EU Commission and EFPIA Activities against Counterfeit Medicine

On 16 December 2008, the European Commission informed in a press release about the "MEDI-FAKE" action, which targeted customs control on illegal medicines entering the EU: On the basis of a risk profile disseminated by the Commission, customs from the 27 Member States put special focus over a two month period on coordinated action to stop illegal medicines from entering the European Union. This first EU coordinated action had tremendous results, with more than 34 million illegal medicines seized. It also highlighted a number of ways of improving the fight against trafficking in illegal, dangerous or counterfeit goods. It paves the way for future similar actions.

The Commission, Member States' customs experts and pharmaceutical specialists met and identified key risk indicators and high risk pharmaceuticals to be the subject of reinforced controls. These were transformed into an agreed common risk profile to target high risk traffic at all points of the external border controls.

The risk profile, together with updated information and results of the controls carried out, was communicated through the Community Risk Management System (CRMS), managed by the Commission. This ensures systematic, real-time exchange of information necessary to achieve equivalent and effective controls at the frontier. The effectiveness of the profile is continuously reinforced by new risk information obtained from immediate feedback.

The effective elements of the profile will continue to be used by Member States in the coming period.

The MEDI-FAKE action has highlighted areas where improvements can be made in the fight against imports of illegal, dangerous or counterfeit goods. It makes it evident that increasing cooperation with industry is very important. The EFCG, a sector group of CEFIC, will organise their 4th Meeting on Strategies for Compliant Pharma Soucring on 13 – 14 May in Brussels. Among other topics the new draft EU Directive to combat counterfeit medicine will be discussed in detail.

EFPIA is working on a project of Coding and Identification of medicinal products. Various coding solutions have been implemented by Member States, each with their own objectives and motivation. The coexistence of these different systems constitutes an obstacle to enhanced tracking and tracing of medicines at an EU level and adds production costs for manufacturing.

This has led EFPIA to recommend the implementation of a standardised identification solution for pharmaceutical products across Europe. This solution is a unique bar code (Data Matrix) supported by a pan-European verification system enabling pharmacists to check each medicine pack before dispensing it to the patient.

This system would contribute to enhancing the safety and security of the supply chain, whilst also addressing the issues of product surveillance and help gain a better understanding of dispensing risks. The new Europe-wide project will solve the problem with the different coding schemes implemented or proposed by different member states.

The EFPIA concept on identification and coding of pharmaceutical products consists in two parts:
1. The harmonisation of pharmaceutical products codification throughout Europe via the implementation of a serialised Data Matrix (ECC200) on secondary packaging of all products sold in Europe (product code + batch number + expiry date + serial number)

2. The verification of pharmaceutical products at their point of dispensing (serial numbers)

A presentation is available on the EFPIA web page which informs about the technical details of this project. New coding and identification systems already established or currently under development (e.g. Italy, Turkey) will be discussed at a GMP conference on Tracking and Tracing in Berlin, Germany, on 28 and 29 April.

Prepared by
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

European Commission (

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