(by Francesca Maculan)

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 to ensure the availability of medicinal products”, the written confirmation requirement is waived when a plant manufacturing an active substance for export has been inspected by a Member State and was found to comply with good manufacturing practice. Such waiver lasts for a limited period of time, i.e. “for a period not exceeding the validity of the certificate of good manufacturing practice”.

Notwithstanding the entrance into force of the abovementioned rules, the implementation of the Directive has not been completed yet,  for two reasons. Firstly, delegated acts by the EC are still to be issued in order to complete some aspects of the Directive. In particular, detailed measures shall be issued as regards the “safety features” to be shown on the outer packaging which enable to verify the authenticity of the medicinal product and identify individual packs by means of a “unique identifier” (Art. 1(12) of the Directive). As regards the sale of medicinal products to the public over the internet, the EC shall adopt implementing acts regarding the so called “common logo” introduced by Art. 1(11) of the Directive, that is to say the identification “stamp” to be displayed on every page of the website of authorized online pharmacies. The common logo shall also contain a link to an official national register of legally-operating retailers. The regulation in any case do not undermine national legislations prohibiting the offer for sale at distance of prescription medicinal products to the public; therefore, the assessment of whether and how a medicinal product can be sold over the internet remains a decision of each Member State.

As regards the second aspect, finally, some Member States have not transposed the Directive yet, even if they were asked to do so by last 2 January. For this reason an infringement procedure has been recently opened towards Italy (no. 2013_0147) for the very non-transposal.