In early May 2018, Mexico notified the World Trade Organization (WTO) of draft regulations from Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) with regard to cannabis and its derivatives: Regulations of the General Health Law in Matters of the Health Control of Cannabis and Its Derivatives. See G/SPS/N/MEX/339 and G/TBT/N/MEX/405. The draft regulations would apply for scientific and medical purposes as well as industrial use. To date, this is the first notification regarding a comprehensive cannabis regulatory measure by any WTO member country. Comments must be submitted to COFEPRIS by July 2, 2018.
Here are some of the highlights of the draft regulations:
- Research: The draft regulations set out requirements for conducting medical and scientific research in Mexico, including registration, traceability, and methods for destroying surplus substances or waste.
- Medical Use of Cannabis and Its Derivatives: The draft regulations require authorization from COFEPRIS to plant, cultivate, and harvest cannabis for medical purposes. The requirements include an approval letter from the Committee of New Molecules or a current sanitary registration; a sanitary license for the manufacture of drugs; a certificate of good manufacturing practices; and a site inspection by COFEPRIS.
- Import/Export Permit Requirements: The draft regulations require obtaining permits for import and export. While permit applications will be processed within 14 days, permits will be valid for only 90 days and can be extended only for an additional 90 days.
- Importation of Medicines Containing Derivatives of Cannabis or Certain Raw Materials: The draft regulations require Mexican establishments that import such medicines to obtain a sanitary license for narcotic or psychotropic drugs. The importer must have adequate facilities for safe and secure handling, and it can only import medicines with an expiration date that will occur later than one year after delivery. The draft regulations also set out a list of documents that must be presented to Mexican customs, including an original and copy of the invoice certificated by the Mexican consul in the country of origin. In addition, the importer must request that a sanitary verifier remove the seals from the imported product in the presence of the owner or manager of the Mexican establishment where the product is consigned and verify the contents.
- General Requirements to Market, Import, and Export Products for Industrial Use: The draft regulations require that, to market, import, or export products or substances containing cannabis derivatives in concentrations of up to 1 percent tetrahydrocannabinol (THC) for industrial use, COFEPRIS must perform a health risk evaluation and provide authorization. The draft sets out the list of documents and other information that a party must provide to COFEPRIS to obtain authorization.
- Additional Requirements for Food, Dietary Supplements, Non-Alcoholic Beverages, and Alcoholic Beverages: The draft regulations require, with regard to COFEPRIS's health risk evaluation, consideration of the effects per cumulative dose, and establishment of a maximum permissible dose of up to 1 percent THC per package or per piece.
- Additional Requirements for Herbal Remedies: The draft regulations require that persons involved in all aspects of the process, from manufacturing to distribution, obtain an alphanumeric key from COFEPRIS and provide a long list of information, including the qualitative and quantitative formulas of the components and additives. Obtaining the alphanumeric key for foreign-manufactured herbal remedies requires submission of additional information, including a certificate of free sale and a certificate of good manufacturing practices (GMP certificate).
A few additional items of note:
- The draft regulations appear to indicate in several instances that many of the details will be set out in official Mexican standards (NOMs) and additional regulations. This suggests that COFEPRIS should delay the regulations' entry into force until these supplementary measures have been published to avoid creating uncertainty in the marketplace.
- The draft regulations appear to require the submission of a GMP certificate to COFEPRIS with respect to any foreign-manufactured, cannabis-containing product classified as an "herbal remedy" under Mexican law. No such requirement appears to exist for such products that are domestically produced. In addition, the regulations appear to require submission of a certificate of free sale issued by the health authority of the country of origin. This could prohibit export to Mexico of any cannabis-containing product that would be classified as an "herbal remedy" under Mexican law, if the exporting jurisdiction prohibits its sale. For example, it is possible that a U.S. company may not be able to obtain the requisite certificate of free sale, which would prevent the company from exporting a cannabis-containing herbal remedy to Mexico.
- The requirement to submit the qualitative and quantitative formulas of the components and additives of an herbal remedy risks exposure of a manufacturer's confidential business information. Depending how they are implemented, other provisions may raise trade concerns as well. These include the requirements and procedures regarding alphanumeric code, labeling, consul certification, sanitary verification, permit validity, and recognition of conformity assessment bodies.
- Many of the international standards under development in ASTM International's D37 Committee on Cannabis could be relevant for COFEPRIS as it develops the draft regulations, as well as other regulations and NOMs that Mexico will develop to implement the regulatory scheme. The next meeting of the D37 Committee will take place in San Diego, California on June 24-26, 2018.
Venable has an experienced team of international trade and FDA law practitioners who are actively monitoring the development of cannabis laws, regulations, and standards and are available to advise on these or related issues.