February 2005

CONSULTATION NOTICE

Health Canada, in collaboration with Advertising Standards Canada (ASC), has developed draft Consumer Advertising Guidelines for Marketed Health Products (Guidelines). The Guidelines apply to consumer-directed advertising of nonprescription drugs, including natural health products, for human use. They do not apply to advertising of prescription drugs to consumers nor are they intended to propose any regulatory amendments related to the advertising of products to consumers for the treatment, prevention or cure of Schedule A diseases (i.e., cancer, heart disease). These guidelines, which once approved, will replace and supersede Health Canada's 1990 Consumer Drug Advertising Guidelines, are intended to help advertisers develop advertising messages that meet all the relevant provisions of the Food and Drugs Act and Regulations, the Natural Health Products Regulations and other related Health Canada Policies and Guidelines.

The Guidelines are divided into two sections:

Section A - Advertising Guidelines
Section B - Legislation, Regulations and Policies

The Guidelines will form the basis upon which Health Canada-endorsed preclearance agencies will review and approve advertising for products in the categories of nonprescription drugs including natural health products, and will help ensure consistency in advertising review. ASC is currently the only agency endorsed by Health Canada to review advertising material directed to consumers for nonprescription drugs and natural health products.

Health Canada has mandated ASC to collate comments received during this external stakeholder consultation period and to submit a revised draft along with a tabulation of comments to Health Canada for review and finalization of the Guidelines. Implementation of these guidelines once approved is proposed for January 2006.

Should you wish to provide comments or suggestions on the Guidelines, you are requested to do so by April 22, 2005. Please address comments and questions to:

Nicole Bellam
Director, Advertising Clearance Services
Advertising Standards Canada
175 Bloor Street East , South Tower , Suite 1801
Toronto , Ontario M4W 3R8
Telephone: (416) 961-6311
Fax: (416) 961-7904
Email: guidelines@adstandards.com

The draft Consumer Advertising Guidelines for Marketed Health Products are posted on ASC's Website at http://www.adstandards.com. They are also posted on Health Canada's Website at
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advertising_e.html with other Health Canada Advertising Policies and on the Natural Health Products Directorate home page at
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html. Hard copies are available upon request.

Consumer Advertising Guidelines for Marketed Health Products¹

For Nonprescription Drugs including Natural Health Products

CONSULTATION DRAFT

February 2005

Developed by:

TABLE OF CONTENTS

Section A: Advertising Guidelines

A.1 Overview
A.2 Scope
A.3 Advertising Preclearance Overview
A.4 Health Canada and Preclearance Agency Roles and Consultation Related to Advertising Review and Complaint Adjudication
A.5 Consumer and Trade Complaints about Therapeutic Aspects of Nonprescription Drug Advertisements including Natural Health Product Advertisements
A.6 Advertising Guidelines: Guiding Principles

1.0 Product Characteristics Based on Section 9(1) of the Act

1.1 Authorization - Terms of Market Authorization
1.2 Product Representation
1.3 Indication/Recommended Use - Single Medicinal Ingredient
1.4 Indication/Recommended Use - Multiple Medicinal Ingredients
1.5 Direction for Uses/Dosage and Administration
1.6 Duration of Action
1.7 Duration of Use
1.8 Efficacy
1.9 Medicinal vs. Non-Medicinal Ingredients
1.10 Onset of Action

2.0 Claims and Representations Under Section 9(1) of the Act

2.1 Absence of Ingredient Statements
2.2 Absence of Side Effect Statements
2.3 Children
2.4 Clinically Tested/Proven
2.5 Comparative Claims - Therapeutic Comparisons
2.6 Comparative Claims - Non-therapeutic Comparisons
2.7 Endorsements/Seals
2.8 Exaggeration of Product Merit
2.9 Extra Strength/Maximum Strength
2.10 Government/Health Canada Approved
2.11 Graphics/Schematics/Statistics/Terminology
2.12 Health/Healthy/Healthful
2.13 Implied/Indirect Claims
2.14 Natural
2.15 Natural Action/Naturally
2.16 Need
2.17 New/Improved
2.18 Organic
2.19 Potent/Potency
2.20 Power/Strength
2.21 Risk Information Communication
2.22 Risk Reduction Claims
2.23 Safe/Side Effect Free
2.24 Sampling
2.25 Scare Advertising
2.26 Storage Conditions
2.27 Structure Function Claims
2.28 Superscripts/Footnotes or "Supers"
2.29 Testimonials/Quotations
2.30 Therapeutic Guarantees/Absolute Claims
2.31 Therapeutic Claims
2.32 Unique
2.33 Withdrawal of Terms of Market Authorization

Section B: Legislation, Regulations and Policies

B.1 Definitions Under the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations

B.2 Legislation, Codes and Policies that Apply to Marketed Health Product Advertising

B.3 Appendix Material

Appendix A - Schedule A to the Food and Drugs Act
Appendix B - Appendix 2 of Product Licensing Guidance Document (NHP)
Appendix C - Excerpts from the Health Canada Policy Changes to Marketed New Drug Products
Appendix D - Excerpts from the Food and Drug Regulations
Appendix E - Advertising of Medical Devices

Section A - Advertising Guidelines

A.1. Overview

The draft Consumer Advertising Guidelines for Marketed Health Products (the "Guidelines") apply to advertising of nonprescription drugs (NonRx drugs) including Natural Health Products (NHPs). The Guidelines, which will replace and supersede the 1990 Consumer Drug Advertising Guidelines, are designed to help advertisers develop advertising messages that meet all the relevant provisions of the Food and Drugs Act and Regulations, the Natural Health Products Regulations and other related Health Canada policies and guidelines.

The Guidelines are divided into two sections:

Section A - Advertising Guidelines
1. Product Characteristics based on Section 9(1) of the Food and Drugs Act
2. Claims and Representations under Section 9(1) of the Food and Drugs Act
Section B - Legislation, Regulations and Policies
1. Definitions
2. Legislation, Codes and Policies that apply to Marketed Health Product Advertising
3. Appendix Material

Appendix A: Schedule A to the Food and Drugs Act
Appendix B: Appendix 2 of Product Licensing Guidance Document (NHP)
Appendix C: Excerpts from the Health Canada Policy Changes to Marketed New Drug Products
Appendix D: Excerpts from the Food and Drug Regulations
Appendix E: Advertising of Medical Devices

The Guidelines are intended to provide the advertiser with the tools to understand drug advertising principles before advertising copy is considered and submitted for review to the Health Canada endorsed preclearance agency. The Guidelines will form the basis upon which Health Canada's endorsed preclearance agencies² will review and approve advertising for nonprescription drugs including natural health products, and will help ensure consistency in advertising review.

