This webinar will deal with the many different post-approval changes and describe which medicinal products regulations has to be followed. It will address the different types of variations (Type IAIN Variations, Type IA Variations, Type IB Variations, Type II Variations), but also extension applications, other types of post-approval changes, grouping of variations and work-sharing
Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as:
the manufacturer’s name
a minor change to a control method
deleting details of where the product is packaged
Type IAIN is a sub-type of Type IA where regulatory authorities require ‘immediate notification’, within 2 weeks of the change being implemented.
If the change is more significant than an IA change but is not a Type II change or an extension, it is considered a Type IB change.
Regulatory Authorities need to approve major variations (Type II variations) before they are made.
Why Should You Attend:
The legislation on the new scheme came fully into effect in 2013, but many companies report that they still need time to adapt to the changes. The EU system for dealing with applications for post-authorisation approvals is very complex and still in an implementation phase.
On the other hand, the importance of post-approval changes is increasing due to the increasing number of changes. The number of variations per marketing authorisation has gone up considerably.
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.
Areas Covered in this Webinar:
The webinar will start to explain that changes are classified as major (type II) or minor. Minor changes are either Type IA or IB.
The Company can apply for:
a single change to one marketing authorisation (MA)
multiple changes to one or more products and/or MAs
Type IB changes must be submitted to the Authorities and the company must wait 30 days before the changes can be implemented.
Major variations (Type II) are more complex and may have a significant impact on the quality, safety and/or efficacy of the product. One example of a major change is adding a new therapeutic indication to a product or updating the current indication (the medical needs the product is used for).
Although extensions are still considered a type of variation, their impact on a product is so significant that the Company will need to follow the application process to apply for a new MA.
Extensions can be:
changes to the active substance(s), including the salt/ester, isomer or biological active substance
changes to strength, pharmaceutical form or route of administration
If the variation (e.g. change of manufacturer) affects details of the labels, leaflets and or packaging of the product, the Company will need to include the updated versions with the submission to be assessed.
Proposals for work-sharing applications should be sent to:
the European Medicines Agency (EMA) if any of the MAs the Company wants to change were granted under the centralised procedure
the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) if the MAs were granted under the mutual recognition and/or decentralised procedures and the reference member states were different *the reference member state if the authorisations were granted under the mutual recognition and/or decentralised procedure and the reference member state is the same for each MA
the competent authorities for the relevant countries if the MAs were granted under purely national procedures.
Understanding how the system for post-approval changes for medicinal products in the EU works
Being able to apply the rules for grouping and work-sharing
Who Will Benefit:
Regulatory Affairs Personnel
CRAs and CRCs
QA / Compliance personnel
QA / QC Auditors and Staff
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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