Patented drugs submission checklist

Last updated on December 9, 2025

The patented drugs submission checklist is also available as a PDF: Patented drugs submission checklist (PDF, 200KB) 

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

Below are the documents required by the Ministry of Health and the Common Drug Review (CDR).

If B.C.-specific Category 1 documents are not ready when CDR Category 1 documents are submitted, then the B.C.-specific Category 1 documents can be sent later, when the B.C.-specific and CDR Category 2 documents are submitted.

The checklist of required Category 1 documents specific to the CDR should not be used to replace the CDR Procedures for Reimbursement Reviews which is more detailed. You are not required to send any Category 1 documents that are specific to the Ministry of Health to the CDR

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

Category 1 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

❏ Letter confirming that written notification of any future changes will be provided – signature required
❏ Letter confirming the availability of the drug pre-Notice of Compliance (NOC) – signature required

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

❏ Letter confirming that periodic safety update reports submitted to Health Canada will also be submitted to the Ministry of Health – signature required
❏ Letter declaring all known unpublished studies have been disclosed – signature required

❏ Table of all known ongoing trials for indications different than the indication being submitted for review

Access applicable information and templates from:

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

Category 1 CDR documents

❏ Completed CDR application overview template

The CDR template replaces the need for a letter confirming disclosure of all known unpublished studies.

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
  • CDA/CDR (Canada’s Drug Agency/Common Drug Review)
  • PMPRB
  • health authorities including regional health authorities
  • contracted third party reviewers who are subject to a signed confidentiality agreement

❏ Cover letter – signature required

❏ Executive summary

❏ Product monograph

Health Canada documentation

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

❏ Letter of clarifaxes

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

❏ Common Technical Document sections 2.5, 2.7.1, 2.7.3, 2.7.4, 5.2, or statement indicating any section(s) not required for the Health Canada submission
❏ Reference list of clinical studies and errata
❏ Clinical studies
❏ Table of studies
❏ Reference list of editorial articles (or statement that no editorials)
❏ Copies of editorial articles
❏ Reference list and copies of new data
❏ Reference list of articles for validity of outcome measures
❏ Copies of articles for validity of outcome measures

Economic and epidemiologic documentation

❏ Pharmacoeconomic evaluation for the full population identified in the approved Health Canada indication(s) to be reviewed by CDR

❏ Economic model used in the initial submission

❏ Number of patients accessing a new drug to within 20 business days of the submission being filed
❏ Disease prevalence and incidence data, with specified population breakdown (if available)

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
❏ Method of distribution
Sharing of information
❏ Letter authorizing unrestricted sharing of information – signature required
Pre-NOC letters
❏ Letter for sending the NOC or NOC/c to CDA – signature required*
❏ Letter for finalized Category 1 requirements if submission filed on a pre-NOC basis – signature required
Category 2 Ministry of Health Documents

❏ Drug Product Request Form for Patented Drug Products *Applies to Common Drug Review (CDR) Submissions Only*Access and complete the Ministry of Health Drug Product Request Form for 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
  • Name of drug manufacturer and each vendor/associate company working on the submission
  • Contact information for the primary and backup person
A high-level executive summary describing the submission

❏ Budget Impact Analysis (BIA) for B.C. Submit as PDF and Excel.

standards published by the PMPRB (PDF).

❏ BIAs for Other Drug Plans. Submit as PDF and Excel.

standards published by thePMPRB (PDF).
❏ Summary list of the drug submission product’s associated patents and the patent expiry dates as documented on the Health Canada Patent Register
Category 2 CDR documents

❏ Budget Impact Analysis (BIA). Submit as PDF and Excel

  • Include BIAs in accordance with the individual requirements of British Columbia (BC), Alberta, Saskatchewan, Manitoba, Ontario, New Brunswick, Nova Scotia, Prince Edward Island, Newfoundland and Labrador, and the Non-Insured Health Benefits Program
    • When data specific to Prince Edward Island are unavailable, the BIA for Prince Edward Island is to be based on Nova Scotia data
  • The base unit price used in the BIAs must be the same as the price submitted in the Category 1 requirements and must be clearly identified in each BIA. Jurisdiction-specific markups or discounts can then be applied, if applicable
❏ Copies of all supporting documentation used and/or cited in the BIAs
Additional information (must be requested)
❏ Harms and safety information
❏ Periodic Safety Update Reports as submitted to Health Canada
❏ Clinical Study Reports

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