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Entering the Brazilian market means complying with one of the most robust regulatory processes in Latin America. Marketing authorization from ANVISA (Agência Nacional de Vigilância Sanitária) is mandatory for manufacturing, importing, or commercializing medicines in Brazil and is crucial in ensuring the legal and safe distribution of pharmaceutical products.
Nesta terceira edição da série Essenciais LATAM, apresentamos os fundamentos: como os medicamentos são classificados no Brasil, o que deve conter o seu dossiê regulatório, como navegar pelos sistemas digitais da ANVISA e o que esperar após a aprovação.
Product Classification and Regulatory Pathways
ANVISA classifies medicines based on their origin, complexity, and therapeutic use. This determines the type of evaluation process:
- New medicines: new molecules or indications
- Generics and similar medicines: with known active ingredients
- Biological and biosimilar products: under specific guidance
- Special categories: orphan drugs or controlled substances (Portaria 344/98)
Each category follows different timelines and documentation requirements. While innovative products often face extended review periods, certain generics may be eligible for faster approval routes.
What Should the Technical Dossier Include?
The dossier must follow the CTD (Common Technical Document) format, aligned with ICH guidelines.
It should contain:
- Module 3 – Quality: composition, manufacturing process, controls, specifications, validation, and stability data
- Module 4 – Non-clinical studies: pharmacological and toxicological data, if applicable
- Module 5 – Clinical studies: human trials, bioequivalence, or comparability studies (for biologicals)
Additional requirements:
- Electronic submission form
- Proof of fee payments
- GMP Certificate (CBPF)
- Certificate of Pharmaceutical Product (CPP or CPS)
- Labels and package insert in Portuguese
Digital Platform: Peticionamento Eletrônico and Datavisa
Applications must be submitted through Peticionamento Eletrônico, part of ANVISA’s Datavisa system.
This platform allows:
· Secure upload of regulatory documents ️· Status tracking and communication with ANVISA · Digital signatures and authentication by local legal representatives
Use of the digital system is mandatory and requires a registered user profile.
Technical Review and Approval
Once submitted, ANVISA conducts a full technical evaluation. Timelines depend on the product type and complexity and usually range from 180 to 365 business days.
In some cases, inspections or additional information may be required. ANVISA may also apply special pathways, such as priority review or reliance on foreign regulatory agencies.
Once approved, marketing authorization is valid for five years and is renewable.
Post-Approval Obligations
Any changes to the product (e.g., formulation, presentation, manufacturing site, MA holder) must be submitted to ANVISA through the appropriate post-approval pathway (notification, variation request, or revalidation).
Holders must also comply with pharmacovigilance regulations and submit periodic safety updates or benefit-risk reports when required.
How Freyr Supports You in Brazil
At Freyr Solutions, we support national and international pharmaceutical companies throughout the entire regulatory journey in Brazil, from dossier preparation to lifecycle management.
Our services include:
- CTD dossier preparation and review
- Strategic consulting based on product type
- End-to-end support on the Datavisa platform
- Legal representation and local digital signature
- Pharmacovigilance and post-approval compliance
With our global reach, regional presence, and technical expertise, we help companies meet ANVISA requirements efficiently and confidently, aligned with Brazilian expectations and international standards.
Ready to take your regulatory strategy to the next level?
Contact our experts and chart a clear path toward successfully approving your products in Brazil.
