21/22 October 2020
Two weeks ago, we pointed out in our News titled MRA Countdown: 10, 6, 4, 2... that the Mutual Recognition Agreement (MRA) with the USA was on track. The News concluded with the statement that Germany and Slovakia were missing. Meanwhile, things have changed!
Germany has also been recognised since 26 June. Slovakia, whose recognition is expected by the middle of July 2019, is still awaited. Now, what will happen next? The answer is to be found in a Question and Answer document (Q&A) of the EMA updated on 27 June 2019. It explains which countries were recognised when, what has been in force since 1 November 2017, which products are included or excluded, how Combination Products are included and what will happen next. Full recognition of all EU Member States is expected by 15 July. This would be the prerequisite for additional complete testing of a medicinal product imported from the USA to be no longer necessary.
You will find the EMA's updated Question and Answer document on the EU-USA MRA on their website.