European citizens should have the right to access safe, good quality and effective medicines. Falsified medicines may contain poor quality or inappropriate dosages – too high or too low – and therefore pose a serious threat to the health of EU citizens. The directive, which came into force on 2 January 2013 – makes medicines in the EU safer as it provides for measures to verify their authenticity and to improve the quality of their ingredients. The main innovations introduced are the following three:
- Firstly, prescription medicines should bear, in their outer packaging, a unique serial number and an anti tampering device, enabling the pharmacist to verify that the medicine is genuine and has not been opened. Thus, fake medicines cannot reach the patients.
- Secondly, the active ingredients of the medicines must be manufactured according to appropriate quality standards (“good manufacturing practice for active substances”), regardless of whether they have been produced in the EU or imported. If imported, the country of origin must certify that the active ingredient has been manufactured in accordance with standards equivalent to those of the European Union. These arrangements ensure that only safe, high-quality ingredients will be used in medicines in the EU.
- Thirdly, legitimate pharmacies on the internet will be identified with a single logo across the EU. By clicking on this logo, you will be able to verify that this pharmacy is legal. Thus, EU citizens will be able to make informed choices, when buying medicines online.
The Falsified Medicines Directive is a real landmark, for the safety and quality of medicines that circulate in the EU: it not only makes it harder to manipulate medicines that reach patients but also enables them to buy online medicines from guaranteed certified sources. In addition, the Directive ensures that only high-quality ingredients are used in the formulation of medicines in the EU, something which can only have a positive impact on the level of public health protection in the EU.
On 9 February, the Commission published the delegated regulation on the safety features on the packaging of medicinal products for human use – the most recent but equally important of a series of legislative measures adopted by the Commission to implement the Falsible Directive medicines. The regulation introduces authentication of medicines through two safety features – a unique identification code and a tamper detection mechanism – to protect patients from the dangers of falsified medicines and the consequences of common mistakes. The unique identifier – a unique code that identifies a given drug package – is encoded in two-dimensional bar code and can be read by simple scanners. The counterfeit detection mechanism guarantees that the packaging of the drug has not been opened and tampered with.
The regulation also describes in detail the way in which the authenticity of medicinal products must be verified and by whom. The authenticity of medicines is ensured through a terminal endpoint system, supplemented by controls based on the risk that wholesalers will carry. Medicines are subject to systematic control at the point of sale to the public (eg in the pharmacy) Medicines at greater risk of falsification (returned medicines or medicines not directly distributed by manufacturers, marketing authorization holders or persons acting on their behalf) are also controlled at the wholesale level. The authenticity of the medicines is ensured by checking the unique identification code on a given package against legitimate unique identifiers stored in a repository system set up and administered by the parties concerned under the supervision of the competent national authorities.
The immediate consequence of the regulation, to be implemented from 2019, is that medicines will be systematically authenticated before they are available to patients, preventing not only falsified medicines but also other common mistakes such as cessation of withdrawal or withdrawal of medicinal products. In addition, the European supply chain for pharmaceuticals will be digitized thanks to a repository system linking manufacturers, wholesalers, pharmacists and hospitals. This will improve the flow of information and facilitate drug recall and return procedures.
In general, the regulation is an important step forward in the safety of EU medicines and the protection of public health in the EU.
For further information, see below the relative Directive (FMD) 2011/62 EE on Falsified Medicines and the relative Regulation (DR) 2106/161 EE.