Drug Submission Requirements

Manufacturers must apply to the program to have their product considered as a benefit. The following information outlines the process by which new drug products, line extensions, resubmissions, new indications and generic products are considered for inclusion as PharmaCare benefits.

All prescription drugs submitted for inclusion as eligible benefits under the PharmaCare Program must undergo a review to determine the therapeutic advantage, the cost effectiveness of the drug compared to existing benefits in the same drug category, and its economic impact on PharmaCare.

New drug products and new chemical entities will be reviewed through the National Common Drug Review process. All other products will be reviewed by PharmaCare.

Drug manufacturers are required to forward copies of their submission to:

Director, Formulary Management
Pharmaceutical Services Division
Ministry of Health Services
3-2, 1515 Blanshard Street
Victoria BC V8W 3C8
The submission should include the following:
  1. a) One copy of the submission if the application is for a new entity, new combination product, or generic product.
    b) Two copies for line extensions, resubmissions and new indications.

  2. Evidence of approval from Health Canada, including Notice of Compliance (NOC), Drug Identification Number (DIN) and Product Monograph.

  3. Unrestricted letter of consent permitting communication with Health Canada, other Canadian provinces and territories, Canadian Agency for Drugs and Technologies in Health (CADTH)
    and the Patented Medicines Prices Review Board with respect to the product under review.

  4. Current pricing information, including all dosage forms and strengths and package sizing.

  5. Manufacturer's assurance of their ability to supply product for the anticipated demand.

  6. Disclosure of any patent issues.

  7. Information regarding the availability of new drug, prior to receiving the NOC either as compassionate supply from the manufacturer, under the Special Access Program, or as part of a clinical trial.

  8. In addition, for cross-referenced generic products, the manufacturer of the cross-referenced product should submit a letter to confirm that the product is identical to the listed brand, except for product markings and packaging.

  9. Copies of published trials or of trials accepted for publication in peer reviewed literature on therapeutic use, efficacy, safety and adverse effects.

    In the case where a trial has been accepted for publication by a peer-reviewed journal, the manufacturer is required to provide proof of acceptance by the journal.

    The manufacturer may also include a trial that has been submitted for publication to at least three journals and has been refused publication. In this case, the unpublished trial reports will be given the full weight of a published trial assuming reasonable proof of the trial from the three journals is provided.

    Clinical Trial results that have been accepted for publication will be considered confidential until published.

  10. Provincial Budget Impact Analysis.

  11. Written notification of any change in the product (e.g., DIN, product monograph, formulation, price).

    12. Please note: Submissions for generic products should include requirements #1 through #6 as well as #8 and #11 identified above.

    Submissions for new drug products, line extensions, resubmissions, new indications (trades) must meet all requirements #1 - #11.

All submissions with incomplete information will be returned to the manufacturer with a request for a complete submission. Incomplete submissions will not be reviewed.

British Columbia has a dynamic formulary and does not have submission or formulary publication date deadlines. New products added to the Low Cost Alternative (LCA)/Reference Drug Program (RDP) are published routinely in the PharmaCare Newsletter. New categories to be added to the LCA/RDP would be identified in the PharmaCare Newsletter, indicating the implementation date.

Note: PharmaCare is currently undergoing a program review. These requirements are current as of March 2004, but are subject to change pending the outcome of the review.