ARCHIVED 1. List of drugs for exceptional importation and sale [2022-08-03]
Drugs included on the list for exceptional importation and sale are called "designated drugs". They are eligible for exceptional importation and sale as per sections C.10.004 to C.10.011 of the Food and Drug Regulations. This list is incorporated by reference in these regulations. Health Canada maintains and updates this list as required.
Designated drugs are eligible for exceptional importation into Canada before the date listed in the "Date importation no longer allowed" column. Products cannot be exceptionally imported after this date, but products already imported may be sold until their expiry dates.
For more information on the exceptional importation and sale of drugs, please consult the following:
- Drug shortages regulations and guidance
- Guide to the exceptional importation and sale of drugs in response to drug shortages
Supercedes: 2022-07-15
Date issued: 2022-07-25
Access the archived versions of this list associated to the Food and Drug Regulations.
Before these regulations were in force, similar provisions existed under the Second Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. Consult the list of drugs (now archived) that were authorized for exceptional importation under the IO no. 2.
| Brand name of drug, medicinal ingredient(s) | Dosage form, strength, route(s) of administration | Country of authorization, name of foreign regulatory authority, identifying code or number | Name of importing licensee | Lot number and quantities | Date product added to this list | Date after which drug may no longer be imported | Information to support safe use made available by importer |
|---|---|---|---|---|---|---|---|
| Cortef, Hydrocortisone | Tablet, 10 mg, Oral | United States, Food and Drug Administration, National Drug Code (NDC) 0009-0031-01 | Pfizer Canada ULC | N/A | May 18, 2022 | September 30, 2022 | Contact Pfizer Canada at: 7300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| PrismaSATE BGK4/0/1.2, Multiple Medical Ingredients (CRRT) | Solution, Dialysis, Intravenous Use | United States, Food and Drug Administration
License Number K072908 Product Code: 110411 |
Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | CContact Baxter Corporation at:
7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| Prostin VR Pediatric, Alprostadil | Sterile Solution, 500 mcg/mL, intravenous infusion | United States, Food and Drug Administration, NDC 00009-3169-06 | Pfizer Canada ULC | N/A | March 7, 2022 | April 29, 2022 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Depo-Provera, Medroxyprogesterone Acetate |
Suspension for Injection, 150 mg/mL, Intramuscular |
United States, Food and Drug Administration National Drug Code (NDC) 0009-7376-11 |
Pfizer Canada ULC | N/A | March 31, 2021 | June 1, 2023 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Propofol Injectable Emulsion, USP, Propofol | Emulsion, 1000 mg per 100 mL (10 mg/mL), Intravenous |
United States, Food and Drug Administration NDC 25021-608-51 |
Omega Laboratories Limited | N/A | April 28, 2021 | March 2, 2022 | Contact Omega Laboratories Limited at: 11177 Hamon Street Montreal, Quebec Canada, H3M 3E4 |
| Diprivan 10mg/mL, Propofol |
Emulsion, 10mg/mL, Intravenous use |
Italy, Agenzia Italiana del Farmaco 026114025 |
Aspen Pharmacare Inc. | N/A | September 18, 2020 | March 2, 2022 | Contact Aspen Pharmacare Canada Inc. at: 8 - 1155 North Service Road West, Oakville, Ontario L6M 3E3 Telephone: 1-844-330-1213 |
| Erwinase, Erwinia L-asparaginase | Powder for solution, 10,000 IU, Subcutaneous, Intravenous, Intramuscular |
United Kingdom, Medicines and Healthcare products Regulatory Agency, PL44403/0002 |
SteriMax Inc. | W060172, W060517, W061186, W061933, W062155 |
April 4, 2022 | September 30, 2022 | SteriMax Inc., 2770, Portland Drive, Oakville, ON, L6H 6R4 Phone: +1-800-881-3550 Fax: +1 -877-546-7667 E-mail: medinfo@sterimaxinc.com |
| Hydralazine Hydrochloride Injection USP, Hydralazine | Sterile Solution, 20mg/mL, Intravenous, Intramuscular | United States, Food and Drug Administration, National Drug Code (NDC) 0517-0901-25 | SteriMax Inc. | N/A | July 11, 2022 | November 1, 2022 | SteriMax Inc., |
| Levofloxacin Injection in 5% Dextrose, levofloxacin | Injectable Solution, 5 mg/mL, intravenous infusion | United States, Food and Drug Administration, NDCs: 0143-9722-24 (50 mL) 0143-9721-24 (100 mL) 0143-9720-24 (150 mL) |
