Post-approval changes for medicinal products in the EU

Adriaan Fruijtier

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Why you should attend ?

The EU system for dealing with applications for post-authorisation approvals is very complex.

Particular difficulties are seen with “grouping” of variations and “work-sharing”. A Company can apply multiple changes to a single product using the ‘grouping’ format, as long as the changes are directly related.

For example, a Company can make a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to one product. The type of procedure (Type IA, IB, II) depends on the extent of the change. In the work-sharing procedure one authority will assess the changes on behalf of all the other authorities involved. A Company can use the work-sharing format if the same Type IB or Type II change or group of changes to multiple MAs is submitted.

Knowing and applying the rules will ensure that you can file the variations successfully and avoid rejections.

Learning Objective 

  • Understanding how the system for post-approval changes for medicinal products in the EU works
  • Understanding the difference between extension applications and variations
  • Being able to distinguish the different types of variations
  • Applying the rules to concrete examples
  • Being able to apply the rules for grouping and work-sharing
  • Knowledge of the submission requirements for the different types of changes

Areas covered in this webinar

  • Overview of the different types of variations
  • Type IA variations
  • Type IAIN variations
  • Type IB variations
  • Type II variations
  • Extension applications
  • Grouping

Who will benefit?

Regulatory Affairs personnel, Project Managers

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Adriaan Fruijtier,

Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet, he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands

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