Request: Name Change of a Manufacturer with Several Functions

How should a variation requiring notification concerning a change in the name of a manufacturer that performs several functions (for example, quality control and batch release of the finished product) be submitted?

Consequential notifications can be submitted. In the case mentioned, it is a notification №12 with a follow-up notification №12. However, if a manufacturer is responsible for both the manufacture and the quality control of the active substance, only a change № 10 needs to be submitted.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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