Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations

On 7 January 2020 EMA updated how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations.

In December 2019 the EMA revised how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations. As the US FDA does not issue GMP certificates, applicants should submit all available documents as proof of GMP compliance for US manufacturing sites that have been previously inspected by US FDA.

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