Guidance document : annual update of seasonal influenza vaccines. : H164-381/2024E-PDF

"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.

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publications.gc.ca/pub?id=9.941909&sl=1

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