In its notice of 31 March 2014, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the corresponding implementing decisions of the EU Commission K(2014)307 of 16 January 2014.

To the risk assessment procedure (BfArM) (available in German only)

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Information from the EMA