Insulin pump submission checklist

Last updated on March 4, 2026

The drug line extension checklist is also available as a PDF: Insulin pump submission checklist (PDF, 160KB)

Only insulin pump 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.

BC Ministry of Health documentation

❏ Signed cover letter explaining: 

  • The submission coverage request
  • The rationale for requesting a review of the submission
  • The date that the product will be available in B.C.
  • The sponsor’s assurance of their ability to supply product for the anticipated demand
  • The sponsor’s commitment to provide written notification of any change in the product

❏ Product information (e.g., device specifications, features, etc.)

Health Canada documentation

❏ Evidence of approval by Health Canada (i.e. Medical Device Licence)

Efficacy, effectiveness, and safety documentation (including supplementary appendixes)

❏ User guides

❏ Clinical evidence summary, including safety reports

Pricing information

❏ Current pricing information (to four decimal places)
Budget Impact Analysis (BIA)

❏ A Provincial budget impact analysis (BIA) for B.C. that is consistent with the standards published by the Patented Medicines Prices Review Board (PMPRB)
Promotional materials

❏ A copy of any promotional material used to market the insulin pump

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

❏ Letter of consent permitting unrestricted communication and sharing of information with Health Canada, other Canadian provinces and territories including their agencies and departments, Canadian Drug Agency (CDA), Patented Medicines Prices Review Board (PMPRB), health authorities including regional health authorities with respect to the product under review, and third party reviewers who are contracted by the province to assist with the evaluation of the submission and are subject to a signed confidentiality agreement.

The Ministry of Health reserves the right to ask for additional information as required.

Resources