Elk velvet antler, in all forms, is considered to be a natural health product by Health Canada. All natural health products ( NHPs) sold in Canada are subject to the Natural Health Product Regulations, which came into force on January 1, 2004. The Regulations help give people access to a wide range of natural health products that are safe, effective and of high quality. To be legally sold in Canada, all NHPs 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 labeling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.
Product Licencing Requirements
The licencing requirements of the Natural Health Products Regulations apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada. All natural health products must have a product licence before they can be sold in Canada. To get a licence, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s). Once Health Canada has assessed a product and decided that it is safe, effective and of high quality, it issues a product licence along with an eight-digit Natural Product Number which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada.
Canadian Rocky Mountain Ranch Ltd. received product licences for its Qeva brand products on July 07, 2012. The NP Number for the capsules is 80033434 and for the powder product is 80033435.
Evidence of Safety and Efficacy
The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.
All NHPs must meet specific labeling requirements, to help you make safe and informed choices about the NHPs you choose to use. Information required on the NHP labels includes: product name; product licence number; quantity of product in the bottle; complete list of medicinal and non-medicinal ingredients; recommended use, including purpose or health claim, route of administration and dose; any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product; and any special storage conditions.
Adverse Reaction Reporting
The Natural Health Product Regulations require product licence holders to monitor all adverse reactions related to their product. Licence holders must report serious adverse reactions to Health Canada. Canadian consumers should report unwanted side effects ( adverse reactions ) to their health care provider and to Health Canada directly. Reporting side effects is important because it helps Health Canada identify rare or serious adverse reactions, make changes in product safety information, issue public warnings and advisories, and/or remove unsafe products from the Canadian market.
Reference: About Natural Health Product Regulations in Canada – Health Canada, www.hc-sc.gc.ca