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Brazil: Import and Use of Marijuana-Based Medicine Products Authorized

(Mar. 28, 2016) On March 18, 2016, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) enacted Collegiate Board Resolution No. 66 (Resolução da Diretoria Colegiada – RDC No. 66 de 18 de Março, D.O.U. No. 54, de 21 de Março de 2016), which was published in the country’s Official Gazette (Diário Oficial da União, D.O.U.) on March 21, 2016.

The resolution allows the prescription and the import of products containing the substances Cannabidiol and Tetrahydrocannabinol (substances found in marijuana) in their formulation. The authorization to import these products is granted to individuals for their own exclusive use in health care, and the import must meet all the provisions of RDC No. 17/2015, which provides for good manufacturing practices. (Resolução da Diretoria Colegiada – RDC No. 17 de 16 de Abril de 2010, D.O.U. No. 73, de 19 de Abril de 2010.)

The patient or a legal guardian must apply to ANVISA (on the proper form) for exceptional authorization to import and use the product. Along with the form, the person must also include the prescription, a medical report, and a statement of responsibility and clarification signed by the physician and the patient or a legal guardian. In addition, the products to be imported must be legally authorized and manufactured in their countries of origin. (Anvisa Permite Prescrição e Importação de Produtos com Canabidiol e THC na Formulação, ANVISA website (Mar. 21, 2016).)

Background on ANVISA

ANVISA was created on January 26, 1999, by Law No. 9,782. It is a governmental regulatory agency characterized by its administrative independence, financial autonomy, and the stability of its directors. ANVISA is governed by a Collegiate Board of Directors composed of five members. In the federal public administrative structure, the agency is connected to the Ministry of Health, with whom a periodic management contract is signed. (ANVISA, The Agency, ANVISA website (last visited Mar. 21, 2016).)

ANVISA’s primary goal is to protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients, and technologies that pose any health risks. The agency is also responsible for public health control in ports and airports and at borders, as well as for establishing relations with the Ministry of International Affairs and with foreign organisms and institutions to deal with international affairs regarding health surveillance. (Id.)