Canada's Natural Health Products Regulations have been in force since 2004. However, there are an estimated 11,700 natural health product licence applications pending with Health Canada.
The Natural Health Products (Unprocessed Product Licence Applications) Regulations came into force on August 3, 2010. These Regulations will allow a temporary exemption from the prohibition on sale in the Natural Health Products Regulations for many products for which a licence has not yet been issued. The Minister of Health must assign an exemption number to a natural health product before the later of: a) August 20, 2010; and b) 180 days after the application for the product licence was filed. Notice is sent to the product licence applicant. Within 60 days, the applicant may opt into the exemption system by agreeing to the posting of the product name and exemption number on the Health Canada website and certifying that the product does not fall into certain classes that are ineligible for exemption. Examples of products ineligible for exemption are drugs indicated for certain life-threatening diseases or for children under 12 years old. Upon the posting on the website, the applicant is deemed to have been issued a product licence.
The product, however, may not be sold until the applicant has submitted information about the manufacturing, packaging, labelling and distribution sites, certified compliance with good manufacturing practices and has been issued a site licence.
Many provisions of the Natural Health Products Regulations will apply to natural health products with a deemed product licence, most notably adverse event reporting and good manufacturing practices.
The Regulations will be repealed on February 4, 2012.