Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations and the critical issues that you need to be aware of when completing a variation.
Did you know that Article 20 of Commission Regulation (EC) N° 1234/2008 (the ‘Variations Regulation’) allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one marketing authorisation from the same Marketing Authorisation, in one application? In this article Meg […]
In this article, we look at the issue of Repeat Use Procedure. We give an overview and consider some of the issues that need to be addressed during the process.
In this article we look at the possible changes that could be made to package leaflets to improve their comprehension and readability.
The pharmaceutical and medical device sectors are facing unprecedented commercial pressures in every major healthcare market in the world. Issues such as increased competition, uncertainty regarding geopolitical issues such as Brexit and the individual nation’s drug pricing strategies have sent shock waves through the industry. Now, in order to survive and thrive there is a […]