Combination Products (Ch. 16) Flashcards

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1
Q

What determines the regulatory approval pathway for a device and medicinal product placed on the EU market together?

A

Which component has the principal (primary) action, and which is ancillary (secondary)

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2
Q

How is the following regulated?

A combination product with principal medicinal substance

A

A combination product with principal medicinal substance:

Regulated as medicinal products under the MPD - Medicinal Products Directive 2001/83/EC

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3
Q

How is the following regulated?

A medicinal product with an integral medical device

A

A medicinal product with an integral medical device:

Regulated by both the MPD and MDR

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