Natural Health Products Regulations

NATURAL HEALTH PRODUCTS REGULATIONS

Prepared from Health Canada

FOOD AND DRUGS ACT

Implementation of NHP RegulationsImplementation 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.


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Identify licensed natural health productsStakeholders 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


IntroductionIn 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


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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 & ProgramsThe 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.


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Product LicensingAll 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 licensingA 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)

Good Manufacturing Practices (GMPs)

for natural health products must be

employed to ensure product safety

and quality.

specifications (product);

premises;

equipment;

personnel;

sanitation program;

operations;

operations;

This requires that appropriate

standards and practices regarding

product manufacture, storage,

handling and distribution of natural

health products be met. The GMP for

NHPs cover:

quality assurance;

stability;

records;

sterile products;

lot or batch samples, and

recall reporting.

Information on the GMPs for NHPs is available in the Good Manufacturing Practices Guidance Document


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Adverse Reaction ReportingThe Natural Health Products Regulations require product

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


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Health Canada Concerns


Clinical trialsA 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

Technical

Feasibility

Social

Acceptability


LabellingStandard 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.


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

Table of Contents

Recommendations re: DefinitionsRecommendations re: Expertise and Regulatory StructureRecommendations re: SafetyRecommendations re: Quality/Good Manufacturing PracticesRecommendations re: EfficacyRecommendations re: Product LicensingRecommendations re: LabellingRecommendations re: Section 3 and Schedule A of the Food and Drugs ActRecommendations re: Importation of Human-Use Drugs for Personal UseRecommendations re: Cost RecoveryRecommendations re: Appeal ProcessRecommendations re: Informed ChoiceRecommendations re: NHP PractitionersRecommendations re: EnforcementRecommendations re: Aboriginal HealersRecommendations re: Plant ConservationRecommendations re: TransitionAppendix AAppendix B


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Compliance Policy for Natural Health ProductsThe 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 ProductsThe 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 ApplicationAn 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 Documentshttp://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


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