Post-registration of medicines | Brazil Resolution RDC N° 219

This Resolution applies to requests for post-registration alteration of medicines and biological products filed with Anvisa before and after Law 13.411 of 28 December 2016. Art. 2.

The maximum period for the final decision in the post-registration change processes of medicines and biological products will be, respectively:

I - for the priority category, of sixty days, counted from the date of the respective prioritization protocol;

II - for the ordinary category, one hundred and eighty days, counted from the date of the respective post-registration change protocol.

Paragraph 1. The aforementioned period may be extended by up to one-third of the original term, once, by means of a reasoned decision of Anvisa issued at least fifteen business days before the end of the original term.

Paragraph 2. The aforementioned period will have their countdown suspended when they request information or requirements, until they are attended to.

Art. 6. Petitions for post-registration changes petitioned before the enactment of Law n° 13.411, of 2016, for which a safety and efficacy report is required, will have its analysis procedures maintained and can only be implemented after approval by Anvisa.

Art. 8. The Anvisa areas responsible for medicine registration, inspection, monitoring and monitoring will establish a program to monitor post-registration changes implemented in accordance with the conditional approval set forth in this Resolution.

Art. 9. During follow-up inspections or inspection actions, the company must provide all documentation related to the complete technical dossier, required by the health regulations in force at the time of the petition, which deals with post-registration changes.

Art. 17. This Resolution comes into force on the date of its publication.