Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application

Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application 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. 2022-06-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetysubmission of licensinglicensing applicationslicensing for vaccinesvaccines for human-useharmonized requirements Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an ApplicationHTML 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 ApplicationHTML 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

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.

Data and Resources

Similar records