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Future perspectives of regulations — the concept of a European medicines office

  • T. M. Jones
Part of the CMR Workshop Series book series (CMRWS)

Abstract

  1. 1.

    The current, diverse, systems used for reviewing applications for product licences by national authorities within the Member States of the European Community are inappropriate to deal with medicines regulation in the future.

     
  2. 2.

    Total mutual recognition is unlikely to be successful and the experience to date on mutual recognition through the CPMP multi-state procedure is not encouraging.

     
  3. 3.

    A European Medicines Office should be created consisting of a professional secretariat with advisory bodies and procedures for the timely review of applications and appeals.

     
  4. 4.

    National authorities within each Member State would still have a role in medicines regulation.

     

Keywords

Member State Medicine Regulation National Authority Marketing Authorization Mutual Recognition 
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.
    COM (88) 143 finalGoogle Scholar
  2. 2.
    Poggiolini D, Scrip 1293; 23.3.88Google Scholar

Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • T. M. Jones

There are no affiliations available

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