Submitting risk management plans draft guidance document: RMP summary template
Description
The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.
Resources
| Name |
Format |
Description |
Link |
|
21 |
|
https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans/summary-template.html |
|
21 |
|
https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/presentation-plans-gestion-risques/modele-sommaire.html |