07/08/2020

How to register cannabis-based medicine in Brazil

How to register cannabis-based medicine in Brazil How to register cannabis-based medicine in Brazil

Anvisa has released cannabis-based substances (THC and CBD) in Brazil for the production of medicines

Anvisa (National Health Surveillance Agency) is the Brazilian agency responsible for regulating products: medicines, cosmetics, food and others.

In Brazil, cannabis-based drugs can only be prescribed when there is no other therapeutic alternative on the Brazilian market or as palliative care for terminally ill or irreversible patients.

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Anvisa classifies the product based on cannabis as a herbal medicine. Every company that works with medicines must obtain the CGMP, therefore, in order to register a cannabis-based medicine in Brazil, it is essential to obtain the Certificate of Good Manufacturing Practices. Learn more: Certificate of Good Manufacturing Practices.

Do you know what it takes to register cannabis-based medicine in Brazil? In this content you will find the main points of each regulatory step necessary to register a cannabis-based medicine in Brazil.

Company Regularization

Regularizing the company to register cannabis-based medicine in Brazil is a slightly different process than the others, as it has additional steps. To register a cannabis-based medicine in Brazil, it is initially necessary:

Establishing a physical location: The first step in registering a cannabis-based medicine in Brazil is to establish a physical location following all guidelines imposed by VISA and Anvisa.

Operating License: This process is carried out with the local or state VISA (Local Health Surveillance). In this process, the company must adapt its physical structure in order to receive an inspection from a VISA inspection agent. The adequacy must be in accordance with the RDC (Collegiate Board Resolution) related to the types of products that the company intends to sell. In addition, all the bureaucratic process is done around the activity performed by the company: manufacturer, distributor, storage, importer and so on. Learn more: Operating License.

Operating Permits: This process has a federal scope and takes place in Brasília. The entire process will be evaluated directly by Anvisa agents. At that moment, documents are collected, fees are collected and others. Learn more: Operating Permits

In addition to the aforementioned requirements for registering cannabis-based medicine in Brazil, it is necessary to obtain an AE (Special Authorization). Special Authorization is mandatory for every company that works with controlled drugs. The process for applying for AE involves a series of documentation and evidence from previous processes.

The last step is to obtain a Sanitary Authorization from Anvisa for the production of herbal medicine based on cannabis. This Health Authorization is valid for 5 years. After publication in the Federal Official Gazette, it is possible to enter the process to register a cannabis-based medicine in Brazil.

What do you need to register cannabis-based medicine in Brazil?

To register a cannabis-based medicine in Brazil, it is essential to present information to Anvisa about the efficacy and safety of the medicine. In addition, specific information such as: composition, labeling, box layout, form of administration and others will be requested. It is important to note that the concentration of the substance must be in accordance with that allowed by Anvisa, in addition, the product may not display the trade name in the label, being only allowed the name of the plant or phytopharmaceutical with the addition of the name of the responsible company. Learn more: Product registration.

Register cannabis-based medicine in Brazil is even more complex than other drug registrations. Count on Stone Okamont to register cannabis-based medicines in Brazil and avoid unnecessary waste and expense.

Don't waste any more time! Fill out the form below, talk to one of our professionals and ask all your questions about how to register cannabis-based medicine in Brazil.

Editor: Gabriela Batman Carvalho

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