Hikma Canada Limited | N/A | April 11, 2022 | July 29, 2022 | Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 Mississauga, ON Canada L5R 3P9 Phone: 1-800-656-0793 |
| Disoprivan 1%, Propofol |
Solution, 500mg/50mL (1%), Intravenous use |
Switzerland, Swiss Medic, 47162 076 |
Aspen Pharmacare Canada Inc. | N/A | July 23, 2020 | March 2, 2022 | Contact Aspen Pharmacare Canada Inc. at: 8 - 1155 North Service Road West, Oakville, Ontario L6M 3E3 Telephone: 1-844-330-1213 |
| Fresenius Propoven, Propofol | Emulsion for injection or infusion, 100mL vial - 20mg/mL (2%), Intravenous use |
Austria and Sweden, Inner vial label: M080395 Outer box label: M080396 Package leaflet: M080510 |
Fresenius Kabi Canada Ltd. | N/A | April 16, 2020 | March 2, 2022 | Dear Healthcare Professional Letter |
| Propylthiouracil 50mg Tablets; Propylthiouracil |
Tablet, 50mg, Oral use |
United Kingdom, Medicines and Healthcare Products Regulatory Agency, PL 00042/0205 PA 1888-2-1 |
Accelera Pharma Canada | 61096F |
August 21, 2020 | June 1, 2022 | Contact Accelera Pharma Canada at: 210B-219 Dufferin Street Toronto, ON M6K 3J1 Telephone: 1-289-208-4191 |
| PTU™, Propylthiouracil |
Tablet, 50mg, Oral use |
Australia, Therapeutic Goods Administration, AUST R 13313 |
Phebra Canada Inc. | Lot: 801460, 848726, 883345, 876591, 889241, 897976 | June 18, 2020 | June 1, 2022 | Company Communications for Healthcare Professionals |
| TECHNETIUM TC 99M TSC, Sodium Thiosulfate Pentahydrate |
Powder for Solution, Kit, 2mg/vial, Oral, Intravenous, Intraperitoneal |
United States, Food and Drug Administration, National Drug Code (NDC): 45567-0030-1 |
GE Healthcare Canada Inc. | N/A | July 13, 2022 | August 12, 2022 | Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court Mississauga, ON, Canada L5N 0C9, Phone: 866-281-7545 |
| TPOXX , tecovirimat | Capsule, 200 mg, Oral | United States, Food and Drug Administration, National Drug Code (NDC) 50072-200-42 |
Innomar Strategies Inc. | N/A | July 25, 2022 | December 31, 2022 | Contact SIGA Technologies, Inc. at 1-888-899-3472 |
| 0.9% Sodium Chloride Injection, USP, Sodium Chloride |
Solution, 9mg/mL, Intravenous, Intramuscular or Subcutaneous use |
United States, Food and Drug Administration National Drug Code (NDC): 00409-4888-10 |
Pfizer Canada ULC | N/A | January 28,2022 | March 2, 2022 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Actemra, Tocilizumab | Solution, 80 mg/4 mL, Intravenous Use |
Canadian Actemra (Health Canada, DIN: 02350092) |
Hoffmann-La Roche | N/A | February 22, 2021 | June 1, 2022 | Contact Hoffmann-La Roche at: 7070 Mississauga Road Mississauga, ON L5N 5M8 Telephone: 1-888-762-4388 Fax: 1-905-542-5610 |
| Actemra, Tocilizumab | Solution, 200 mg/10 mL, Intravenous Use |
Canadian Actemra (Health Canada, DIN: 02350106) in global EFA packaging and labelling (Global Trade Item Number: 00056090899314) | Hoffmann-La Roche | N/A | February 22, 2021 | June 1, 2022 | Contact Hoffmann-La Roche at: 7070 Mississauga Road Mississauga, ON L5N 5M8 Telephone: 1-888-762-4388 Fax: 1-905-542-5610 |
| Actemra, Tocilizumab | Solution, 400 mg/20 mL, Intravenous Use |
Canadian Actemra (Health Canada, DIN: 02350114) in global EFA packaging and labelling (Global Trade Item Number: 07640128015208) | Hoffmann-La Roche | N/A | February 22, 2021 | June 1, 2022 | Contact Hoffmann-La Roche at: 7070 Mississauga Road Mississauga, ON L5N 5M8 Telephone: 1-888-762-4388 Fax: 1-905-542-5610 |
| PrismaSol BGK4/0/1.2, Multiple Medical Ingredients (CRRT) | Solution,Dialysis, Intravenous Use | United States, Food and Drug Administration NDC 24571-114-06 | Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| PrismaSATE BK0/3.5 Multiple Medical Ingredients (CRRT) | Solution,Dialysis, Intravenous Use | Mexico, Comisión Federal para la Protección contra Riesgos Sanitarios, License number: 2369C2009 SSA Product Code: 105353 |
Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| PrismaSol BGK4/2.5 Multiple Medical Ingredients (CRRT) | Solution,Dialysis, Intravenous Use | United States, Food and Drug Administration NDC: 24571-105-06 |
Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| Zepzelca, lurbinectedin | Sterile powder, 4mg/vial, Intravenous Infusion | United States, Food and Drug Administration, National Drug Code (NDC): 68727-712-01 | Jazz Pharmaceuticals Canada Inc. | 1888484, 1000 vials | April 25, 2022 | June 30, 2022 | Contact Jazz Pharmaceuticals Canada Inc. at: 4080 Confederation Parkway, Suite 602, Mississauga, ON, Canada L5B 0G1 Phone: 647-946-8801 Fax: 647-946-8802 |
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