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EU-US Mutual Recognition Agreement for inspections

EU

With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, the Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA’s website.

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