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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Type IA and Type IB variations

Marketing authorization variations are the keys to product life-cycle management. Authorizations are legally binding and hence changes to them require regulatory review and approval. Compliance with the authorization is crucial. Type IA variations are those changes to the licence which have a minimal or no impact on quality, safety or efficacy of the medicinal product. BioVentures Consulting Limited can review proposed changes to our client’s authorizations and provide guidance on the appropriate variation classification. We can provide advice on the EU Variation Regulation relating to the CP/MRP/DCP (Regulation (EC) No 1234/2008) and on National MAs (Directive 2009/82/EC). In the EU, national variations have different national procedures, and only some EU Member States have followed the EU regulation. BioVentures Consulting Limited can provide advice relating to these variation guidelines.

BioVentures Consulting Limited can provide advice on how to avoid unnecessary variations

Example of Type I variations which BioVentures Consulting Limited can implement on behalf of clients may relate to change in the name of the manufacturer, tightening the specification limits, change in the name of the medicinal product or the ATC code, change in the batch size of the active substance or the composition of excipients of the finished product, deletion of a manufacturing site and changes in the existing pharmacovigilance system (DDPS).

Type IB variations are undefined changes which require a modest technical and risk assessment in product quality, safety or efficacy.

In many cases BioVentures Consulting Limited can advise how to avoid variations as far as possible (e.g. include only those elements of GMP and QA in the MAA which are product specific and not site specific). BioVentures Consulting Limited can work with clients throughout product development and is able to point out strategies and provide advice on how to avoid unnecessary variations.

However, where a Type IA or Type IB variation is required BioVentures Consulting Limited can make the submission on client’s behalf, compiling the cover letter and Application Form fully and carefully (including implementation date), telling a clear and simple story. We can also manage grouped variations and worksharing as appropriate. BioVentures Consulting Limited recognises that a well-organised and documented product history is needed, since it is likely that throughout the product life-cycle different personnel will be involved in the project at different stages who need to understand the product history, as well as the need to drawn upon this information in many ways, right up to Marketing Authyorization renewal and beyond.

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