The Falsified Medicines Directive published in the Official Journal of the European Union

After the formal adoption of the Falsified Medicines Directive by the EU Council on 27 May 2011 the Directive has now been published in the Official Journal of the European Union. The publication date was the 1 July 2011 and this date is also the beginning of a 18 months period where the Directive has to be transposed into national law by each Member State of the European Union (please see our News dated 1 June 2011).

The new legislation aims to ensure that medicines are safe and that the trade in medicines is rigorously controlled in order to improve the protection of public health. To this end harmonised measures will be implemented which include:

  • An obligatory authenticity feature on the outer packaging of the medicines (this feature will be decided at a later stage via a delegated act);
  • A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
  • Strengthened record-keeping requirements for wholesale distributors;
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients.

The provisions for controls of manufacturers and distributors of pharmaceutical raw materials have been considerably strengthened. Article 46, point (f) of the Directive 2001/83/EC which now will be amended by the new Directive stipulates the obligations of the manufacturing authorisation holder with respect to APIs and pharmaceutical excipients.

The holder of the manufacturing authorisation shall:

  • verify compliance by the manufacturer and distributors of APIs with good manufacturing pratices and good distribution practices by conducting audits.... The manufacturing authorisation holder shall verify such compliance either by himself or ... through an entity acting on his behalf under a contract.
  • ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is. This shall be ascertained on the basis of a formalised risk assessment ...
  • to verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established.
  • to verify the authenticity and quality of the active substances and the excipients.

The restrictions on importation of APIs into the European Union (Article 46b) are the following:

Active substances shall only be imported if...

  • the active substances have been manufactured in accordance with the standards of GMP at least equivalent to those laid down by the Union (3rd paragraph of Article 47)
  • the active substances are accompanied by a written confirmation of the exporting third country. This confirmation shall include

    - the standards of GMP to the plant manufacturing the exported API are at least equivalent to those laid down by the Union (3rd paragraph  of Article 47),
    - the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of GMP, including repeated and unannounced inspections...,
    - in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without delay.

The European Commission is required to establish guidelines applicable to APIs and pharmaceutical excipients.  According to Article 47 (3rd and 4th paragraph) of the Directive the Commission shall adopt:

  • the principles and guidelines of good manufacturing practice for active substances referred to in the first paragraph of Article 46(f) and in Article 46b,
  • the principles of good distribution practices for active substances in form of guidelines,
  • guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in the 2nd paragraph of Article 46(f).

The full name of the new Directive is:

"DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the leagl supply chain of falsified medicinal products".

Here you can find the official publication of the Directive.

On the EU Commission website you can find a Video (title: "EU fights fake medicines") on the risks of fake medicines and on the wide range of actions taken by the EU to ensure the highest possible level of citizens' health.

Please note:

During the course "GMPs for pharmaceutical Excipients" in Barcelona, Spain, from 27 - 28 September 2011, you will have access to first-hand information about how to verify appropriate GMP compliance of excipients and to the new excipients certification scheme "Excipact".

The "ICH Q7 Auditor Training Course" in Heidelberg from 26 - 28 October 2011 will provide excellent knowledge about the techniques to be used during an audit.

In the course "The new Pharma Directive" in Berlin, Germany, from 5-6 October 2011 you will learn how the amendment of the Pharma Directive will alter national medicinal law.


Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)


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