Falsified medicines: new rules to enhance patients' safety
Entry into force of new rules on safety features for prescription medicines sold in the EU
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.
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.