Module 3 - Strategic case studies in practice

1

29 May 2019

EMA/CHMP/QWP/BWP/259165/2019 2 Committee for Medicinal Products for Human Use (CHMP)

3 4

Guideline on the quality requirements for drug-device 5 combinations 6 Draft 7

Draft agreed by Quality Working Party

May 2019

Draft agreed by Biologics Working Party

May 2019

Draft agreed by Committee on Advanced Therapies

May 2019

Adopted by CHMP for release for consultation

29 May 2019

Start of public consultation

03 June 2019

End of consultation (deadline for comments)

31 August 2019

8 9 Comments should be provided using this template. The completed comments form should be sent to QWP@ema.europa.eu 10 Keywords Drug-device combination products, drug delivery, medical devices, integral, non-integral, Article 117, Notified Body opinion

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