A new regulation will apply as of Saturday to the safety devices for prescription drugs sold in the European Union (EU) which is banking on the implementation of this directive to fight against the falsification of drugs which constitutes “a serious threat” to public health.
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,” EU Health and Food Safety Commissioner Vytenis Andriukaitis said in a statement on Friday.
“In other words,” he added, “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.”
Specifically, the manufacturer is now required to affix a two-dimensional barcode and an anti-tamper device on the packaging of prescription drugs.
Pharmacies, including online pharmacies, and hospitals are also called upon to verify the authenticity of medicines before dispensing them to patients, according to the terms of the new regulation which aims to ensure the safety and quality of medicines sold in hospitals in the EU.
Drugs produced before Saturday 9 February 2019 without safety devices may remain on the market until their expiry date. However, under the new end-to-end verification system, authorised persons (especially pharmacists and hospital staff) will be required to check the authenticity of products throughout the supply chain.
The new system will allow Member States to better trace the origin of medicines, especially when one of them poses a problem, says the European Commission.
According to WHO figures it is estimated that 1 in 10 medicines in low and middle-income countries are falsified. The overall proportion of falsified medicines is thought to be much lower in the EU where some 400 notifications of falsified medicines were reported between 2013 and 2017.