Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

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EU Medicines Competent Authorities

The NB can choose any EU medicines CA for the consultation, apart from human blood derivatives and some chemical molecules which must be reviewed by EMA

Limited number who are willing to conduct such assessments for NBs at the present time

Prioritisation of Covid -19 Work has impacted timelines

Lists of available CAs on HMA Website: https://www.hma.eu/about-hma/combination-products.html

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Impacts of Brexit

Under MDD, MHRA conducted over 70% of medicinal consultations for all NBs Transfers of MHRA Consultations are taken into consideration and acceptable as part of MDR re-consultation process but…… UKCA applications for devices with ancillary medicinal substances ???

Module 2 : Summaries Quality / Non-Clinical / Clinical

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