Exceptional Importation and Sale of Drugs – Canada

/in /by

On March 20, Canada’s Health Minister signed an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This interim order allows certain drugs that may not fully meet regulatory requirements to be imported and sold in Canada.

Drugs included on the List of Drugs for Exceptional Importation and Sale are “designated drugs” which are eligible for the exceptional importation and sale provisions provided for in the Interim Order. Canadian importers may import and sell designated drugs as long as 1) the drug is included in the List of Drugs for Exceptional Importation and Sale and 2) the importer Drug Establishment License (DEL) has been updated with respect to foreign buildings supplying finished drug products and their active pharmaceutical ingredients. 

Importers must notify Health Canada at least 5 days before importing a designated drug into Canada and provide the necessary information on the drug product and entry point into Canada that has been identified.

During the application of the interim order, Canadian importers may bring designated drugs into the country without meeting all the requirements of the Food & Drug Regulations. Health Canada is however reminding industry of the following obligations:

  • Importers must report all adverse drug reactions in association with imported drugs
  • Hospitals and medical professionals must continue to report serious adverse drug reactions.
  • Importers must report all product recalls that have been conducted.
  • Importers must adhere to all Drug Establishment License requirements including listing foreign buildings on their DEL.

While importers must be compliant with Health Canada’s Good Manufacturing Practices (GMP), the IO does provide some noteworthy exceptions. Importers during this time will not be required to maintain master production documents, validation reports, executed batch records and stability records at their site. But this information must be made available to Health Canada upon request.

Product release, the mechanism by which importers confirm products meet their finished product specifications must also be done according to Health Canada requirements. Release procedures during the IO may be based on visual inspection of drugs to confirm their identity and upon review of Certificates of Analysis generated from foreign buildings listed on the importer Drug Establishment License. Importers should ensure drugs have been transported and stored properly in order to ensure their quality and safety.

These new interim measures will allow Health Canada to leverage the equivalency of drug standards among international regulatory authorities to provide Canadians with timely access to safe and effective drugs.