Natural Health Product Regulations Flashcards
NHP must be __ to use as OTC and not need a _____ to be sold
safe
prescription
what would happen if NHP were categorized as food
there would be no provisions in the legislation to make claims of a health or therapeutic nature about the use of or side effects of the product
what was regulated as a drug before
anything that carried a claim or levels of ingredients exceeding those allowed in food
ie. NHP
what would companies who wanted to market NHp have to do
submit a DIN application to the therapeutic products directorate
major drawbacks of NHP being regulated as drugs
inadequate info
inappropriate costs on industry, government, and consumers
restricted access
what are NHPs now considered
a subset of drugs under the food and drugs act regulated by health canada
when were NHP regulations published
2003
purpose of NHP regulations
help assure that canadians have access to NHPs that are safe effective and of high quality
all NHPs must have ___
product licenses
who must have site licenses
canadian sites whic maufacture, package, label, and import NHPs
what must be met to obtain product and site licenses
specific labelling and packaging requirements
good manufacturing practice standard
evidence norms
who do the regulations licenses not apply to
HCP who compound products on an individual basis for patients or to retailers of NHPs
who administers the licenses
health canadas health products program
definition of NHP in regulations simplified
substance in schedule 1 or combo of substance in schedule 1, a homeopathic medicine, a traditional medicine sold for:
treatment/prevention/etc of a disease/disorder/ect
restoring or correcting organic functions in humans
modifying organic functions in humans
what does a natural health product not include
anything that contains a substance in schedule 2
schedule 1
plant, algae, fungus, bacteria, non human anumal materials vitamins and minerals amino acids essential fatty acids synthetic duplicates probiotics
schedule 2
radiopharmaceuticals biologics antibiotics from algea, fungus, etc tobacco products products to be injected controlled substances
other things excluded from natural products
prescription meds traditional synthetic OTC drugs medical devices cosmetics food products for animals
what wil be on all licensed NHPs
will have a NPN or DIN-HM followed by 8 digit number
what is health canada responsible for
market authorization
determines what medicinal ingredients require a prescription
what is napras role
DOES NOT approve new health products
drug scheduling after a product recieves HC approval
what decisions are made by the province
place of sale
what included in the national drug schedules program
scheduling of approved drug products
used to include NHP that went through the process of obtaining a DIN
are NHP on the napra drug schedule
NPN or DIN-HM beyond the scope of napras NDS
older NHPare in the NDS for now new products will not be found there
