Regulatory Information on article 57 database :
On 17 December 2015 the EMA Management Board considered that the Article 57 database is functional for the purpose of notifications of changes in QPPV and PSMF information.
As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for Pharmacovigilance and the Pharmacovigilance System Master File.

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.