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      <marc:subfield code="a">Guidance document : </marc:subfield>
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      <marc:subfield code="a">Annual update of seasonal influenza vaccines</marc:subfield>
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      <marc:subfield code="a">Ottawa, ON : </marc:subfield>
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      <marc:subfield code="a">Issued also in French under title: Ligne directrice : mise à jour annuelle des vaccins contre la grippe saisonnière.</marc:subfield>
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      <marc:subfield code="a">Includes bibliographical references.</marc:subfield>
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      <marc:subfield code="a">"This guidance document applies to sponsors seeking authorization for annual updates to influenza vaccines. The document covers the process, data requirements, and associated timelines for the submission, review, and lot release of seasonal influenza vaccines in Canada. The material covered in this document only applies to changes associated with the annual update to seasonal influenza vaccines, specifically: changes to the virus strain(s); changes to the seed banks and/or starting material that are required to produce vaccine for the upcoming influenza season, and; changes to the product labelling to reflect strain changes and the season of use"--Introduction, page 9.</marc:subfield>
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      <marc:subfield code="t">Ligne directrice : </marc:subfield>
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