New EU Rules Against Falsified Medicines

Further to general implementation started on 2 January 2013, a second set of rules of Directive 2011/62/UE (the "Directive") will come into effect for UE Member States on next 2 July. The Directive amended Directive 2001/83/CE on a Community code relating to medicinal products for human use (the "Medicines Code") "in order to prevent the entry into the legal supply chain of falsified medicinal products".

As we already explained here on this blog, the update of the existing legislation was necessary in order to face the increasing diffusion (including on the web) of falsified medicinal products, i.e. medicines entailing "a false representation of their identity...their source...or their history" (Art. 1(1)(c)): basically, medicinal products containing sub-standard or falsified ingredients or ingredients in the wrong dosage, or medicinal products lacking ingredients they should contain.

In this context, the rules coming into force on 2 July foresee in particular that active substances to be used in the manufacture of a medicinal product for human use shall only be imported in the EU if requirements set forth in new Art. 46ter(2) of the Medicines Code - added by Art. 1(6) of the Directive - are met: firstly, they shall be manufactured in accordance with "standards of good manufacturing practice at least equivalent to those laid down by the Union". Secondly, said active substances shall always be accompanied by a "written confirmation" from the competent authority of the exporting third country acknowledging the abovementioned accordance, the fact that the manufacturing plant is subject to regular and strict controls and the promptness of the exporting third country in supplying information to the EU in the event of findings relating to non-compliance. However, pursuant to new Art. 46ter(3) of the Medicines Code, no written confirmation is required for active substances coming from third countries which, following their request, have been assessed and are considered by the European Commission ("EC") as having equivalent rules for good manufacturing practice to those in the EU. To date, amongst third countries which have submitted application to be dispensed with the abovementioned written confirmation, only Switzerland, Australia, Japan and the United States have been granted such authorisation. Finally, new Art. 46ter(4) of the Medicines Code added by the Directive foresees that "exceptionally and where necessary...