Natural Health Products Regulations

NATURAL HEALTH
PRODUCTS REGULATIONS
Prepared from Health Canada

FOOD AND DRUGS ACT

Implementation of NHP
Regulations
Implementation of the Natural Health Products Regulations
on January .1, 2004., and apply to all NHPs as of this date.
NHPs with a valid Drug Identification Number (DIN) have
six years (until December 31, 2009) to obtain a product
licence under the Regulations.
Natural Health Products Regulations came into force, a
commitment was made to undertake a review of the
regulations within the first three to five years of their
implementation.
This review has been launched further to that commitment
and in consideration of challenges and issues which have
been identified in the first three years of regulating
NHPs.

NHP - Health Canada /RK 08/03/2010

Natural Health Products
Regulatory Review
Guidance documents have been created to help the natural
health product (NHP) industry
The Review) is being undertaken as part of the Health
Products and Food Branch's (HPFB) Blueprint for
Renewal initiative, which aims at modernizing the
regulatory system for all health products and food
regulated by Health Canada.
To help Canadians maintain and improve their health, Health
Canada's Health Products and Food Branch strives to
ensure that they have access to safe and effective health
products, safe and nutritious food, and the information
they need to make healthy choices. Protecting the health
and afety of Canadians is our priority.


Identify licensed natural
health products
Stakeholders can identify licensed natural health products by
looking for the eight-digit Natural Product Number (NPN) or
Homeopathic Medicine Number (DIN-HM) designation on
the label

The LNHPD is managed by Health Canada and includes
information on licensed natural health products, such as
vitamin and mineral supplements, herb and plant-based
remedies, traditional medicines (such as Traditional Chinese
Medicines or Ayurvedic [Indian] Medicines), omega 3 and
essential fatty acids, probiotics and homeopathic medicines
as well as many everyday consumer products, such as
certain toothpastes, antiperspirants, shampoos, facial
products and mouthwashes.


NATURAL HEALTH PRODUCTS
• A plant or a plant material, an alga, a bacterium, a fungus or a non-
human animal material

• An extract or isolate of a substance described in item 1, the primary
molecular structure of which is identical to that which it had prior to
its extraction or isolation

• Any of the following vitamins: biotin, folate, niacin, pantothenic acid,
riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C,
vitamin D, vitamin E, vitamin K1, vitamin K2,

• An amino acid

• An essential fatty acid

• A synthetic duplicate of a substance described in any of items 2 to 5

• A mineral

• A Probiotics


Introduction
In Canada, natural health products and foods are regulated
under the Food and Drugs Act (FDA) and its associated
regulations.

Products that meet the definition “natural health product” in the
Natural Health Products Regulations (NHPR) are subject to
the FDA as it applies to a drug and to the NHPR.

Products that are foods as defined in the FDA are subject to
the FDA as it applies to food and to Parts A, B and D of the
Food and Drug Regulations (FDR).

A product, that is both a natural health product and a food is
subject to the NHPR but is exempted from the FDA and its
regulations as they apply to a food


The product information
For every licensed product listed in the LNHPD, the following details are
provided:

Product Name

Product Licence Holder

Natural Product Number (NPN) or Homeopathic Medicine Number
(DIN-HM)

Product's Medicinal Ingredients

Product's Non-Medicinal Ingredients

Product's Dosage Form

Product's Recommended Use or Purpose (i.e. its health claim or
indication)

Risk Information Associated with the Product's Use (i.e. cautions,
warnings, contra-indications and known adverse reactions)


What Is an Act?
An Act is a means by which laws are made. Generally,
Acts begin in draft form ("bills") and can originate
either in the House of Commons or in the Senate.
For a bill to become law, it must be approved by
both the House of Commons and the Senate and by
the Governor General of Canada.
Finally, a bill becomes law (an Act) through a formal
process known as proclamation. Proclamation is
done by the Governor in Council (Cabinet, i.e., the
Prime Minister and his or her Federal Ministers).


What Are Regulations?
Regulations (often referred to as delegated legislation
or subordinate legislation) are a means of making
laws and should reflect policy objectives.
Regulations are not made by Parliament but rather by
someone to whom Parliament has delegated the
authority to make them,
In the case of the Food and Drugs Act, the Governor in
Council (Cabinet) is given the power to make
regulations.
All regulations must be consistent with the authority
under which they are made. They can't go beyond
what the Act provides


What Is the Canada
Gazette?
The Canada Gazette is the official newspaper of the
Government of Canada and is published under the
authority of the Statutory Instruments Act. It consists of
three parts, Part I, Part II and Part III.

Part I contains all formal public notices, official appointments,
miscellaneous notices and proposed (draft) regulations
from the government and private sectors

Part II of the Canada Gazette contains regulations (as
adopted by the appropriate authority) and certain other
classes of statutory instruments.

Part III of the Canada Gazette contains the most recent Acts
of Parliament and their enactment proclamations.


What Are Guidance
Documents?
Guidance documents (sometimes called guidelines or
directives) are important administrative documents
which support laws and regulations.
Unlike laws and regulations, guidance documents do not
have the force of law.
However, they are important documents which set out
how a department, regulatory authority or other body
applies laws and regulations under their jurisdiction.
They provide transparency in decision-making and fill in
details sometimes missing from the strict nature of
legal language in laws or regulations.


The purpose of this
guidance document
Natural Health Products Directorate (NHPD) administers
sections 9, 10, 30 and 31 of the Natural Health
Products Regulations (the Regulations). Such
procedures will be referred to herein as the
"Reconsideration Process".
It is the goal of the NHPD to attempt to resolve all
disputes to which this Reconsideration Process may
apply in a fair, transparent, and timely manner.
The Reconsideration Process complements existing
informal dispute resolution mechanisms at the NHPD
such as discussions between the NHPD and
applicants that may take place during the assessment
of licence applications.


Offices & Programs
The NHPD is composed of the following areas:

Director General's Office

Bureau of Business Planning and Operations

Bureau of Policy Development and Regulatory
Affairs

Bureau of Product Review and Assessment

Bureau of Promotion, Liaison and Development

Natural Health Product Research Program


Natural Health Product
Regulation in Canada
The Regulations include provisions on:

Product licensing;

Site licensing;

Good manufacturing practices;

Adverse reaction reporting;

Clinical trials;

Labelling; and

Provisions for a full range of health claims that will be supported by evidence.

Products that fall within these Regulations include herbal remedies, homeopathic
medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and
essential fatty acids.

Information on natural health products that have been licensed for sale in Canada is
available in the Licensed Natural Health Products Database.


Product Licensing
All natural health products require a product licence before
they can be sold in Canada.
Obtaining a licence requires submitting detailed information on
the product to Health Canada, including: medicinal
ingredients, source, potency, non-medicinal ingredients and
recommended use(s).
Once a product has been assessed and granted market
authorization by Health Canada, the product label will bear
an eight digit product licence number preceded by the
distinct letters NPN (which stand for Natural Product
Number), or, in the case of a homeopathic medicine, by the
letters DIN-HM (which stand for Homeopathic Medicine
Number).
This number on the label will inform consumers that the
product has been reviewed and approved by Health
Canada for safety, efficacy and quality.


Site licensing
A system of site licensing requires that all
Canadian manufacturers, packagers,
labellers, and importers of natural health
products be licensed.
Sites must have procedures in place
respecting distribution records and product
recalls and for the handling, storage and
delivery of their products, and demonstrate
that they meet good manufacturing practice
requirements.


Good Manufacturing
Practices (GMPs)
This requires that appropriate
standards and practices regarding
Good Manufacturing Practices (GMPs) product manufacture, storage,
for natural health products must be handling and distribution of natural
employed to ensure product safety health products be met. The GMP for
and quality. NHPs cover:

specifications (product); quality assurance;

premises; stability;

records;
equipment;
sterile products;
personnel;
lot or batch samples, and
sanitation program;
recall reporting.
operations;
Information on the GMPs for
NHPs is available in the
operations; Good Manufacturing
Practices Guidance
Document


Adverse Reaction
Reporting Regulations require product
The Natural Health Products
licence holders to monitor all adverse reactions
associated with their product. Serious adverse reactions
must be reported to Health Canada through the Adverse
Reaction Reporting Form Template.

