EEC directives and guidelines applicable to radiopharmaceuticals — 1993

Abstract

The manufacture, scale and supply of radio-pharmaceuticals in the EEC is regulated by directives that are incorporated into the national laws of the member states. The situation as of 1 January 1993 was not too optimistic, however, as the processing of licensing applications had been completely misjudged. Not one product had been registered as of 1 January. The costs involved are also high and since the European market for radio-pharmaceuticals is relatively small, the market cannot afford this. It would appear that the EEC directives are inadquate and too non-specific, so revision is indicated.