Drug Submission Requirements Checklist for Line Extension Drug Products to the BC Ministry of Health

LINE EXTENSION DOCUMENTS FOR NEW STRENGTHS, DELIVERY MECHANISMS, DOSAGE FORMS AND BIOSIMILARS REQUIRED FOR DRUG PRODUCTS REVIEWED BY THE BC MINISTRY OF HEALTH

Drug submission sponsors may request a Line Extension from the Ministry of Health to have new strengths, delivery mechanisms, or dosage forms of an existing drug, including biosimilars, listed on the PharmaCare program formulary for the same indication where no other formulation changes have been made.

To request coverage for a Line Extension, drug 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 for new strengths, delivery mechanisms, dosage forms, and biosimilars below to ensure the submission package is complete
  • Send the complete drug submission package of Line Extension 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
Medical Beneficiary and Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Note:

  • Unless otherwise stated in the checklist, 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
  • For biosimilar products only, drug submission sponsors should be aware of the following:
    • Not all documents and information listed in the checklist below will be available for Line Extensions of biosimilar products
    • Prepare a letter printed on company letterhead, which is signed by an appropriate senior official and submitted to the Ministry of Health as an electronic copy, that refers to the specific biosimilar documents that are listed below and that will be included or will not be included in the complete drug submission package
  • 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 drug submission packages that include all checklist documents below, except for some biosimilar products, 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 Line Extension documents for new strengths, delivery mechanisms, dosage forms, and biosimilars

  • 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 drug 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. 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 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*

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

❏ Letter confirming the availability of the drug, pre-NOC  *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.

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*

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

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

Budget Impact Analysis (BIA)

❏ A Provincial Budget Impact Analysis (BIA) for BC that is consistent with the standards published by the Patented Medicines Prices Review Board (PMPRB)

Access the PMPRB BIA Guidelines at www.pmprb-cepmb.gc.ca/CMFiles/BIA-may0738LVV-5282007-5906.pdf.

Pricing and Distribution Information

❏ Summary list and/or table on unit pricing information

Include all dosage forms, strengths and package sizes, to four decimal places.

❏ Method of distribution

Provide all available information on how the drug shall be distributed.

❏ Letter of commitment to honour the submitted price  *Signature Required*

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

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)
  • PMPRB
  • 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 period of time 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, printed on company letterhead and signed by an appropriate senior official, 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.

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