Pharmacy Courses

ANVISA Dossier Review Process and GMP Inspection

ANVISA Review Process of Registration Dossier

There are 5 common steps of rgistration dossier review process in ANVISA:

  1. Applicant submits registration dossier to ANVISA
  2. GEPEC reviews the Safety, efficacy and pharmacological data provided in the submission dossier
  3. (CMED )Chamber of Drug Market Regulation discusses drug price with applicant
  4. ANVISA carry out facility GMP inspection
  5. ANVISA approves the drug and grants marketing authorization 

Content of the application for GMP inspection

  • Petition form completed, stamped and signed
  • Valid GMP certificate issued by the health authority of the country of origin. Certificates issued in English or Spanish will be accepted without the need of a sworn 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 availabale

Timelines for ANVISA inspection

  • ANVISA inspection of manufacturing site occurs approximately 6 months after submitting the request for inspection to ANVISA
  • ANVISA issues the Good Manufacturing Practice certificate to company 45 to 60 days after inspection 

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Resource Person: Ananda Ferreira
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