Foreign-authorized drug submissions

Last updated on January 13, 2025

As part of addressing drug shortages in B.C, the Ministry of Health has established these submission requirements for foreign-authorized supply. These guidelines are for importers and distributors.

Drugs must be on Health Canada's list of drugs for exceptional importation and sale.

On this page: How to submit documents | Submission requirements | What to expect after submitting documents

How to submit documents

Send submissions as attachments in a single email to these four recipients:

File type

The preferred formats for file attachments are .docx and .pdf.

Do not use a file type blocked by Outlook, and do not share through cloud-based platforms such as SharePoint, OneDrive, or Google Drive. Please avoid *.zip extensions.

Submission requirements

The following items must be included in the submission.

Cover letter (mandatory)

The cover letter must contain:

  • Generic drug name, brand name (if applicable), dosage, strength, formulation, PIN (if available)
  • Brief summary of the submission, including purpose, and any relevant background information
  • Contact information

Cover letter template: Cover letter – foreign-authorized drug submissions (DOCX, 31.4KB)

Official product monograph from country of origin (mandatory)

The official product monograph from the country of origin should contain:

  • Comprehensive information on dosing, indications, storage conditions
  • Prescriber and patient inserts and product monograph in English and French (to support information-sharing with national and other provincial bodies)
  • A list of non-active ingredients, if possible

Information-sharing letter (mandatory)

This letter authorizes the sharing of relevant information between the importer and the BC Ministry of Health, Health Canada, and other Canadian provinces and territories. 

Information-sharing letter template: Information-sharing letter – foreign-authorized drug submissions (DOCX, 30.7KB)

Risk communications (mandatory)

Include all product risk information that was submitted to Health Canada.

Availability, pricing, distribution information table (mandatory)

The table (example below) must include:

  • Pricing information: Detailed pricing information, including packaging sizes and minimum quantities for ordering
  • Expiry dates: Expiry dates for all lots of the product being imported, and corresponding quantities. This helps with managing inventory and ensuring products are used before they expire
  • Distributors: Details about the distribution channel(s), including names of the wholesalers and order numbers for each supplier, if available. This ensures a clear understanding of the supply chain
  • Allocation strategy: Any allocation strategy in place, such as distribution per province, health authority, or retail (wholesaler). This helps with managing and prioritizing distribution of the product
  • Availability date: Date that the product will be available for distribution, and in what quantities

Availability, pricing, distribution letter template: Availability, pricing, distribution letter – foreign-authorized drug submissions (DOCX, 33KB)

Example of availability, pricing, distribution table
Product Packaging Availability date Quantity Allocation Distributors Price per unit Expiry
10 mg tablets 30 tablets per box September 1, 2024 1000 boxes 700 to wholesaler A Wholesaler A 2.25 per tablet All lots expire in 2025
        300 boxes Wholesaler B    
    October 15, 2024 400 boxes 400 boxes Wholesaler B    
20 mg extended-release tablets 28 tablets per box November 15, 2024 500 boxes 500 Wholesaler A 5.89 per tablet 100 Lot: 12345 expires January 31, 2025 and Lot: 12366 expires June 30, 2025
    November 30, 2024 100 boxes 100 Wholesaler B   expires June 30, 2025

Injectable information (mandatory for injectables)

Include information on use, including whether it is a single-use vial or multi-dose vial; and information on the needle injector or tubing that can be used with the product.

Estimated consumption (optional)

Include an estimate of the drug product's consumption in B.C., including by health authorities, agencies, and PharmaCare (outpatients).

Product listing agreement (PLA) compliance (optional)

For drugs subject to product listing agreements (PLAs), include a letter agreeing to maintain the terms of the agreement.

What to expect after submitting documents

Review time

The estimated time for review is 2 weeks for complete submissions.

Communication of coverage decisions

Coverage decisions are communicated by email, and when the decision is positive, posted on the Drug shortages web page. Major shortages are announced in the PharmaCare Newsletter as well.

Coverage amount

When possible, PharmaCare coverage of the foreign product is equal to the coverage of the Canadian product in shortage. However, in cases where the price of the imported product is much higher, coverage may differ.

Coverage post-shortage

BC PharmaCare coverage for foreign drugs is generally continued for 6 months after a Tier 3 shortage ends.

Assigned PINs

Because foreign-authorized products do not have a drug identification number (DIN), a product identification number (PIN) is assigned to allow claims to be processed in PharmaNet. To support consistency across the country, B.C. generally uses PINs assigned by Ontario. When these are not available, B.C. will assign a PIN.

PINs and drug benefit status are published on the Drug shortages web page.

Don't miss a shortage update. Subscribe to the Drug shortages web page

Resources

 

​​