Medicinal products for human use

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


Period of consultation

From 11 March 2008 to 9 May 2008.

Contributions to and results of the consultation

A summary of the responses is available here.

The following submitting parties requested their submission not to be published (all): Eli Lilly and Company, Bayer Healthcare, SICPA and Thornton & Ross Ltd. The following submitting parties requested their submission not to be published (parts): PANalytical B.V. and First Ondemand Ltd.

Below are the public responses to the abovementioned public consultation:

Consumers, patients, academics

Health professionals, pharmacists, health insurances


Targeted stakeholders

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.

Objective of the consultation

These measures relate to:

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

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. Counterfeiting 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.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information: