EMA: Update of Q&A on EU-US MRA
In December 2019, the European Medicines Agency (EMA) revised a four-page Q&A document on the EU-US Mutual Recognition Agreement (MRA) on marketing authorisation applications and variations.
Updated question 1: How does the EU-USA Mutual Recognition Agreement (MRA) affect marketing authorisation applications or variations?
The corresponding answer lists all available documents that have to be submitted as proof of GMP compliance for US manufacturing sites that have previously been inspected by the US FDA.
EMA: Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations