Module 12 Presentations

xEVMPD Product Record

Medicinal products are being characterized as part of the initial xEVPRM submissions based on the main following characteristics:

• Name of the medicinal product

• Marketing authorisation holder

• Marketing authorisation number

• Authorising body (i.e., Competent Authority)

• Official language Whenever any of the characteristics described above for a medicinal product are different, a separate medicinal product entity should be submitted in the XEVMPD.

As a result, an EV-Code, looks like: PRD123456

The Organisation for Professionals in Regulatory Affairs