New regulatory provisions for distributing Canadian drugs outside Canada and providing information related to drug shortages

Drug Establishment Licensing Bulletin 120 November 23, 2021

On this page

• Summary
• Background
• What this means for DEL holders
• What this means for both DEL holders and market authorization holders
• Contact us

Summary

Health Canada is making amendments to the Food and Drug Regulations (FDR) to make permanent certain provisions that were introduced through interim orders (IOs) in 2020. The provisions concern the:

• prohibition on DEL holders distributing Canadian drugs for consumption or use outside Canada if there are reasonable grounds to believe that doing so would cause or worsen a shortage
• requirement for both DEL holders and market authorization holders (MAH) to provide information to Health Canada related to a drug shortage if certain criteria are met

Guidance for both sets of provisions is now available, ahead of their entry into force on November 27, 2021.

Background

In 2020, new regulatory requirements were put in place through IOs to help protect against drug shortages in Canada. Some of these provisions are now being made permanent as amendments to the FDR. The amendments will enter into force at different times, depending on when their respective IOs expire.

The provisions on distributing Canadian drugs for use outside Canada and on requirements to provide information were contained in the Interim Order respecting drug shortages (safeguarding the drug supply). This IO is in effect until November 26, 2021.

The new regulations were published on September 1, 2021, and come into force on November 27, 2021. Some minor changes were made to the IO provisions to fit in the permanent regulations. Information on the changes can be found in the transition provisions published in Canada Gazette.

Guidance documents were created to help DEL holders and MAHs abide by the regulatory provisions that are entering into force on November 27. They are:

• Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145)
• Guide on the requirements for providing information related to drug shortages (GUI-0146)

The provisions related to the exceptional importation and sale of drugs in relation to a shortage will also be transitioned to permanent regulations. These changes will take effect on March 1, 2022. A guidance document will be provided before those provisions come into force.

What this means for DEL holders

Provisions on the bulk distribution of drugs

Until November 26, 2021:

• all provisions related to the prohibition of the distribution of drugs meant for the Canadian market for consumption or use outside Canada under the Safeguarding the Drug Supply IO remain in force
• continue to use the Guidance document for the Safeguarding the Drug Supply IO
• records of assessments will now need to be maintained as per the new regulations

As of November 27, 2021:

• decisions to distribute drugs meant for the Canadian market for consumption or use outside Canada will be conducted under the FDR

What this means for both DEL holders and market authorization holders

Provisions on providing information related to actual or anticipated shortages

Until November 26, 2021:

• all provisions related to requests for information under the Safeguarding Drug Supply IO remain in force
• continue to respond to requests using the guidance document for the Safeguarding the Drug Supply IO

As of November 27, 2021:

• requests for information will be conducted under the FDR

Contact us

Email the Drug Shortages Division at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca