Transcription of Annex 2 Recommendations for inactivated rabies …
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Annex 2 Recommendations for inactivated rabies …
83 World Health OrganizationWHO Technical Report Series No 941, 2007 Annex 2 Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggsThese 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.
85 This document focuses on the recommendations for production, control and evaluation of rabies vaccines, which as stated above, are one of the
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