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Draft Guidance Document Labelling of Pharmaceutical Drugs for Human Use

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Contact: Policy Bureau Enquiries

Notice

July 7, 2010

Our file number: 10-112274-341

Release of Draft Guidance Document for Consultation: Labelling of Pharmaceutical Drugs for Human Use

Health Canada is pleased to announce the release of the draft guidance document Labelling of Pharmaceutical Drugs for Human Use for stakeholder consultation.

The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations, the Controlled Drugs and Substances Act, and its related Regulations including the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations and the Benzodiazepines and Other Targeted Substances Regulations. Once finalised, adherence to this guidance is expected to support the safe and effective use of drugs by health care professionals, patients, and consumers.

It should be noted that the previous guideline, Labelling of Drugs for Human Use, revised in 1991, is no longer available or in use. Sponsors may, therefore, use the draft document as an acceptable approach with respect to labelling, until such time as the guidance is finalized.

This guidance document is applicable to pharmaceutical drug products for human use. It is not applicable to disinfectants, drugs for veterinary use, drugs regulated solely as natural health products subject to the provisions of the Natural Health Products Regulations, and radiopharmaceuticals and biological drugs as listed in schedules C and D of the Food and Drugs Act.

The development of this draft guidance document is the result of a thorough survey of existing Canadian legislation, regulations, guidance documents, policies and current practices within Health Canada.

Comments should be provided to Health Canada, preferably in electronic format using the attached template, within 120 days from the date of this notice. All comments will be considered in the finalization of the draft guidance.

Comments should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Fax: (613) 941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

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Labelling of Pharmaceutical Drugs for Human Use
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Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Table Of Contents

1. Introduction

1.1 Policy Objectives

It is Health Canada's policy that labelling of pharmaceutical drug products for human use:

  1. complies with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act (the Act),as well as related provisions of the Food and Drug Regulations (the Regulations), the Controlled Drugs and Substances Act, and its related Regulations including the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations and the Benzodiazepines and Other Targeted Substances Regulations;
  2. is consistent with the Health Canada guidance documents and policies that apply to pharmaceutical drug products for human use; and
  3. supports the safe and effective use of drugs by health care professionals, patients, and consumers.

1.2 Scope and Application

This guidance document is applicable to pharmaceutical drug products for human use. It is not applicable to disinfectants, drugs for veterinary use, drugs regulated solely as natural health products subject to the provisions of the Natural Health Products Regulations, and radiopharmaceuticals and biological drugs as listed in schedules C and D of the Food and Drugs Act.

This guidance document contains:

  • excerpts from the Food and Drugs Act and Food and Drug Regulations, and related Acts and Regulations;
  • definitions of terms; and
  • current interpretations of labelling requirements by Health Canada personnel based on legal precedents, advisory opinions, and precedent product decisions.

The examples provided in this guidance are for illustrative purposes only and do not represent actual drug products.

1.3 Background

Labelling of Pharmaceutical Drugs for Human Use replaces the Health Canada guidance document Labelling of Drugs for Human Use. This guidance document came into effect in 1989, was subsequently revised in 1991, and has since been removed from circulation by Health Canada because much of its content was deemed to be out-of-date.

2. Eneral Labelling Requirements

The labelling of drugs is governed by sections 3, 9, and 10 of the Act and by sections contained in Parts A, C, D, G, and J of the Regulations. Part A is more general and refers to the labelling of food and drugs, whereas parts C, D, G, and J refer to drugs only.

Section 9 of the Act states that:

  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.
  2. A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the Regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Section 3 of the Act states that

  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.

For exceptions to this rule, please refer to Section 2.7, "Schedule A Claims," of this guide. Sponsors should consult the Regulations for specific labelling requirements for specific drugs, as this information is not part of this guidance document.

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2.1 Placement of Information

Specific requirements of the Food and Drug Regulations for the placement of information on labels are summarized below. Health Canada's interpretation of these requirements is further detailed in Section 3, "Label Information," of this guide.

2.1.1 Main Panel or Principal Display Panel

The main panel or principal display panel is the main product display surface visible to the user under normal or customary conditions of display or use. Pursuant to sections C.01.004 and C.01.005 of the Regulations, the main panel of an inner or outer label should carry the following information:

  • The brand name or if no brand name exists the proper or common name, if applicable;
  • The proper or common name of the finished product, if applicable;
  • The standard for the drug, if any;
  • The notation "sterile (stérile) ," if so required by the Regulations;
  • The scheduling symbol, if required; and
  • The Drug Identification Number (DIN).

Note: The labelling of small containers is exempt from these requirements. See sections 3.6.2 and 3.6.3 of this guide for more information.

2.1.2 Any Panel

Pursuant to section C.01.004 of the Regulations, the following information should be disclosed on any panel of the inner and outer labels:

  • The name and address of the manufacturer, and of the distributor if the manufacturer is not Canadian;
  • The lot number;
  • The expiration date;
  • Adequate directions for use of the drug; and
  • A quantitative list of the medicinal ingredients.

