Licensing of Radiopharmaceuticals in European Countries 1982

Abstract

Licensing of individual pharmaceuticals has been used for many years as a mean of securing efficacy and safety of such products. During the last ten years a number of countries have introduced legislation in the field of radiopharmaceuticals (radioactive material intended for use in medical diagnosis or therapy). In order to obtain an up-to-date survey of the situation in European countries on the requirements for a licensing of radiopharmaceuticals letters were sent to authorities and individuals in all European countries. The following very short summary was written based on the replies received, and on information supplied by individuals. In the annex a list of adresses of relevant national authorities is given. In most countries regulations with the purpose of radiation protection with regard to workers and patients have been in force for many years. Such regulations are not reviewed here.