ABSTRACT
The purpose of this chapter is to describe, in broad terms, the existing requirements for registering medicinal products based on new chemical active substances in the European Community (EC). The rules, details of the procedures, and extant guidelines have been published in three volumes issued by the Commission of the European Communities. These are: Volume I, The rules governing medicinal products for human use in the European Community; Volume II, Notice to applicants for marketing authorisations for medicinal products for human use in the member states of the European Community’; and Volume III, Guidelines on the quality, safety, and efficacy of medicinal products for human use. References in this chapter to ‘Vol. I’, ‘Vol. II’, and ‘Vol. III’, are to these three volumes.
