manufacturing practice standards. To be ‘legally’ sold and imported into Canada, NHPs must undergo pre-market review and be granted product licences (NPNs), and the Canadian facilities that manufacture, package, label and import NHPs must obtain valid site licences. Note that the intent of these regula-tions is based on a self-care model. That is, the intent of these regulations is to cover NHPs that consumers can access without the need to consult a health care provider. V.C.: Are these regulations beneficial? Dr. Derganc: The intent of these regu-lations is to provide Canadians access to a wide range of natural health products that are safe, effective and of high quality. Regarding quality, good manufacturing practices, or GMPs, are ongoing measures designed to ensure an effective overall ap-proach to product quality control by set-ting appropriate standards and practices for product testing, manufacturing, stor-age, handling and distribution. proved by Health Canada for safety, efficacy and quality. V.C.: What are the recent developments in the NHP regulatory industry? Dr. Derganc: Because Health Canada has not yet evaluated all natural health products currently on the market, recent legislation called Unprocessed Product Licence Applications Regulations (UP-LAR) has been enacted. This incorpo-rates the granting of an Exemption Num-ber (EN) to eligible products in order to make them ‘legal’ for sale and importing into Canada while the licensing process within Health Canada continues. The exemption number will be listed on the product label preceded by the letters EN. V.C.: Is it safe to use a natural health product that does not have a Natural Product Number (NPN), Exemption Number (EN) or Homeopathic Medicine Number (DIN-HM) on the label? Dr. Derganc: The absence of a NPN, EN, or DIN-HM on the label does not health care practitioners can sell NHPs to their patients. V.C.: Some practitioners have heard it can be less expensive to order natural health products from the United States and import them for resale. Is this legal? Dr. Derganc: It would not be compliant with Health Canada’s Natural Health Prod-uct Regulations if an individual or business imported NHPs into Canada for the pur-pose of resale without a valid site license. Any business or individual that brings into Canada an NHP for the purpose of sale is considered to be an importer. Also, retail-ers selling products obtained from a busi-ness that does not take responsibility as the importer and, therefore, does not have a site licence, will themselves be considered the importer and will require a site licence. V.C.: Some practitioners have patients who question why they recommend a dose of a product that is outside the recommended dose on the label. How can they reassure these patients that the doses they are recommended are still safe? Dr. Derganc: As mentioned previ-ously and stated by Health Canada, “In developing the Natural Health Products Regulations, Health Canada’s intent was to cover products that consumers can select and use themselves, without the need to consult a health care provider and obtain a prescription.” As highly trained primary health care professionals, you have access to clinical experience, medical knowledge, and rel-evant patient information which allows you to make a detailed assessment and treatment plan for your patient. Based on the expertise and opinion of the health care practitioner, it is pos-sible that an NHP may be prescribed for a condition other than what has been ap-proved by the NHPD for self-care use. Also, based on the expertise and opinion of the health care practitioner, treatment of certain conditions may require a dif-ferent recommended dose other than what has been approved by the NHPD for self-care use. • Based on the expertise and opinion o f t h e h e a l t h c a r e p r a c t i t i o n e r, t r e a t m e n t o f c e r t a i n c o n d i t i o n s m a y r e q u i r e a d i ff e r e n t recommended dose other than what has been approved by the NHPD for self-care use. VC: What does the process of getting a natural health product licensed for sale in Canada involve? Dr. Derganc: Obtaining a product li-cence, or natural product number (NPN) requires submitting product specific safety, efficacy, and quality evidence to Health Canada, Natural Health Products Directorate. Depending on the complex-ity of the product, the licensing process may take several months or longer. Once a product has been licensed, it will bear a product license number preceded by the distinct letters NPN (which stand for Natural Product Number), or, in the case of a homeopathic medicine, by the let-ters DIN-HM (which stand for Homeo-pathic Medicine Number). This number on the label will inform consumers that the product has been reviewed and ap-18 • CANADIAN CHIROPRACTOR | APRIL 2011 necessarily mean that the product is un-safe. It means that the product has not been licensed for sale and that Health Canada has not had the chance to assess the product’s safety, quality or the valid-ity of its health claims. It is also possible that a licensed and/or exempted natural health product may not have an NPN or EN on the label due to the time needed by the manufacturer to revise label texts. V.C.: Are private practitioners legally able to sell natural health products to their patients? Dr. Derganc: The Natural Health Products Directorate does not regulate the chiropractic, naturopathic, or other regulated health care professions. Pro-viding there is no restriction within the practitioner’s scope of practice, regulated REFERENCES Health Canada NHPD Main Page: h t t p : / / w w w. h c -s c . g c . c a / d h p -m p s / prodnatur/index-eng.php www.canadianchiropractor.ca
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