Description

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.

Resources

Name	Format	Description	Link
Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-identification-numbers-schedulec-2019/document.html#s1
Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/identification-numerique-drogues-annexec-2019/document.html

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