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 i s 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 b een completely misjudged. Not one product had been registered as of 1 January. The costs involved are also high and since the European marke t for radiopharmaceuticals is relatively small, the market cannot affo rd this. It would appear that the EEC directives are inadquate and too non-specific, so revision is indicated.