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Variations
Variations are any change to the licensed details following approval in any Member State.
The current variations regulation Commission Regulation (EC) 1234/2008 came into force on 01 January 2010. Currently, there are three main types of variations detailed in the regulation:
- Type IA variations - these "minor" variations generally refer to changes in the name/address of the Marketing Authorisation Holder or a change to the manufacturer's name and address, a minor change to the batch size, submission of a Certificate of Suitability for the drug substance, amongst others. There are two types of Type IA variations;
- Type IA immediate notification
- Type IA notification within 12 months
The timetable for approval of a Type IA variation is 30 days.
- Type IB variations - these "minor" variations generally refer to a change in the name of the product, minor changes to the method of manufacture for the drug substance or drug product, swapping one excipient for a comparable excipient, changes to batch size, change in shelf life of the drug product, etc. Type IB is the default variation type for variations not listed in the Regulation.
The timetable for approval of a Type IB variation is 30 - 90 days.
- Type II variations – these "major" variations are any variations that are deemed to be outside the scope of the variations specifically listed as Type I. For a national licence the in the Regulation and they require prior approval before they can be implemented. The timetable for approval is 30 – 90 days, although the usual time is 60 days.
Ivowen Limited can prepare variations to your licence for you. We can also give you advice on what supporting data you would need for a particular variation, review the data as it becomes available and answer any questions that the Health Authority may have on your application.
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