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New EU rules on fake drugs enter into force

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New EU rules on fake drugs enter into force

Prescription medicines - Image EC

(BRUSSELS) - New rules on safety features for prescription medicines sold in the EU entered into force Saturday, heralding the introduction of end-to-end verification and safety features on prescription medicines.

From 9 February, the industry will have to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines.

The pharmacies – including online pharmacies – and hospitals will have to check the authenticity of medicines before dispensing to patients.

This forms the final step in implementation of the EU's Falsified Medicines Directive, adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the EU.

The entry into force is an important milestone, according to the Health Commissioner Vytenis Andriukaitis, as "every pharmacy or hospital in the EU will be required to have a system that will make the detection of falsified medicines easier and more efficient."

He acknowledged that work still needed to be done following the launch to ensure proper functioning of the new system across the EU. But he added: "I am positive that we are providing another safety net for citizens to protect them from the dangers of unauthorised, ineffective or dangerous medicines."

Medicines produced before Saturday 9 February 2019 without safety features may also remain on the market until their expiry date.

But the new end-to-end verification system will require authorised persons (and in particular pharmacists and hospitals) to verify, throughout the supply chain, the authenticity of the products.

The new system will allow Member States to better trace individual medicines, in particular if a concern is raised for one of them.

New safety features for medicines sold 
in the EU - background guide

Falsified medicines


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