Submission of DMF updates

Type II variations now possible


Updates to Drug Master Files (DMF) or Active Substance Master Files (ASMF) and to documents for active substances in Part IIC of the documentation in NTA format for veterinary medicinal products may now be submitted to Swissmedic as a single type II variation. Until now, such updates required several type IA/IAIN, IB or II variations depending on their scope. This new procedure matches the one followed by the EU and will be applicable for variation applications received by Swissmedic from 1 July 2020.

The document

published on the Swissmedic website has been updated and describes under 3.14 the submission and charging modalities for type II variations.