ANVISA Review Process of Registration Dossier
There are 5 common steps of rgistration dossier review process in ANVISA:
- Applicant submits registration dossier to ANVISA
- GEPEC reviews the Safety, efficacy and pharmacological data provided in the submission dossier
- (CMED )Chamber of Drug Market Regulation discusses drug price with applicant
- ANVISA carry out facility GMP inspection
- 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
