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Notice: Posting information in the Drug Product Database Online

Revised date: February 2, 2024

Our reference number: 24-100732-711

This is an updated version of the Health Canada notice posted on June 18, 2015 regarding the posting of information in the Drug Product Database online.

As of April 2, 2024, Health Canada will publish all "approved (but not marketed)" products in the Drug Product Database online. The following types of approved products will be available to the general public at the time of authorization:

  • Human
  • Veterinary
  • Disinfectants
  • Schedule C drugs, such as radiopharmaceutical products

This includes the 3 previously exempted monographed product groups under Division 1, Part C of the Food and Drug Regulations:

  • Anti-dandruff shampoo
  • Hard surface disinfectants
  • Sunscreen, which includes:
    • sunscreens
    • lipstick making a SPF claim
    • cosmetic-like products with sunscreen claims

This will end the interim exception of a 6-month delay after approval for inclusion in the Drug Product Database online for these 3 product groups.

Including all products in the Drug Product Database online at the time of approval supports 2 important government initiatives:

  • the Plain Language Labelling Initiative (Plain Language Labelling Regulations)
  • Health Canada's commitment to enhance transparency and openness in the drug approval process

Health Canada is committed to:

  • sharing information with the public once regulatory decisions are made
  • making relevant, timely and useful information available to the public in easy to access formats

The Plain Language Labelling Initiative requires sponsors to conduct a brand name assessment against:

  • all Schedule C drugs authorized for sale in Canada
  • all products that have been assigned a drug identification number (DIN)

As a result, Health Canada continues to make the brand names of approved drug products searchable in the Drug Product Database online.

The online database still displays the status of products as follows:

  • Approved products will show as "Approved"
  • Marketed products will show as "Marketed"
  • Cancelled products will show as:
    • "Cancelled Pre-Market" if the DIN is cancelled before the market notification
    • "Cancelled Post-Market" if the DIN is cancelled after the market notification

Contact us

Contact us if you have any questions about this notice.

Marketed Health Products Directorate
Office of Submissions and Intellectual Property
Jeanne Mance Building
200 Eglantine Driveway
Ottawa, ON K1A 0K9

Email: osip-bppi@hc-sc.gc.ca

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2024-02-02

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