To the attention of Marketing Authorisation Holders
In the context of the implementation of the new pharmacovigilance legislation on the NAMMD website, under the heading “Press releases”, interested pharmaceutical companies will find the “EMA press release on publishing the updated set of mandatory Article 57(2) requirements for marketing authorisation holders”, accompanied by the document “Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004, “Electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency”.