Module 18 2021

Combination products

EU ● No legal definition ● Regulatory jurisdiction based on primary action – Pharmacological = MEDICINE regulated by EMA/national medicines agencies – Prefilled syringe – Disposable insulin pen – Physical = DEVICE regulated by notified bodies on behalf of competent authorities – Drug-eluting stent – Refillable insulin pen

TOPRA MSc Module 18: Drug Device Combinations and other Technology