Legislation
In June 2011, the European Parliament and the Council adopted Directive 2011/62/EU[1], also known as the Falsified Medicines Directive. The aim of the Directive was twofold: (i) to address the increase in the number of falsified medicinal products detected in the EU and (ii) to strengthen supervision of the legal supply chain of medicinal products for human use.
The directive introduced harmonized European rules to ensure that falsified medicines do not enter the legal supply chain of the single market and do not reach patients. It stipulates that prescription medicinal products for human use must bear safety features on their packaging. European citizens have the right to use safe, quality and effective medicines. Falsified medicines can contain ingredients of low quality or at an inappropriate dosage – too high or too low – and therefore pose a serious threat to the health of EU citizens.
The Directive that 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 innovations are as follows: firstly, prescription medicinal products will have to bear, on their outer packaging, an MKA and an anti-tampering device enabling the pharmacist to verify that the medicine is genuine and has not been opened. In this way, falsified medicines will not be able to reach patients.
Secondly, the active ingredients of 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 substance has been manufactured according to specifications equivalent to those of the Union. These arrangements ensure that only safe, high-quality ingredients are used in medicines in the EU.
The Falsified Medicines Directive is a real milestone for the safety and quality of medicines marketed in the EU: not only does it make it more difficult to falsify medicines that reach patients, but it also enables them to buy medicines online from guaranteed certified sources. In addition, the Directive will ensure that only high-quality ingredients are used in the formulation of medicines in the EU, which can only have a positive impact on the level of public health protection in the EU.
The detailed rules for those security features are laid down in Delegated Regulation (EU) 2016/161[2]. The Delegated Regulation entered into force in 2019 and introduced verification mechanisms and mandatory safety features for medicines. Those verification mechanisms and specific security features shall be:
- a unique identifier (Data Matrix), the authenticity of which proves the authenticity of an individual pack of a medicinal product.
- a tamper-detection device, the integrity of which proves the authenticity of the medicinal product on its packaging.
The regulation also details how the authenticity of medicines must be verified and by whom. The authenticity of medicinal products is ensured through an end-to-end control system, complemented by risk-based checks carried out by wholesalers. Medicinal products are systematically checked at the point where they are supplied to the public (e.g. in a pharmacy). Medicinal products at higher risk of falsification (returned medicinal products or medicinal products not dispensed directly by manufacturers, marketing authorisation holders or persons acting on their behalf) are also controlled at wholesale level. The authenticity of medicinal products shall be ensured by checking the unique identifier on each individual pack against the legitimate unique identifiers stored in a repositories system set up and managed by interested parties under the supervision of national competent authorities.
A direct consequence of the regulation, which will apply from 2019, is that medicines will be systematically authenticated before being made available to patients, preventing not only falsified medicines, but also other common errors, such as inadvertently dispensing expired or withdrawn medicines. In addition, the European pharmaceutical supply chain will be digitalised, thanks to a system of repositories linking manufacturers, wholesalers, pharmacists and hospitals. This will improve the flow of information and facilitate drug recall and return procedures.
Overall, the regulation is an important step forward for the safety of EU medicines and the protection of public health in the EU. European law granted Greece an extension of the transition period in order to adapt its existing system to EU rules. Therefore, Greece is obliged to join the EU system as of 9/02/2025.
For more information, the relevant Directive (FMD) 2011/62 EU on Falsification, Regulation (DR) 2106/161 EU and the Joint Ministerial Decision with elements D3(a)41169/19/8-7-2020 (Government Gazette B ́6124) are listed below.
[1] Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of falsified medicinal products entering the legal supply chain (OJ L 174, 1.7.2011, p. 74).
[2] Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules concerning the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).