Notice (Revised): Posting information in the Drug Product Database Online

Therapeutic Products Directorate
Office of Submissions and Intellectual Property
Finance Building, Address Locator 0201A1
101 Tunney's Pasture Driveway
Ottawa, ON KIA OK9

June 18, 2015

Our reference number: 15- 107209-676

This notice is an updated version of the Health Canada notice posted on April 13, 2015 on the subject noted above.

As of June 18, 2015, approved but not marketed products are included in the Drug Product Database (DPD) online. Approved human, veterinary, disinfectants and Schedule C drugs (for example, radiopharmaceutical products) products will be available in the DPD online at the time of authorization, except three monographed product groups under Division 1, Part C of the Food and Drug Regulations: sunscreen (sunscreens, lipstick making a SPF claim, cosmetic-like products with sunscreen claims, etc.), anti-dandruff shampoo, and hard surface disinfectants. For these products with applications filed after June 15, 2015, there will be a six-month delay after approval for the inclusion in the DPD online.

These products do not pose a high risk for brand-name confusion with prescription products, and therefore, have been selected as appropriate for the interim exception. This is also in line with the objectives of the Consumer Health Products (CHP) Framework. Evaluation will be conducted on an ongoing basis, and if any instances of brand name confusion that could impact safety are identified, Health Canada will determine whether products should continue to be excluded from immediate Drug Identification Number (DIN) publication.

Sponsors should indicate in their cover letter that they are applying under one of the three monographs within the scope of the exemption at the time of application. Following a review of their application, Health Canada will issue a DIN to the sponsor and this approval will appear in the DPD online as an "approved" drug six months later or upon market notification if earlier.

The inclusion of the approved products in the DPD online at the time of approval supports the following important government initiatives:

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

Health Canada is committed to:

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

The new regulations amending the Food and Drug Regulations as part of the Plain Language Labelling Initiative, requires sponsors to conduct a brand name assessment against all products in respect of which a DIN has been assigned and all Schedule C drugs authorized for sale in Canada. As a result, Health Canada has made brand names of approved drug products searchable in the DPD Online.

In order to implement this change, the DPD online has undergone alterations in the way it displays information. In its previous configuration, the DPD online displayed marketed products as "active" and discontinued products as "discontinued" or "discontinued (by company post-market)". Pre market products previously did not appear online.

In the new version of the DPD online the status of products appears as follow:

• 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

Please note that information on all approved drug products, including the ones that are within the exception mentioned above, will continue to be available to the public upon request.

If you have any further questions regarding this notice, please do not hesitate to contact the Office of Submissions and Intellectual Property (OSIP) by phone at 613-941-7281 or by email at: SIPD-DINREQUEST@hc-sc.gc.ca.

If you have question with regards to the exception, please contact Natural and Non-prescription Health Products Directorate by email at: nnhpd_dpsnso@hc-sc.gc.ca.