Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe
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 and Pharmacovigilance 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 of pharmacovigilance 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 authorisation holders, 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.
Related News
-
News Introducing the Pharmaceutical Sustainability Ecosystem from CPHI
The Sustainability Collective from CPHI unveils the groundbreaking Pharmaceutical Sustainability Ecosystem to drive pharmaceutical knowledge sharing, connection, and collaboration in order to change the face of sustainability in pharmceutical... -
News US Government shutdown leads to the FDA grinding to a halt
The US Congress reached a deadlock after not being able to come to an agreement regarding funding, specifically reaching an impasse when Republicans and Democrats were unable to reach an agreement regarding Obamacare subsidies. The resulting shutdown o... -
News Biosimilars for the better: an expert view from Ecolab
Ecolab expert Renato Azevedo shares his insights on the current state of the biosimilars market in pharmaceuticals, after a high number of biosimilar drug approvals throughout the year confirming the shift of focus in this field. -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ...