L9-Regulation

Question 1

What are NHP?

Answer 1

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.

Question 2

What do NHPs refer to?

Answer 2

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.

Question 3

NHPs must be safe to use as _____ and _____

Answer 3

OTC and not need a Rx to be sold

Question 4

Where did NHPs fit in the past?

Answer 4

In the past, through its definitions, legislation restricted health‐related claims for foods, food ingredients, and NHPs.

Question 5

T/F: NHPs weren’t really considered food nor drugs in the past.

Answer 5

True

Question 6

What if NHP were to be categorized as food?

Answer 6

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

Question 7

In the past, how were NHPs regulated?

Answer 7

Anything that carried a claim or levels of ingredients exceeding those allowed in food, i.e. supplement, etc…was regulated as a drug.

Question 8

In the past, if companies wanted to market NHPs or functional foods would have to ____

Answer 8

submit a DIN application to the Therapeutic Products Directorate (cost of the review would vary, but was often prohibitive)

Question 9

List 3 major drawbacks of categorizing them as NHPs or functional foods.

Answer 9

1. inadequate information
2. inappropriate costs on industry, government, and consumers
3. product access was becoming restricted

Question 10

How are NHPs regulated now?

Answer 10

NHPs are now considered a subset of drugs under the Food and Drugs Act
– Regulated by Health Canada

Question 11

See slide 7

Answer 11

ok

Question 12

According to the current regulations, sale of NHPs is subject to ?

Answer 12

Subject to the licensing provisions of the Natural Health Products Regulations

Question 13

When did the current NHP regulations come into effect?

Answer 13

January 1, 2004

Question 14

What are NHPs considered a subset of?

Answer 14

Food & Drugs Act

Question 15

What is the purpose of the current NHP regulations?

Answer 15

To help assure that Canadians have access to NHPs that are safe, effective and of high quality.

Question 16

All NHPs must have a _____

Answer 16

Product licence

Question 17

When are SITE LICENCES required? And what must be met to obtain them?

Answer 17

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.

Question 18

T/F: NHP applies to HCP who compound products on an individual basis for patients or to retailers of NHPs.

Answer 18

FALSE - does not apply

Question 19

Which governing body administers NHP site licences?

Answer 19

Health Canada’s Natural Health Products Program

Question 20

Define NHP in the regulations.

Answer 20

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.

Question 21

Can NHPs contain Schedule 2 products?

Answer 21

NAH

Question 22

List e.g. of Schedule 1 NHPs.

Answer 22

• 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

Question 23

List e.g. of Schedule 2 NHPs.

Answer 23

-radiopharmaceuticals
-biologics**
-antibiotics from algae, fungus, or bacterium, or synthetic duplicates
-tobacco products
-products to be injected
-controlled drugs/substances
above
(eg. DHEA, progesterone)

Question 24

What are Schedule 2 biologics?

Answer 24

**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

Question 25

Besides Schedule 2 NHPs, what else is excluded?

Answer 25

Prescription medicines, conventional synthetic OTC drugs, medical devices, cosmetics, food, products for animals (drugs)

Question 26

Licensed NHPs will have a ?

Answer 26

Natural product number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label

Question 27

Where does NAPRA fit in?

Answer 27

NAPRA plays a role in drug scheduling after a product receives HC approval.

Question 28

What does NAPRA not do?

Answer 28

1. Does not approve new health products
2. Beyond whether a product requires a prescription, all other decisions about the place of sale for drug products is a provincial responsibility

Question 29

What is NAPRA’s policy for NHPs?

Answer 29

-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.