Medicinal Products Regulatory Support in Brazil

Overview

The Brazilian government believes that healthcare is a constitutional right, and hence, constantly updates its Regulatory standards. This high-quality system has given a boost to the trade as well, making Brazil the largest pharmaceutical market in LATAM. Brazil dominates the pharma market not only in LATAM, but also on a global level. With a total share of 2.6%, Brazil holds the sixth position in the global largest pharma markets’ list. Experiencing a steady growth since a decade, Brazil pharma industry is constantly booming and stands as a major ground for investments with huge returns.

Agência Nacional de Vigilância Sanitária (ANVISA) is the drug Regulatory Authority under Health Ministry in Brazil. ANVISA is a part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing, and use of products, and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.

Freyr assists with Pharmaceutical product registration, Regulatory affairs consulting, and Pharma market access effectively.

Medicinal product classification

  • New synthetic drugs
  • Generic drugs
  • Similar drugs (a generic drug marketing with a brand name)
  • Potentized medicines (homeopathic, anthroposophic, and antihomotoxic)
  • Specific medicines
  • Notified medicines (low risk)
  • OTC (over the counter) drugs
  • Herbal medicines
  • Medicinal gases
  • Biologic products
  • Radiopharmaceuticals

Medicinal product registration

After the classification of the medicinal product, an application should be submitted to the ANVISA to have the product registration granted. It is necessary for a foreign entity, who does not have any local presence, to appoint a local agent. The agent acts as a Market Authorization Holder (MAH) and carries out the registration process.

 the applicant should identify the subject code of their petition and file a petition. It is necessary to obtain documents like Sanitary license of the local agent, Federal Sanitary License (AFE and/or AE), GMP certification, Pharmacovigilance reports, Clinical & Nonclinical Studies, Chemical, manufacturing, and Quality Control Report, Product labeling in Portuguese, Worldwide Registration Status Report of the product, etc. These are a part of the registration dossier. Then, the GAP analysis, review, compilation & submission of the dossier is carried out.

ANVISA carries out expert evaluation of each document and generates a query, if necessary. ANVISA checks if the dossier satisfies the current regulation. Once all the evaluations & inspections are done, the product is approved or rejected.

Product Maintenance & Compliance

Sl. No

 Validity of Registration Certificate

Renewal

Post-approval Changes (Variations)

01

Ten (10) years

The renewal application must be submitted six (6) months before expiration of the existing registration certificate, along with documents mentioned in the format given in RDC 317/2019.

Any change of registered medicine must be sent to ANVISA with relevant documents in accordance with the current requirements.

Freyr Expertise

  • End-to-end Product Registration
  • Product Classification Services according to the ANVISA
  • Strategic Regulatory Guidance during Product Development & Regulatory Affairs Support
  • Carrying out Gap Analysis, Reviewing & Submitting the Dossier to the ANVISA
  • Interpreting the Regulations and Developing the Regulatory Documentation
  • Representing as RA CMC in Health Authority Meetings
  • Interacting with the ANVISA
  • Strategically handling the HA Queries and Preparing Response Packages
  • Query Support Management
  • Lifecycle Management Support
  • Managing Artwork & Labeling requirements
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