On August 11, 2022, the National Administration of Medicines, Food and Medical Technology (hereinafter “ANMAT”) issued Provision No. 6431/2022, which approved the document “Guide for the Sanitary Authorization of Cannabis-based products and their derivatives intended for use and application in human medicine, according to Ministry of Health’s Resolution No. 781/22” (the “Provision”). This guide sets forth the standards of good manufacturing, import, export, commercialization, monitoring, inspection and dispensing practices for industrialized products containing cannabis plant derivatives. The purpose is to guarantee quality-controlled inputs, raw materials and products that are subject to the principles of good manufacturing practices, free of hazardous contaminants such as pesticides and heavy metals, among others.
The Provision was previously submitted to public consultation, which was carried out from June 23 to July 2, 2022, in order to gather opinions and concerns about the project.
The Provision was issued within the scope of Law No. 27,350 that regulates the medical and scientific research on the medicinal, therapeutic and/or palliative use of the cannabis plant and its derivatives, and its Regulatory Decree No. 883/2020, which one of its main objectives is the creation of the necessary conditions to guarantee the access of the population to products containing cannabis derivatives, through the issuance of operational standards and procedures that must consider the quality of cannabis and its derivatives.
The Provision is also linked with Resolution No. 781/2022 of the Ministry of Health (MoH), which created the category of ”Cannabis-based plant products and their derivatives intended for use and application in human medicine”, being a different category from the products already regulated as medicine, medicinal specialty, according to Decree No. 150/1992, and herbal medicine, according to Resolution of the MoH No. 1817/2013. Article 2 of the Provision defines “Cannabis-based plant products and their derivatives intended for use and application in human medicine” as any product with a clearly defined and verifiable qualitative-quantitative composition containing as Active Pharmaceutical Ingredient(s) (API) one or more cannabinoids derived from plant origin obtained in accordance with established good manufacturing practices.
The Provision covers local and foreign public or private laboratories with domicile in the country that manufacture, import, export and commercialize active pharmaceutical ingredients (API) and industrialized products containing derivatives of plants or herbal derivatives of Cannabis, in national jurisdiction and/or for interjurisdictional transit. Such laboratories must have the corresponding authorization, the Good Manufacturing and Control Practices (GMP) according to ANMAT Provision No. 3602/18, as amended and will be responsible for guaranteeing the quality and safety of the products. The laboratories will have to apply for a Sanitary Authorization for cannabis-based plant products and their derivatives intended for use and application in human medicine, required to carry out the aforementioned activities. The application will be carried out by means of a simplified procedure that will be enabled for this purpose through the Electronic Document Management System (GDE).
Chapter 2 of the Provision sets forth that the Sanitary Authorization issued by ANMAT and its re-registrations shall be valid for a term of four (4) years. The laboratory interested in its renewal must request the re-registration within thirty (30) days prior to its expiration. After the expiration date, the product in question cannot be manufactured or marketed.
Chapter 3 regulates the Active Pharmaceutical Ingredient (API). Establishments whose activity is based on manufacturing APIs with one or more cannabinoids derived from plants belonging to the cannabis genus, containing pure CBD of natural origin or CBD present in extracts and natural oils of certain parts of the plants, which comply with MoH Resolution No. 781/22, must apply for authorization for cannabis-based plant products and their derivatives intended for use and application in human medicine – MoH Resolution No. 781/22. Those who already have authorization must apply for the corresponding extension forthis category of products.
In the same sense, Chapter 4 sets forth that all establishments engaged in the processing of cannabis-based plant products and their derivatives intended for use and application in human medicine must apply for the aforementioned authorization. Those laboratories that are already authorized as manufacturers of medicinal specialties or herbal products that wish to produce herbal products based on cannabis and its derivatives intended for use and application in human medicine must have an authorization certificate issued by the National Institute of Medicines (INAME) for herbal products based on cannabis and its derivatives intended for use and application in human medicine – MoH Resolution No. 781/22.
Chapter 5 details the quality control requirements to be applied to any cannabis-based plant product and its derivatives intended for use and application in human medicine, to be administered orally and topically, and the information that must be included in order to obtain the Health Authorization.
Finally, the Provision sets forth that any violation of the regulations may cause 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 No. 16,463 on Medicines and its regulations, as amended.
This report cannot be considered as legal or any other kind of advice by Allende & Brea.