The Adverse Reaction Reporting System for natural health
products assists Health Canada in issuing warnings and
advisories, where appropriate, to the public. This type of
reporting is an important part of a product authorization
system based on risk assessment and risk management


Health Canada Concerns


Clinical trials
A clinical trial is an investigation of a natural health
product that involves human subjects and is
intended:

To discover or verify the product's clinical,
Pharmacological or Pharmacodynamic effects;

To identify any adverse events that are related to its
use; to study its absorption, distribution, metabolism
and excretion; or

To ascertain its safety or efficacy.


Barriers to introduction of new
medical product

Economic Viability

Social Technical
Acceptability Feasibility


Labelling
Standard labelling requirements are established to ensure consumers
can make informed choices. Some of the information required on a
natural health products label includes:
 Product name
 Quantity of product in the bottle
 List of medicinal and non-medicinal ingredients
 Recommended conditions of use (including use or purpose, dosage
form, route of administration, dose, and any cautionary statements,
warnings, contra-indications and possible adverse reactions
associated with the product)
 Any special storage conditions
Further information on the labelling and packaging requirements for
natural health products is available in the Labelling Guidance
Document.

Natural Health Products: 53
Recommendations of the Standing Committee
on Health
Table of Contents

Recommendations re: Definitions
Recommendations re: Expertise and Regulatory Structure
Recommendations re: Safety
Recommendations re: Quality/Good Manufacturing Practices
Recommendations re: Efficacy
Recommendations re: Product Licensing
Recommendations re: Labelling
Recommendations re: Section 3 and Schedule A of the Food and Drugs Act
Recommendations re: Importation of Human-Use Drugs for Personal Use
Recommendations re: Cost Recovery
Recommendations re: Appeal Process
Recommendations re: Informed Choice
Recommendations re: NHP Practitioners
Recommendations re: Enforcement
Recommendations re: Aboriginal Healers
Recommendations re: Plant Conservation
Recommendations re: Transition
Appendix A
Appendix B


Compliance Policy for
Natural Health Products
The Regulations define what NHPs are and set out the
requirements for their sale, manufacture, packaging,
labelling, importation, distribution, and storage. This
document explains Health Canada's compliance policy
with respect to these products.

This document replaces and supersedes the Interim DIN
Enforcement Directive (1998) which ceased to be in
effect as of January 1, 2004, and, as it relates to NHPs
as defined in the Regulations, the Therapeutic
Products Compliance Guide (1999).


Schedule I of the Natural Health
Products
The following are included natural health product substances:
A plant or a plant material, an alga, a bacterium, a fungus or a non-human
animal material

An extract or isolate of a substance described in item 1, the primary molecular
structure of which is identical to that which it had prior to its extraction or
isolation

Any of the following vitamins: biotin, folate, niacin, pantothenic acid, riboflavin,
thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E

An amino acid

An essential fatty acid

A synthetic duplicate of a substance listed in any of 2 to 5 above

A mineral

A probiotic


Schedule 2 of the Natural Health
Products
The following are excluded natural health product substances:
A substance set out in Schedule C to the Act

A substance set out in Schedule D to the Act, except for the following:

a drug that is prepared from any of the following micro-organisms,
namely, an alga, a bacterium or a fungus; and

any substance set out on Schedule D when it is prepared in
accordance with the practices of homeopathic pharmacy

A substance regulated under the Tobacco Act

A substance set out in any of Schedules I to V of the Controlled Drugs
and Substances Act

A substance that is administered by puncturing the dermis

An antibiotic prepared from an alga, a bacterium or a fungus or a
synthetic duplicate of that antibiotic


NATURAL HEALTH PRODUCTS
REGULATIONS
(1) These Regulations apply to
(a) the sale of natural health products;
(b) the manufacture, packaging, labelling and importation
for sale of natural health products;
(c) the distribution of natural health products; and
(d) the storage of natural health products for the purposes
of any of the activities referred to in paragraphs (b) and (c).
(2) For the purposes of these Regulations, a substance or
combination of substances or a traditional medicine is not
considered to be a natural health product if its sale, under
the Food and Drug Regulations, is required to be pursuant
to a prescription when it is sold other than in accordance
with section C.01.043 of those Regulations.


