In December 2008, the European Commission presented proposals for ensuring safe medicinal products and combating counterfeit medicinal products. The package, which comprises a total of three points, also includes the introduction of safety features on the packaging of medicinal products. One of the proposed features is the 2D Datamatrix Code on packages of prescription medicinal products. We reported on 17 December 2008 and 28 January 2009.
On this topic, the Committee on the Environment, Public Health and Food Safety held a meeting at the beginning of December 2009. At this meeting, some of the details continued to be the subject of controversial discussion. The Rapporteur of the Committee on Environment - Public Health and Food Safety, Marisa Matias, agrees with the Commission in that the safety features should only be required for prescription medicinal products. Françoise Grossetête, Shadow Rapporteur of the European People's Party, however, was of the opinion that the safety features should become mandatory for all medicinal products, i. e. also for non-prescription medicinal products. Yet, the Committee will presumably advise to use safety features exclusively on prescription medicinal products.
The subjects "Repackaging of original medicinal products - yes or no?" and "Extending the directive's scope to the Internet retailing of medicinal products" were also debated in this context.
It will be interesting to follow the further course of this legislative procedure. In January, another meeting of the Committee on the Environment will be held; until 9 February, Committee members can submit further proposals. It is planned for the Committee on the Environment to vote on 6 April 2010; then the plenary of the European Parliament will vote on this matter in May 2010.
Should Committee, European Parliament and Council come to an agreement, a final passing of the directive on the fighting of counterfeit medicinal products can be expected in summer 2010. Afterwards, the new directive would have to be transposed into national law in the member states within a period of 18 months.
The European Compliance Academy (ECA) will conduct the second Tracking & Tracing Conference in Stockholm, Sweden, from 16-17 June 2010, dealing with the topic of mass serialisation by means of 2D code and its implementation possibilities.
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)