Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Post-market requirements

The only amendment related to post-market regulation is the Minister's new (continued) authority to impose terms and conditions for a designated COVID-19 drug (C.01.014.21).

To ensure the safe and effective use of a product, additional post-market requirements may be imposed as a term or condition on the authorization. An example of a post-market term or condition on the authorization is the submission and implementation of a risk management plan ((RMP) and/or elements thereof). Otherwise, existing post-market regulations remain the same.

For more information on the scope of RMPs, consult the:

• Guidance document on the submission of risk management plans and follow-up commitments

On this page

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

Pharmacovigilance reporting requirements

Adverse reaction reporting

Adverse reactions must be reported to the Canada Vigilance Program.

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

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

However, adverse reactions associated with COVID-19 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 COVID-19 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

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

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

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

Record keeping

Under sections C.01.020(1) of the Regulations, manufacturers of a COVID-19 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 COVID-19 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, see the Interim order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19.

For more information on reporting shortages, authorization holders of veterinary drugs 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, see the list of guidance documents.