Variation To Register Manufacturer of Bi-Component Antihypertensive Drug As A Part of Mutual Recognition Procedure In Europe

Abstract

Variations plays an important role during the life cycle of any medicinal product. Variation leads to change in an approved dossier, all information included in the dossier is considered as a part of the marketing authorization. Any change made to an approved medicinal product needs to be notified to the Regulatory Authority before implementing the change. The majority of variations involve small improvements/changes to Module 3/ Quality section. The study centers on a specific variation undertaken for a Bi-component Antihypertensive Drug, which is already authorized in European member states via Mutual Recognition Procedure. The study involves variation submission for inclusion of manufacturing site and minor change in manufacturing process and the changes were grouped as Type IB variations. The purpose of the study conducted is to perform a comprehensive review of regulations and guidelines for the submission of such variations. The study summaries and includes the conditions to be met and documents required to update the Module 3 CMC part of the dossier when submitting a variation for a change in manufacturing site.