Endorsement of reliance on the Article 57 database for QPPV contact details and PSMF location

2015-12-23 10:58

Article 57 database now functional for the purpose of notifying changes to the Qualified Person Responsible for Pharmacovigilance (QPPV) and the location of Pharmacovigilance System Master File (PSMF)

On 18 December 2015 the Agency announced that the Article 57 database is functional for the purpose of notifications of changes in QPPV and PSMF location information.
This delivers an administrative simplification to Marketing Authorisation Holders and from 1 February 2016 Type IA variations for QPPV and PSMF location no longer need to be submitted for either centrally authorised or nationally authorised products.
In line with legal obligations, Marketing Authorisation Holders should continue to ensure entries in the Article 57 database for medicinal products for human use are up to date, including with QPPV and PSMF information. Further information on the data submission requirements can be found on the dedicated Agency’s website.