About Natural Health Product Regulation in Canada

The Natural Health Products Regulations are the result of a comprehensive and inclusive consultation process with Canadian consumers, academics, health care practitioners and industry stakeholders, and are a part of the Government's response to the House of Commons Standing Committee on Health's report and 53 recommendations on the regulation of natural health products (NHPs) in Canada. The Regulations include provisions on:

• Product licensing;
• Site licensing;
• Good manufacturing practices;
• Adverse reaction reporting;
• Clinical trials;
• Labelling; and
• Provisions for a full range of health claims that will be supported by evidence.

Products that fall within these Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids. In addition, many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as NHPs in Canada because of their medicinal ingredients and intended uses.

The Natural Health Products Regulations came into force on January 1, 2004, and apply to all NHPs as of this date. NHPs with a valid Drug Identification Number (DIN) have six years (until December 31, 2009) to obtain a product licence under the Regulations.

The Compliance Policy for Natural Health Products, and the Natural Health Products Compliance Guide, explain Health Canada's approach with respect to non-compliant NHPs on the Canadian market. Part A of the Compliance Guide lists substances that can and those that cannot be considered natural health products.

Information on natural health products that have been licensed for sale in Canada is available in the Licensed Natural Health Products Database.

Product Licensing

All natural health products require a product licence before they can be sold in Canada. Obtaining a licence requires submitting detailed information on the product to Health Canada, including: medicinal ingredients, source, potency, non-medicinal ingredients and recommended use(s). Once a product has been assessed and granted market authorization by Health Canada, the product label will bear an eight digit product licence number preceded by the distinct letters NPN (which stand for Natural Product Number), or, in the case of a homeopathic medicine, by the letters DIN-HM (which stand for Homeopathic Medicine Number). This number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety, efficacy and quality.

Site licencing

A system of site licensing requires that all Canadian manufacturers, packagers, labellers, and importers of natural health products be licensed. Sites must have procedures in place respecting distribution records and product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice requirements.

Good Manufacturing Practices (GMPs)

Good Manufacturing Practices (GMPs) for natural health products must be employed to ensure product safety and quality. This requires that appropriate standards and practices regarding product manufacture, storage, handling and distribution of natural health products be met. The GMP for NHPs cover:

• specifications (product);
• premises;
• equipment;
• personnel;
• sanitation program;
• operations;
• quality assurance;
• stability;
• records;
• sterile products;
• lot or batch samples, and
• recall reporting.

The GMPs are designed to be outcome based, ensuring safe and high quality products, while giving manufacturers, packagers, labellers, importers and distributors of NHPs the flexibility to implement quality systems appropriate for their product lines and businesses. Further information on the GMPs for NHPs is available in the Good Manufacturing Practices Guidance Document.

Adverse Reaction Reporting

The Adverse Reaction Reporting System for natural health products assists Health Canada in issuing warnings and advisories, where appropriate, to the public. This type of reporting is an important part of a product authorization system based on risk assessment and risk management. The Natural Health Products Regulations require product licence holders to monitor all adverse reactions associated with their product. Serious adverse reactions must be reported to Health Canada through the Adverse Reaction Reporting Form Template.

Clinical trials

A clinical trial is an investigation of a natural health product that involves human subjects and is intended:

• to discover or verify the product's clinical, pharmacological or pharmacodynamic effects;
• to identify any adverse events that are related to its use; to study its absorption, distribution, metabolism and excretion; or
• to ascertain its safety or efficacy.

While the Natural Health Products Regulations set out requirements for conducting a clinical trial, the Natural Health Products Directorate's Standards of Evidence framework allows for a range of evidence to be submitted in support of the safety and efficacy of a natural health product and the quality of a natural health product, or of a homeopathic medicine.

Further information on the clinical trial process for natural health products is available in the Clinical Trials for Natural Health Products Guidance Document.

Labelling

Standard labelling requirements are established to ensure consumers can make informed choices. Some of the information required on a natural health products label includes:

• product name
• quantity of product in the bottle
• list of medicinal and non-medicinal ingredients
• recommended conditions of use (including use or purpose, dosage form, route of administration, dose, and any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product)
• any special storage conditions

Further information on the labelling and packaging requirements for natural health products is available in the Labelling Guidance Document.