Canada Submission Types
New Submission Scenarios
Submission Type Acronym Abbreviated New Drug Submission ANDS Application for a Drug Identification Number for a pharmaceutical product, including non-prescription products attesting to a Labelling Standard DINA Application for a Drug Identification Number for a biological product DINB Extraordinary Use New Drug Submission EUNDS Supplement to an Extraordinary Use New Drug Submission EUSNDS In-Licensing New Drug Submission NDS Pre-submission Meeting Package – DIN MPNDIN Pre-submission Meeting Package – NC MPNC Pre-submission Meeting Package – NDS MPNDS Pre-submission Meeting Package – ANDS MPANDS Pre-submission Meeting Package – SANDS MPSANDS Product License Application PLA Pre-Clinical Trial Application Meeting PRECTA Re-File Supplement to an Abbreviated New Drug Submission SANDS Supplement to a New Drug Submission SNDS Supplement to a New Drug Submission – Confirmatory SNDS-c
Supplemental Submission Scenario
Submission Type Acronym Amendment and Notification (Natural Health Product) – ANDS – Administrative – ANDS – Labelling – Submission for a DIN DINA Submission for a DIN DINB Development Safety Update Reports DSUR Drug Notification Form DNF Fundamental Change (Natural Health Product) – Level I – Supplements Supplement to ANDS SANDS Level I – Supplements SNDS Level II Supplements (Safety) – Level III Changes – Annual Notifications – Pre-submission Meeting Package – SNDS MPSNDS Notifiable Change (NC) for human biologic or radiopharmaceutical drug quality changes NC Periodic Benefit-Risk Evaluation Report – Confirmatory PBRER-C Periodic Benefit-Risk Evaluation Report PBRER-PV Periodic Safety Update Report – Confirmatory PSUR-C Periodic Safety Update Report PSUR-PV Post-authorization Division 1 Change for a pharmaceutical product PDC Post-authorization Division 1 Change for a biologic drug product PDC-B Risk Management Plans RMP-PV Transfer of Ownership TOO Undefined Data (e.g. DIN cancellation, Withdrawal of file) UD-RA Undefined Data Post-market Vigilance (e.g. Post marketing surveillance, Signal work-up, Benefit risk, Notification of change in benefit risk, Risk communication document) UD-PV Yearly Biologic Product Reports YBPR
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