NonRx drugs including NHPs are subject to the provisions of the Food and Drugs Act. Drugs are subject to the Food and Drug Regulations. NHPs are subject to the Natural Health Products Regulations and to those provisions of the Food and Drug Regulations that have been incorporated by reference into the NHP Regulations (e.g. Section 103 of the NHP Regulations).

Furthermore, the Guidelines form the basis for many types of consumer advertising and may be expanded in the future to include consumer advertising for other human product categories such as medical devices.

The Guidelines may be updated on an as-needed basis.

A.2. Scope

The Guidelines apply to all consumer-directed advertising for NonRx drugs including NHPs, in all Canadian media³.

The Guidelines present current interpretations of the advertising provisions found in the Food and Drugs Act and Regulations, the Natural Health Products Regulations, and other relevant Health Canada and Health Canada's endorsed preclearance agency⁴ policies and procedures. The Guidelines are intended to be used in conjunction with these aforementioned provisions and policies.

The Guidelines do not apply to products for which there are specific consumer-directed advertising restrictions in the Food and Drugs Act and Regulations and the Controlled Drugs and Substances Act [e.g. controlled drugs, narcotics, Schedule F - prescription drugs, Limit Dose drugs (section C.01.021 of the Regulations)].

The Guidelines do not currently⁵ apply to the advertising of:

• Medical devices to consumers*
• Veterinary drugs to consumers

* However, Appendix E gives a general guidance on the advertising of medical devices, as regulated under the Medical Devices Regulations and the Food and Drugs Act.

The Guidelines do not apply to the advertising of:

• Nonprescription drugs including NHPs to health professionals⁶
• Prescription drugs to consumers
• Prescription drugs to health professionals
• Veterinary drugs to health professionals

The Guidelines do not apply to informational messages such as, but not limited to:

• Institutional messages
• Patient support group messages
• Help-seeking announcements
• Clinical trial recruitment messages

A.3. Advertising Preclearance Overview

Health Canada's endorsed preclearance agencies, provide advertising copy review services to advertisers/advertising agencies to help ensure that their advertising, in all media, meet the relevant provisions of the Food and Drugs Act and Regulations, the Natural Health Products Regulations, and the policies that apply to NonRx drugs including NHPs. Copy should be submitted prior to production to avoid costly changes to final executions. "Approved" advertising is assigned a clearance number that signifies to the carrying media that the advertising has been assessed and is considered to be in compliance with the applicable legislations and regulations.

Preclearance services generally include the review of advertising copy both for traditional media, including radio, television and mass print (e.g. newspaper, magazine, outdoor, transit), for other categories (e.g. flyers, point of purchase, consumer brochures) and for Internet advertising. Preclearance agencies may also offer consultation services for new product launches and new advertising concepts.

A.4. Health Canada and Preclearance Agency Roles and Consultation Related to Advertising Review and Complaint Adjudication

The specific roles of Health Canada and the endorsed preclearance agency are set out in the Health Canada Policy: Advertising Standards Canada and the Therapeutic Products Directorate's Roles and Consultation Related to Advertising Review and Complaint Adjudication, which can be found on the Health Canada website. (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html)

This policy sets out the conditions under which the preclearance agency may consult with Health Canada on policy issues related to advertising and complaint adjudication.

A.5 Consumer and Trade Complaints about Therapeutic Aspects of Nonprescription Drug Advertisements including Natural Health Product Advertisements

Preclearance agencies are responsible for managing and administering consumer and trade complaints about therapeutic aspects of nonprescription drug advertising including natural health product advertising. Preclearance agencies are expected to bring to the attention of Health Canada:

• Any complaints that relate to advertising which, in the preclearance agency's judgement, contravene the Act and Regulations and present an imminent and/or significant health hazard, or
• Any complaints that relate to advertising which, in the preclearance agency's judgement, contravene the Act and Regulations and for which it has been unable to bring into compliance with its Standards and Procedures, e.g., through willful nonparticipation in, or noncompliance with the Standards and Procedures.
• Advertising complaints related to products unauthorized by Health Canada.

A.6. Advertising Guidelines

Guiding Principles

• Advertising must respect Section 9(1) of the Food and Drugs Act:
  "No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety".
• Health and safety of consumers is paramount.
• To allow consumers to make an appropriate and informed choice, advertising should clearly communicate the intended use of the product in a manner that is consistent with the Terms of Market Authorization (TMA).

The following table provides guidance regarding the present interpretations of Section 9(1) of the Food and Drugs Act related to specific claims and representations. The examples provided are for guidance only. The ultimate acceptability of any claim must be evaluated within the overall context of the advertisement.

1.0 Product Characteristics Based on Section 9(1) of the Act

** The guidelines set out in this section do not apply to advertisements displaying only the brand name of the product (with no embellishments). Any advertisement, which contains the name of the product and a claim, must however be in accordance with all guidelines of this section.

1.1 Authorization - Terms of Market Authorization

Guideline

Therapeutic claims must be consistent with the Terms of Market Authorization (TMA):

- For NHPs:

• Product Licence (PL)

- For NonRx Drugs:

• Labelling Standards, Category IV Monographs, Product Monographs or Authorized Labelling (with evidence that such claims were specifically reviewed and authorized by Health Canada).

Application

• Claims found in the TMA may be paraphrased, but must remain consistent with those authorized. Claims must not directly or indirectly exceed the scope of the TMA.
• Visuals and copy must not be used to directly or indirectly suggest product benefits beyond those found in the TMA.

Note: Guidance regarding regulatory requirements for changes to products may be found in the following documents:

- NHPs: see Appendix 2 of the Product Licensing Guidance Document⁷: "Regulatory Requirements Resulting from Changes to Products".

- NonRx drugs: see Health Canada Policy: Changes to Marketed New Drugs⁷, or Section C.01.014.4⁸ of the Food and Drug Regulations.

1.2 Product Representation

Guideline

An advertisement must not be misleading as to the product category under which it received its TMA.

Application

• The advertised product must not be directly or indirectly misrepresented as to product classification. For example, a nonprescription product must not be represented as a food, cosmetic, or medical device.

1.3 Indication / Recommended Use - Single Medicinal Ingredient

Guideline

The advertisement must clearly communicate the intended use of the product.

Application

• An authorized clear therapeutic indication is required.
• For single medicinal ingredient / single indication products: The product's sole indication must be presented in the advertisement.

