Guidance on the Food and Drug Regulations for public health emergency drugs: Post-market requirements

On this page

• Pharmacovigilance reporting requirements
• Annual summary reporting
• Issue-related summary reports
• Other post-market requirements

Pharmacovigilance reporting requirements

Health Canada manages an evidence-based post-market surveillance program to monitor and assess risks after health products have been authorized in Canada, and makes regulatory decisions to manage those risks. Market authorization holders (MAHs) contribute safety information to this evidence base through their reporting obligations under the Food and Drug Regulations (regulations).

Adverse reaction reporting

Adverse reactions must be reported to the Canada Vigilance Program.

The MAH must report within 15 days of receiving the following information (C.01.017 of the regulations):

• domestic serious expected and unexpected adverse drug reactions (C.01.017)
• foreign serious unexpected adverse reactions (C.01.017)
• unusual failures in efficacy for new drugs (C.08.007, C.08.008)

However, adverse reactions associated with public health emergency drugs are a priority. MAHs are strongly encouraged to submit reports related to this priority area to Health Canada without delay. MAHs should identify in the report that the drug is a public health emergency drug.

For information and general procedures on how to report serious adverse drug reactions, consult the guidance document on:

• Reporting adverse reactions to marketed health products (human drugs)

You can also obtain more information on submitting reports electronically.

For details on how to report adverse reactions associated with veterinary drugs, MAHs of veterinary drugs are encouraged to contact the Veterinary Drugs Directorate by email at hc.pv-vet.sc@hc-sc.gc.ca.

Annual summary reporting

Once a year and when requested by the Minister of Health, MAHs must conduct a concise, critical analysis of the adverse reactions and serious adverse reactions to a drug. They must also prepare a summary report relating to the reports received during the previous 12 months (C.01.018).

For information on preparing and submitting an annual summary report, consult the guidance document on:

• Preparing and submitting summary reports for marketed drugs and natural health products (human drugs)

Issue-related summary reports

Health Canada may request an issue-related summary report (C.01.019) any time. This report is a concise, critical analysis of a specific safety or effectiveness issue.

For information on preparing and submitting an issue-related summary report, consult the guidance document on:

• Preparing and submitting summary reports for marketed drugs and natural health products (human drugs)

Additional good pharmacovigilance practices

For additional information on good pharmacovigilance requirements, consult the:

• Good pharmacovigilance practices (GVP) guidelines (GUI-0102)

Foreign actions reporting

Under section C.01.050 of the regulations, authorization holders must notify Health Canada of foreign regulatory actions. These include serious risk related to recalls, suspension or revocation of manufacturing or market authorizations within one of the specified foreign regulatory jurisdictions.

For information on this reporting requirement, consult the guidance document on:

• Notifying Health Canada of foreign actions

Other post-market requirements

DEL holders that fabricate, package/label, distribute or import a public health emergency drug are subject to several other post-market requirements, including record keeping, reporting shortages and discontinuation of sale.

Record keeping

Under subsection C.01.020(1) of the regulations, manufacturers of a public health emergency drug must maintain records and case reports as they relate to sections C.01.017 to C.01.019.

Under section C.02.020, DEL holders must maintain records for each public health emergency drug that they fabricate, package/label, distribute or import.

For more information, consult the:

• Good manufacturing practices guide for drug products (GUI-0001)

Shortages or discontinuation of sale

For drugs for human use, authorization holders should consult sections C.01.014.9 and C.01.014.10 and the guide to reporting drug shortages and discontinuations. The guide contains additional information and general procedures on how to report drug shortages and discontinuations of sale.

For details on shortages, refer to the:

• Drug shortages in Canada: Regulations and guidance

For more information on reporting shortages, authorization holders should contact the Veterinary Drugs Directorate by email at vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.

Compliance and enforcement

Health Canada monitors compliance, undertakes enforcement activities and works to prevent non-compliance. When taking compliance and enforcement action, Health Canada considers a number of factors while adhering to the legislative framework and principles of our compliance and enforcement policy for health products (POL-0001).

For further guidance, consult the list of guidance documents.

Pre-positioning a public health emergency drug

A promising public health emergency drug may be imported into Canada before it receives a Canadian market authorization. This early importation and placement in Canadian facilities is referred to as "pre-positioning." It facilitates the immediate distribution of the drug upon authorization, making it available to Canadians as early as possible.

This mechanism may be used to import a promising public health emergency drug into Canada if the Chief Public Health Officer of Canada (CPHO) has notified the Minister of Health identifying the public health emergency drug that is to be pre-positioned.

To be eligible to import a public health emergency drug for pre-positioning, several conditions are required:

• The Government of Canada has entered into a contract for its procurement.
• An authorization for the drug has not been issued.
• The manufacturer has filed a submission for the drug's authorization.
• The DEL holder is authorized to import and the public health emergency drug is within the same category of drugs that is authorized by the licence
• The CPHO has provided the Minister with information required under paragraph C.08.009.03(1)(a).
• The DEL holder has provided the Minister with information required under paragraph C.08.009.03(1)(b).