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Regulation of the General Health Law on sanitary control for the medicinal use of Cannabis

  • 07 April 2021
  • New legislation

Finally, on January 12, the Regulation of the General Health Law on Sanitary Control for the Production, Research, and Medicinal Use of Cannabis and its Pharmacological Derivatives (Regulation) was published, which regulates the reforms to the General Health Law and the Federal Criminal Code, published on June 19, 2017, in the Official Gazette of the Federation.

This reform contemplates the medicinal use and scientific research of cannabis and its pharmacological derivatives. According to the transitory provisions of the reform, when it came into force, the Executive Power, through the Ministry of Health, had 180 days to harmonize the legal orders. The lack of a timely regulation resulted in the subsequent exhortation made by the Supreme Court of Justice of the Nation to the Ministry of Health to regulate the medicinal use of cannabis and its derivatives since this omission affected the effectiveness of the human and constitutional right to health protection.

The Regulation consists of 80 articles, which are divided into 6 titles: General Provisions; Quality control Laboratories; Of the Purposes of Cannabis; Of the Import and Export; Of the Institutions for Medical Attention that supply Cannabis Medications, and Of the Advertising and Marketing.

The purposes of this Regulation are the regulation, control, promotion, and sanitary surveillance of raw material, pharmacological derivatives, and cannabis medicines, for production, research, manufacturing, and medical purposes.

Activities regulated by this Regulation must exclusively have one of the following purposes:

  1. Primary production
  2. Investigation
  3. Manufacture of pharmacological derivatives and medicines.
  4. Physicians for diagnostic, preventive, therapeutic, rehabilitative, and palliative care.

The agencies of the Federal Public Administration28 empowered to carry out the surveillance actions of this regulation are:

  • Federal Commission for Protection against Sanitary Risks (COFEPRIS);
  • Ministry of Agriculture and Rural Development (SADER), through the National Service of Health, Safety, and Agri-Food Quality (SENASICA) and the National Service of Seed Inspection and Certification (SNICS);
  • Ministry of Economy, and
  • Ministry of Finance and Public Credit, through the Tax Administration Service (SAT).

Overall, the use of cannabis for medical and scientific research purposes will also be regulated by the provisions applicable to raw material and controlled medicines of the current health normativity, such as the General Health Law; the Regulation of Health Supplies; the Regulation of the General Health Law on Health Research; the Regulation of the General Health Law on the Provision of Medical Care Services; the Regulation of the General Health Law on Advertising; NOM-059-SSA1-2015 Good drug manufacturing practices, among others.

Finally, it is important to highlight that this Regulation does not regulate the recreational use of cannabis.

At ClarkeModet we have the experience advising companies in this industry from technological intelligence studies to strengthen and refine the development of new products and technologies, to regulatory issues related to obtaining permits from COFEPRIS and registration of trademarks, intangible assets, and patents.

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