Process and Documentation for Registration of Pharmaceuticals in Brazil



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 ANVISA which accepts the dossier in eCTD format and is primarily categorized as New Drugs, Branded and Non-Branded Generics.


  • New Drugs are innovative products whose safety and efficacy are been proven by various non-clinical and clinical trials.

  • Branded Generics, these products are similar to already registered products having same concentration, dosage form, therapeutic value and can only differ in size, labeling and packaging and should be determined by their trade names.

  • Non-Branded Generics, these are in all way similar to all registered drugs with ANVISA and primarily can be used interchangeably.


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


It is governed by RDC 200/2017 – inclusion of some types of innovation, RDC 204/2017 – Priority Pathway, RDC 205/2017 – Special procedure for rare diseases


The process of registration of drugs is as follows:

  1. Submission of Application dossier to ANVISA

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

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

  4. GMP inspections of the manufacturing facilities are carried out by ANVISA

  5. 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:

Module 1:

1. Sanitary License of the local representative

2. Operating Authorisation letter of local representative

3. Registration of local Pharmacist at professional counsel

4. Petition form

5. Justification for product registration

6. Labeling of different presentations

7. Mention any previous communications with ANVISA

8. The certificate of pharmaceutical product (CPP) issued from the health authority in country of origin

9. GMP certificates issued from the health authority in country of origin

10. GMP certificates Issued by Brazilian Health Authority- ANVISA as per Resolution of the Board of Directors (RDC) No 214, dated February 7th, 2018

11. Worldwide registration status

12. Pharmacovigilance data

13. Labels of products in Portuguese

14. Documentation on the control of transmissible spongiform encephalopathies (TSE)


Module 2:

1. Table of contents of Module 2

2. Introduction

3. Quality Overall Summary

4. Non-clinical Overview

5. Clinical Overview

6. Non-clinical Summary

7. Clinical Summary


Module 3:

1. Table of contents of Module 3

2. Body of data

  • Drug Substance

  • Drug Product

3. Literature references used in Module 3


Module 4:

1. Table of contents of Module 4

2. Study reports

  • Pharmacology

  • Pharmacokinetics

  • Toxicology

3. Literature references used in Module 4


Module 5:

1. Table of contents of Module 5

2. Tabular listing of all clinical studies

3. Clinical study reports

  • Reports of biopharmaceutic studies

  • Reports of human pharmacokinetic (PK) studies

  • Reports of human pharmacodynamic (PD) studies

  • Reports of efficacy and safety studies

  • Reports of post-marketing experience

  • Case report forms and individual patient listings

4. Literature references used in Module 5


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


Timelines:

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.