Reminder: Regulatory requirements prior to distributing Canadian drugs outside Canada
Drug Establishment Licensing Bulletin 190, May 20, 2025
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Summary
Health Canada is issuing this DEL bulletin to remind stakeholders of certain relevant regulatory obligations.
The Food and Drug Regulations (regulations) prohibit drug establishment licence (DEL) holders from distributing Canadian drugs for use outside Canada if this could cause or worsen a drug shortage.
Health Canada remains available to stakeholders to answer questions about the requirements.
Background
DEL holders must not distribute certain Canadian-authorized and labelled drugs for use outside Canada if this could cause or worsen a shortage. This prohibition has been in effect since November 27, 2021.
Under the regulations, DEL holders must:
- assess whether their decision to distribute drugs meant for the Canadian market outside Canada could cause or worsen a shortage
- keep records of these assessments
This prohibition does not apply to:
- drugs intended for the Canadian market and sold outside of Canada if the sale will not cause or worsen a drug shortage in Canada
- drugs that are not intended for the Canadian market and are manufactured solely for export
- people purchasing or dispensing drugs for individual use
Learn more about the regulatory provisions:
Contact us
Email the Drug Shortages Unit at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.