To the attention of Marketing Authorisation Holders
In the context of implementation of the new pharmacovigilance activity, interested pharmaceutical companies will find the following announcement under the heading “Press releases” on the NAMMD website:
“The European Medicines Agency (EMA) announces the launch of a new e-learning course concerning mandatory requirements, in accordance with Article 57(2) of Regulation (EU) 1235/2010, for electronic submission of information on medicinal products for human use”
For further information please access: http://eudravigilance.ema.europa.eu/human/training7.asp.