Post Marketing Procedures

Guidance documents - Regulation (EU) 2019/6

Best practice guide for changing the reference member state

Guidance for marketing authorisation transfer - National requirements

Guidance for Management of Post-Authorisation Procedures and Pharmacovigilance Activities after Partial Marketing Authorisation Transfer at National Level Following Mutual Recognition or Decentralized Procedure or subsequent Recognition Procedure (so-called Partial MAH Transfer)

Templates relevant for all procedure types

The Qualified Person's declaration template

Applicant's template for post-authorisation commitments

Variations

Pharmacovigilance