Why you should buy this report

The report comprises all the necessary information required for the registration of a new medicinal product with the ANVISA. It is well known that Brazil has traditionally been Latin America’s largest pharmaceutical market and by 2022, the Pharmaceutical market is expected to touch $ 31 bn. This particular domestic pharma sector market has a relatively low price of medicines in comparison to other large markets in America. The report provides insight into the core elements that regulate the pharmaceutical sector in Brazil.

Summary

• The report details the registration process for a new medicinal product at the ANVISA.
• The report provides information on labeling (primary and secondary packaging labels) for pharmaceutical products.
• The report underlines the regulations levied on the import and also the requirements of a legal representative.
• The report provides precise information on health authority fees, along with the timelines and modes of submission.
• The report includes information on advertising requirements, pharmacovigilance, GMP inspection/recognition.
• The report provides additional information on the variation fillings and timelines, the validity of the registration and renewal process.

Table of Contents

1. List of Abbreviations
2. Governing Regulatory Body
3. Definition and Categorization
4. Registration Requirements
   1. Registration Process for a New Medicinal Product
      1. General Information Regarding Registration
      2. Product Registration Process
   2. Requirements for Submission
   3. Language Requirements for the Documentation and Correspondence
5. Renewal (Re-Registration) of a Product
   1. General Information for Renewal
   2. Renewal Registration Process
   3. Renewal Registration Timelines
6. Variations
   1. General Information for Variations
   2. Variations Timelines
   3. Change of the Applicant (owner)
7. Agency Registration Fees and Validity
8. Labeling Requirements
9. Advertising Requirements
10. Pharmacovigilance
11. GMP Recognition or GMP Inspection
12. Authorized Representative
13. Import Requirements
14. References