L9-Regulation Flashcards
What are NHP?
Products which are used and marketed for a variety of health purposes, such as for the prevention or treatment of an ailment or condition, the reduction of health risks, or the maintenance of good health.
What do NHPs refer to?
Refer to a range of health products including: vitamin and mineral supplements, herbal remedies, traditional medicines, homeopathic medicines, omega and essential fatty acids and probiotics.
NHPs must be safe to use as _____ and _____
OTC and not need a Rx to be sold
Where did NHPs fit in the past?
In the past, through its definitions, legislation restricted health‐related claims for foods, food ingredients, and NHPs.
T/F: NHPs weren’t really considered food nor drugs in the past.
True
What if NHP were to be categorized as food?
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
In the past, how were NHPs regulated?
Anything that carried a claim or levels of ingredients exceeding those allowed in food, i.e. supplement, etc…was regulated as a drug.
In the past, if companies wanted to market NHPs or functional foods would have to ____
submit a DIN application to the Therapeutic Products Directorate (cost of the review would vary, but was often prohibitive)
List 3 major drawbacks of categorizing them as NHPs or functional foods.
- inadequate information
- inappropriate costs on industry, government, and consumers
- product access was becoming restricted
How are NHPs regulated now?
NHPs are now considered a subset of drugs under the Food and Drugs Act
– Regulated by Health Canada
See slide 7
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According to the current regulations, sale of NHPs is subject to ?
Subject to the licensing provisions of the Natural Health Products Regulations
When did the current NHP regulations come into effect?
January 1, 2004
What are NHPs considered a subset of?
Food & Drugs Act
What is the purpose of the current NHP regulations?
To help assure that Canadians have access to NHPs that are safe, effective and of high quality.
All NHPs must have a _____
Product licence
When are SITE LICENCES required? And what must be met to obtain them?
Canadian sites which manufacture, package, label and import NHPs must have
Site Licences
-Specific labelling and packaging requirements, good manufacturing practice standards, and evidence norms that must be met in order to obtain product and site licences.
T/F: NHP applies to HCP who compound products on an individual basis for patients or to retailers of NHPs.
FALSE - does not apply
Which governing body administers NHP site licences?
Health Canada’s Natural Health Products Program
Define NHP in the regulations.
Includes Schedule 1 products.
Homeopathetic medicine/traditional medicine that is manufactured, sold or represented for use in:
(a) Dx, Tx, Px, mitigation of a disease, disorder, abnormal physical state, 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.
Can NHPs contain Schedule 2 products?
NAH
List e.g. of Schedule 1 NHPs.
- plant, plant material, algae, fungus, bacterium, non‐human animal materials, and their extracts and isolates
- vitamins & minerals
- amino acids
- essential fatty acids
- -OR synthetic duplicates of the above
- probiotics
List e.g. of Schedule 2 NHPs.
-radiopharmaceuticals
-biologics**
-antibiotics from algae, fungus, or bacterium, or synthetic duplicates
-tobacco products
-products to be injected
-controlled drugs/substances
above
(eg. DHEA, progesterone)
What are Schedule 2 biologics?
**a drug prepared using a biological starting or source material and using, for example, conventional manufacturing methods (high, not low risk – eg. vaccines), recombinant DNA technology and/or another novel approach
Besides Schedule 2 NHPs, what else is excluded?
Prescription medicines, conventional synthetic OTC drugs, medical devices, cosmetics, food, products for animals (drugs)
Licensed NHPs will have a ?
Natural product number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label
Where does NAPRA fit in?
NAPRA plays a role in drug scheduling after a product receives HC approval.
What does NAPRA not do?
- Does not approve new health products
- Beyond whether a product requires a prescription, all other decisions about the place of sale for drug products is a provincial responsibility
What is NAPRA’s policy for NHPs?
-Products with an NPN or DIN‐HM are deemed beyond the
scope of NAPRA’s NDS
- But some older natural health products are currently listed in the NDS and these continue to be maintained in the drug schedules for now.
- Discussions continue regarding a possible framework for determining the place and conditions of sale for NHPs.
