According to the EMA, the plans for the agreement to come into operation in all EU Member States by 15 July 2019 are well on track. Germany, Luxembourg, the Netherlands and Slovakia are still not officially recognised. The US FDA will continue to carry out its inspections there.

In addition to the listing of Bulgaria and Cyprus, the EMA has revised the Q&A on the MRA. It informs inter alia about which products are included or not in the scope of the MRA. Furthermore, it clarifies questions regarding combination products or the necessity of import re-testing. By the way: this control must still be carried out until all European member states have been approved by the FDA.

More detailed information on the MRA can be found here.

Quelle:

EMA: News