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RECOMMENDATIONS FOR INACTIVATED RABIES …

ANNEX 2 RECOMMENDATIONS FOR INACTIVATED RABIES VACCINE FOR HUMAN USE PRODUCED IN CELL SUBSTRATES AND EMBRYONATED EGGS 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 large type have been written in the form of requirements so that if a national regulatory authority so desires these parts may be adopted as definitive national requirements. The parts of each section that are printed in small type are comments and RECOMMENDATIONS for guidance. It is recommended that modifications to these RECOMMENDATIONS be made only on condition that the modifications ensure that the vaccine is at least as safe and efficacious as that prepared in accordance with the RECOMMENDATIONS set out below.

ANNEX 2 RECOMMENDATIONS FOR INACTIVATED RABIES VACCINE FOR HUMAN USE PRODUCED IN CELL SUBSTRATES AND EMBRYONATED EGGS These Recommendations provide information and guidance to national regulatory

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