Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs, Annex 2, TRS No 941

Overview

Full version of the WHO Technical Report Series N° 941

These Recommendations provide information and guidance to national regulatory authorities and vaccine manufacturers concerning the characterization, production and control of rabies vaccines in order to facilitate their international licensure and use. Each of the following sections constitutes a recommendation. The parts of each section that are printed in normal type have been written in the form of requirements so that if a national regulatory authority so desires these parts may be adopted as defi nitive national requirements. The parts of each section printed in small type are comments and additional guidance. It is recommended that modifi cations to these Recommendations be made only on condition that the modifi cations ensure that the vaccine is at least as safe and effi cacious as that prepared in accordance with the Recommendations set out below.