• For single medicinal ingredient / multiple indication products: At least one indication must be presented in the advertisement

1.4 Indication / Recommended Use - Multiple Medicinal Ingredients

Guideline

The advertisement must clearly communicate the intended uses of the product, as per the TMA.

Application

• For multiple medicinal ingredients / multiple indication products: At least one clear therapeutic indication for each medicinal ingredient must be presented in the advertisement (equal focus on each therapeutic indication is not required).

1.5 Direction for Uses / Dosage and Administration (See also "2.3 Children")

Guideline

An advertisement must not be misleading as to the Directions for Use / Dosage and Administration

Application

• When described or depicted, directions for use / dosage and administration must be consistent with the TMA.

• Depictions of ingestion, e.g. graphics/visuals, must be consistent with the product's TMA.

1.6 Duration of Action

Guideline

An advertisement must not be misleading as to the duration of action of the advertised product.

Application

• When described or depicted, the duration of action must be consistent with the TMA.

• Duration of pharmacological action must not be equated with duration of relief unless clearly specified in the TMA.

1.7 Duration of Use

Guideline

An advertisement must not be misleading as to the duration of use of the advertised product.

Application

• When described or depicted, the duration of use must be consistent with the TMA.
• When a product must be used for a specific period of time to obtain the desired effect, this information must be included in the advertisement.

1.8 Efficacy

Guideline

An advertisement must not directly or indirectly exaggerate the degree of relief/benefit to be obtained from use of the advertised product.

Application

• When depicted or described, efficacy claims must be consistent with the TMA.

1.9 Medicinal vs. Non-medicinal Ingredients

Guideline

Product benefits must not be presented in a manner that misleads the consumer as to the nature of either the medicinal or non-medicinal ingredients.

Application

• No medicinal benefit can be directly or indirectly attributed to a non-medicinal ingredient

1.10 Onset of Action

Guideline

An advertisement must not be misleading as to the time to onset of action of the advertised product.

Application

• When depicted or described, the onset of action must be consistent with TMA, e.g., claims for action within a specific time period are only permitted if contained in the TMA.

• Time to onset of action must not be equated with time to onset of relief, unless clearly specified in the TMA.

2.0 Claims and Representations Under Section 9(1) of the Act

The following table provides guidance regarding the present interpretations of Section 9(1) of the Food and Drugs Act related to specific claims and representations. The examples provided are for guidance only. The ultimate acceptability of any claim must be evaluated within the overall context of the advertisement.

** The requirements set out in section 2.21 (Risk Information Communication) do not apply to advertisements displaying only the brand name of a product (with no embellishments).

2.1 Absence of Ingredient Statements
(Reference Document: Health Canada Policy Absence of Ingredient Statements)

Guideline

An advertisement must not include an absence of ingredient claim in a manner that creates an erroneous impression about the advertised product or competitor product(s).

Application

• Absence of ingredient statements for medicinal and non-medicinal ingredients are acceptable under the following conditions:
• Medicinal
  • The statement provides useful and easily identifiable information to the consumer that reinforces existing labelling and aids consumer medication selection.
  • For single ingredient products, the absent ingredient is of the same product class as the actual medicinal ingredient.
  • For multiple ingredient products, the absent ingredient would likely be found in a combination product of that type.
  • There is no misleading representation as to the safety and merit of the absent ingredient.

• Non-Medicinal
  • The statement provides useful and easily identifiable information to the consumer to aid in product selection for secondary non-therapeutic attributes such as taste, odour, caloric content, allergic potential or other meaningful attribute.
  • The statement is accurate.
  • There is no direct or indirect implication that the absent ingredient is medicinal.

• Sweetening Agents
  • A product can be described as "sugar free" if it contains none of the chemical classes of sugar, including sugar alcohols.
  • However, if it is sweetened with an alternative sweetener, that sweetener must be identified. If a synthetic sweetener is used, it must be identified on the product label.

2.2 Absence of Side Effect Statements (See also: "2.23 Safe / Side Effect Free")

Guideline

An advertisement must not include a claim for an absence of side effect in a manner that creates an erroneous impression about the advertised product or competitive product(s).

Application

• Absence of side effect statements are acceptable under the following conditions:
  • Scientific evidence exists to support the statement, e.g. incidence of side effect is compared to placebo and is consistent with the product's Terms of Market Authorization.
  • There is a widely held consumer perception that the side effect is associated with comparable components of that class.
  • No undue emphasis of statement.
  • The statement provides practical information (i.e. the side effect or benefit can be readily identified by the consumer).

2.3 Children (See also "1.5 Directions for Use / Dosage & Administration)

Guideline

It is misleading to suggest that a child is capable of making a rational decision regarding the use of the advertised product.

Note: Drug advertising in broadcast media directed to children is prohibited by the Canadian Association of Broadcasters Broadcast Code for Advertising to Children.

Application

• Drug advertising must be overtly directed to adults.

• An advertisement must not depict or encourage unsupervised use of drugs by children or suggest that a child can self diagnose and self medicate.
• A child may approve of the taste of a medicine, but may not make recommendations concerning the use of the advertised product.
• Advertisements must not depict product storage in locations accessible to children.

2.4 Clinically Tested / Proven

Guideline

An advertisement must not be misleading with respect to use of the statement "clinically tested/proven".

Application

• Claims for product benefits that are "clinically tested/proven" are limited to those that are consistent with the TMA. Results from clinical studies that would expand the scope of permissible advertising claims cannot be used in advertising until the new claim(s) are authorized by Health Canada, and evidence of the Health Canada authorization is provided to the preclearance agency.

2.5 Comparative Claims - Therapeutic Comparisons

Guideline

Therapeutic superiority including superlative claims, must meet the criteria set out in the Health Canada Policy: Therapeutic Comparative Advertising Directive and Guidance Document (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html).

Application

• Comparative claims are reviewed under the above-mentioned Health Canada Policy and Advertising Standards Canada Therapeutic Comparative Advertising SOP.

2.6 Comparative Claims - Non-therapeutic Comparisons

Guideline

Non-therapeutic comparative claims must meet the criteria set out in the Health Canada Policy: Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html).

Application

• Non-therapeutic comparisons / claims are reviewed under the above-mentioned Health Canada policy and Advertising Standards Canada Clearance Policy Claims about Non-Therapeutic Aspects of Nonprescription Drugs in Consumer Directed Advertising.

2.7 Endorsements / Seals (See also "2.29 Testimonials / Quotations)

Guideline

Seals and endorsements must not be used in a manner that creates an erroneous impression regarding product merit.

Application

• Endorsements by, or seals of recognized groups are acceptable, providing the terms of the endorsement/recognition are consistent with the TMA.

Note: For preclearance evaluations of such claims, the advertiser should provide written material from the endorsing agency describing the nature and scope of the endorsing agency, and the nature and scope of the product recognition.

2.8 Exaggeration of Product Merit

Guideline

An advertisement must not mislead consumers by exaggerating product merit.

Application

• It is unacceptable to suggest that use of the advertised product is a substitute for good health practices.

• It is unacceptable to exaggerate the severity of the condition that can be relieved with the advertised product.

2.9 Extra Strength / Maximum Strength (See also: "2.20 Power / Strength")

Guideline

It is misleading to suggest that an "extra" strength product provides a greater benefit than a "regular" strength product in cases where both are indicated for the same condition.

Application

• It is acceptable to use terms such as "extra strength" or "ultra strength" to describe items in a product line where various quantitative amounts of medicinal ingredients are available. However, it is not acceptable to suggest that there is a correlation between the amount of medicinal ingredient and degree of efficacy unless this is part of the TMA.

2.10 Government / Health Canada Approved

Guideline

An advertisement must not make any direct or indirect reference to the Act or Regulations, as per Section C.01.007 of the F&D Regulations, and Section 92 of the NHP Regulations.

Application

• Claims that state or imply product endorsement or authorization by government or government agencies are prohibited.
• It is acceptable to show in advertising a factual representation of a product label that bears a DIN/DIN-HM or NPN.
• It is acceptable to state the DIN, DIN-HM or NPN.
• It is not acceptable to claim the product is authorized or approved by Health Canada.

2.11 Graphics / Schematics / Statistics / Terminology

Guideline

Graphics, language, schematics, statistics, and terminology used to present product features or characteristics must not do so in a manner that will mislead the consumer as to the therapeutic merits of the product.

Application

• Risk information should be presented to the consumer in absolute rather than relative terms.
• Scientific or technical information should be presented in terminology suitable for the target audience.

2.12 Health / Healthy / Healthful

Guideline

It is misleading to suggest that a product may restore, maintain or promote health, unless such claims are included in the TMA.

Application

• It is unacceptable to make claims regarding health or promotion of health unless such claims are included in the TMA.

2.13 Implied / Indirect Claims

Guideline

Implied or indirect claims must be consistent with the TMA.

Application

• All elements of an advertisement will be considered when assessing conformity to the TMA, including, but not limited to: visuals, placement of text, context, graphics, special effects, music, and sounds.

2.14 Natural (See also: "2.18 Organic")

Guideline

An advertisement must not mislead a consumer to believe that a product is "natural" or "natural source(d)" if it has undergone more than minimal processing or refinement.

Application

• Natural: A product can be described as "natural" if it is sold in its original state with a minimal processing or refinement, i.e. cut, dried or irradiated⁹.

• Natural source(d): A product can be described as "natural source" if it contains a medicinal ingredient obtained via extraction.
• Ingredients found in nature that are obtained by chemical synthesis or other means may not be referred to as "natural" or "natural source(d)" (the word synthetic is included on labels when the ingredients are synthetically manufactured).

2.15 Natural Action / Naturally

Guideline

It is misleading to claim that a product acts "naturally" since all NonRx drugs including NHPs modify the body's physiological processes.

Application

• A product's therapeutic effect cannot be described as "natural action" or as "acting naturally".

2.16 Need

Guideline

An advertisement must not mislead consumers by suggesting that the advertised product is essential.

Application

• It is not acceptable for an advertisement to claim that a consumer "needs" a specific product. However, it is acceptable to suggest that an individual "needs relief".

2.17 New / Improved

Guideline

The terms of "new" and "improved" may be used for a period of one year from the date of marketing a new formulation.

Application

• The nature of the improvement should be clearly communicated, e.g., "improved taste", "improved format".

2.18 Organic (See also: "2.14 Natural")
NHP Reference Document: Product Licensing Guidance Document

Guideline

An advertisement must not mislead a consumer to believe a product is "organic" unless it is certified according to organic standards.

Application

• Advertisers must provide evidence of certification, i.e. copy of Organic Certificate. Certification according to any standard reference by a certification body is acceptable.
• Products that are certified organic or contain certified organic ingredients may display the following terms and symbols:
  • Organic
  • Organically grown
  • Organically raised
  • Organically produced
  • Trademark of the certification body.
  1. When the percent certified organic content expressed as a percentage¹⁰ of total ingredients by mass or fluid volume, excluding water and salt, is 95% or more, the following claims and symbols are permitted:
     • Organic, and
     • All other terms above, and
     • Trademark of certification body
  2. When the percent certified organic content is 70% or more, the following claims are permitted:
     • "Contains X% organic ingredients" or
     • "Contains X% certified organic ingredients" when the certified organic ingredients are listed; or
     • "Contains X% organic "Y'", when the actual (X) percentage of a specified ingredient "Y" constitutes 70% or more of the total ingredients.
  3. When the percent certified organic content is less than 70%, the following claims are permitted:
     • Certified organic ingredients labelled as "organic" in the list of ingredients only.

2.19 Potent / Potency (See also: 2.20 Power / Strength)

Guideline

NonRx drugs : It is misleading to refer to nonprescription drugs as being "potent" or having a "potent" formulation.

NHPs : It is misleading to refer to NHPs as "potent", however claims for "potency" (as defined in the NHP Regulations) are permissible for NHPs when part of the PL.

DIN-HM : For homeopathic medicines, the term "potency" refers to the "quantity" as defined in the NHP Regulations.

Application

• All NonRx drugs are adequately medicated to be effective as per their authorized therapeutic indications. Therefore, the relief to be derived from a NonRx drug is an indicator of its effectiveness and not its "potency".

• As per section 5(c)(iii) of the NHP Regulations: "Potency": amount per dosage unit of the standardized component which further characterises the quantity -- "Quantity": amount of medicinal ingredient per dosage unit.

• The potency of homeopathic medicines is to be expressed by dilute factor expression as set out in Evidence for Homeopathic Medicines Guidance Document¹¹ .

2.20 Power / Strength (See also: "2.19 Potent / Potency" and "2.9 Extra Strength / Maximum Strength")

Guideline

It is misleading to suggest that a particular product is more than sufficiently medicated to relieve/treat/prevent a particular condition or symptom.

It is misleading to suggest that there is a correlation between the amount of medicinal ingredient and degree of efficacy unless this is part of the TMA.

