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

Drug Establishment Licensing Bulletin 120 November 23, 2021

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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:

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:

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:

As of November 27, 2021:

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:

As of November 27, 2021:

Contact us

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

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