Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products
Health Canada is holding a 60-day consultation on revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.