Application

• All drugs are formulated (i.e., are "sufficiently medicated") to be effective for the condition/symptoms they are designed to relieve/treat/prevent.
• It is thus appropriate to claim that a product is "sufficiently medicated", e.g., "effective", "strong enough", or "tough enough", for the condition or symptoms it is designed to relieve/treat/prevent. It is unacceptable to suggest that the product, in and of itself, is "strong", "powerful" or "tough".

2.21 Risk Information Communication

Guideline

Consumers must be made aware of serious adverse drug reactions associated with the use of the advertised product (either information already established or newly discovered information) in order to make informed decisions. Consequently, Health Canada has determined that in cases where an "Advisory/Warning" has been issued and posted on Health Canada's Website about a specific NonRx drug including a NHP, or medicinal ingredient, this information should be communicated to consumers in advertising, or, at a minimum, consumers should be directed to a source for such information.

Note: Consumer Advisories/Warnings for health products are posted on Health Canada's Website on an ad hoc basis to alert consumers of important new health and safety product information (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html).

Application

• Promotional material for such products should describe both the positive effects and the associated known serious adverse reactions so that the consumer can make an informed choice of medication.
• If the advertised product, when used according to the directions has known serious adverse reactions¹² (in terms of severity and clinical importance) or is contraindicated for a known group of people because it could cause serious adverse reactions, an appropriate warning of those reactions must be given in the advertisement.
  • Such advertisements must contain the following statements (or words with the same meaning): "Always read the label" & "Use only as directed".
  • Where relevant to the product, i.e. if the indication is for symptomatic relief, or a similar indication, such advertisements must contain the following statement (or words with the same meaning): "If symptoms persist see your health care professional".

2.22 Risk Reduction Claims

Guideline

Description: describes the relationship between using a medicinal ingredient and reducing risk of developing a specific disease or abnormal physiological state, by significantly altering a major risk factor or factors recognized to be involved in the development of the chronic disease or abnormal physiological state.

Application

• It is unacceptable to make a risk reduction claim if it is inconsistent with the Terms of Market Authorization and if it:
  • Is related to Schedule A (See Schedule A and Section 3: Guidance Document at:
    http://www.hc-sc.gc.ca/hpfb-dgpsa/sched_a_gui_doc_cp_e.html)
  • Requires a prescription drug
  • Is not appropriate for self diagnosis
  • Is one that requires monitoring by a health care provider.

2.23 Safe / Side Effect Free (See also: "2.2 Absence of Side Effect Statements")

Guideline

Claims for "safe" and "side effect free" are unacceptable.

Application

• It is misleading to suggest that a product is "safe" or "side effect free" since all products carry some degree of risk.
• It is misleading to suggest that a product is "safe" or that it can be used without harm or without side effects because it is derived from nature.

2.24 Sampling

Guideline

In accordance with Section 14 of the Food and Drugs Act, which prohibits the distribution of drugs as samples to the general public, advertising for drug sampling is prohibited.

Application

• Advertisements must not include offers for samples to the general public.

2.25 Scare Advertising

Guideline

An advertisement must not create an erroneous impression regarding the merit of a product by using fear-inducing copy or dramatic devices.

Application

• An advertisement must not:
  • Suggest that the health of a consumer will suffer, or that full health cannot be attained without using the advertised product.
  • Describe the possible consequences of not treating a condition or disorder.
  • Describe more serious diseases or effects that may result from the original condition if left untreated.

2.26 Storage Conditions

Guideline

An advertisement must not mislead consumers regarding the safe and appropriate storage conditions of a product.

Application

• When depicted or described, the storage conditions must be consistent with the TMA.

2.27 Structure Function Claims

Guideline

Description: describes the effect of a medicinal ingredient on a structure or physiological function in the human body, or a medicinal ingredient's support of an anatomical, physiological, or mental function.

Application

• It is unacceptable to make a structure function claim if it is inconsistent with the Terms of Market Authorization and if it:
  • Is related to Schedule A (See Schedule A and Section 3: Guidance Document at:
    http://www.hc-sc.gc.ca/hpfb-dgpsa/sched_a_gui_doc_cp_e.html)
  • Requires a prescription drug
  • Is not appropriate for self diagnosis
  • Is one that requires monitoring by a health care provider.

2.28 Superscripts / Footnotes or "Supers"

Guideline

Superscripts and footnotes (also known as "supers") must not be used to correct an otherwise misleading impression about a product.

Application

• Superscripts or footnotes may be used to provide clarification or additional information about a product.
• Superscripts/Footnotes must appear clear, legible and be understood by the consumer
• If a super is necessary for the ad to be considered acceptable, this super must stay on screen for a sufficient length of time to be read by the average person.

2.29 Testimonials / Quotations (See also: "2.7 Endorsements / Seals")

Guideline

It is misleading to use a testimonial or quotation to state or imply a benefit that exceeds a product's TMA.

Application

• No claim in advertising, regardless of the source may exceed those permissible in the product's TMA.

2.30 Therapeutic Guarantees / Absolute Claims

Guideline

Some individuals may respond to a particular medication and others may not, part of the inherent variability of drug action in a population. Therefore, an advertisement must not be misleading as to the merits of a product by directly or indirectly suggesting that it will be effective for all individuals, or that it will be effective every single time it is used.

Application

• When depicted or described, an advertisement must realistically present the product's efficacy.

Note: Guarantees of purity, quality or physical characteristics are acceptable (i.e., guarantees about non-therapeutic attributes) if true and supportable

2.31 Therapeutic Claims

Guideline

Description: relate to the diagnosis, treatment, and mitigation or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans.

Application

• It is unacceptable to make a therapeutic claim if it is inconsistent with the Terms of Market Authorization and if it:
  • Is related to Schedule A (See Schedule A and Section 3: Guidance Document at:
    http://www.hc-sc.gc.ca/hpfb-dgpsa/sched_a_gui_doc_cp_e.html)
  • Requires a prescription drug
  • Is not appropriate for self diagnosis
  • Is one that requires monitoring by a health care provider.

2.32 Unique

Guideline

It is misleading to describe a product as unique if it does not provide a unique or exclusive therapeutic benefit/effect.

Note: Any claims for "unique" that meet the Health Canada definition of a comparative therapeutic claim must meet the requirements set forth in Health Canada's Directive and Guidance Documents regarding Comparative Therapeutic Advertising and Advertising Standards Canada Therapeutic Comparative Advertising SOPs

Application

• It is unacceptable to claim that a product has a unique therapeutic formulation or provides a unique therapeutic benefit unless the product is unique in both therapeutic formulation and effect and that this term is part of the market authorization for the product.

