New EU rules on falsified medicines

When new EU rules enter into force on 9 February 2019, it will be harder for falsified medicines to reach patients in the EU. The new rules, which introduce new safety features on the packaging of medicines and other measures, are to prevent falsified medicines from entering the legal supply chain of medicines – for example in pharmacies and hospitals. 

On 9 February, new rules on falsified medicines enter into force, aimed to improve patient safety throughout the EU. Under the new rules, medicines will in future be fitted with an anti-tampering device so you can tell if a pack has been opened, and it will also bear a barcode making it possible to check if the medicine is falsified.

Until recently, the products most frequently falsified in wealthy countries were lifestyle medicines, such as hormones, steroids and antihistamines. According to the European Medicines Agency, EMA, we now also see this with anticancer medicines and antivirals. Although we rarely see problems with falsified medicines in the legal supply chain in Denmark, the new rules will have a considerable impact at the European level.

Due diligence

"This is about due diligence. Patients are entitled to effective and safe medicines of a high quality. Falsified medicines can be of low quality and be in the wrong doses, and this may jeopardise health. Although the new rules will bring major readjustments to pharmacies and pharmaceutical companies, the initiative is a good example of how the collaboration between all EU countries with great help from pharmacies, wholesalers and the pharmaceutical companies can improve patient safety not only in Denmark, but for hundreds of millions of Europeans", said Mette Aaboe Hansen, Director of Medicines Licensing in the Danish Medicines Agency.

Besides the new safety requirements for the outer medicine packaging in the form of a barcode and anti-tampering device, a common European repositories system will be established so that the authenticity of prescription-only medicines covered by the new rules can be verified and controlled.

Read more here:

Information on falsified medicines and the new rules from the European Medicines Agency.