9 - NHP Regulation in Canada Flashcards
NHPs refer to a range of health products including: ?
- vitamin and mineral supplements
- herbal remedies
- traditional medicines
- homeopathic medicines
- omega and essential fatty acids
- probiotics
NHPs are products marketed for what purposes?
- prevention or treatment of an ailment or condition
- reduction of health risks
- maintenance of good health
In the past, through it’s definitions, legislation restricted _____-_____ _____ for foods, food ingredients and NHPs
health-related claims
In the past, NHPs weren’t really considered ____ nor ____
food nor drugs
If NHP were to be categorized as a ______ - no provisions in the legislation to make claims of a health or therapeutic nature about the use of, or even the possible side effects, of the product
FOOD
NHPs were first regulated as _____
drugs
Companies that wanted to market NHPs or functional foods would have to submit a DIN application to the ______ _______ ________
Therapeutic Products Directorate
What are some drawbacks of marketing NHPs as drugs?
- inadequate information
- inappropriate costs on industry, government and consumers
- product access was becoming restricted
NHPs are now considered a subset of ____ under the Food and Drugs Act regulated by Health Canada
drugs
Sale of NHPs is subject to the licensing provisions of the ?
Natural Health Products Regulations
What is the purpose of the Natural Health Product Regulations?
To help assure that Canadians have access to NHPs that are safe, effective and of high quality
All NHPs must have a ______ ______
Product License
What is the definition of NHP in the regulations?
NHP means a substance set out in schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or traditional medicine, that is 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
c) modifying organic functions in humans, such as modifying those function in a manner that maintains or promotes health
However, a NHP does not include a substance set out in _____ _
Schedule 2
**i think these schedules are different from NAPRA schedules
What is in Schedule 1 of NHPs?
- plant, plant material, algae, fungus, bacterium, non-human animal materials and their extracts and isolates
- vitamins & minerals
- amino acids
- essential fatty acids
- synthetic duplicates of the above
- probiotics
