Anvisa cannabis product regularization: how to do it?
Learn how to regularize cannabis products with Anvisa. Check out the step-by-step process, documents, deadlines, and rules of RDC 327/2019. Read the guide!
The regularization of cannabis products with the National Health Surveillance Agency (Anvisa) is the official and mandatory procedure for companies wishing to manufacture, import, or market products derived from the plant in Brazil. Understand in this article how regularization works.
The entire process is carried out digitally through the Federal Government's Sistema Solicita.
In this article you will see:
Who can apply: Requirements for companies and GOV.BR access.
Step-by-step in Solicita: How to fill out and submit the petition.
Deadlines and costs: Authorization validity and analysis timeframe.
Legislation and rights: Current regulations (RDC 327/2019 and Law 6,360/1976).
Who can request health authorization?
The service is exclusive to Legal Entities (companies) operating in the health and pharmaceutical market.
To file the request, the following basic requirements must be met:
Active CNPJ duly registered in Anvisa's database.https://sechat.com.br/noticia/anvisa-flexibiliza-prescricao-de-cannabis-e-retira-exigencia-de-tarja-preta-para-produtos-com-baixo-thc
Security Manager associated with the company for system access.
GOV.BR account with Silver or Gold level of trust.
[LEARN MORE: How to request individual cannabis import authorization for patients]
Step-by-step in Anvisa's Sistema Solicita
The process is 100% electronic, which guarantees traceability and speed in monitoring.
Step 1: Make the initial request
Access Sistema Solicita using the security manager's login.
Navigate to: Draft > New > Initial Petition.
In the activity search, select "Medicines".
Choose the subject compatible with the type of product (phytopharmaceutical or herbal medicine), observing the THC concentration.
Attach the checklist of documents required by Anvisa and submit the petition.
Step 2: Monitor the process
After submission, the company can monitor the analysis in the "Processes" menu by filtering by CNPJ.
Upon approval, the product is published and listed on the Anvisa Consultation Portal (consultas.anvisa.gov.br).
Deadlines, costs, and validity
| Parameter | Health Detail |
|---|---|
| Estimated analysis time | On average 365 calendar days (legal deadline for medicines). |
| Service cost | Free on the Federal Government portal. |
| Authorization validity | Valid for 5 years (no automatic extension). |
[LEARN MORE: Understand the regulatory differences between RDC 327/2019 and RDC 660/2022]
Applicable legislation and user rights
The regularization of cannabis derivatives follows a strict regulatory framework in Brazil:
RDC No. 327/2019 (Anvisa): Regulates the conditions for manufacturing, importing, and marketing Cannabis products for medicinal purposes.
Law No. 6,360/1976: Provides for health surveillance applied to medicines and pharmaceutical ingredients.
Decree No. 8,077/2013: Regulates the operating conditions for companies in the health sector.
According to Law No. 13,460/2017, the agency's service must follow principles of politeness, accessibility, transparency, and efficiency, guaranteeing priority service to the elderly, pregnant women, and people with disabilities.
Sources and References Consulted (E-E-A-T):
BRAZIL. Agência Nacional de Vigilância Sanitária (Anvisa). Board Resolution - RDC No. 327, of December 9, 2019.
BRAZIL. Federal Government. Service: Request Regularization of Cannabis Products. Available at:
[https://www.gov.br/pt-br/servicos/solicitar-regularizacao-de-produtos-de-cannabis](https://www.gov.br/pt-br/servicos/solicitar-regularizacao-de-produtos-de-cannabis).BRAZIL. Law No. 6,360, of September 23, 1976 and Law No. 13,411, of December 28, 2016.
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