Mutual recognition or a central European office?

  • Y. Juillet
Part of the CMR Workshop Series book series (CMRWS)

Abstract

  1. 1.

    Mutual recognition of marketing authorizations is the solution recommended by the regulatory authorities and pharmaceutical industry in France, for future drug registration in Europe.

     
  2. 2.

    The European Federation of Pharmaceutical Industry Associations (EFPIA) has recently provided the European Commission with a policy document.

     
  3. 3.

    This document proposes that the two procedures (mutual recogntion or direct access) should work in parallel.

     
  4. 4.

    SNIP maintains, in the context of this EFPIA document, that the choice of procedures should be left exclusively to manufacturers.

     
  5. 5.

    Regardless of the procedure, authorization should enable free circulation of a medicinal product in all EEC countries, without any obligation on the manufacturer to market in all countries.

     

Keywords

Medicinal Product Direct Access Marketing Authorization Mutual Recognition Proprietary Medicinal Product 
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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Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • Y. Juillet

There are no affiliations available

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