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The Brazilian National Health Agency (“ANVISA“) published the Collegiate Board of Directors Resolution No. 327/2019, which sets forth the procedures for granting marketing authorizations, as well as the requirements for the manufacturing, sale, prescription, dispensing, monitoring and inspection of Cannabis Products for medicinal purposes.
Brazilian National Health Agency (ANVISA) approves new resolution on cannabis-based products, but bars cultivation
Today the Brazilian National Health Agency (“ANVISA“) approved a new regulation which determines the procedure for granting health permits for the manufacture and importation of cannabis-based products for medical purposes, as well as establishing specific criteria for the prescription, sale, dispensing, inspection and monitoring of these products. Notwithstanding, the Agency vetoed the proposal which intended to allow the cultivation of cannabis in Brazil for medical or scientific purposes.
Due to the constant technical and scientific developments relating to the subject on the global scene, ANVISA determined that the approved Joint Steering Committee Resolution (Resolução da Diretoria Colegiada) (“RDC”) will be reviewed within three (3) years.
For the time being, the RDC has the following guidelines:
A company interested in filing an application with ANVISA for the registration of a medical cannabis product must have: i) a Federal Operating Permit (Autorização de Funcionamento) (“AFE“) that includes manufacture or importation activities with medicines; ii) a Special Operating Permit (Autorização Especial) (“AE“); iii) a Good Manufacturing Practices Certificate (Certificado de Boas Práticas de Fabricação) (“CBPF“); iv) Good Distribution and Storage Practices Certificate; v) a technical and scientific rationale that justifies the formulation of the medical cannabis product and route of administration; vi) technical documentation evidencing the quality of the product; vii) operational capability for carrying out quality control analysis in Brazil; and viii) capacity to receive and handle reports of adverse effects and technical complaints about the product.
Furthermore, the company must be aware of the concentration levels of the main cannabinoids present in the product formulation, including Tetrahydrocannabinol (THC) and Cannabidiol (CBD), as well as being able to justify the development of the medical cannabis product.
Other important highlights include:
- Specific rules for labelling and packaging;
- Leaflets must contain warning messages, such as the indication of possible physical or mental dependence and the prohibition of transferring the product to another person;
- The RDC allocates responsibility for the prescription and form of use of medical cannabis products to the attending physician and requires patients to sign an Informed Consent Form (Termo de Consentimento Livre e Esclarecido) (“TCLE“);
- If the THC concentration levels are up to 0.2 %, medical prescription of such product shall be allowed only to terminally ill patients or those who have exhausted treatment alternatives.
- The dispensing of medical cannabis products must be restricted to non-compounding pharmacies or drugstores;
- Medical cannabis product manufacturers that opt to import cannabis ingredients must import it as semi-finished raw materials and not the plant or part thereof;
- Prohibition of the compounding of any product derived from cannabis; and
- Each unit sold must be registered in the Brazilian National System for the Management of Controlled Products (Sistema Nacional de Gerenciamento de Produtos Controlados) (“SNGPC“).
Lastly, the RDC will enter into force ninety (90) days following its publication.
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