The judicialization of the applications submitted to ANVISA

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

Marcio Raposo de Almeida

MRA Consulting Business, Brazil

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

One of the biggest problems that businesses face when it comes to ANVISA is the length of its claims. In this situation, which does not include the appeals process in case of refusal, the Company has invested in technology, marketing, research and development, among other things, cannot wait that long for a final decision on its application for registration. The Law 6.360/76, specifically in � 3, the Art. 12 provide that the registration will be granted no later than ninety (90) days. (very different time those presented in the table above). The judiciary is deferring injunctions that ANVISA review the claims of the Company and provides deadlines for compliance. Indeed, it is not uncommon to see in the Official Gazette records are granted to have their claims have been reviewed by court order. Importantly, the judge hardly determines that ANVISA grant a record, but expedite the examination of a resource, for example, is common. You cannot generalize the deadlines, because everything depends on the documentation of the quality, complexity, among other factors involving each specific case. The international inspections were also the subject of injunctions in 2014 and today the Inspection Management is doing everything to compliance with judicial decisions and those cases that preferred to wait in line. The goal here is not to encourage the companies to seek the judiciary to solve all your problems, but expose the current panorama of the justiciability of matters involving ANVISA. Solve administratively is always the best option, but to wait years to see their drug application, for example, be analyzed, is too much for one company that has invested and does not see the return with the brevity that the law requires. Finally, ANVISA is doing everything to improve these analyzes, either by creating or modifying regulations its internal structure. So it is important to follow the meetings of the Board of Directors, in addition to the technical meetings with ANVISA make associations and syndicate.

Biography :

Email: mraposo@mraposo.com.br