Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use

EUCounterfeiting of medicinal products has become an increasing threat for patients, healthcare professionals and industry and a concern for EU and national policy-makers. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products in an effort to combat the counterfeiting of medicinal products.

For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products.

These measures relate to:

  • Manufacture, placing on the market of medicinal products and related inspections
  • Import, export, transit (transhipment) of medicinal products
  • Manufacture, placing on the market of active substances and related inspections

For further information, please download: "Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicines"

Contributions from all stakeholders and interested parties are welcome. This includes, for example, associations representing patients, health care professionals, the industry, as well as academic bodies. Citizens are also welcome to contribute to this consultation.

Contributions should be sent by e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it. by 09 May 2008. Contributions will be made publicly available on the Pharmaceuticals website of Directorate General Enterprise and Industry once the consultation period is over. Upon specific request for confidentiality, only an indication of the contributor will be disclosed.

Respondents should indicate whether they are a company, consumer, academic association or other. If they are a company, the approximate size (turnover, employees) and the main market (product and geographical market) should be indicated.

All contributions will be carefully analysed. A summary of the outcome of the consultation will be published on the Pharmaceuticals website of the Directorate-General Enterprise and Industry.

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