Type IA variations not required any more for administrative changes to EU QPPV and PSMF
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Type IA variations not required any more for administrative changes to EU QPPV and PSMF

Based on the application of Article 57(2) of Regulation (EC) No 726/2004, as of 1 February 2016 the marketing authorisation holders of medicinal products for human use are no longer required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF). This includes QPPV contact details and PSMF location and affects both centrally and nationally authorised medicines. At its December 2015 meeting the EMA Management Board confirmed that the Article 57 database is now functional for the purpose of notifications of changes to QPPV and PSMF information and that this takes effect from 1 February 2016*.

On 5 February 2016 EMA published a Legal Notice on the implementation of Article 57(2) of Regulation (EC) No 726/2004 where, in point 4, the pharmacovigilance information is included. Now, the national competent authorities in the EU have access to this information at a single point. This is expected to provide companies with more flexibility in setting up their pharmacovigilance system by reducing the administrative burden.

* Details provided in EMA Q&A on pharmacovigilance system are available here.

Post reviewed and updated: February 2024