Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) (French, HTML)

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Publisher-reported update

2021-07-06

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. The objective of this regulatory amendment is 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. Along with the new requirement for all Schedule C drugs to have a DIN, the labelling requirements have also been updated to reflect the new requirement: instead of requiring the Establishment Licence number to be on the label, there will now be a requirement for the DIN to be on the label.

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