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  1. The radiopharmaceutical industry and European Union regulations.

    Article - En anglais

    After a brief historical introduction to Council Directives relating to the manufacture of radiopharmaceuticals the work of the Association of Radiopharmaceuticals Producers - Europe (ARPE) is discussed.

    ARPE has played a significant role as an officially recognized interlocutor with the EEC, influencing decisions on the registration of radiopharmaceuticals and labelling ; this role is reviewed and difficulties identified.

    The future of radiopharmaceuticals is then considered ; it is emphasized that harmonization of national laws by the European Council would represent a first step to enabling radiopharmaceutical manufacturers to access the largest possible market for their products.

    Mots-clés Pascal : Médecine nucléaire, Industrie pharmaceutique, Produit radioisotopique, Europe, Législation, Réglementation, Organisation

    Mots-clés Pascal anglais : Nuclear medicine, Pharmaceutical industry, Radiopharmaceuticals, Europe, Legislation, Regulation, Organization

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 97-0070280

    Code Inist : 002B30A05. Création : 21/05/1997.