Regulatory information – Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

18/12/2015

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance andPharmacovigilance System Master File

At its December 2015 meeting, the European Medicines Agency’s (EMA) Management Board confirmed that the Article 57 database of medicines authorised in the European Union (EU) can now be relied upon to provide the name and contact details of the Qualified Person Responsible for Pharmacovigilance (QPPV) for each authorised medicine in the EU and the location where the Pharmacovigilance System Master File (PSMF) of the marketing-authorisation holder of a given medicine is held.

This endorsement by the Board allows EMA and the national competent authorities in the EU to fully rely on the Article 57 database for this information. This allows all EU regulators to access this information at a single point facilitating their work and helping to coordinate enquiries from regulators to companies and the conduct ofpharmacovigilance inspections.

As a result of reliance on the Article 57 database, for medicines for human use companies will no longer be required to submit type IA variations to notify regulators of changes in relation to the contact details of their QPPV or the location of their PSMF, simplifying processes for the notification of these changes for both companies and regulators.

The simplification will apply from 1 February 2016. From that date, type IA variations for QPPV and PSMF location no longer need to be submitted. In line with legal requirements, the Article 57 database will need to continue to be kept up to date with any changes to products authorised for human use. 

The Article 57 database is a repository of structured and quality-assured information on all medicines for human use that are authorised in the European Economic Area (EEA), whether they are centrally or nationally authorised. EMA established the database in 2012 and it currently contains approximately 500,000 medicines.

The information contained in the database is provided by marketing authorisationholders, based on the legal obligation set out in Article 57 of Regulation 726/2004/EU. The quality of the data is continuously verified by EMA according to a robust quality assurance and control process, established together with the industry.

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