The Council of the European Union adopts Falsified Medicines Directive! Major challenges for Users and Producers of APIs and pharmaceutical Excipients to be expected

On 27 May 2011 the EU Council has formally adopted the Falsified Medicines Directive. Its publication in the Official Journal of the European Union is about to happen within the next days. This new Directive contains substantial changes in the provisions with respect to GMP/GDP for APIs and Excipients and will have comprehensive consequences for the industry dealing with these materials.


On the 4th European GMP Conference which was held in Heidelberg some weeks ago a presentation was provided by Julie Maréchal-Jamil from the Brussels based European Generic medicines Association (EGA). The presentation informed among others about the key issues in this new Directive with regard to APIs and Excipients. Open questions related to the implementation of the upcoming new GMP/GDP requirements for APIs and Excipients were highlighted and the following main concerns were discussed intensively:

  • A written confirmation of compliance with EU-GMP for imported APIs from non-EU origin will be mandatory. This confirmation has to be provided by the competent authority of the API exporting country. There are 2 waivers:
    1. The exporting country is on the list of equivalent countries.
    2. Under exceptional circumstances where a medicine's availablility is an issue in the EU. In this case the waiver will only be granted if an EU GMP certificate not older than 3 years exists and the European Commission is informed.

    - Neither a format nor an expiry period is defined for this written confirmation. A format that mimics the GMP certificate of the site and is valid for 3 years is recommendable. The confirmation should be stored in the Eudra GMP database.
    - The decision making process for granting the waiver should be transparent.
    - Leverage on existing and operating initiatives (e.g. PIC/S membership and processes) is needed to establish equivalence of countries.
    - An intensified regulatory dialogue with key non-EU API exporting countries like India, China, Turkey, Mexico, South Korea and Taiwan should be of high priority - first to raise awareness of upcoming mandatory EU requirements and second to allow full readiness of new processes by the time of entry into force to secure EU patients access to medicines.

  • A registration of all EU-based activities related to APIs will be mandatory. This applies to manufacturers, importers, distributors and brokers of APIs. The registration will be done after a 60 day process prior to intended commencement of the activity by the Competent Authority where the operator is established. Annual notification of changes is mandatory. Changes impacting quality or safety have to be notified immediately.
    The QP of the final dosage form manufacturer will have extended responsibilities. He has to verify the API activity registration as well as the safety, quality and authenticity of APIs and excipients by audits. He has to state dates and outcomes of the audits in the so called “QP declaration”. Moreover he must inform the competent authority in case of suspicion of falsified medicines or starting materials.

- The registration should be formalised by means of an EU template registration form and the handling of changes/change notification should be harmonised.
- The notification procedure has to be adapted to EU multi-site operators in order to avoid duplication.
- A public repository of inspection outcomes is needed.


  • It will be the responsibility of the final dosage form manufacturer to perform a formalised risk assessment to establish which GMP requirements should apply to the excipients he is going to use for the medicinal product manufacture. In particular the source of the excipients, the intended use and previous instances of quality defects have to be taken into account.

- The guidelines on the formalised risk assessment yet to be established and adopted by the Commission should fairly reflect today’s best practices in performing risk assessments. It should further focus on principles and be cost-effective.


The Falsified Medicines Directive was adopted by the European Parliament on 16 February 2011 and by the EU Council on 27 May 2001. After publication in the Official Journal of the European Union the EU member states are required to transpose the Directive into national law within a 18 months period. For sure this Directive will be a major challenge for both the API industry of many non-EU countries and most of the excipients manufacturers as well as for agents, brokers, traders and of course for the pharmaceutical industry. It will be of key importance to be prepared to the new situation.

Please also see the EU Council's press release.


To find out more please see the currently applicable directive 2001/83/EC, the final draft of the directive as well as the latest modifications in the Directive from 12 April 2011. This will also be the version expected to be published in the Official Journal of the EU (after formal approval in the European Council). Please find here the explanatory note for this latest corrigendum.


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



Julie Maréchal-Jamil
Sr Manager Quality & Regulatory Affairs


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