Cannabis – The ANMAT approved a procedure to authorize cannabis-based medicinal products

Cannabis – The ANMAT approved a procedure to authorize cannabis-based medicinal products

By Belen Recchini and Antonella Balbo.

On August 16, 2022, the National Administration of Medicines, Food, and Technology (ANMAT, for its acronym in Spanish), approved through Provision No. 6431/2022, the “Guide for the sanitary authorization of cannabis-based plant products and their by-products intended for use and application in human medicine” (Guide), in line with Resolution 781/2022.

The ANMAT, as the health enforcement authority, will be responsible for authorizing public or private, local or foreign laboratories (with local domicile), to manufacture, import, export, and/or commercialize active pharmaceutical ingredients and industrialized products, containing derivatives of plants or herbal derivatives of Cannabis.

Interested companies must file the applications prior to the manufacture, import, export and/or commercialization of the product. Once submitted, the authorization process will have a simplified procedure.  

The Sanitary Authorization may only be requested by laboratories that have the corresponding qualifications and comply with the Good Manufacturing and Control Practices according to ANMAT Provision No. 3602/18 (t.o. ANMAT Provision No. 3827/18).

The ANMAT will issue an evaluation report prior to the Authorization, and may request the laboratory any additional requirement they deem necessary, to ensure the quality and safety of the products.

The Sanitary Authorization may authorize the manufacturing, commercialization, import and/ or export of raw material, products in bulk, in primary packaging, and/or finished products.

Once issued, the Sanitary Authorization will be valid for four years. The interested party must request its re-registration within thirty days prior to its expiration. Once this term has expired, the authorized product may not be manufactured or commercialized.

Any subsequent change to the Sanitary Authorization issued by ANMAT must be communicated to ANMAT.  The Sanitary Authorization may only be transferred to laboratories that comply with the previously mentioned requirements.

The mentioned procedures must be carried out through the Electronic Document Management System (GDE).

The Guide also details the Quality Control requirements that shall apply to any Cannabis-based plant product and its by-products intended for use and application in human medicine to be administered orally and topically. Parenteral routes of administration are excluded.

Regarding the labeling of these products, the Guide stipulates that the following information must be included on the primary and/or secondary packaging of these products:

– Trade name of the cannabis-based plant product;

– Common name of the cannabis-based plant product;

– Qualitative-quantitative formula;

– Batch number;

– Expiration date;

– Storage conditions in a closed container after opening;

– Sanitary authorization number.

In addition, they must contain a statement indicating that they are prescription products. Likewise, they must include the following statements: “The use of this product during pregnancy or breast-feeding may be harmful to health” and “Keep out of reach of children”.

The labeling should clarify that the safety and efficacy of the products has not been evaluated, together with the recommendation to consult a physician before using it in combination with dietary supplements or medications. 

No statements that imply a therapeutic action and/or any symbols, figures, or drawings that allow a misinterpretation that gives these products additional characteristics, may be included.

The application of the Guide will be under the competence of the National Institute of Medicines (INAME for its acronym in Spanish).

The Guide establishes that, in case of any infringement to the stated provisions, the Authorization may be suspended, and the product may be withdrawn from the market, without prejudice to the sanctions that may correspond under the terms of Law 16.463 on Technical and Economic Control of Medicines, Drugs and all other products of use and application in human medicine and its regulatory, modifying and complementary rules.

You can read the complete Guide at the bottom of the following link:

In Ojam Bullrich Flanzbaum we have a team of professionals specialized in the field. We offer a personalized service by adapting to the specific needs of our clients.

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