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

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 […]