The role of the CPMP in the EEC

  • C. A. Teijgeler
Part of the CMR Workshop Series book series (CMRWS)

Abstract

  1. 1.

    The Committee for Proprietary Medicinal Products (CPMP), set up by the EEC in 1975, plays an important role in the harmonization of drug regulations between Member States.

     
  2. 2.

    When objections are raised within the Multi-State procedure for applications for marketing authorization, the CPMP considers these and the manufacturer’s response, before drafting recommendations.

     
  3. 3.

    The introduction of the Multi-State procedure has improved co-operation between national delegations, an essential basis for a free market of medicinal products in Europe.

     
  4. 4.

    The CPMP has so far received six applications for biotechnology products under the High-tech concertation procedure, which came into effect on 1 July 1987. This procedure represents an important step towards a single assessment accepted throughout the community.

     
  5. 5.

    In addition to establishing various working parties to provide recommendations and guidelines, the CPMP has important pharmacovigilance responsibilities, concerning the side-effects of drugs.

     
  6. 6.

    The future role of the CPMP will largely depend on the system chosen for the free market of medicinal products in Europe in 1992.

     

Keywords

Member State Medicinal Product Free Market Working Party Competent Authority 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Report from the Commission of the EEC. Com (88) 143Google Scholar

Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • C. A. Teijgeler

There are no affiliations available

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