October 2019

Did you know?

Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. Between 2013 & 2017 the European Commission received 400 notifications of falsified medicines.

EDC News: Falsified Medicine: new rules to enhance patients’ safety

In 2017, almost €7 million of falsified medicines were confiscated at the EU borders by Interpol, Europol and national medicines agencies. Falsified medicine is hard to identify due to the increased sophistication of tampering techniques, not going through obligatory checks and its ability to access legal supply chains due to complex distribution networks.

In order to simplify the identification of the falsified medicines, the EU has adopted the Falsified Medicines Directive (DIR 2011/62/EU). It outlines safety characteristics for prescription medicine packaging, e.g. unique identification code for authentication and an anti-tampering device. Moreover, in order to control the supply chain and who contributes to it, the directive includes stricter rules on the import of active pharmaceutical ingredients (DIR 2001/83/EU) (Implementing Decision 2013/51/EU), as well as, improving record-keeping requirements for wholesale distributors. In addition, the European Commission has developed a logo, which is used to identify legal online pharmacies (Implementing Regulation 2014/699). All prescription and over the counter medicines to be sold on the EU market must adhere to safety measures outlined in the Commission Delegated Regulation 2016/161. To limit the number regulation infringements, all EU Member States are required to set and implement penalties for those violating national laws (based on DIR 2001/83/EU). The Commission has created a report that includes an overview of the penalties of each EU country along with a qualitative assessment of their effectiveness; this report was given to the European Parliament and Council in January 2018.

For more information:

• Amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source (COM 2008/668 final; 2009/C 317/10; impact assessment SEC 2008/2674)
• Regulation on pharmacovigilance of medicinal products for human use, Regulation 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (additonal information: COM 2008/664 final; 2008/0257 (COD))
• Community code relating to medicinal products for human use as regards pharmacovigilance (DIR 2001/83/EC; DIR 2010/84/EU)
• Safety of medicinal products in the EU (including clinical trials, marketing authorisation, manufacturing, packaging, distribution, retailers, advertising, pharmacovigilance and falsified medicinal products), DG Health and Food Safety, European Commission
• Guideline for Member States Supervision of the National Medicines Verification Systems/ Organisations – developed to ensure a harmonised approach regarding application of the rules (September 2018), DG Health and Food Safety, European Commission
• WG IV: Implementation of the Falsified Medicines Directive in the hospital setting, (September 2018), DG Health and Food Safety with Expert Group
• New rules on importing active pharmaceutical ingredients into the European Union – including frequent questions and answers regarding the written confirmation for the compliance with the rules and a sample of the form to be filled by competent authorities of the exporting country, Health and Consumers, European Commission
• Directorate-General Health and Food safety webpage, European Commission
• Report for the European Parliament: New Technologies for the Marketing and Sale of Medicines on the Internet and Television Networks, Universitat Pompeu Fabra, Barcelona
• Falsified medicines webpage, European Commission
• Press Release “More than €165 million of trafficked medicines seized in Operation MISMED 2”, Europol (March 2019)
• International trade in medicinal and pharmaceutical products (EU-27 - 2002-2019) (for the full article press on the plus sign), Eurostat
• An overview of European Union (EU) statistics related to the use of medicines, covering prescribed medicines (2014), Eurostat