Federal Court forces ANVISA to Accept Foreign GMP Certificates
November 10, 2017

The 2nd Federal Court of Brasília has recently granted a preliminary injunction forcing ANVISA to accept foreign Good Manufacturing Practices (GMP) certificates due to the agency’s inactivity. The federal Judge based his decision on ANVISA’s delay in analyzing requests for international inspection of manufacturing plants located in Europe. The plaintiff in the case is a pharmaceutical company seeking GMP certificates from ANVISA to commercialize and use imported goods. However, until the filing of the lawsuit, ANVISA had not analyzed any of the plaintiff’s requests presented in this regard. Since the plants in question had already been inspected by foreign authorities and obtained the correspondent GMP certificates, the preliminary injunction was a way to overcome the agency’s inactivity. After hearing both parties, the court ordered ANVISA to admit the foreign certificates and noted that its silence and delays are harmful to the plaintiff’s business. The decision is also based on the growing case law forcing ANVISA to analyze pending matters within a reasonable time frame. This decision may create a new pathway for companies seeking to overcome ANVISA’s delays. It highlights that the courts are actively remedying abuses from Federal Agencies including omissions that, unfortunately, are part of the routine of everyone whose business depends on the Government’s efficiency. If you have any questions or need additional information, please contact us at prevail@localhost/licks/site.

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