The Paper Work with Applications for Registration of Radiopharmaceuticals in Denmark

Abstract

The term paper work here is attributed to the work connected with preparation and handling of an application for registration of a radiopharmaceutical product. The material to be presented derives from applications for registrations submitted in Denmark since 1976 with the exception of applications later withdrawn. It is considered of general interest since the registration material in most cases seems to be identical to that submitted to registration authorities in other countries. At the start of the Danish registration system for radiopharmaceuticals (January 1 1976) a grandfather clause was granted for products, which were well known and well established and had been in regular use for several years. For these products registration could take place without full documentation with respect to the pharmacological, toxico1ogical and clinical developing work. With respect to these points such products of course too are excluded from the present study of quality of the applications. The questions raised by the registration authority according to the first review are considered to represent the most open defects and errors and thus form the basis of most of the presented material.