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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 15 July 2013 | By Louise Zornoza
Brazil's National Agency for Sanitary Surveillance (Anvisa) opened a public consultation (Consultation No. 22/13) on 12 July 2013 concerning new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs).
The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer would have to notify Anvisa of changes according to the impact on the safety of the product. For certain changes, the notification must be made annually, while others require immediate notification to the agency after the changes have been implemented or even before their adoption.
The deadline for comments is 2 September 2013.
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Tags: Consultation, pharmaceutical, brazil, drug, API