The Brazilian Regulatory Authority (ANVISA) published the regulation RDC 327/2019, determining the technical requirements that technical dossiers for Cannabis-based Products should contain for future analysis by the Agency. This new legislation should be in force in 90 days from the date of publication in the Brazilian Official Gazette. This approval by ANVISA creates a class of products, i.e. those based on Cannabis spp. Read more...
After the Meeting of the Collegiate Board (DICOL) of the National Health Surveillance Agency (ANVISA), on Dec/03/19, the medicinal use of Cannabis sp. products was approved. The next step is the publication by ANVISA of the Collegiate Board Resolution (RDC), which will standardize the rite of registration of these products, determining the technical requirements that technical dossiers should contain for future analysis by the Agency. Once published, the Collegiate Board Resolution (a.k.a. RDC) should be in force in 90 days from the date of publication in the Brazilian Official Gazette. This approval by ANVISA creates a class of products, i.e. those based on Cannabis sp.
Regulatory Requirements for Companies to Hold the Market Approval
Companies that will submit the registration processes to market Cannabis sp. products in the future, must meet the following regulatory requirements:
- Only companies established in Brazil can submit registration with ANVISA for products based on Cannabis sp.;
- The company must have Working Permit granted by ANVISA (a.k.a. AFE) to Manufacture and/or Import Pharmaceutical Medicines and Ingredients (as applicable to each case), in addition to the Distribution activity, for those who wish to import only finished products. For manufacturers, it is not necessary to have this activity highlighted in AFE, since manufacturing activity already encompasses the distribution of their own products;
- Have Special Working Permit (a.k.a. EA) for Controlled Products, since both Canabidiol (CBD) and Tetrahydrocannabinol (THC) are described in Ordinance SVS/MS No. 344 / 98, updated by RDC no. 325/19 (03/12/19);
- Have a Certificate of Good Manufacturing Practices (both for domestic manufacturers and foreign laboratories). Companies exclusively Importers and Distributors (of finished products) must have a Certificate of Good Distribution and Storage Practices;
- Operating conditions to perform Quality Control in Brazilian territory. Therefore, analytical processes should be implemented and validated;
- Have a Pharmacovigilance system that allows the processing of notifications of adverse effects, relying on a database for systematic recording of these adverse effects. Emergency situations should be reported to ANVISA within 72 hours of the date of occurrence. It should be noted that the company should count on a responsible for the Pharmacovigilance system and a substitute, both duly registered in the ANVISA system (this is a general requirement for the class of medicines and not specific to Cannabis sp.-based products);
Regulatory Requirements for Cannabis sp. based Products:
- Labelling and packaging may not contain:
- Designations, names, symbols, drawings or figures that induce the consumer to error or confusion;
- The terms like Medicine, Herbal Medicine, Supplement, Natural or any other that bears similarity to them.
- Packaging should have a horizontal strip of black color, covering all its sides, with the dimensions defined in specific legislation;
- Cannabis products containing up to 0.2% THC should bring engraved on the black stripe the following phrases in Portuguese (in capital letters): "SALE UNDER PRESCRIPTION" and "CAN ONLY BE SOLD WITH PRESCRIPTION RETENTION";
- Cannabis products containing above 0.2% THC should bring engraved, on the black strip, the following phrases in Portuguese (in capital letters): "SALE UNDER PRESCRIPTION" and "THE USE OF THIS PRODUCT CAN CAUSE PHYSICAL OR PSICOLOGICAL DEPENDENCE".
Regulatory Requirements for the Prescription of Cannabis sp. Products:
- The indication and use of Cannabis sp. products are on behalf the responsibility of the Doctor;
- The patient must sign a Free and Informed Consent Form (a.k.a. TCLE), which should detail the specific product data based on Cannabis sp.;
- The Prescribing Physician should use Brazil’s Type B Prescription for products with THC concentration up to 0.2% and Brazil’s Type A Prescription (similar to that used for morphine) for products with concentrations greater than 0.2% THC.
Handling of Cannabis sp. Products:
- Handling of Cannabis products is prohibited by handling pharmacies;
- The regulation is specific for medicinal products intended for use in humans and there is no provision for the veterinary use of such products;
- The product sale may only occur through pharmaceutical assistance in drugstores and pharmacies, under a Doctor’s prescription, without handling by a handling pharmacy.
Planting Cannabis Sativa L. :
It is forbidden to plant Cannabis sativa L. throughout the Brazilian territory, according to Ordinance SVS/MS no. 344/98, List E, adhering, Item 1.
Ordinance SVS/MS no. 344/98 (Prescription Products Controlled by ANVISA)
Ordinance SVS/MS no. 344/98 was updated on Dec/03/19, through RDC no. 325/19. Cannabidiol is listed in List C1 (item 23) and Tetrahydrocannabinol is listed in List F2 (item 139).
Technical annotations on these pharmaceutical active ingredients are described as follows:
- List A3, adhering, item 2;
- List C1, adhering, item 1.3;
- List E, adhering, items5, 7 and 8;
- List F2, adhering, items 1.2; 3 and 6.
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