Guidance on the Food and Drug Regulations for public health emergency drugs: Post-market requirements
On this page
- Post-market requirements for sponsors
- Record keeping
- Shortages or discontinuation of sale
- Compliance and enforcement
- Related links
Post-market requirements for sponsors
DEL holders that fabricate, package, label, distribute or import a PHED are subject to several other post-market requirements. To support the safe and effective use of a product, additional post-market requirements may, in applicable circumstances, be imposed as terms and conditions on the DIN. Otherwise, existing post-market regulations remain the same. Sponsors should be aware of their post-market requirements under the regulations.
Record keeping
Under subsection C.01.020(1) of the regulations, manufacturers of a PHED 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 PHED that they fabricate, package, label, distribute or import.
Learn more:
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 more information on reporting shortages, authorization holders should email the Veterinary Drugs Directorate at vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.
Learn more:
- Guide to reporting drug shortages and discontinuations
- Drug shortages in Canada: Regulations and guidance
- Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs)
Compliance and enforcement
Health Canada monitors compliance, undertakes enforcement activities and works to prevent non-compliance. When taking compliance and enforcement action, we consider a number of factors while adhering to the legislative framework and principles of our compliance and enforcement policy for health products (POL-0001).
Learn more:
Related links
- Guidance document on terms and conditions (T&Cs) for human and veterinary drugs
- Reporting adverse reactions to marketed health products (human drugs)
- Preparing and submitting summary reports for marketed drugs and natural health products (human drugs)
- Good pharmacovigilance practices (GVP) guidelines (GUI-0102)
- Notifying Health Canada of foreign actions
- Adverse veterinary drug reactions (veterinary drugs)