EU Proposal Seeks To Address Borderline Product Classification ‘As Early As Possible’

 
• By Neena Brizmohun

The European Commission’s draft regulation for reforming the EU medicines legislation has proposed a new product classification mechanism for borderline cases where it is not clear if a product is a medicine or falls under another area such as medical devices.

Pills or capsules as a question mark and white plastic bottle.
For borderline cases it can be unclear if a product is a medicine • Source: Shutterstock

The European Commission has proposed introducing a new mechanism for classifying whether a product under development is a medicine in situations where there are borderline issues and it is unclear whether the product is, for example, a drug, a medical device or a cosmetic.

Under the proposal, the European Medicines Agency would be empowered to give scientific recommendations on whether a product that could...

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