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Regulation of Pharmaceuticals in Brazil by ANVISA

Updated: Mar 31

Brazil is the largest pharmaceutical market in South America with a CAGR of 10.6%. With the rise in globalization pharmaceutical companies are keen on launching their products in the Brazilian market. Though the market it has established regulatory system yet it’s highly complex. In order to register a product in Brazil, one needs approvals from The Agência Nacional de Vigilância Sanitária (ANVISA) under the Ministry of Health, which accepts the dossier in eCTD format.

Regulation Pharmaceuticals Brazil ANVISA

Categorisation of Pharmaceuticals in Brazil by ANVISA

The ANVISA categorizes the drugs into :

  • New synthetic and semi-syntheric drugs

  • Generic drugs

  • Similar drugs (branded generics)

  • Potentized medicines (homeopathic, anthroposophic and antihomotoxic)

  • Specific medicines

  • Notified medicines (low risk)

  • OTC (over the counter) drugs

  • Herbal medicines

  • Medicinal gases

  • Biologic products

  • Radiopharmaceuticals

Key Regulation of Pharmaceuticals in Brazil by ANVISA

Pharmaceutical or Submission Category

ANVISA Regulations

New synthetic and semi-synthetic drugs

Generic drugs

Similar drugs

Potentized medicines

Specific medicines

Notified medicines

OTC drugs

Herbal medicines

Medicinal gases

Biologic products


Clinical trials with drugs and biological products

Marketing Authorization

Post-marketing Variations

  • Resolution RDC No. 73/2016

  • Law 6360/1973

Registration of Pharmaceuticals in Brazil with ANVISA

The registration of pharmaceuticals in Brazil can be initiated by the local company legal constituted in Brazil. The foreign manufacturers shall appoint a local representative for the registration of their pharmaceuticals with ANVIA, Brazil. For product commercialization in Brazil, the following registration process needs to be followed:

  • Preparation of registration dossier for ANVISA: Preparation of dossiers to be compliant to ANVISA guidelines

  • Submission of documents to ANVISA- Once the documents are prepared, the submission process needs to be initiated.

  • GMP Inspection by ANVISA- Further, health authority inspectors would carry on GMP inspections of the manufacturing sites

  • Local product testing- The products need to be tested locally within Brazil

The process of registration of drugs is as follows:

  • Submission of Application dossier to ANVISA

  • Review of safety, efficacy data as provided by applicants in the modules by Office for New Drugs, Research and Clinical Trials (GEPEC)

  • Chamber of Drug Market Regulation discusses with the applicants regarding the pricing points for their products

  • GMP inspections of the manufacturing facilities are carried out by ANVISA

  • Post thorough review of the documents submitted and the inspection, the market authorization is granted to the applicant by ANVISA

Documents needed to initiate the process of submission to health authority is categorized in five modules such as:

  • Administrative: Includes the administrative and local information and is covered within Module-1

  • Technical: This includes include summaries of pre-clinical studies, CMC data along with nonclinical and clinical reports and data and is covered within Modules 2, Module 3, Module 4 and Module 5

The list of documents needed to be presented to ANVISA within each module are:

Regulation Pharmaceuticals Brazil ANVISA

BE Studies

The documents mentioned within five modules are needed for New Drugs whereas for Branded and Non-Branded drugs only documents needs are Module 1 and Module 3. Also, the requirement for BE study document is for Branded and Non-Branded Drugs only.

Process of GMP inspection by ANVISA:

  • Requirement for completed, stamped and signed petition form

  • Valid GMP certificate issued by the health authority of the country of origin (Certificates issued in English or Spanish is accepted; no need for translation)

  • Plant Master File - AMP or Site Master File – SMF

  • Periodical Product Review (RPP)

  • Inspection Report from other health authorities in country of origin if available


GMP Inspection: ANVISA can inspect a manufacturing site anywhere around 6 months from the submission of request for inspection. Post inspection ANVISA takes around 45-60 days to issue the GMP certificate

Registration Process: The Standard review process generally takes 365 days for registration and 180 days for Post approval changes whereas the priority review process takes anywhere around 120 days for registration and 60 days for Post approval changes.

At Artixio, we have a team of experts who understand the Brazilian market and comes with decades of experience working with the authorities in Brazil. Our team has helped numerous pharmaceutical companies complying to ANVISA’s regulatory needs. Our experts have expertise in providing end to end solution for Brazilian registration requirements:

  • Preparation and submission of dossier, complying to necessary guidelines to ensure a smooth process of submission for medicinal products

  • We have a team of consultants who have experiences handling GMP audits for manufacturing sites updating system as per GMP requirements

  • Artixio team can partner as your authorized legal representative for Brazil helping with health authority (ANVISA) communication on a regular basis

  • We have our partners who can also assist you with local clinical and non-Clinical testing of your products at ISO compliant laboratories.

Our team would be happy to assist you with your requirements for Medicinal/ Pharmaceutical Product registrations in Brazil.


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