EEC directives and guidelines applicable to radiopharmaceuticals--1993. Status quo with particular emphasis on the registration of radiopharmaceuticals which were on the market prior to January 1992

The manufacture, scale and supply of radiopharmaceuticals 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 radiopharmaceuticals is relatively small, the market cannot afford this. It would appear that the EEC directives are inadequate and too non-specific, so revision is indicated.

Published by European journal of nuclear medicine, 1993. The guideline itself is at the source linked here.

doi.org/10.1007/BF00181764