Exception Access Regime – cannabis products and derivatives

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The National Ministry of Health issued Resolution No. 654/2021 (hereinafter referred as the “Resolution”) This Resolution approved an Exception Access Regime for products that contain cannabinoids or derivatives of the cannabis plants devoted exclusively for medicinal uses in individual treatments or in the framework of scientific research.

The Resolution states the cases in which the Exception Access Regime is applicable.

In case of products for individual treatments whose import is authorized by the National Food, Drug and Medical Technology Administration (hereinafter referred as ANMAT for its acronym in Spanish):

  • The products must be prescribed by doctors duly registered before the health authority.
  • Doctors prescribes the products under their own responsibility about the quality, safety, and efficacy of the product.
  • The request must be done thorough the electronic government platform (“TAD platform”). For cases in which it is impossible to use the TAD platform, the ANMAT will provide an alternative way to do the request.  
  • The authorized import will cover the amount of product needed for a treatment to cover a treatment of up to 180 days.
  • The import authorization issued by the ANMAT´s responsible officer is considered sufficient to be submitted to the Customs Administration. The form will be valid for 180 days from the date of the authorization.
  • The ANMAT will be able to request updated information on the use and marketing of the product, form working groups for each case and request opinions from specialized scientific societies, among others.

The Resolution also states the procedure to import products for medicinal and scientific research in the framework of the Exception Access Regime.

Finally, it is important to mention that patients that at the day of the entry into force of the Resolution have access to a specific product in the framework of Resolution No.133/19, will be able to continue with the importation of the product.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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