Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?

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 …

EMA electronic Product Information (ePI) Consultation

Expert and public comments sought on ePI, open until 31/July/2021. The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online …