The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …
Continue reading “Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?”
Pharma Whisper 