After almost 3 years, Mexico’s “General Health Law’s regulations on production, investigation and medicinal use of Cannabis and its pharmaceutical derivatives” were published in the Official Gazette on January 12, 2021 and entered in force on January 13, 2021.
Amongst other subjects, the most relevant topics that the regulations tackle are as follows:
- The need for the parties that obtain a sanitary registration for cannabis pharmaceutical products to have a “Quality Control Lab”.
- Rules and procedures that parties looking to conduct pharmaceutical investigation activities (including those on humans) need to fulfill.
- Rules and procedures that parties looking to sow, cultivate and harvest cannabis for medical purposes, for pharmaceutical and health investigation, and for producing pharmaceutical products and pharmaceutical derivatives need to fulfill.
- Guidelines and requirements in connection with advertising, prescription and sale of cannabis pharmaceutical products.
- Rules involving authorizations to prescribe, as well as some operations considerations for businesses that provide medical care and cannabis pharmaceutical products.
- Measures that must be taken by those that produce, store and process cannabis pharmaceutical products and pharmaceutical derivatives.
- Guidelines that must be followed for importing and exporting raw materials, cannabis pharmaceutical products and pharmaceutical derivatives.
Lastly, the regulations will also act as a framework for related Government entities and other Laws / regulations to become adjusted. This includes those in the fields of health, safety and quality of food and agricultural products; seed inspection and certification; protection against health risks; and import and export of materials. As a consequence, a broader structure that monitors and promotes the medical use of cannabis from different points of view will be created.
Due to the above, the only remaining aspect concerning cannabis legalization in Mexico is in the hands of the House of Representatives, as the Senate recently approved the “Federal Law for Cannabis”, which regulates the recreational and industrial use of cannabis. News from the Chamber of Deputies approving the Law are expected by the end of february, 2021.
Do not hesitate to contact the Panamericana de Patentes y Marcas team in case you have questions about the new regulations or the approval process and regulation of cannabis in México.
We are at your service should you have any questions.