At this time, drugs that meet both of the following criteria will be considered for addition to the list of designated drugs:
- Significant shortage: Only drugs in shortage designated as a Tier 3 shortage are eligible, as defined by the Multi-Stakeholder Steering Committee Protocol on Notification of Drug Shortages.
Good manufacturing practices compliance: Drugs must be manufactured in accordance with GMP requirements. Companies that are importing and selling the designated drugs must have a Drug Establishment Licence (DEL):
- The DEL must cover the importation of the drug under the applicable category and dosage form.
- Buildings outside Canada must be listed in the Foreign Annex of the importer’s DEL for the applicable activity, category of drugs and dosage.
NOTE: Other criteria may also be considered by Health Canada in adding products to the list of designated drugs.
Visit the drug shortages website and sign up for daily notifications of drug shortages.