The EMA has released the detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 ( Chapter 3.II:  XEVPRM User Guidance, Version 3.0, dated 5 March 2012).

Posted on the EMA wesbite on 1 February 2013