Summary: Guidance Document - Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits)

From: Health Canada

Date adopted: 2017/01/19
Date posted: 2020/03/23
Effective date: 2020/04/01

PDF format (311.08 KB, 12 pages)


On December 13, 2017, Health Canada published the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs in Dosage Form Listed in Schedule C to the Food and Drugs Act) in Canada Gazette, Part II, to apply to Schedule C Drugs (Radiopharmaceuticals and Kits) the requirement to have a Drug Identification Number (DIN) in order for a drug to be sold in Canada. This guidance provides information on how sponsors can follow these new regulations.

Who this guide is for

Market Authorization holders of Schedule C drugs

View complete guide

For assistance

Office of Policy and International Collaboration
LCDC Building
100 Eglantine Driveway, Tunney's Pasture
Ottawa, ON K1A 0K9


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