By Paola Testori Coggi, Director General for Health and Consumers, European Commission

European citizens are entitled to medicines that are safe, of high quality and effective. Falsified medicines may contain ingredients of low quality or in the wrong dosage – either too high or too low – and therefore pose a major health threat to EU citizens. The Falsified Medicines Directive – which entered into force on 2 January 2013 – makes medicines safer by providing measures to verify their authenticity and improve the quality of their ingredients. The main novelties are three:

• First, prescription medicines will need to bear, on their outer packaging, a pack-specific number and an anti-tampering device that will allow the pharmacist to verify that the medicine is authentic and unopened before dispensing it. This will prevent falsified medicines from reaching the patients.
• Second, the active ingredients of medicines are to be manufactured according to appropriate quality standards (“good manufacturing practice for active substances”) regardless of whether they are manufactured in the EU or imported. If imported, the country of origin has to certify that the active ingredient has been manufactured according to standards equivalent to those of the Union. These provisions ensure that only safe, high quality ingredients are used in medicines in the EU. 
• Third, legitimate online pharmacies will be identified by the same logo across the EU. The logo, when clicked, will allow the verification of the legitimacy of the pharmacy. This will allow EU citizens to make an informed choice when buying medicines over the internet. 

The Falsified Medicines directive marks a real breakthrough for the safety and quality of medicines circulating in the EU: not only it will be more difficult for falsified medicines to reach patients, but European citizens will be able to buy medicines online through verified sources. Furthermore the Directive will also ensure the use of only high quality of ingredients in the composition medicines in the EU. This can only have a beneficial effect on the level of public health protection in the EU.