Understanding the New Regulation
Brazilian Health Regulatory Agency (ANVISA) has published in the Official Gazette its RDC #327/2019, which regulates the use of cannabis for medicinal purposes in Brazil, as announced in our previous client alert.
The regulation established the procedure for the granting of the Sanitary Authorization for the manufacture and importation of medicinal cannabis-based products, as well as establishes requirements for the commercialization, prescription, dispensing, monitoring and supervision of those products.
The regulation provided, as a relevant criterion, that cannabis-based products may be prescribed only when other therapeutic options available in the Brazilian market are exhausted (5th Article). The prescription of Cannabis products is restricted to medical professionals legally authorized by the Federal Council of Medicine (CFM), as defined in Article 13.
CBD-products’ composition and Restrictions
As for the composition, cannabis-based products must contain predominantly cannabidiol (CBD) and not more than 0.2% tetrahydrocannabinol (THC), as provided in 4th Article. However, there is a waiver for patients subject to palliative care or in irreversible or terminal clinical situations – in those cases, THC level is not restricted. Isolated substances of synthetic or semi-synthetic origin may not be added to the products, except those with excipient function. Cannabis-based products will be authorized for oral or nasal use only. Imported Cannabis products must be properly regulated by the competent authorities in their countries of origin (Article 11).
Several other restrictions are established in the RDC for cannabis-based products, such as: (i) not bear trade names and must be designated by the name of the plant or plant protection derivative together with the name of the company (9th Article); (ii) the products are not allowed to be marketed as a plant drug of the Cannabis spp. or parts thereof, even after the stabilization and drying process, or in their crushed or pulverized form, even if available in any pharmaceutical form (Article 10, §6º); (iii) any type of advertisement is prohibited (Article 12); (iv) “free sample” is not allowed for cannabis-based products (article 14); (v) the manipulation of master formulas containing cannabis derivatives or phytopharmaceuticals is prohibited (article 15); (vi) Specific requirements and prohibitions regarding product labeling, packaging and package leaflet (Articles 32-38).
Sanitary Authorization Procedure
ANVISA will grant Sanitary Authorization for the manufacture and importation of cannabis-based products (7th Article), for 5 years (8th Article). It is highlighted in Resolution’s 3rd Article that cannabis-based products are not considered drugs/medicines yet, despites its therapeutic purposes. The Agency equates cannabis-based products’ regulation with those in force of phytotherapics e phytopharmaceuticals.
During the 5-year period, cannabis products that do not fit the category of medicines will have the Sanitary Authorization canceled (Article 74). Companies should follow their research strategies to prove the effectiveness and safety of their formulations. ANVISA provided that the registration of any cannabis-based medicines is allowed and will follow current legislation (6th Article).
The procedure for granting the Sanitary Authorization of Cannabis products will have a simplified rite. This represents that ANVISA incorporated to the RDC the concern with the excessive bureaucracy existing in the previous model, seeking efficiency gain in the procedure. For the purpose of granting the authorization, as it is a simplified rite, the prior assessment of the documentation submitted by the company is not required by ANVISA (Article 17, §1º).
For the request of the Sanitary Authorization as well as its modifications, the requesting company must petition and protocol the necessary documents exclusively by electronic means.
The procedure begins with a specific request petitioned by the interested company, prior to the manufacture, importation or marketing of the product, with the addition of the documents required in the RDC. Health Authorization number will be granted for each commercial presentation of cannabis-based products.
The company in applying for the authorization must present to ANVISA the following documents:
| SANITARY AUTHORIZATION – COMPANY DOCUMENTS |
|---|
| a) Company Operation Authorization (AFE) issued by ANVISA with activity of manufacturing or importing medicine; |
| b) Special Authorization (EA); |
| c) ANVISA’s Certificate of Good Manufacturing Practices (CBPF) of Medicines for the manufacturer of the product; |
| d) Good drug distribution and storage practices; |
| e) Technical and scientific rationale that justifies the formulation of the cannabis-based product and the route of administration. For the technical and scientific rationale, the company must consider the formulation, the dose, the duration of use and the target population; |
| f) Technical documentation of product quality; |
| g) Operational conditions to perform quality control analyzes in Brazilian territory; |
| h) Ability to receive and deal with notifications of adverse effects and technical complaints about the product; and |
| i) Knowledge of the concentration of the main cannabinoids present in the formulation, among them, minimally, CBD and THC and be able to justify the development of the product of cannabis, whether phytotherapeutic or phytopharmaceutical. |
Cannabis-based products authorized in accordance with the criteria of ANVISA’s RDC shall have up to 365 (three hundred and sixty-five) days to be commercialized, counted from the date of publication of the authorization grant.
The original Portuguese version of RDC #327/2019 is available here. For English version in PDF click here.