Falsified medicines: new rules to enhance patients’ safety

medicines 2019

(Unsplash, 2019)

This article is brought to you in association with the European Commission.


The falsification of medicines has remained a serious threat to public health in the EU for too long. As of tomorrow, the new rules on safety features for prescription medicines sold in the EU will apply.

From now on, the industry will have to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines. The pharmacies – including on-line pharmacies – and hospitals will have to check the authenticity of medicines before dispensing to patients. This is the final step in the implementation of the Falsified Medicines Directive, adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the EU.

“On 9 February 2019, we will reach yet another milestone for patients’ safety across the EU. Almost 7 years after its adoption, the implementation of the Falsified Medicines Directive will be complete thanks to the introduction of end-to-end verification and safety features on prescription medicines. In other words, 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.  While some more work will need to be done after the launch of the system to make sure that the new system functions properly across the EU, I am positive that we are providing another safety net for citizens to protect them from the dangers of unauthorised, ineffective or dangerous medicines”, said Commissioner for Health and Food Safety Vytenis Andriukaitis.

“Since the beginning of my mandate, I have been encouraging national ministers to monitor the implementation of this new system and help all stakeholders prepare for the new rules that prevent falsified medicines ending up in the hands of patients. In the coming weeks and months, the new system will be monitored to make sure that it functions properly. Still, I am eagerly anticipating tomorrow’s launch given that, on the eve of the European elections, it is yet another example of the added value of EU cooperation” he added.

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.

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