EMA issues Q&A guidance on variations regulation
This article was originally published in The Gold Sheet
Executive Summary
The European Medicines Agency has provided a guide to help manufacturers comply with the new variations regulations, which went into effect on Jan. 1. The "Post-Authorization Procedural Advice" guidance explains the procedures for submitting Type IA variations, Type IB variations, Type II variations and extension applications. The guide also explains how variations can be grouped together and the procedures for submitting variations under different types of worksharing arrangements