Combination Products (Ch. 16) Flashcards
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)
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
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