PRODUCT LICENCES
Prohibition
(1) Subject to subsections (2) and (3), no person shall sell a
natural health product unless a product licence is issued in
respect of the natural health product.

(2) No product licence holder, manufacturer, importer or
distributor of a natural health product for which a product
licence is issued shall sell the natural health product during
any period that the sale of that natural health product is
directed to be stopped under section 17.

(3) No person shall sell a natural health product for which a
product licence is issued

(a) during the period of any suspension of the licence under
section 18 or 19; or
(b) after cancellation of the licence under paragraph 20(b).

Licence Application
An application for a product licence shall be submitted to the Minister
and shall contain the following information and documents:

(a) the name, address and telephone number, and if applicable,
the facsimile number and electronic mail address of the applicant;
(b) if the address submitted under paragraph (a) is not a Canadian
address, the name, address and telephone number, and if
applicable, the facsimile number and electronic mail address of
the applicant's representative in Canada to whom notices may be
sent;
(c) for each medicinal ingredient of the natural health product,
(i) its proper name and its common name,
(ii) its quantity per dosage unit,
(iii) its potency, if a representation relating to its potency is to be
shown on any label of the natural health product,
(iv) a description of its source material, and
contd.


Licence Application
v) a statement indicating whether it is synthetically manufactured;

(d) a qualitative list of the non-medicinal ingredients that are proposed for the
natural health product and for each ingredient listed, a statement that indicates the
purpose of the ingredient;
(e) each brand name under which the natural health product is proposed to be sold;
(f) the recommended conditions of use for the natural health product;
(g) information that supports the safety and efficacy of the natural health product
when it is used in accordance with the recommended conditions of use;
(h) the text of each label that is proposed to be used in conjunction with the natural
health product;
(i) a copy of the specifications to which the natural health product will comply; and
(j) one of the following attestations, namely,

(i) if the natural health product is imported, an attestation by the applicant that
the natural health product will be manufactured, packaged, labelled, imported,
distributed and stored in accordance with the requirements set out in Part 3 or in
accordance with requirements that are equivalent to those set out in Part 3, or
(ii) if the natural health product is not imported, an attestation by the applicant
that the natural health product will be manufactured, packaged, labelled,
distributed and stored in accordance with requirements set out in Part 3.


Product Number
(1) The Minister shall assign a product
number to each natural health product in
respect of which a product licence is issued.
(2) In the case of a natural health product
that is a drug for which a drug identification
number is assigned in accordance with
subsection C.01.014.2(1) of the Food and Drug
Regulations, the product number required
under subsection (1) shall be the drug
identification number.


Site Information
(1) Subject to subsection (2), the licensee shall provide the Minister with the following information
prior to commencing the sale of the natural health product:

(a) in respect of each manufacturer, packager, labeller and importer of the natural health product

(i) the person's name, address and telephone number, and if applicable, the person's facsimile
number and electronic mail address, and
(ii) if the person conducts the activity in Canada, the number assigned to the site licence issued in
respect of that activity;

(b) the name, address and telephone number, and if applicable, the facsimile number and electronic
mail address of each distributor of the natural health product;
(c) the address of each building in which the natural health product is manufactured, packaged or
labelled;
(d) the address of each building in which the natural health product is stored for the purposes of
importation or distribution; and
(e) if the natural health product is imported, evidence demonstrating that the natural health product
will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the
requirements set out in Part 3 or in accordance with requirements that are equivalent to those set
out in Part 3.

