ANMAT Disposition No. 6431/2022: Guide for the sanitary authorization of Cannabis-based plant products and their Derivatives intended for use and application in human medicine.
Healthcare & Life Sciences Department Report | ANMAT Disposition No. 6431/2022: Guide for the sanitary authorization of Cannabis-based plant products and their derivatives intended for use and application in human medicine
Dear Sir or Madam,
Disposition No. 6431/2022 issued by ANMAT (the “Disposition”), published in the Official Gazette on August 16th, 2022, approves the “Guide for the sanitary authorization of Cannabis-based plant products and their derivatives intended for use and application in human medicine” (the “Guide”), which has the purpose to establish guidelines for the manufacture, import, export, marketing, monitoring and inspection of industrialized products containing plant or herbal derivatives of Cannabis, intended for use and application in human medicine (the “Products”).
The Guide applies to all laboratories, public or private, domiciled in the country that carries out the aforementioned activities concerning the Products and/or active pharmaceutical ingredients containing plant or herbal derivatives of Cannabis intended for use and application in human medicine (“APIs”). A brief description below reports the main points regulated by the Guide.
A. Authorization to Market and Manufacture Products
• Any laboratory wishing to market or manufacture a Product and/or manufacture APIs must first obtain the sanitary authorization issued by ANMAT (the “Sanitary Authorization”).
• The Sanitary Authorization may only be requested by laboratories that have the corresponding authorization and that comply with the Good Manufacturing and Control Practices (GMP). As for any other medicinal product or API, the laboratory holder of the Sanitary Authorization is responsible for the quality and safety of the Products.
• The procedure for granting the Sanitary Authorization will have a simplified procedure, consisting of an application and the submission of certain documentation.
• The Sanitary Authorization may authorize the manufacture, marketing, import, or export of raw materials, products in bulk, in primary packaging, and/or finished products.
• Unlike the sanatory authorizations for other medicines, which have a 5-year term, the Sanatory Authorization and its re-registration will be valid for a 4-year term.
• As in the case of other medicinal products, the transfer of a Sanatory Authorization can only be made to laboratories that have the corresponding authorization and that comply with GMP.
• Companies manufacturing APIs must comply with Disposition 3602/18 which regulates the GMP of medicinal products.
• Any API or product with a percentage of tetrahydrocannabinol higher than 0.3% w/w on a dry basis, considering the tetrahydrocannabinol acid that may be present, shall be subject to the regime corresponding to Substances Subject to Special Control.
B. Product Quality Control
• All Products must comply with the requirements established in Resolution No. 781/2022 of the Ministry of Health, which creates the category of Products as different from that of medicines regulated by Decree No. 150/1992.
• The documentation to be provided is specifically established (including, among others, the geographical area -province/region/country- of origin of the raw material, species, variety, chemotype, the origin of the seeds, and propagation material, if applicable, cultivation -harvesting technique and date, chemical substances for agricultural use, applied post-harvest treatment and drying, post-harvest humidity control, packaging, storage and transport conditions, among others).
• Certain tests must be carried out on the Products, which must be duly justified according to appropriate technical-scientific criteria, and must be performed using validated or verified methods if they are codified in internationally or nationally recognized pharmacopoeias in force.
• All requirements and characteristics with which the Products and APIs have to comply in order to be marketed are established.
C. Infringements
• Any infringement of the provisions of the Disposition may give rise, as a preventive measure, to the suspension of the authorization and the withdrawal of the product from the market, without prejudice to the penalties that may apply under the terms of Law 16.463 and its regulatory, amending and complementary rules.
If you have any queries, please do not hesitate to contact us.
Sincerely,
Ana Andrés
Julieta Gonzalez