Natural Health Product Regulations

Question 1

NHP must be __ to use as OTC and not need a _____ to be sold

Answer 1

safe

prescription

Question 2

what would happen if NHP were categorized as food

Answer 2

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

Question 3

what was regulated as a drug before

Answer 3

anything that carried a claim or levels of ingredients exceeding those allowed in food
ie. NHP

Question 4

what would companies who wanted to market NHp have to do

Answer 4

submit a DIN application to the therapeutic products directorate

Question 5

major drawbacks of NHP being regulated as drugs

Answer 5

inadequate info
inappropriate costs on industry, government, and consumers
restricted access

Question 6

what are NHPs now considered

Answer 6

a subset of drugs under the food and drugs act regulated by health canada

Question 7

when were NHP regulations published

Answer 7

2003

Question 8

purpose of NHP regulations

Answer 8

help assure that canadians have access to NHPs that are safe effective and of high quality

Question 9

all NHPs must have ___

Answer 9

product licenses

Question 10

who must have site licenses

Answer 10

canadian sites whic maufacture, package, label, and import NHPs

Question 11

what must be met to obtain product and site licenses

Answer 11

specific labelling and packaging requirements
good manufacturing practice standard
evidence norms

Question 12

who do the regulations licenses not apply to

Answer 12

HCP who compound products on an individual basis for patients or to retailers of NHPs

Question 13

who administers the licenses

Answer 13

health canadas health products program

Question 14

definition of NHP in regulations simplified

Answer 14

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

Question 15

what does a natural health product not include

Answer 15

anything that contains a substance in schedule 2

Question 16

schedule 1

Answer 16

plant, algae, fungus, bacteria, non human anumal materials
vitamins and minerals
amino acids
essential fatty acids
synthetic duplicates
probiotics

Question 17

schedule 2

Answer 17

radiopharmaceuticals 
biologics 
antibiotics from algea, fungus, etc 
tobacco products
products to be injected 
controlled substances

Question 18

other things excluded from natural products

Answer 18

prescription meds
traditional synthetic OTC drugs
medical devices
cosmetics 
food 
products for animals

Question 19

what wil be on all licensed NHPs

Answer 19

will have a NPN or DIN-HM followed by 8 digit number

Question 20

what is health canada responsible for

Answer 20

market authorization

determines what medicinal ingredients require a prescription

Question 21

what is napras role

Answer 21

DOES NOT approve new health products

drug scheduling after a product recieves HC approval

Question 22

what decisions are made by the province

Answer 22

place of sale

Question 23

what included in the national drug schedules program

Answer 23

scheduling of approved drug products

used to include NHP that went through the process of obtaining a DIN

Question 24

are NHP on the napra drug schedule

Answer 24

NPN or DIN-HM beyond the scope of napras NDS

older NHPare in the NDS for now new products will not be found there

Question 25

what is in discussion right now for NHP

Answer 25

possible framework for determining the place and conditions of sale for NHPs