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Updated EU Guide On Safety Features Addresses Parallel Trade Repackaging

 
• By Vibha Sharma

The EU guideline on complying with the requirement to affix safety features on medicine packs has been updated to address specific aspects of parallel trade, such as re-sealing of medicine packs that are legally opened to replace patient information leaflets.

Smiling pharmacist and indian pharmacy technician posing in drugstore
Parallel Traders May Fit New Anti-Tampering Devices On Resealed Packs • Source: Shutterstock

The European Commission has issued updated guidance on the safety features – a unique identifier and an anti-tampering device (ATD) - that are required on most medicinal packs from February 2019 under the EU Falsified Medicines Directive. The updated guidance offers advice on the practical implications of this requirement for parallel trade.

It clarifies, among other things, that if a medicinal pack is lawfully opened by a parallel trader/manufacturer under the supervision of a national competent authority in order to replace the...

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