Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

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Changes to Medicinal Products with Integral Device ?

What is a substantial change? How do I manage my supplier? Is there any guidance?

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EMA Q&A 21 October 2019 Rev.1 EMA/37991/2019

Existing Guidance relevant to assess changes

 Responsibility of MAH to determine if changes are substantial  Do liaise with NB to obtain NBOp  NB can not determine if change is substantial

 Variation guidance has been updated to include some device changes but Not clear on how to determine whether changes are substantial

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