The following information is to be disclosed on any panel of the outer label:

  • The net amount of drug; and
  • A quantitative list of all preservatives in parenteral preparations and of all mercurial preservatives in any drug containing mercury.

Note: The labelling of small containers is exempt from these requirements. See sections 3.6.2 and 3.6.3 of this guide for more information.

2.2 Official Languages

The Regulations state that:

The adequate directions for use required to be shown on the inner and outer labels of a drug pursuant to subparagraph C.01.004 (1)(c)(iii) shall be in both the French and English languages if the drug is available for sale without a prescription in an open self-selection area.
(subsection A.01.015(2))

An "open self-selection area" is a retail area where a drug is freely available for selection and purchase by the general public. Therefore, prescription drugs, drugs available in hospitals and clinics only, or drug products for professional use only do not require bilingual labelling. The manufacturer can label these drugs in the customer's choice of language.

Note that some provincial regulatory requirements may go beyond existing federal Regulations and may specify further labelling language requirements (for example [e.g.], in Quebec).

2.3 Legibility

The Regulations are flexible regarding type size. However the Regulations state:

"All information required to appear on a label of a food or drug shall be:
clearly and prominently displayed on the label; and
readily discernible to the purchaser or consumer under the customary conditions of purchase and use." (section A.01.016)

Sponsors should consider the colour, contrast, position, and spacing of the information when complying with the above general requirement. Health Canada recommends a font size of 10 points for text and a minimum of nine points for inner and outer labels and tables for the labelling of consumer information. For further information, refer to the Guidance to Industry: Product Monograph.

2.4 Abbreviations

The proper or common names of the drug and any ingredient in the drug must not be abbreviated in any manner.

The names of pharmacopoeialcompendia may be abbreviated as indicated in Schedule B of the Act. Units of weight, volume, or potency may be abbreviated according to the Weights and Measures Act or where that abbreviation is in common use and considered to be understood by the consumer. Standard units of measure and abbreviations (e.g., ounces, oz.) may be included on the label provided that the metric units are also present. Acceptable abbreviations for microgram are "μg" and "mcg"; however, Health Canada recommends that mcg be used where possible, as μg may be difficult to see in some print and size formats.

Abbreviations used exclusively to describe routes of administration (e.g., "i.v." for intravenous) or other product attributes are generally discouraged in consumer labelling and for most prescription drugs. Abbreviations should appear in full at least once if used elsewhere in the information. Labels affixed to small containers (e.g., vials, ampoules) may contain only an abbreviation (e.g., i.v.) provided that the outer labelling (e.g., carton) indicates the term in full.

In the prescribing information section of Product Monographs, or other labelling directed toward health care professionals, and in labelling directed toward consumers, abbreviations and acronyms should appear in full at least once if used elsewhere in the information.

For further information regarding the use of abbreviations in drug labelling, see the resources listed in Appendix C.

2.5 Reference to the Act and Regulations

The Regulations state that:

No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations. (subsection C.01.007)

Labels that may be considered in violation of subsection C.01.007 are those that make any mention of Health Canada or a component of Health Canada. This includes but is not limited to the following phrases and symbols:

  • Health Canada approved, Health Products and Food Branch (HPFB) approved, Therapeutic Products Directorate (TPD) approved;
  • Registered (or endorsed or promoted or acceptable or recommended) by Health Canada, (HPFB, TPD, or any other acronym commonly associated with Health Canada); or
  • Use of the Health Canada logo.
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2.6 Voluntary Industry Guidelines

This guidance document provides an interpretation of the minimum label requirements for pharmaceutical drug products. Numerous third party guidance documents exist, many by independent professional associations or public interest groups, which provide further guidance for labelling. Additional product labelling, standardized formatting, or other considerations suggested by these documents are acceptable provided they do not conflict with regulatory requirements. See Appendix C for other sources of guidance for labelling.

2.7 Schedule A Claims

Section 3 of the Act prohibits the labelling and advertising of a drug to the general public, as a treatment, preventative, or cure for the diseases, disorders, or abnormal physical states, including synonymous names, listed in Schedule A of the Act. However, there are three cases where Schedule A diseases can be mentioned in labelling:

  1. Pursuant to section C.01.010 of the Regulations, where mention of the condition is necessary to provide adequate directions for the safe use of a parenteral drug or drug listed in Schedule F of the Regulations;
  2. When such conditions are mentioned as part of precautions or contraindications; and
  3. Under sections A.01.066 to A.01.068 of the Act, non-prescription products can be labelled with an authorized preventive claim related to a disease listed in Schedule A. Refer to the Health Canada draft guidance document, Schedule A and Section 3 to the Food and Drugs Act for further information.

