DEL 175: Drug quality and shortage and discontinuation reporting requirements in light of shipping disruptions

Drug Establishment Licensing Bulletin 175, April 29, 2024

Health Canada is closely monitoring impacts to shipping due to shipping disruptions through the Red Sea, shortages of cargo ships and containers, and increased demand for air freight.

This DEL bulletin has been issued to:

• provide guidance on good manufacturing practices (GMP) during transportation and storage disruptions
• remind you of your regulatory requirements related to drug quality and shortages

On this page

• Transportation and storage considerations
• Requirements to report drug shortages and discontinuations

Transportation and storage considerations

Actions taken related to ongoing geopolitical events have caused:

• shipping disruptions through the Red Sea
• shortages of cargo ships and containers
• increased demand for air freight

This may lead to Canadian suppliers using new shipping methods or routes.

Canadian importers, distributors and wholesalers must ensure that shipping conditions will not impact the safety, efficacy or quality of the drugs that we rely on.

To this end, you should ensure such changes are evaluated in accordance with quality risk management (QRM) principles. You should also:

• evaluate the new shipping route or method to determine potential risks and extreme environmental conditions, including weather events
• review known information about the product, such as all stability data and freeze/thaw and high temperature cycling studies, where available
• wholesalers should seek guidance and recommendations from their suppliers if they don't have this information
• apply mitigation strategies such as adding temperature monitoring points throughout the load to better assess transportation conditions
• review and update your risk evaluations from time to time

For more information on shipping and storage requirements, consult the following guidance document:

• Guidelines for temperature control of drug products during storage and transportation (GUI-0069)

Requirements to report drug shortages and discontinuations

The ongoing shipping disruptions may affect the drug supply. Therefore, we would like to remind all market authorization holders (MAHs) and DEL holders that they must notify or report drug shortages and discontinuations to us. MAHs are to report drug shortages and discontinuations on drugshortagescanada.ca.

Early reporting helps stakeholders who are affected to take action to help them prevent or manage the adverse health effects of drug shortages and discontinuations.

The Food and Drug Regulations outline the timelines for reporting discontinuations and shortages:

• at least 6 months before the day an anticipated shortage or discontinuation is expected to start (if more than 6 months away) or
• within 5 days of becoming aware of an anticipated shortage or discontinuation (if less than 6 months away) or
• within 5 days of becoming aware of an actual drug shortage or an unanticipated discontinuation

Stakeholders must also update existing drug shortage and discontinuation reports within 2 days of becoming aware of any changes to the information in the reports.

For more information on how to comply with the regulations, consult the following guidance document:

• Guide to reporting drug shortages and discontinuations

An MAH should also notify the Drug Shortages Unit of any shortages or discontinuations if:

• you hold a significant market share of the affected drug in Canada (are a sole supplier) or
• the drug is currently classified to be a Tier 3 shortage

To notify the unit, send an email to drug.shortages-penurie.de.medicament@hc-sc.gc.ca.