PubMed · 6404399
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E S Snell. 1983-04-09. Generic substitution.. https://doi.org/10.1136/bmj.286.6372.1216-c
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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.