3/18/2020
On March 10, the Resolution 327/2019 (RDC), which regulates the procedures and requirements for the registration and commercialization of Cannabis products for medical purposes for human use only in Brazil came into force.
The resolution of the Brazilian Nacional Health Surveillance Agency (Anvisa) was approved last December, establishing the procedures for manufacture, importation, commercialization, dispensation and monitoring of these products
In order to clarify the most diverse questions and make the regularization process transparent, Anvisa has recently published the “Manual for Filling the Application Form for Cannabis Products” and an orientation guide, with 119 questions and answers. Our team have separated some of the main points addressed by Anvisa:
- Cannabis products are those containing exclusively plant-derived or psychopharmaceutic-active ingredients from Cannabis sativa, with a predominance of CBD, with only the import of dry extract (which is a plant derivative) being allowed, with the import of the plant or parts of the plant Cannabis spp being prohibited.
- The THC content is limited to 0.2%, and THC contents above 0.2% will be admitted provided they are intended for palliative care, exclusively for patients without other therapeutic alternatives and in irreversible or terminal clinical situations.
- THC concentration levels are not prohibitive limits. There will only be a differentiated control for the two types of products (less or more than 0.2%), according to the psychoactive action of this substance.
- Cannabis products will be authorized for use only orally (does not include sublingual administration) or nasal. Thus, cannabis products that cover, for example, health products such as dressings, are not regulated.
- The indication and use of the cannabis product is the responsibility of the doctor, who must ensure that the alternative chosen is effective and safe for the patient.
- Cosmetics, smoking products, health products or foods based on Cannabis spp. and their derivatives are not considered cannabis products for medicinal purposes.
- No isolated substances of synthetic or semi-synthetic origin can be added to Cannabis products, except for those with excipient function.
- Cannabis products shall not be in the form of the plant drug Cannabis spp.
- The Sanitary Authorization is not to be confused with the Special Authorization of Operation or registration of the product, being a form of regularization of the product that, in an analogous way to a registration, allows the commercialization and dispensation of the products in Brazil for the non-extendable period of 5 years, counted from the date of publication of the Authorization in the DOU.
- There is no legal term for the granting of the Sanitary Authorization by Anvisa, and the Agency undertakes to make the necessary efforts so that all internal procedures occur in the shortest time possible.
- Within a period of 3 years from the publication of DRC no. 327/2019, an equivalent document issued by a sanitary authority of a country recognized by Anvisa shall be accepted, provided that it is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), with regard to proof of the rules of Good Manufacturing Practices (GMP) of drug.
- Within the same 3-year period, the authorized company shall file an application for the Good Manufacturing Practices Certificate (GMPC) for Drugs at Anvisa, and the absence of the protocol within the established period shall result in the cancellation of the Sanitary Authorization.
- There is no obligation to submit GMPC issued by Anvisa to the manufacturing company. The inputs must have pharmaceutical standards.
- Until the expiration of the Sanitary Authorization, the authorized company that intends to continue manufacturing, importing and marketing cannabis product in Brazil must request regularization through the registration of drugs, for which clinical studies are required.
- When applying for the Sanitary Authorization, a stability report shall be required, and shall only be accepted if all applicable requirements for drugs are followed, in accordance with the provisions of RDC No. 318/2019.
- There is currently no Sanitary Surveillance Fee charged for the grant of the Sanitary Authorization, nor is there any interference by the Drugs Market Regulation Chamber (CMED) in the setting of prices.
- The manufacturing process of the cannabis product, whether partial (one or more manufacturing steps) or total (finished product), must be performed in facilities certified by Anvisa in accordance with the GMPC of drugs.
- It is possible to outsource all or part of the quality control for the import of cannabis finished product, in national territory, with a laboratory accredited by the Brazilian Network of Health Analytical Laboratories (REBLAS) or with manufacturing companies that have GMPC to manufacture drugs.
- It is possible to outsource all the manufacture of the cannabis product as long as the documentation requirements required by the standard are met, including GMPC requirements.
- The importing company and holder of the Sanitary Authorization must also have the Good Distribution and Storage Practices Certificate (GDSPC) issued by Anvisa or a favorable inspection report issued by VISA, and it is not necessary to submit the said documents (GDSPC or inspection report) at the time of the application for Sanitary Authorization of the product.
- The packaging of Cannabis products cannot bear trade names or logos, and the name of the plant derivative or psychopharmaceutic must be indicated together with the name of the holder of the Sanitary Authorization, in accordance with the Company Operating Authorization (AFE) issued by Anvisa.
- Whenever there are changes in any information provided through the initial Health Authorization (AS) application, companies must make a new application for the cannabis product. Concomitantly with the request for a new Sanitary Authorization, the company must request the cancellation of the current Sanitary Authorization of the product.
- The Sanitary Authorization of a cannabis product is not subject to transfer of ownership. Therefore, a new request for Sanitary Authorization must be submitted to Anvisa.
Finally, it is worth mentioning that the current technical-scientific stage of cannabis products in the world is not sufficient for their approval as a drug. Thus, the new rule will allow clinical researches that are able to prove the efficacy and safety of these products, in addition to other requirements for their classification as drug.
Our Regulatory team is at your disposal to deal with doubts related to this subject and other matters.
Sueli de Freitas Veríssimo Vieira – Partner
Raissa Pinati do Nascimento – Lawyer
