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QWP-BWP Guideline on medicinal products used with a ...

Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 22 July 2021 EMA/CHMP/QWP/BWP/259165/2019 Committee for medicinal products for Human Use (CHMP) Guideline on quality documentation for medicinal products when used with a medical device Draft agreed by quality Working Party, Biologics Working Party and Committee for 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)

Committee for Medicinal Products for Human Use (CHMP) Guideline on quality documentation for medicinal products when used with a medical device Draft agreed by Quality Working Party, Biologics Working Party and Committee for Advanced Therapies May 2019 Adopted by CHMP for release for consultation 29 May 2019

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