ABSTRACT
The requirement for Expert Reports was introduced in 1975 in Directive 75/319/ EEC. This stated that the ‘documents and particulars’ for marketing authorisation applications must be drawn up by ‘experts with the necessary technical and professional qualifications’. The Experts were supposed to provide a detailed report. However, this requirement had not been implemented systematically by the authorities in all of the EC Member States-in most it was honoured more in the breach than the observance.
