Miscellaneous NHPD Information
Tidbits of information...
1. The Natural Health Products Regulations do NOT pertain to the sale of natural health products (NHPs) by retailers.
They are requirements for the manufacturing, packaging, labeling, storing, importing, distributing and selling of natural health products (NHPs)
2. The NHP Regulations are intended to ensure that all Canadians have ready access to NHPs that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity.
3. The NHP Regulations are administered by the Natural Health Products Directorate (NHPD), Health Products and Food Branch, Health Canada.
4. All of the policies, guidance documents and other sources of information can be found on the
Internet.
5. In developing the NHP 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.
6. Clinical trials conducted in Canada using NHPs are also subject to the NHP Regulations.
7. When there are risks associated with the use of a NHP (for example, use by a particular group of people, such as seniors), NHPD may ask applicants to take certain measures to manage the risk, including putting advisory information on the product label, or restricting the route of administration, source or preparation, or form in which the NHP is presented.
8. If the NHPD considers a NHP unsafe for use in humans according to the recommended conditions of use, the NHPD will not authorize the sale of a NHP under the NHP Regulations.
9. The Natural Health Products Regulations are a set of new regulations under the Food and Drugs Act.
10. The NHP definition has two components: function and substance.
Function: The function component refers to the NHP definition capturing those substances that are manufactured, sold or represented for use in:
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(b) restoring or correcting organic functions in humans; or
(c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
Substance: The substance component refers to the medicinal ingredient in a NHP.
11. Manufacturers, packagers, labelers, distributors and importers who handle or sell bulk or loose NHPs are subject to the requirements of the NHP Regulations.
12. A policy for bulk herbs will set out the labeling requirement for bulk herbs ready for use by the consumer. Further guidance on this issue will be forthcoming.
13. Each NHP sold in Canada requires a product licence.
A site licence is required in order to manufacture, package, label, and import for sale, a NHP.
14. A laboratory that solely tests a NHP is not required to obtain a site licence.
15. A manufacturer is a person who fabricates or processes a NHP for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a NHP to sell to that patient.
16. The manufacturer definition does not include:
• Health care practitioners who compound products at the request of patients (for example, pharmacists, Traditional Chinese Medicine practitioners, herbalists, naturopathic doctors);
• Complementary and alternative health care practitioners and Aboriginal medicine practitioners.
