Canada Border Services Agency (CBSA) issued Customs Notice CN20-36 to provide importers and carriers with guidance on importing COVID-19 drugs, including vaccines, covered under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Importers of drugs authorized under the Interim Order are required by Health Canada to hold a Drug Establishment License (DEL). Authorized drugs are issued a Drug Identification Number (DIN). Health Canada also issues a Letter of Authorization to the applicant (drug manufacturer) for drugs authorized under the Interim Order. A copy of the Letter of Authorization is to accompany each shipment.
Importers of COVID-19 drugs covered under Health Canada’s Interim Order are directed to use the PARS-EDI (Service Option 125) to request customs release. PARS requests can be submitted 30 days in advance of arrival and it is strongly encouraged to do so as early as possible. The Single Window IID (Service Option SO911) is not to be used.
To help facilitate entry, carriers should include, in addition to the COVID-19 drug being described in the description field, the text “COVID-19 Vaccines” or “COVID-19 Drugs” in the special instructions field on EDI cargo submissions. DIN or “Pseudo DIN” numbers are to be listed in the description of goods field. Please also be sure to include accurate shipper and consignee name and address (i.e. freight forwarder, broker should not be listed as consignee).
Health Canada’s Interim Order regarding pre-positioning refers to the importation and movement of COVID-19 drugs in preparation of impending approval and subsequent immediate distribution. Since these COVID-19 drugs are not yet approved in Canada, they will not follow standard importation requirements or procedures. A Letter of Authorization issued by Health Canada is required and should accompany each shipment in order for these goods to be imported to Canada.
Additionally, authorized importers are encouraged to provide advanced notice to Health Canada of anticipated imports including details such as the Drug to be Imported, Anticipated date of Entry, Port of Entry, Cargo Control Number and Quantity of the Drug to facilitate communication with the CBSA and release of the goods.
Health Canada has provided a guidance document regarding the Interim Order to explain how to apply for authorization of COVID-19 drugs in order for them to be imported, sold or advertised in Canada. Email contacts for questions are found in Appendix A.
Any questions concerning this notice should be directed to the CBSA’s Border Information Service (BIS):
Calls within Canada (toll free): 1-800-461-9999
Calls outside Canada (long distance charges apply): 1-204-983-3500 or 1-506-636-5064