Post Marketing Procedures

Best practice guide for changing the reference member state

Best practice guide for changing the reference member state track changes

Guidance for marketing authorisation transfer - National requirements (April 2021)

Guidance for post authorisation activities after partial marketing authorisation transfer - Partial MAH transfer

Guidance for administration of the Sunset Clause

Templates relevant for all procedure types

The Qualified Person's declaration template

Applicant's template for the post-authorisation commitments

Variations

Renewals

Pharmacovigilance