• The term unique is acceptable when used to accurately describe non-therapeutic/cosmetic product features, e.g. unique fragrance.

2.33 Withdrawal of Terms of Market Authorization

Guideline

Advertising is not permitted for products for which the TMAs have been withdrawn by Health Canada for health and safety reasons, or for products which have voluntarily been withdrawn or discontinued by the manufacturer.

Application

• In the case of a product for which the TMAs have been withdrawn, or products voluntarily discontinued by the manufacturer, the preclearance agency will immediately revoke any previously assigned approval numbers.

Note: Product Advisories and Warnings are posted on Health Canada's website (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html).

Section B
Legislation, Regulations and Policies¹³

B.1. Definitions Under the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations¹⁴

Advertisement (Food and Drugs Act Section 2):

'advertisement' includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device

Drug (Food and Drugs Act Section 2):

'drug' includes any substance or mixture of substances manufactured, sold or represented for use in

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals,
2. restoring correcting or modifying organic functions in human beings or animals, or
3. disinfection in premises in which food is manufactured, prepared or kept

Brand name (Food and Drug Regulations Section C.01.001(1))

'brand name' means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

1. that is assigned to the drug by its manufacturer,
2. under which the drug is sold or advertised, and
3. that is used to distinguish the drug

Natural Health Product (NHP Regulations Section 1(1))

"natural health product" means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
2. restoring or correcting organic functions in humans; or
3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

Schedule 1: INCLUDED NATURAL HEALTH PRODUCT SUBSTANCES

Schedule 2: EXCLUDED NATURAL HEALTH PRODUCT SUBSTANCES

Product Licence (NHP Regulations Section 14(1))

A product licence shall set out the following information:

1. the name and address of the licensee;
2. the product number of the natural health product;
3. the dosage form that is authorized for the natural health product;
4. the recommended route of administration that is authorized for the natural health product;
5. the recommended dose that is authorized for the natural health product;
6. the recommended duration of use, if any, that is authorized for the natural health product;
7. in respect of each medicinal ingredient of the natural health product
   1. its authorized quantity per dosage unit,
   2. its authorized potency, if any, and
   3. its authorized source material;
8. the recommended use or purpose that is authorized for the natural health product; and
9. the date on which the licence was issued

Note: For NHPs, the Product Licence constitutes the Terms of Market Authorization.

OTHER DEFINITIONS

Brand Name (NHP Regulations Section 1(1))

"Brand name" means a name in English or French, whether or not it includes the name of a manufacturer, corporation, partnership or individual

1. that is used to distinguish the natural health product; and
2. under which a natural health product is sold or advertised

Drug Identification Number (DIN)

A Drug Identification Number is an eight (8) digit numerical code following the acronym DIN assigned by Health Canada to a particular drug when it is authorized for sale.

Homeopathic Medicine (Evidence for Homeopathic Medicines Guidance Document)

Medicines that are manufactured from or contain as medicinal ingredients only those substances or sources referenced in the Homeopathic Pharmacopoeia of the United States (HPUS), the Homoopathische Arzneibuch (HAB), the Pharmacopée francaise (PhF) or the European Pharmacopoeia, as they are amended from time to time, and that are prepared in accordance with these pharmacopoeias.^15,16

Homeopathic Medicine Number (DIN-HM)

A Homeopathic Medicine Number is an eight (8) digit numerical code following the acronym DIN-HM assigned to each homeopathic medicine authorized to be marketed under the Natural Health Products Regulations.

Natural Product Number (NPN)

A Natural Product Number is an eight (8) digit numerical code following the acronym NPN assigned by Health Canada to a particular NHP when it is authorized for sale.

TERMS OF MARKET AUTHORIZATION / AUTHORIZED PRODUCT INFORMATION

Drugs

For drugs that are subject to the requirements of Division 8 , Part C of the Regulations (new drugs), the Terms of Market Authorization are comprised of all information in the Product Monograph (PM) that accompanies the Notice of Compliance (NOC) and in the document that assigns a DIN and related product labelling.

For drugs that are not subject to Division 8 , Part C of the Regulations , the Terms of Market Authorization are identified in the document that assigns a DIN and related product labelling. This information is derived from the review of information on the drug product that is required to be submitted for regulatory review and authorization, as outlined in the Food and Drugs Act and Regulations and interpretive guidelines and policies.

It is important to note that during the course of a screening review of Category IV Monograph and Labelling Standard products, Health Canada does not conduct a complete label review. The Health Canada review is limited to the verification of the minimum requirements related to ingredients, concentrations, basic indications, directions and warnings as outlined in the appropriate Monograph. It is the manufacturer's responsibility to ensure that all non-therapeutic claims, variations and expansions of Monograph claims and all other additional claims are consistent with the Monograph, Labelling Standard and Food and Drugs Act and Regulations.

Natural Health Products

For NHPs, the Product Licence (PL) constitutes the TMA.

It is important to note that an NHP that is authorized by Compendial Monograph (CM) submission may only make those claims that appear on the CM the PL are referring to. Claims found in a PL, but not authorized by Health Canada for that particular product, must be authorized by Health Canada through the appropriate regulatory submission before they may be used in advertising.

Therapeutic Claim (Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document)

A claim which relates to the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans.

Transition Period¹⁷

As of January 1, 2004, the Natural Health Products Regulations (Regulations) came into force and apply to all NHPs.

There is a six-year transition period for product licensing, from January 1, 2004 to December 31, 2009, for natural health products with Drug Identification Numbers (DIN) issued under the Food and Drug Regulations. The applicable provisions of the Food and Drug Regulations continue to apply for products with a DIN until they are licensed under the Natural Health Products Regulations at which time they will receive a Product Licence (PL) and a Natural Product Number (NPN) or an Homeopathic Medicine Number (DIN-HM).

From January 1, 2004, all NHPs (i.e. products not previously authorized for sale) that fit the natural health products definition (see Overview of the Natural Health Products Regulations Guidance Document) must comply with the Natural Health Products Regulations immediately and must be subject to the full licence application process in order to be sold in Canada.

All natural health products must comply with all the Regulations by January 1, 2010.

