Drug Submission Requirements for Patented Drug Products

Drug submission sponsors (sponsors) are required to apply to the Ministry of Health (the Ministry) to have their drug product considered as a PharmaCare benefit. The following information outlines the submission requirements for patented drug products that must be submitted to the Ministry.

The Ministry makes PharmaCare coverage decisions based on a range of considerations including existing PharmaCare policies, programs, therapeutic options, resources and the evidence-informed recommendations of an independent advisory body called the Drug Benefit Council (DBC). The DBC’s advice to the Ministry is based upon a review of many considerations, as well as available clinical and pharmacoeconomic evidence, clinical practice, patient and ethical considerations, and the recommendations of the national Common Drug Review (the CDR), when applicable.

In order for patented drug product submissions for new drugs, new combination products, and drugs with new indications to be considered by the Ministry, the submission must undergo an initial review by the CDR. Drug products that are designated as Subsequent Entry Biologics (SEBs) are also required to go through the national CDR process.

All other submissions, including those for line extensions and modification of criteria should be submitted directly to the Ministry.

Review timelines

The target timeline to a decision (time-to-decision) is defined as the time from when the Ministry begins its review to the time the Ministry publicly communicates its decision. The target timeline to a decision for a standard review is nine (9) months and for a complex review is twelve (12) months. Complex reviews may be due to the need to develop clinical coverage criteria, to develop a Special Authority form, to complete a Product Listing Agreement, or to complete other implementation steps as required.

  • For submissions reviewed by the CDR, the review start date will be the issue date of the final Canadian Expert Drug Advisory Committee (CEDAC) Recommendation and Reasons for Recommendation.
  • For other patented drug submissions (including line extensions and modification of criteria), the review start date will be the date the complete submission is received by the Ministry.

Refer to the Quarterly Report on Drug Review Timelines (PDF 416K) for review period information on recently reviewed patented drugs.

Submitting the documents

Sponsors are required to submit copies of their submissions to:

Director, Formulary Management
Pharmaceutical Services Division
Ministry of Health
3-2 1515 Blanshard Street
Victoria BC  V8W 3C8

Submissions that are e-mailed to the Ministry will not be accepted for review. For all drug submissions with incomplete information, the manufacturer will be contacted with a request to complete the submission. Incomplete submissions will not be reviewed.

Criteria for specific submissions

Drug Submission Requirements for patented drug products:

Printable version

Additional information on the drug review process