Blood glucose test strip submission checklist

Last updated on December 9, 2025

The blood glucose test strip submission checklist is also available as a PDF: Blood glucose test strips submission checklist (PDF, 165KB) 

Submission sponsors may request that the Ministry of Health cover their blood glucose test strip products.

Only drug submission packages that follow the checklist criteria and that include all checklist documents will be reviewed. If you have questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management team at: DrugReviewProcess@gov.bc.ca

All letters, unless otherwise stated, must be prepared on company letterhead and signed by an appropriate senior official. Documents may be signed with an e-signature.

Patented drugs submission checklist

Ministry of Health documents

❏ Cover letter – signature required

The cover letter should identify:

  • the type of drug submission to be reviewed
  • each indication, strength and the Drug Identification Number (DIN) to be reviewed
  • the name of each vendor/associate company working on the submission
  • contact information for the primary and backup person who can be contacted about the submission under review

❏ Drug Product Request Form for Patented Drug Products and Biosimilars

*Applies to Non-Common Drug Review (CDR) Submissions Only*
Access and complete the Ministry of Health Drug Product Request Form for non-CDR Submissions as a Word document.

  • the name of the manufacturer and each vendor/associate company working on the submission
  • contact information for the primary and backup person who can be contacted regarding the submission
  • a high-level executive summary describing the submission

❏ Summary of specifications of the blood glucose test strip product including information submitted to Health Canada for approval:

  • enzyme system
  • sample size
  • time to test
  • any other relevant information

❏ Letter confirming that written notification of any future changes will be provided – signature required

❏ Letter confirming ability to supply for anticipated demand – signature required

Health Canada documentation

❏ Medical device license 

Health Canada documentation

❏ NOC or Notice of Compliance with conditions (NOC/c)

❏ Letter of clarifaxes

Pricing and distribution documentation
❏ Summary list and/or table on the unit price for all dosage forms, strengths and package sizes, to four decimal places

❏ Letter of consent authorizing the unrestricted communication and sharing of information – Signature Required

The letter authorizes the Ministry of Health to share information with respect to the drug product under review, with:

  • Health Canada
  • Other provinces and territories
  • Canada’s Drug Agency/Common Drug Review (CDA/CDR)
  • Patented Medicines Prices Review Board (PMPRB)
  • Health authorities including regional health authorities
  • Contracted third party reviewers who are subject to a signed confidentiality agreement
Communications documentation

❏ All promotional materials

If the materials are not available at the time of submission, the submission sponsor should submit a letter indicating the reason for the delay and when the materials are expected to be available. Once available, the submission sponsor should provide them to the Ministry of Health to complete the submission.

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