Module 12 Presentations

What is xEVMPD & Art. 57

• e X tended E udra V igilance M edicinal P roduct D ictionary

• Article 57 is the addition to the, at that time already existing, Regulation to electronically submit medicinal product information by MAH

• It is a database that should have a complete inventory of all medicines authorized for human use in the EEA (CP and nonCP, including Norway, Iceland, and Liechtenstein)

• It became a mandatory and legal obligation as of 2 July 2012 – 1 year before the public format available

• It is also a first step towards the use of structured medicinal product data

The Organisation for Professionals in Regulatory Affairs