Advertising claims will be assessed against the regulatory status in effect for the advertised product at the time of submission to the Health Canada endorsed preclearance agency. As described above, if a product still has a DIN, the claims contained in the DIN authorization are permissible in advertising. If a product has an NPN or a DIN-HM, the claims contained in the PL are permissible in advertising. Products that meet the definition of a NHP, but have neither a DIN nor an NPN or a DIN-HM must obtain a PL before any advertising for that product can be approved by the Health Canada endorsed clearance agency.

B.2. Legislation, Codes and Policies that Apply to Marketed Health Product Advertising

The full text of sections C.01.012, C.01.015(2)(f), C.01.044, and C.01.0625 can be found in Appendix D.

Food and Drugs Act - Umbrella Requirement

The Food and Drugs Act applies to both NHPs and NonRx drugs.

Section 3 of the Food and Drugs Act - Schedule A

3(1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A²⁰.

(2) No person shall sell any food, drug, cosmetic or device
that is represented by label, or
that the person advertises to the general public
as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

(3) Except as authorized by regulation, no person shall advertise to the general public any contraceptive device or any drug manufactured, sold or represented for use in the prevention of conception.

Section 9(1) of the Food and Drugs Act - Deception

9(1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

Section 14 of the Food and Drugs Act - Sampling

No person shall distribute or cause to be distributed any drug as a sample.

Food and Drug Regulations

Section C.01.007 - Reference to the Act & Regulations

No reference, direct or indirect, to the Act or to these regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these regulations

Section C.01.027 - Limit Dose Drugs

(1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it

1. contains a drug set out in the table to section C.01.021²¹; and
2. carries on its label
   1. a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or
   2. a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug.

Subsection (1) does not apply to products containing

1. acetaminophen
2. acetylsalicylic acid;
3. choline salicylate;
4. magnesium salicylate; or
5. sodium salicylate.

(3) Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers.

Section C.08.002(1) - New drugs

No person shall advertise a new drug unless

1. the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister;
2. the Minister has issued, pursuant to section C.08.004²², a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission;
3. the notice of compliance in respect of the submission has not been suspended pursuant to section C.08.006²³; and
4. the manufacturer of the new drug has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with that new drug, and a statement setting out the proposed date on which those labels will first be used.

G.01.007 - Controlled Drugs

No person shall

1. advertise a controlled drug to the general public

Natural Health Products Regulations

Section 2(2) - Product is not an NHP if prescription is required

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.01.043²⁴ of those Regulations.

Section 92 - Reference to the Act & Regulations

No reference, direct or indirect, to the Act, the Food and Drug Regulations or to these Regulations shall be made on any label of or in any advertisement for a NHP unless the reference is specifically required by law.

Section 103 - Tablet Disintegration Times

Subsection C.01.015(1)²⁵ and paragraphs C.01.015(2)(d) to (f) of the Food and Drug Regulations apply in respect of natural health products.

Narcotic Control Regulations
Section 70

No person shall
(c) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic;

Other Applicable Code
Canadian Association of Broadcasters (CAB) Broadcast Code for Advertising to Children

The Canadian Association of Broadcaster's Code states:
All Children's advertising must conform to the Code, be pre-cleared in accordance with the procedures set out from time to time by the ASC and have the requisite ASC clearance number.

The Code defines "Children's Advertising" as:
Any paid commercial message that is carried in or immediately adjacent to a children's program. Children's advertising also includes any commercial message that is determined by the broadcaster as being directed to children and is carried in or immediately adjacent to any other program.

Product Prohibitions - Clause 4(b)

Children's advertising is prohibited for:
Drugs, proprietary medicines and vitamins in any pharmaceutical form, with the exception of children's fluoride toothpastes.

Health Canada Advertising Policies

Numerous Health Canada policies and guidelines apply to the advertising of marketed health products. They may be found on the Health Canada website at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html and are listed below.

Health Canada Advertising Policies on the Health Canada Website at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index_e.html:

• Therapeutic Comparative Advertising: Directive and Guidance Document
• ASC and Health Canada Roles and Consultation Related to Advertising Review
• Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products
• The Distinction Between Advertising and Other Activities
• Fact Sheet - Overview of Drug Advertising
• Absence of Ingredient Statements (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/absence_pol_e.html)
• Schedule A and Section 3: Guidance Document (http://www.hc-sc.gc.ca/hpfb-dgpsa/sched_a_gui_doc_cp_e.html)

B.3. Appendix Material

Appendix A - Schedule A to the Food and Drugs Act

Schedule A to the Food and Drugs Act includes a number of diseases, disorders or abnormal physical states. Section 3 of the Act prohibits the advertising to the general public of any food, drug, cosmetic or device for the treatment, prevention or cure of any of the diseases listed on Schedule A. The section also prohibits the sale of a food, drug, cosmetic or device that is labelled in this manner.

The basis of this prohibition against claims relating to diseases listed in Schedule A is Section 3 of the Act which states:

3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A

(2) No person shall sell any food, drug, cosmetic or device

1. that is represented by label, or
2. that the person advertises to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

(3) Except as authorized by regulation, no person shall advertise to the general public any contraceptive device or any drug manufactured, sold or represented for use in the prevention of conception.

Section 3 and Schedule A to the Food and Drugs Act were originally meant to:

1. prevent fraud;
2. prohibit advertisements to the public respecting treatments for conditions where no treatments existed;
3. prohibit the advertisement of treatments where self treatment was not considered safe; and
4. encourage people to seek medical attention for serious conditions.

Schedule A and Section 3: Guidance Document available at: http://www.hc-sc.gc.ca/hpfb-dgpsa/sched_a_gui_doc_cp_e.html.

Appendix B - Appendix 2 of Product Licensing Guidance Document (NHP)

When changes are required to information relating to licensed natural health products, licensees must make Natural Health Products Directorate aware of these changes. Some changes, which do not affect the safety and efficacy of the product, only require the licensee to notify NHPD within 30 days of making the change. [Natural Health Products Regulations: section 12] These types of changes include changes to licensee contact information or approved brand names (see Appendix 2).

Other changes are those that may affect the safety and efficacy of the product, and as such must be evaluated by NHPD before the change is implemented. [Natural Health Products Regulations: section 11] These types of changes include changes to the recommended dose or recommended use or purpose (see Appendix 2). When NHPD consider the changes to be acceptable, NHPD will issue an amended licence (the product number remains the same).

Some changes to a product are so fundamental that they require a complete new product licence application. In this case, NHPD issues a new product licence and product licence number. [Natural Health Products Regulations: section 13] These types of changes include changes to the dosage form, or addition of a medicinal ingredient (see Appendix 2).

Licensees must provide NHPD with information relating to the sites where it manufactures, packages, labels and, when applicable, imports the natural health product.

