Canada

Policy

While the new regulations on the manufacturing and sale of natural health products are comprehensive, there is currently no set of regulations, policy or program on TM/CAM.  All herbal medicines are regulated under the auspices of the NHPD and presently no herbal medicines are listed on an essential drug list. The Natural Health Products Directorate (NHPD), a part of the Health Products and Food Branch of Health Canada, is the regulating authority for natural health products for sale in Canada. Products considered to be natural health products are regulated as over the counter self-medications under the Natural Health Products Regulations (NHPR) which came into effect January 2004.  These regulations cover all aspects of manufacturing and sale of natural products including the required licenses, importing, clinical and laboratory studies, labelling and claims.  The NHPR maintains a list of ingredients that are to be excluded for consideration as natural products as well as a general list of ingredients and ingredient forms that are approved.  The ingredient forms list is provided so that the difference between natural health products and foods is more clearly divided.

Contact

Natural Health Products Directorate                       
2936 Baseline Road                                
Qualicum Tower A              
Postal locator: 3302A                              
Ottawa, Ontario K1A 0K9
Website: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.php

 

Laws & Regulations

The Natural Health Products Directorate (NHPD), a part of the Health Products and Food Branch of Health Canada, is the regulating authority for natural health products for sale in Canada. Products considered to be natural health products are regulated as over the counter self-medications under the Natural Health Products Regulations (NHPR) which came into effect January 2004.  These regulations cover all aspects of manufacturing and sale of natural products including the required licenses, importing, clinical and laboratory studies, labelling and claims.  The NHPR maintains a list of ingredients that are to be excluded for consideration as natural products as well as a general list of ingredients and ingredient forms that are approved.  The ingredient forms list is provided so that the difference between natural health products and foods is more clearly divided.

NHPR has established an adverse events reporting system that covers the sale and the study of natural products.  All manufacturers and marketers are required to comply with this segment of the regulations by documenting and reporting adverse events as they occur.  Guidance documents are available from the government.

The NHPR is a comprehensive directorate with many guidance documents available online and listed at the end of this section.

While the new regulations on the manufacturing and sale of natural health products are comprehensive, there is currently no set of regulations, policy or program on TM/CAM.  All herbal medicines are regulated under the auspices of the NHPD and presently no herbal medicines are listed on an essential drug list.

Contact

Natural Health Products Directorate                       
2936 Baseline Road                                
Qualicum Tower A              
Postal locator: 3302A                              
Ottawa, Ontario K1A 0K9
Toll free: 1-888-774-5555
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/regula-regle_over-apercu_e.html
 

 

Standards & Guidelines

All natural health products (NHPs) sold in Canada is subjected to the Natural Health Products Regulations, which came into force on January 1, 2004. NHP include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics and other products like amino acids and essential fatty acids.


All natural health products must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences.


To get product and site licences, specific labelling and packaging guidelines must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided. 


The Natural Health Products Regulatory Review (the Review) is part of the Health Products and Food Branch's (HPFB) Blueprint for Renewal initiative, which aims at modernizing the regulatory system for all health products and food regulated by Health Canada. 


The Natural Health Products Directorate (NHPD) is the regulating authority for natural health products for sale in Canada. The NHPD role is to ensure that Canadians have ready access to natural products that are safe, effective and of high quality

Contact

Address: Health Canada
Address Locator 0900C2
Ottawa, Ontario
K1A 0K9
Tel: 613-957-2991
Fax: 613-941-5366
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
website: http://www.hc-sc.gc.ca