Guidance for market authorization requirements for COVID-19 drugs: Labelling and post-market requirements

Guidance for market authorization requirements for COVID-19 drugs: Labelling and post-market requirements A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug. 2022-07-28 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19COVID-19 drugsmarket authorization requirementsdrug manufacturedsoldregulatory processlabelling requirementspost-market requirements Guidance for market authorization requirements for COVID-19 drugs: Labelling and post-market requirementsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-drugs/labelling-post-market-requirements.html Guidance for market authorization requirements for COVID-19 drugs: Labelling and post-market requirementsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/lignes-directrices-autorisations-mise-marche-medicaments/exigences-etiquetage-post-commercialisation.html

A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug.

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