In its notice of 8 September 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)5113. The European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing domperidone is thus now concluded.

To the risk assessment procedure (available in German only)

Details on the procedure can be found on the website of the European Medicines Agency (EMA):

Domperidone-containing medicines