The licensee must maintain records of the ingredients contained in each lot or batch of the natural health product, and sufficient information to enable a recall of each lot or batch. [Natural Health Products Regulations: section 23]

Appendix C - Excerpts from the Health Canada Policy Changes to Marketed New Drug Products

When changes are required to information relating to marketed new drug products, manufacturers must make Health Canada aware of these changes. Changes to marketed drug products have been grouped into 4 categories (Level 1, 2, 3 and 4) based on the significance of the change and therefore the potential impact on safety and efficacy.

Level 1 - Supplemental New Drug Submission

Level 1 changes are those for which a supplemental new drug submission must be filed pursuant to C.08.003. A Notice of Compliance is required before proceeding with such a change.

1. in the identifying name of the drug product or the brand name;
2. in the dosage form or strength of the drug product;
3. in the formulation, method of manufacture, equipment, or process control of the drug product that requires supporting clinical or bioequivalence data;
4. in the case of Schedule C and D drugs, in the production site, method of manufacture, equipment and process control of the drug substance or in the formulation, method of manufacture, equipment, process control or production site of the drug product;
5. in the labelling including package inserts, product brochures, file cards, and product monographs of the drug product respecting, either explicitly or implicitly:
   1. the recommended route of administration of the drug product,
   2. the dosage of the drug product, and
   3. the claims, including indications, made for the drug product;
6. for sterile drug products, in the specifications to remove the sterility test and replace it with process parametric release.

Level 2 - Notifiable Change (Notice of Intention to Change)

Level 2 changes are those considered to be notifiable. Changes identified in Level 2 require the preparation and filing of the same level and detail of information and scientific justification as is currently required in a supplemental new drug submission. This information and material must be filed prior to the institution of the change. Unless a written objection is received from the Branch within 90 days, the manufacturer may proceed with the change.

1. subject to Level 1 (4), in the production site or method of manufacture of the drug substance;
2. subject to Level 1 (6) and Level 3 (3) & (4), in the specifications of the drug product or the drug substance or the non-medicinal ingredients in the drug product. Provided the conditions of the notice of compliance are not affected, this does not apply to changes in specifications that are required to comply with a standard contained in any publication referred to in Schedule B to the Act;
3. subject to Level 1 (3) & (4), in the formulation, method of manufacture, equipment, process control, or production site of the drug product;
4. subject to Level 3 (1), in the specifications or composition of packaging materials which are either in direct contact with the drug product or help to ensure the stability, sterility or delivery of the drug product;
5. subject to Level 1 (5), in the location of text in the labelling or an addition to the labelling, including package inserts, product brochures, file cards and product monographs, respecting;
   1. overdose symptoms, treatment and related toxicological information,
   2. side effects, contra-indications, warnings and precautions, where no direct or indirect new claim is made, and
   3. references cited;
6. subject to Level 3 (5), in the conditions of storage and expiration period of the drug product;
7. in the case of parenteral drug products, in the container size of the product.

Level 3 - Notice of Change

Level 3 changes are those for which a written notice of change is required. Although supporting data should not be submitted, the data must be available on the manufacturer's premises. The manufacturer may proceed immediately to make the change, but should submit a compilation of all level 3 changes for each of their products in one annual update to be filed with the annual (DIN) notification.

Level 3 changes are those made:

1. with respect to solid drug products, in the specifications of packaging materials which are either in direct contact with the drug product or help to ensure the stability, sterility or delivery of the drug product;
2. with the exception of parenteral drug products, in the container size of the product which do not affect conformity with the conditions of the notice of compliance;
3. in analytical methods that maintain or increase precision, accuracy, specificity and sensitivity;
4. in the specifications which add a test or tighten existing limits or test criteria;
5. subject to the Policy on Extension of Expiration Dates (Dec. 24, 1991), in the expiration period of the drug product when the original expiration period is 2 years or more.

Level 4

Changes not listed in Levels 1-3 may be made without notification. Manufacturers are expected to maintain a list of level 4 changes.

Appendix D - Excerpts from the Food and Drug Regulations

C.01.012

A manufacturer who makes representations on the label of a drug in oral dosage form, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of the drug, or the availability to the body of a medicinal ingredient of the drug shall,

1. before making the representations, conduct such investigations, using an acceptable method, as may be necessary to demonstrate that the site, rate or extent of release to the body of the medicinal ingredient of the drug and the availability to the body of the medicinal ingredient of the drug, correspond to the representations; and
2. on request submit the record of such investigations to the Director

C.01.014.4

If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information,

1. in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f)
   1. that occurs prior to the sale of the drug, a new application shall be made, or
   2. that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and
2. in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k)
   1. that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or
   2. that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Director of the change.

C.01.015(1)

Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,

1. in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;
2. in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and
3. in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.

(2) Subsection (1) does not apply in respect of a drug in the form of a tablet where

1. a notice of compliance in respect of the drug in the form of a tablet has been issued pursuant to section C.08.004;
2. [Repealed, SOR/98-423, s. 7]
3. a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;
4. the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;
5. the drug has been demonstrated by an acceptable method to be available to the body; or
6. representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.

C.01.015(2)(f)

Subsection (1)²⁶ does not apply in respect of a drug in the form of a tablet where (f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.

C.01.021

Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and outer labels other than the inner label of a single dose container carry a statement of

1. the quantitative content of the drug, and
2. the recommended single and daily adult dose designated as such, except for
   1. preparations solely for external use, or
   2. preparations solely for children's use, and
3. adequate directions for use when the drug is recommended for children which shall be either
   1. the statement, "CHILDREN: As directed by a physician", or
   2. a suitably reduced maximum single and daily dose which shall not exceed the following:
      
      

      Age in Years	Proportion of adult dose
      10-14	one-half
      5-9	one-fourth
      2-4	one-sixth
      under 2 years	as directed by physician.

Table of limits of drug dosage for adults

Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced. Accurate dosages may be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.

C.01.043

1. A person may sell a Schedule F Drug, without having received a prescription therefor, to
   1. a drug manufacturer;
   2. a practitioner;
   3. a wholesale druggist;
   4. a registered pharmacist;
   5. a hospital certified by the Department of National Health and Welfare;
   6. a Department of the Government of Canada or of a province, upon receipt of a written order signed by the Minister thereof or his duly authorized representative; or
   7. any person, upon receipt of a written order signed by the Director.
2. Where a person makes a sale authorized by paragraph (1)(f) or (1)(g), he shall retain the written order for the drug for a period of at least two years from the date of filling the order.