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چکیده

Recommendations published by WHO are intended to be scientific and advisory. Each of the following sections constitutes guidance for national regulatory authorities and for the manufacturers of biological products. If a national regulatory authority so desires, these Recommendations may be adopted as definitive national requirements, or modifications may be justified and made by the national regulatory authority. It is recommended that modifications to these Recommendations be made only on condition that modifications ensure that the vaccine is at least as safe and efficacious as that prepared in accordance with the Recommendations set out below. The parts of each section printed in small type are comments for additional guidance intended for manufacturers and national regulatory authorities which may benefit from those details.

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تاریخ انتشار 2004