercial verifications.
TRANSIENT
FIRST. These Regulations shall enter into force the day following their publication in the Official Gazette of the Federation.
SECOND. All administrative provisions that are contrary to this Regulation are repealed.
THIRD. The entry into force of this Regulation will not imply additional expenditures, so the participating Institutions must adjust to their authorized budget for the corresponding fiscal year , and not increase their regularizable budget.
FOURTH. The Ministry of Agriculture and Rural Development, including its decentralized administrative bodies , will have ninety business days, counted from the entry into force of this Regulation, to make the necessary regulatory adjustments for adequate compliance with the provisions of the same.
Given in the Residence of the Federal Executive in Mexico City, on January 8, 2021.- Andres Manuel Lopez Obrador .- Signature.- The Secretary of Finance and Public Credit , Arturo Herrera Gutierrez .- Signature.- Secretary Agriculture and Rural Development , Víctor Manuel Villalobos Arámbula .- Signature.- The Secretary of Health , Jorge Carlos Alcocer Varela .- Signature .
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