Draft for consultation: Guide to reporting drug shortages and discontinuations (GUI-0120): Responsibilities
This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.
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Responsibilities of market authorization holders
Market authorization holders (MAHs) are the legal entity to whom a document was issued under subsection C.01.014.2(1) of the FDR that sets out the drug identification number (DIN) for the drug. MAHs must report the following information on the Drug Shortages Canada website:
- drug shortages
- drug discontinuations
Information on how to create an account for reporting may be found on the Drug Shortages Canada website.
MAHs must also report to Health Canada:
- when a drug is not available for sale for 12 consecutive months
- when selling recommences for a drug following 12 consecutive months without sale
Learn more about reporting 12 months without sale of a drug.
Responsibilities of Health Canada
Under section C.01.014.93 of the FDR, Health Canada is responsible for:
- ensuring that users can report through the Drug Shortages Canada website
- communicating with MAHs when we modify the List of Drugs for the Purposes of the Definition "Drug" in Section C.01.014.8 (Expanded Scope List), including the timelines for coming into compliance
We conduct compliance and enforcement activities related to these regulatory requirements as per our Compliance and enforcement policy for health products (POL-0001).
Learn more: