Regulation of Homeopathic Medicines in Canada
Homeopathic medicines (HMs) are regulated in Canada by Health Canada, the federal government department responsible for ensuring the safety, efficacy and compositional integrity of health care products and medical devices distributed and sold in Canada. Health Canada has formally recognized HMs as pharmaceutical products since 1990 having already issued drug identification numbers for HMs in prior years.
CHPA has, since 1990, advocated the development of a comprehensive regulatory framework for HMs that would take into account the regulatory precedents for HMs established in other countries such as European Union member states and the USA. These regulatory precedents included the formal recognition of methods of manufacture of HMs (homeopathic pharmacy), indications for use, product formulations and potencies contained in internationally recognized pharmacopoeias.
By 1998, Health Canada had adopted several interpretive guidance documents to elaborate on conditions and means of compliance for HMs with the provisions of the Food and Drug Regulations of the Food and Drugs Act. These were Good Manufacturing Practices (GMP) for HMs (1996), a Labelling Standard (1995, revised in 1997) and Indications for Use – Multi-ingredient Low Dilution Homeopathic Preparations (1997, revised in 1998) that included recognition of U.S. and EU pharmacopoeias. By the end of 1998, these guidance documents enabled the licensing of over 4,700 HMs in Canada via the granting of Drug Identification Numbers (DINs), predating Health Canada’s initiative to create the Natural Health Products (NHP) Regulations that came into force in January of 2004.
The definition of NHP contained in the NHP Regulations defines all NHPs as drug products as opposed to foods and includes homeopathic medicines. However, the product licenses granted to HMs by Health Canada have a unique product identifier prefix, DIN-HM, to enable consumers and health care practitioners to more easily identify HMs in the Canadian market, as advocated by CHPA during the development of the NHP Regulations. Since the coming into force of the NHP Regulations in 2004, Health Canada’s Natural Health Products Directorate has also adopted a number of labelling standards for sub-categories of HMs, facilitating the appropriate regulation of thousands of HMs currently available to consumers in Canada. It is important to note that these labelling standards clearly define how HMs may be labelled and what indications for use are specifically permitted.
It is also important to note that Health Canada regulates health care products and not the practice of medicine by health care practitioners. These responsibilities fall under the jurisdiction of Canada’s provincial and territorial governments.