National Drug Schedules and Natural Health Products

Since the Natural Health Products Regulations took effect in January 2004, the applicability of NAPRA’s National Drug Schedules (NDS) to natural health products (NHPs) has been raised a number of times with NAPRA’s Board, the Council of Pharmacy Registrars of Canada (CPRC), the National Drug Scheduling Advisory Committee (NDSAC) and Health Canada.

Products have already been approved for sale as natural health products while concurrently appearing in the NDS. This situation creates confusion for pharmacists and other stakeholders over the condition of sale for such products, and will only worsen over time as all DIN-labeled products that qualify as NHPs will fall under the NHP Regulations by January 1, 2010 at the latest.

In April 2006, NAPRA’s Board of Directors clarified that natural health products, as designated by a Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM), are beyond the scope of NAPRA’s NDS. The principle rationale was that the requirements for obtaining market authorization for NHPs were based on a different paradigm than for traditional pharmaceuticals, and that the monitoring and enforcement of conditions for sale of NHPs were beyond the scope of pharmacy regulatory authorities. Therefore these designated medicinal ingredients will be removed from the NDS once all eligible DIN-identified products become regulated under the NHP Regulations.

To assist in this transition, in the summer of 2006, NAPRA embarked on a project to identify all NHPs that were currently listed in the NDS. With the collaboration of staff from the Natural Health Product Directorate (NHPD), a total of 116 items were identified in the report entitled Identifying Natural Health Products Listed in NAPRA’s National Drug Schedules. The PDF version of the report contained on this page provides details on the study approach and results.

In October 2006, a joint meeting was held between NAPRA and Health Canada (NHPD and Therapeutic Products Directorate). It was agreed that further collaborative work would take place to ensure the full scope of the implications are understood. Health Canada officials recognized and acknowledged the Department’s role in ensuring the safe use of these natural health products, cognizant that they would be removed from the NDS.

NAPRA’s Policy for Natural Health Products was approved by the Board of Directors in November 2006. This policy will be a key guiding document during the transition period up to and including January 1, 2010 when all DIN-labeled products that qualify as NHPs will fall under the NHP Regulations.

Policy for Natural Health Products

Identifying Natural Health Products Listed in NAPRA's National Drug Schedules