Line Extensions – New Strengths

A Line Extension Drug is defined as a new strength of an existing drug listed on the PharmaCare program formulary for the same indication where no other formulation changes have been made.

Submission Requirements

  1. One (1) paper copy and one (1) electronic copy on CD‑ROM or DVD‑ROM disc.

  2. A cover letter explaining the rationale for requesting a review of the drug submission.

  3. Evidence of approval by Health Canada, including a Notice of Compliance (NOC), or Notice of Compliance with Conditions (NOC/c), Drug Identification Number(s) (DIN) and Product Monograph.

  4. A letter committing to provide written notification of any change in the product such as DIN, product monograph, formulation or price as well as changes to the submission sponsor representative contact information.

  5. A letter of consent permitting unrestricted communication with Health Canada, other Canadian provinces and territories including their agencies and departments, Canadian Agency for Drugs and Technologies in Health (CADTH), the 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.

  6. A summary of the current pricing information, including all dosage forms, strengths and package sizes.

  7. The sponsors’ assurance of their ability to supply product for the anticipated demand.

  8. A summary list of the product’s associated patents and the patent expiry dates as documented on Health Canada’s Patent Register.
  9. A Provincial Budget Impact Analysis, specific to BC and consistent with the standards outlined in Budget Impact Analysis Guidelines, published by the Patented Medicines Prices Review Board (PMPRB) and available online at www.pmprb-cepmb.gc.ca/CMFiles/BIA-may0738LVV-5282007-5906.pdf. Please note, the Budget Impact Analysis completion checklist is found in Appendix D (page 53) of the Guidelines.

  10. Either all Pharmaceutical Advertising Advisory Board (PAAB)-approved promotional materials or a draft copy of materials submitted to PAAB.(NEW REQUIREMENT EFFECTIVE JUNE 1, 2011)

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

    If a Manufacturer does not intend to produce and use promotional materials for the product, the manufacturer may request that this requirement be waived. Manufacturers should submit a letter, signed by a senior company official, that includes:

    • 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 reports as submitted to Health Canada. The sponsor also has the responsibility of advising of all data on harm related to the drug under review, including harm and safety issues that may arise during the time that the submission is under review

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