From 1 February 2016 companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance

From 1 February 2016 companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that as of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit to EU regulatory institutions the type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF). Read more