Description

The objective of this document is to establish harmonized requirements for the submission of licensing applications for vaccines for human use. Requiring the same level of information across countries will facilitate the licensing process and ultimately the availability of vaccines.

Resources

Name	Format	Description	Link
Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/drug/harmonized-requirements-licensing-vaccines-guidelines-preparation-application.html
Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/drogues/exigences-harmonisees-homologation-vaccins-lignes-directrices-redaction-demande.html#a12

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