Radiopharmaceuticals 1994 |
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Authors: | Peter H Cox Geerd J Meyer |
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Institution: | (1) Department of Nuclear Medicine, Dr. Daniel den Hoed Cancer Center, PO. Box 5201, 3008 AE Rotterdam, The Netherlands |
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Abstract: | On the basis of the discussions at a symposium held in Düsseldorf and attended by respresentatives of various interested bodies, European legislation as it affects radiopharmaceuticals is reviewed. Due consideration is given to the new, centralised and decentralised, registration procedures, effective since 1 January 1995. The dossier required to support an application for marketing authorisation is discussed, separate consideration being given to single-photon emitters, therapeutic radionuclides and positron-emitting radiopharmaceuticals. The role of the European Pharmacopoiea is also considered. It is concluded that the new, modified procedures for the registration of medicinal products in the European Union may actually inhibit free availability of radiopharmaceuticals within the Community, and that there is a strong case for modification of the European Directives so that radiopharmaceuticals are placed in a separate category to therapeutic drugs, with less stringent registration requirements. |
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Keywords: | Radiopharmaceuticals Registration procedure Marketing authorisation |
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