Submission Requirements Checklist for Blood Glucose Test Strip Products to the BC Ministry of Health

BLOOD GLUCOSE TEST STRIP DOCUMENTS AND INFORMATION REQUIRED FOR PRODUCTS REVIEWED BY THE BC MINISTRY OF HEALTH

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

When submitting a request for coverage of blood glucose test strip products, submission sponsors must:

  • Submit one copy of the complete submission requirements on a USB flash drive to the Ministry of Health. The USB flash drive should be unlocked and fully executable. NEW: Hard/paper copies of drug submissions are no longer accepted
  • Read and follow the checklist of required documents below to ensure the submission package is complete
  • Send the complete submission package of blood glucose test strip documents to the courier address below:

Courier Packages to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
1515 Blanshard Street
Victoria BC  V8W 3C8

Regular Correspondence to:

Director, Formulary Management
Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Note:

  • Unless otherwise stated in the checklists, all letters must be prepared on company letterhead, signed by an appropriate senior official, and submitted to the Ministry of Health as an electronic copy
  • Documents required by the Ministry of Health (e.g., letters) should be addressed to the Director of Formulary Management at the Ministry of Health
  • Only complete submission packages that follow the checklist criteria and that include all checklist documents will be reviewed
  • If you have any 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

Checklist of required Blood Glucose Test Strip product documents

  • Submit all documents to the Ministry of Health electronically. Do not submit as hard/paper copy.
  • Documents with *Signature Required* must be signed by an appropriate senior official. 
  • Documents may be signed using an e-signature. When printing hard copies to sign and scan, use blue ink. 
General Documentation

❏ Cover Letter  *Signature Required*

The cover letter, printed on company letterhead and signed by an appropriate senior official, should describe the blood glucose test strip submission.

❏ 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*

The letter should be printed on company letterhead and signed by an appropriate senior official.

❏ Letter confirming ability to supply for anticipated demand  *Signature Required*

The letter should be printed on company letterhead and signed by an appropriate senior official.

Health Canada Documentation

❏ Medical Device License

Pricing and Distribution Information

Summary list and/or table on unit pricing information

Include all package sizes to four decimal places.

Sharing of Information

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

The letter, printed on company letterhead and signed by an appropriate senior official, authorizes the Ministry of Health to share information with respect to the drug product under review, with: 

  • Health Canada
  • Other provinces and territories
  • CADTH/CDR (Canadian Agency for Drugs and Technologies in Health/Common Drug Review)
  • 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 if 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.

Important: The Ministry of Health reserves the right to ask for additional information as required. The submission sponsor must submit electronic documentation in accordance with copyright permissions.