Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Medicinal Consultation ?

• Scientific opinion on the quality and safety of the ancillary medicinal substance including the clinical benefit/risk profile of the incorporation of the substance into the device • CA will assess data on the quality & safety information of the ancillary medicinal substance including the clinical benefit/risk profile of the incorporation of the substance into the device • Quality data for the medicinal substance and its controls • Quality data for the incorporation of the medicinal substance into the device • Non clinical data for the medicinal substance in the device • Clinical data for the ancillary action of the medicinal substance in the device • NB Usefulness Assessment

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Public

Medicinal Consultation ?

•

Initial Applications • 210 day process post validation of application • CA Follows medicinal product procedures and timelines • Procedure clock stops when questions are raised

•

Subsequent Changes • 60 day process

• Annex IX, 5.2 (f): Where changes are made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, to confirm that the quality and safety of the ancillary substance remain unchanged

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