Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - Update (English, HTML)

Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - Update: English HTML file. From Health Canada, updated Apr 2024. View metadata, licence and the direct download on CanQuery.

Format

HTML

Access

Original download only

Publisher-reported update

2024-04-04

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled distribution programs, are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for the purposes of conducting comparative testing.

Access original file