Commission Delegated Regulation (EU) 2016/161 details the characteristics of the safety features, how medicine authenticity should be verified and by whom. There are currently no plans to exempt additional prescription medicines or product categories from the requirements to bear safety features (“whitelisting”).
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.
The Italian and Greek markets are for the time being exempt from the introduction of the new measures, as they have already adopted similar control systems.
Is it possible to read dows a Q&A dedicated to manufacturers here.
“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.