Mutual Recognition Agreement Between Fda And Ema

In the European Union, the qualified person (qualified person, PQ) shall be relieved of his responsibility for carrying out the checks referred to in Article 22(1)(b) of Council Directive 75/319/EEC, provided that those checks have been carried out in the United States. EMA: www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-11-july_en.pdf The European Union (EU) and the United States have now concluded a fully implemented Mutual Recognition Agreement (MRA) following the recognition of Slovakia by the US Food and Drug Administration (FDA). The MRA will allow both organizations to rely on inspections carried out at production sites of certain drugs for human use in their respective territories.

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