Data requirements for switching medicinal ingredients from prescription to non-prescription status
Description
This guidance document provides information to help sponsors determine what evidence should be submitted to Health Canada when applying to switch a medicinal ingredient from prescription to non-prescription status.
Resources
| Name |
Format |
Description |
Link |
|
21 |
|
https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/data-requirements-switching-medicinal-ingredients-prescription-to-non-prescription-status.html |
|
21 |
|
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/legislation-lignes-directrices/documents-reference/exigences-matiere-donnees-ingredients-medicinaux-passent-ordonnance-a-sans-ordonnance.html |