Policy for Drugs Not Reviewed
Since the establishment of the National Drug Schedules, there have been a few cases in which a manufacturer of a new nonprescription drug or deregulated drug (one that was switched from prescription to over-the-counter status) has not requested a national drug scheduling recommendation by the National Drug Scheduling Advisory Committee (NDSAC) and accordingly, a national drug schedule assignment has not been made. This may occur because, among other reasons, the manufacturer decides not to market the new nonprescription drug in Canada or is unaware of the national scheduling process.
In the absence of an NDSAC review and information to support a specific nonprescription drug status, federally deregulated and newly approved nonprescription drugs are placed in Schedule I of the national drug scheduling model and identified accordingly.
Including drugs that have not been reviewed by NDSAC as Schedule I drugs makes the National Drug Schedules more complete, assists provincial regulatory authorities with the scheduling responsibilities, and promotes harmonization. There has been previous consideration of placing these drugs in Schedule II by default. However, assigning the drugs to Schedule II at the start does not support the policy that the cascading principle is applied beginning with Schedule I factors and assumes NDSAC support for nonprescription status without it having actually undertaken a review.
Policy for Natural Health Products
Only products that have received a market authorization or product licence from Health Canada are approved for sale in Canada. Authorized products will bear a Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM). These numbers serve as a means for the public and health care professionals to know that the product is authorized to be sold on the Canadian market.
NAPRA’s National Drug Schedules (NDS) contain products with a DIN. NAPRA’s Policy for Natural Health Products explains the history of natural health products as they related to the NDS and clarifies the applicability of the NDS to products with the classification of NPN or DIN-HM.
In short, products with an NPN or DIN-HM are deemed beyond the scope of NAPRA’s NDS. However, as the relationship of natural health products to the NDS has evolved over the last decade, some older natural health products are currently listed in the NDS and these continue to be maintained in the drug schedules for now.