Module 18 2021

Products on the drug-device borderline

Integral combination product (medicine)

Integral combination product (device)

Co-packaged drug & device

Non-integral, re- usable (drug- delivery) device

Applicable legislation

• Combination product falls under Medicines legislation • Device component to meet essential requirements for safety & performance

• Combination falls under Devices legislation • Consultation with Medicines authority required for medicinal component

• Drug and

• Drug and

device each fall under the

device each fall under the

respective legislation

respective legislation

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What is a cosmetic product?

“Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity

with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;”

- from Cosmetic Products Regulation (EU) 1223/2009

In short, it’s for cosmetic purposes – keeping things clean, maintaining condition, or making them look or smell better.

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