Annex 3 Recommendations for the production and control of ...

99E World Health OrganizationWHO Technical Report Series, No. 927, 2005 Annex 3 Recommendations for the production and control ofinfluenza vaccine (inactivated) Recommendations published by WHO are intended to be scientific andadvisory in nature. The parts of each section printed in type of normalsize have been written in a form, such that, should a national regulatoryauthority so desire, they may be adopted as they stand as definitivenational requirements or used as the basis of such requirements. Thoseparts of each section printed in small type are comments and recommen-dations for guidance for those manufacturers and national regulatoryauthorities which may benefit from additional is recommended that modifications be made only on condition that themodifications ensure that the vaccine is at least as safe and efficaciousas that prepared in accordance with the Recommendations set out order to facilitate the international distribution of vaccine made inaccordance with these Recommendations , a summary protocol for therecording of results of the tests is given in Appendix terms national regulatory authority and national control laboratory as used in these Recommendations .

101 E Introduction Influenza is a significant cause of morbidity and mortality and has a major social and economic impact throughout the world. During

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