Legal & Regulatory > Mexico > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Cannabinoid drugs, medicinal cannabis and opioid drugs in Mexico – a comprehensive legal overview. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

The use of cannabis has been authorized for medicinal use, including investigational activities and granting marketing authorizations for medicines for which the active ingredient is THC.

On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives was published in the Federal Official Gazette.

The new Cannabis Regulation is intended to regulate, promote, and monitor the use of cannabis and its derivatives for medicinal use. The regulation includes provisions regarding primary production, research, manufacturing of pharmacological derivatives and medicines, distribution, advertising, prescription, and commercialization. This regulation come into force on January 13, 2020.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

So far, the authority responsible for applying and enforcing the regulatory framework in relation to Cannabinoid Drugs is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health. On the other hand, it is worth mentioning that the proposal of this new law refers to the creation of the “Mexican Institute for Regulation and Cannabis Control”. This proposal may impact the role of COFEPRIS, as the main regulatory authority. Additionally this Institute will be in charge of the creation of specific regulation and guidelines concerning the permitted activities with cannabis.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

The General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives recently published established the authorization of Cannabinoid Drugs only for investigation, production and medicinal use. The primary legislation for the authorization, pricing, and reimbursement of these kind of drugs, is the General Health Law (Ley General de Salud) (HL), its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.

Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies’ participation is voluntary. Under the price, control each product’s MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. There are no established sanctions for violations of the MRP. In private sector, there is no reimbursement in Mexico.

Public acquisitions are supported by the Committee for the Negotiation of Drug Prices (CNDP).

4. Which are the cannabinoid drugs that have received market approval to date?

The official Website of COFEPRIS does not show any registration concerning cannabinoid drugs which have an approval on force. However, there have been authorizations granted concerning cannabinoid drugs.

5. Who can prescribe Cannabinoid Drugs?

Healthcare professionals who have registered before COFEPRIS and have been granted with the specialized prescription forms concerning narcotic substances.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

So far, there is no list of doctors authorized to prescribe Cannabinoid Drugs.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

There is no express regulation in this regard.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

N/A

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

So far, there is no list of retailers/distributors authorized to sell Cannabinoid Drugs.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Phar-macological Derivatives was published in the Federal Official Gazette.

On the other hand, it is worth mentioning that the proposal of this new law refers to the creation of the “Mexican Institute for Regulation and Cannabis Control”. This proposal may impact the role of COFEPRIS, as the main regulatory authority. Additionally this Institute will be in charge of the creation of specific regulation and guidelines concerning the permitted activities with cannabis.

11. When are they likely to come into force?

The proposal is still under discussion by the Mexican Congress. An the cannabis path has taken quite a while, therefore we expect one year more for these document to be approved and enters into force.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

The use of cannabis has been authorized for medicinal use, including investigational activities and granting marketing authorizations for medicines which active ingredient is THC. On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives was published in the Federal Official Gazette.

The new Cannabis Regulation is intended to regulate, promote, and monitor the use of cannabis and its derivatives for medicinal use. The regulation includes provisions regarding primary production, research, manufacturing of pharmacological derivatives and medicines, distribution, advertising, prescription, and commercialization. This regulation come into force on January 13, 2020. However, there is still missing the issuance of specific and specialized regulation.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

So far, the authority responsible for applying and enforcing the regulatory framework in relation to Cannabinoid Drugs is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

The General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives recently published, established the authorization of Cannabinoid Drugs only for investigation, production and medicinal use. So far, there is no specific regulatory framework for pricing, and reimbursement of Medicinal Cannabis. The primary legislation for the authorization, pricing, and reimbursement of these kind of drugs, is the General Health Law (Ley General de Salud) (HL), its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

According to the new General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharma-cological Derivatives the production and import of Medicinal Cannabis is regulated by the National Service for Agro-Food Safety and Quality (SENASICA) and the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health. And by the Ministry of Economy.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The new General Health Law Regulation on Sanitary Control for the Produc-tion, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives establishes that the authorization to sow cannabis for the research and manufacturing purposes, must be processed before SENASICA attaching the research protocol, or the marketing authorization of the drug that is intended to be produced.

COFEPRIS may authorize public and private establishments that are destined to the manufacturing process, or that import, export or use Raw Material, Pharmacological Derivatives or Cannabis Medicines, which MUST have control books authorized by COFEPRIS, in which the manufacture of batches of Raw Material, Pharmacological Derivatives or Cannabis Medicines destined to obtain sanitary registration for commercialization of research must be registered.

A permit for commercialization issued by COFEPRIS is required to apply for a sanitary importation permit.

On the other hand, the said General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives establishes that for the import and export of Raw Material, Pharmacological Derivatives and Cannabis Medicines, is required to have a prior sanitary permit for Import or Export, granted by the Ministry of Agriculture and Rural Development (SADER) or COFEPRIS, within the scope of their attributions. However, there is still lack of harmonization of the current sanitary legislation and the International Trade legislation. In the international Trade legislation field, despite of existing tariff schedules allowing importation for certain forms of cannabis, there are some other tariff schedules concerning cannabis are still forbidden; and keep obstaculizing the importation of certain types of products.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

The primary legislation for the marketing and distribution of Medicinal Cannabis is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.

18. How can patients obtain Medicinal Cannabis?

Patients would be entitled to obtain Medicinal Cannabis as long as they have a valid and codified prescription

19. Who can prescribe Medicinal Cannabis?

Healthcare professionals who have registered before COFEPRIS and have been granted with the specialized prescription forms concerning narcotic substances.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There is a database of authorized healthcare professionals. However, so far there is no list of doctors authorized to prescribe Medicinal Cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

The healthcare professionals must be registered before COFEPRIS have been granted with the specialized prescription forms concerning narcotic substances.

The healthcare professionals interested in obtaining the bar code for special prescription recipes for Cannabis Medications must file an application before COFEPRIS for this purpose.

22. Where is Medicinal Cannabis available?

Up today, there is no official information on medicinal cannabis available.

COFEPRIS may authorized drugstores, apothecaries or pharmacies to supply the public with Cannabis Medications.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

So far, there is no list of retailers authorized to sell Medicinal Cannabis.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

N/A

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

So far, the authority responsible for applying and enforcing the regulatory framework in relation to Opioid is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

The primary legislation for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.

Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies’ participation is voluntary. Under the price, control each product’s MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. There are no established sanctions for violations of the MRP. In private sector, there is no reimbursement in Mexico.

28. Which are the Opioid drugs that have received market approval to date?

Morphine.

29. Who can prescribe Opioid Drugs?

The healthcare professionals must be registered before COFEPRIS have been granted with the specialized prescription forms concerning narcotic substances.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is a database of authorized healthcare professionals. However, so far there is no list of doctors authorized to prescribe Medicinal Cannabis.

31. What approvals or notifications are required to prescribe Opioid Drugs?

The healthcare professionals must be registered before COFEPRIS have been granted with the specialized prescription forms concerning narcotic substances.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

N/A.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no list of retailers/distributors authorized to sell Opioid Drugs.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No.

35. When are they likely to come into force?

Not applicable.