Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) - Summary

Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) - Summary When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada 2021-07-06 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance documentregulatory requirementsDINdrug identification numberssummarya drug to be marketed in CanadaDIN printed on the package labelsprescription and non-prescription drugsobtain a DIN Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) - SummaryHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html#1 Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) - SummaryHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/exigences-reglementaires-identification-numerique-drogue/document.html#1

When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada

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