European rules governing radiopharmaceuticals as medicinal products for human use in the EU.
The development of EU legislation affecting radiopharmaceuticals is reviewed. The requirements for the preparation of a Summary of Product Characteristics are set out. It is concluded that, across the Community, there is wide variation in the effectiveness of implementation of the regulations.
Depto. Ingenieria Quimica y Tecnologia Farmaceutica, Facultad de Farmacia, Universidad de La Laguna, Tenerife, Spain.
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Mallol
D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D019275:Radiopharmaceuticals
D019275:Radiopharmaceuticals