New safety features for medicines sold in the EU - Questions & Answers



What are falsified medicines and why are they a problem in the EU?

Falsified Medicines are fake medicines that pass as real, authorised medicines. Falsified medicines may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage – either too high or too low. Since they have not passed through the necessary quality, safety and efficacy evaluation as required by the EU authorisation procedure, they can be a major health threat.

Do we know how many falsified medicines are on the EU market?

Since falsified medicines cannot be completely traced it is difficult to obtain exact figures. The WHO estimates 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. The Commission received 400 notifications of falsified medicines between 2013 and 2017. These notifications are based on investigations carried out by national authorities. Interpol, Europol and national medicines agencies seize many falsified medicines and close hundreds of illegal websites every year. In 2017, counterfeit medicines of a value of nearly €7 million were seized at the EU borders.

What has been done at EU level to prevent falsified medicines from reaching patients?

In 2011, the EU adopted the Falsified Medicines Directive introducing harmonised, pan-European safety and control measures that allow easier identification of falsified medicines, and improve verifications and controls at borders and within the EU. These measures include: safety features on prescription medicines, an EU logo to identify legal online pharmacies, tougher rules on the importation of active ingredients and strengthened record keeping for wholesalers.

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