Detailed guidance on the electronic submission of information on medicinal products for human use. Article 57(2)

5 February 2016
EMA/135580/2012
Information Management. 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) of Regulation (EC) No. 726/2004. Chapter 3.II: XEVPRM User Guidance. Version 3.11

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