Here’s the introduction to their piece published 22 January 2021
On Jan. 12, 2021, the General Health Law Regulations for the Control of Production, Investigation, and Medicinal Use of Cannabis and its Pharmacological Derivatives (the Regulations) were published in the Federal Official Gazette, coming into force Jan. 13, 2021.
The Regulations regulate, control, promote, and monitor the raw materials, pharmacological derivatives, and medicines derived from cannabis, for production, research, manufacturing, and medical purposes. The Regulations apply to activities carried out for the following purposes:
|Manufacturing of pharmacological derivatives and medicines, and
|Medical diagnosis, prevention, therapeutics, rehabilitation, and palliative care.
Quality Control Laboratories
Each health registration holder must have an independent Quality Control Laboratory1 under the authority of a qualified person with the required academic background and experience, pursuant to the procedures established in the laboratory’s Quality Management System2.
Those interested in carrying out cannabis research must obtain authorization for their Research Protocol from COFEPRIS.
The cannabis harvesting permit for research and manufacturing must be filed before SENASICA3, in accordance with the provisions of the Regulations, including the authorization of the research protocol or the sanitary registration for the medicine to be produced.
Prescription of cannabis medicines must observe the provisions set forth in Article 240 of the General Law of Health4 and its Regulations. Professionals who wish to obtain a bar code for special prescriptions for cannabis medicine will need a permit from COFEPRIS.
Public and private establishments involved in the manufacturing process, import, export, or use of raw material, pharmacological derivatives5 or cannabis medicines will be required to maintain a specific control book that complies with the requirements established in the Regulations, and to implement security systems in compliance with Article 46 of the Regulation of Inputs for Health and Pharmacopoeia of the United Mexican States6 and satisfy all of the requirements established by the Regulations.
The control book must be authorized by COFEPRIS and must contain a record of the manufacturing of the pharmacological derivatives for which the sanitary registration for sale is being requested. It must also include, as applicable, the following information:
|Name of the pharmacological derivatives;
|Quantity to be used and balance remaining;
|Use and destination that will be given, and
Producers that consistently require raw materials, pharmacological derivatives, or cannabis medicines must notify COFEPRIS, in January and May, of the quantities that will be needed the following year.
Factories or laboratories that process pharmacological derivatives and storage facilities that hold these products will only be able to sell them to establishments with a valid sanitary license for such purpose.
Owners of pharmacological derivatives must give written notice to COFEPRIS and other relevant authorities of any shortages or waste in their inventories to avoid unintended distribution of such substances.