As of June 18, 2015 the Drug Product Database (DPD) includes approved but not yet marketed products in the online database.
The DPD is an online source of information on drugs approved for use in Canada for the public and industry by Health Canada. It includes human pharmaceutical and biological drugs, veterinary drugs, radiopharmaceutical drugs and disinfectant products. Previously, the database only included marketed products and discontinued products, however now the database will differentiate between “approved” products, “marketed” products, “cancelled pre-market” and “cancelled post-market” products.
These changes to the DPD, specifically the inclusion of approved products are part of Health Canada’s commitment to enhance transparency and openness in the drug approval process and the Plain Language Labelling Initiative. As part of the new Plain Language Labelling Initiative, sponsors are required 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, the brand names of approved drug products are now searchable in the DPD.
The only exception to the inclusion of “approved” products to the DPD is for sunscreen, anti-dandruff shampoo and hard surface disinfectant monograph products. 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. 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.