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
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
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
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Inquests are something which affect a vast range of NHS and private organisations, as well as individual clinicians, and so we provide a brief overview of recent developments as well as a couple of key potential changes to come.
Changes have been made to Turkey's cosmetics regulations. In particular, the amendments ban use of benzylidene camphor, as well as change requirements for non-oxidant hair dyes and the relationship between local and European Union legislation with regard to vivisection.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).