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

Templates relevant for all procedure types

The Qualified Person's declaration template

Applicant's template for the post-authorisation commitments

Variations

Renewals

Pharmacovigilance

Guidance documents - Directive 2001/82/EC

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

Guidance for administration of the Sunset Clause