Overview:
Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.
Introduction
Brazil’s National Health Surveillance Agency (Anvisa) approved the sanitary authorization of yet another cannabis-based product. It is a solution for oral use named Canabidiol Verdemed 23.75 mg/mL.
The product must be sold in pharmacies and drugstores upon medical prescription through a type B prescription (blue in color).
Regulation of Cannabis Products
There are a total of eight Cannabis-based products approved based on RDC 327/2019 – which allows the commercialization of these products to the Brazilian population.
This Resolution defines the conditions and procedures for granting Health Authorization for manufacturing and importation, as well as establishes requirements for the marketing, prescription, distribution, control and surveillance of Cannabis products for medicinal purposes for human use.
Cannabis products containing exclusively plant derivatives or Cannabis phytochemicals as active ingredients must contain predominantly cannabidiol (CBD) and no more than 0.2% tetrahydrocannabinol (THC).
A company that intends to manufacture, import, and market cannabis products in Brazil must apply for regularization through the drug registration process.
The Health Authorization for Cannabis products will have an unextendable term of five (5) years.
To read more about the eighth cannabis product RDC No. 4.475/2021, click here (available only in Portuguese).
About the New Products
There are currently a total of eighth cannabis products approved based on RDC No. 327/2019 – which allows the commercialization of these products to the Brazilian population.
This is the eighth cannabis-based product approved by Anvisa:
- PRATI-DONADUZZI CANNABIDIOL (20 MG/ML; 50 MG/ML AND 200 MG/ML)
- CANNABIDIOL NUNATURE (17.18 MG/ML)
- CANABIDIOL NUNATURE (34.36 MG/ML)
- CANABIDIOL FARMANGUINHOS (200 MG/ML)
- CANABIDIOL VERDEMED (50 MG/ML)
- CANNABIS SATIVA EXTRACT PROMEDIOL (200 MG/ML)
- CANNABIS SATIVA EXTRACT ZION MEDPHARMA (200 MG/ML)
- CANNABIDIOL VERDEMED (23.75 MG/ML).
Countries Authorized to Manufacture CANNABIDIOL VERDEMED
The product, authorized by Anvisa through Resolution RE No. 4.475, will be manufactured in Colombia.
With the authorization, the company can import the product ready for use and begin distribution and marketing in the country.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.