(2) If the natural health product is one in respect of which a drug identification number is assigned in
accordance with subsection C.01.014.2(1) of the Food and Drug Regulations and at the time the
product licence is issued in respect of the natural health product it is already being sold, the licensee
shall provide the information referred to in subsection (1) within 30 days after the day on which the
product licence is issued.


Records
(1) Every licensee who sells a natural health product shall
maintain the following records:

(a) a list of all ingredients contained in each lot or batch of
the natural health product that has been made available for
sale; and
(b) records containing sufficient information to enable the
recall of every lot or batch of the natural health product that
has been made available for sale.

(2) The records shall be maintained by the licensee for a
period of one year following the expiry date of the natural
health product to which that record relates.


Prohibition
(1) Subject to subsection (2), no person shall manufacture,
package, label or import a natural health product for sale
unless

(a) the person holds a site licence issued in respect of the
activity; and
(b) the person conducts the activity in accordance with the
requirements set out in Part 3.

(2) No person who holds a site licence shall manufacture,
package, label or import a natural health product for sale

(a) during the period of any suspension of the licence
under section 39 or 40; or
(b) after cancellation of the licence under paragraph 41(b).

Licence Contents
A site licence shall set out the following information:

(a) the name and address of the licensee;
(b) the site licence number;
(c) each activity that the licensee is authorized to conduct and
a statement indicating whether the activity is authorized to be
conducted in respect of a natural health product in sterile
dosage form;
(d) if the licensee is authorized to manufacture, package or
label a natural health product, the address of each building in
which the licensee is authorized to conduct that activity; and
(e) if the licensee is authorized to import a natural health
product, the address of each building in which the licensee is
authorized to store that natural health product.

Expiry of Site licence
(1) A site licence expires on the first
anniversary of the day on which it was
issued unless it is renewed in
accordance with section 36.
(2) A site licence that is renewed in
accordance with section 36 expires on
the day on which the renewal period
ends unless the licence is further
renewed in accordance with section 36.

GMP Specifications
(1) Every natural health product available for sale shall comply with the specifications
submitted in respect of that natural health product under paragraph 5(i) and with
every change to those specifications made by the product licence holder.

(2) The specifications shall contain the following information:

(a) detailed information respecting the purity of the natural health product, including
statements indicating its purity tolerances;
(b) for each medicinal ingredient of the natural health product, detailed information
respecting its quantity per dosage unit and its identity, including statements
indicating its quantity and identity tolerances;
(c) if a representation relating to the potency of a medicinal ingredient is to be shown
on a label of the natural health product, detailed information respecting the potency
of the medicinal ingredient, including statements indicating its potency tolerances;
and
(d) a description of the methods used for testing or examining the natural health
product.

(3) The specifications and every change to those specifications shall be approved by a
quality assurance person.


Premises
(1) Every natural health product shall be manufactured,
packaged, labelled and stored in premises that are designed,
constructed and maintained in a manner that permits the activity
to be conducted under sanitary conditions, and in particular that
(a) permits the premises to be kept clean and orderly;
(b) permits the effective cleaning of all surfaces in the premises;
(c) permits the natural health product to be stored or processed
appropriately;
(d) prevents the contamination of the natural health product; and
(e) prevents the addition of an extraneous substance to the
natural health product.
(2) Every natural health product shall be stored under conditions
that will maintain the quality and safety of the natural health
product.


Guidance Documents
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-eng.php

Overview of the Natural Health Products Regulations Guidance Document :http://www.hc-
sc.gc.ca/dhp-mps/prodnatur/legislation/docs/regula-regle_over-apercu-eng.php

Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health
Products* :http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-
directrice_reporting-notification/index-eng.php

Advertising: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-
ldir_consom_consum-eng.php

Contact:
Natural Health Products Directorate
Health Products and Food Branch
Health Canada
Address locator: 3302A
2936 Baseline Rd., Tower A
Ottawa, Ontario
K2H 1B3


Natural Health Products Regulations

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