Today (December 11, 2019) the Official Gazette published Resolution 327/2019 (“RDC”), issued by the Brazilian National Health Surveillance Agency (“ANVISA”), which regulates the procedures and requirements for the registration and commercialization of Cannabis` products for medical purposes, which has been long-waited by the market.
The resolution creates a new regulatory category of products, which is the “Cannabis’ products for medical purposes”, establishing that companies intending to exercise manufacturing, importation and commercialization activities of these products must have the Sanitary Authorization (“AS”) before starting its activities.
In order to grant the AS, ANVISA will not previously evaluate the documents submitted by the company, but only if the formal requirements were fulfilled. Besides that, the procedure will be simplified, which means that the company will only have to fill in a specific requirement and present the documents listed in the resolution.
Afterwards, the product will be subject to ANVISA’s regulatory analysis, and the authorization may even be cancelled if the Agency understands that the product does not meet the regulatory requirements for the concession. Only the manufacturing companies that have the Good Manufacturing Practices Certificate – GMPC (Certificado de Boas Práticas de Fabricação – “CBPF”) for drugs or importers who meet ANVISA’s criteria on Good Distribution and Storage Practices for drugs will be able to request the AS.
In addition, the RDC determines that the authorization will be granted only to products developed for oral and/or nasal utilization, excluding other administration via. Besides this restriction, the resolution expressly excludes from the regulatory framework cosmetics, smokable products, health products and food products based on Cannabis and its derivatives.
For the importation of products on its final form, the companies must evidence to ANVISA that such products are properly authorized by the competent authorities in their respective origin countries.
Finally, the resolution provides that any kind of publicity and advertising of Cannabis’ products is forbidden.
Please note that individuals may still exceptionally import Cannabidiol based products in association with other cannabinoids for private use, with the prescription from a legally qualified professional.
The RDC will come into force within 90 days after its publication.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.