Drug line extension checklist

Last updated on October 30, 2024

The drug line extension checklist is also available as a PDF: Drug line extension checklist (PDF, 175KB)

Drug submission sponsors may request a line extension to have new strengths, delivery mechanisms, or dosage forms of a covered drug listed on the PharmaCare program formulary. The line extension must be for the same indication with no other formulation changes.

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.

Drug line extension checklist

BC Ministry of Health documentation

❏ Cover letter – signature required

❏ 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 (DOCX) as a Word document. In the template, include the following:

  • Each indication, strength and the Drug Identification Number (DIN) to be reviewed
  • The name of the drug 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

❏ Product monograph

  • A copy of the most recent product monograph approved by Health Canada with the company, drug brand, and non-proprietary names that correspond to the Notice of Compliance (NOC)
  • A copy of the clean and dated product monograph approved by Health Canada

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

❏ Letter confirming the availability of the drug pre-NOC – signature required

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

Patents documentation

❏ Summary list of the drug product’s associated patents and the patent expiry dates as documented on Health Canada Patent Register

Health Canada documentation

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

❏ Drug Identification Number(s) (DIN)

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

❏ Supporting clinical evidence

❏ Pharmacoeconomic evidence

❏ All other information the drug submission sponsor would like the Ministry of Health to consider

❏ Reference list of key clinical studies and errata

❏ Copies of key clinical studies and errata

❏ Reference list of editorial articles (or statement that there are no editorials)

❏ Copies of editorial articles

❏ Literature search strategies

❏ Reference list of studies included in submission

❏ Copies of studies included in submission

❏ Letter declaring that all known unpublished studies have been disclosed – signature required

❏ Table of all known ongoing trials for indications that are different than the indication being submitted for review
Budget impact analysis

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

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

❏ Method of distribution

Please provide wholesaler name and contact information

❏ Letter of commitment to honour the submitted price – signature required
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
  • CDA/CDR (Canada’s Drug Agency/Common Drug Review)
  • PMPRB (Patented Medicine Prices Review Board)
  • Health authorities including regional health authorities
  • Contracted third-party reviewers who are subject to a signed confidentiality agreement
Communications documentation

❏ All Pharmaceutical Advertising Advisory Board (PAAB)-approved promotional materials or draft copies of materials submitted to PAAB

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

If a drug submission sponsor does not intend to produce and use promotional materials for the product, they may submit a letter, printed on company letterhead and signed by an appropriate senior official, that includes:

  • A request to waive the use of promotional materials
  • The rationale for not using promotional materials
  • The time period during which no promotional materials will be used (from start month and year to end month and year)
Periodic safety update report  

❏ Letter of consent to release periodic safety update reports as submitted to Health Canada *Signature Required*

The letter should state that all data on harm as submitted to Health Canada, related to the drug submission under review, including harm and safety issues that may arise while the submission is under review, will be submitted to the Ministry of Health.

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