2.8 Novel Label Formats

Novel label formats such as peel-back, accordion labels, tags, collar labels, and rotating sleeve bottle labels, and labels on the inside of cartons, bottom of containers, or in any other unusual locations may be acceptable provided that:

  1. gaining access to these labels does not destroy or harm the integrity of the labelling (that is [i.e.], it can be read after opening);
  2. consumers and patients are alerted to the location of the labelling information and;
  3. placement of information does not otherwise contravene the Regulations.

Information required by the Regulations to be on the outer label (e.g., brand name, proper or common name, potency, DIN, manufacturer, and indication, class or purpose) should be clearly visible without the need to further manipulate a novel label format. In other words, obtaining this information does not require the opening or destruction of any outer label, the opening of an accordion label, the opening of a panel, or the opening of the carton itself to gain access to information on the inside.

These novel label formats should be clearly identified and explained in the drug submission.

2.9 Bar Codes

Bar codes may be used on a drug label for appropriate purposes (retail inventory, tracking, confirmation of identity, potency, etc.) provided that:

  1. all regulatory requirements concerning the label have been met and the bar code information does not change the terms of market authorization for the product; and
  2. the bar code does not obscure or displace the required and approved information on the label, especially on small product labels.

2.10 Final Labels

Pursuant to paragraph C.01.014.1(2)(m) of the Regulations, copies of proposed labels must be submitted as part of a drug submission. Submitted labels should accurately represent the final marketed labels, including final text, language, layout, font size, and order, as well as any other symbols, pictures, notations, diagrams, graphs, pictorials, and visible marks (e.g., pictures of electroencephalography [EEG] recordings). Such marks may state or imply certain therapeutic benefits or attributes that are inconsistent with the terms of market authorization for the product and may violate the Act and Regulations. All such material should be revealed at the time of pre-market submission review.

Some factors such as colour, paper, contrast, texture, and so on, cannot be finalised until printing and so do not have to be presented at the time of pre-market review. Manufacturers are responsible for ensuring that final labels are consistent with those granted market authorization.

3. Label Information

The definition of label in the Act (see Appendix A: Definitions) is interpreted to include labels affixed to the container or packaging of the drug, as well as any separate package inserts, product monographs, prescribing information, file cards, fact sheets, patient leaflets, patient diaries, or other material containing information specific to the drug. These separate package labels may be included in the packaging or supplied to the consumer at the time of sale.

3.1 Labelling Versus Other Product Information

Certain product information distributed to patients may or may not be considered labelling, as follows:

Not likely to be considered labelling:

Information regarding a disease that provides a comprehensive, balanced, and complete discussion of treatment options and does not emphasize a particular drug or therapy.

Possibly considered labelling, depending on use:

  • Meal plans (for example, as aid for those taking cholesterol-lowering drugs);
  • Patient diaries to record diet, exercise, weight loss, etc.;
  • Lifestyle advice in support of a drug therapy (for example, auxiliary methods to cope with a smoking cessation regimen).

Likely unacceptable labelling, advertising, or promotional material if distributed to patients:

Drug product information in form of scientific papers, symposia, review articles, reports, or summaries produced by bodies independent of the manufacturer, such as scientists, researchers, health professionals, patient interest groups, health professional associations, public bodies, and governments, as the information may not be balanced.

3.1.1 Distribution at the Time of Dispensing

If the intent of the information that may possibly be considered labelling is to help improve patient compliance or contribute to the effectiveness of the medication regimen, and it is distributed with the medication for this purpose at the time of dispensing or purchase, it is considered labelling.

If the above material mentions the brand name or product name (only product and no others) or several products to be used together (e.g., statin and a diuretic), then it is considered labelling. In other cases, the context and use of this information must be examined on an individual basis to determine whether the material is labelling or other information, such as advertising or general disease information.

3.1.2 Distribution after Dispensing and Purchase

If auxiliary labelling material specific to the product exceeds the limits of market authorization for the product, representing new claims, indications, and so on, then this material should be forwarded to Health Canada for review. If this auxiliary material is consistent with the approved product labelling and the terms of market authorization, and is distributed after dispensing and purchase, Health Canada may not need to review it. Manufacturers may voluntarily forward this material for review to an independent, self-regulated, industry body (e.g., the Pharmaceutical Advertising Advisory Board), which voluntarily reviews post-market, product-specific material.

Additional information is provided in the Health Canada policy document, The Distinction between Advertising and Other Activities. See Appendix B.

3.2 Inner Label

According to section A.01.010 of the Regulations, the inner label is the label affixed to an immediate container of the drug.

3.3 Outer Label

According to section A.01.010 of the Regulations, the outer label includes any label affixed to the drug packaging, including a pouch, card, accordion label, or other construct. There may be more than one outer label in a multiple packaging scheme (e.g., a vial packaged in a pouch, pouch enclosed in a carton, several cartons enclosed in a larger carton). Where a package of a drug has only one label, that label must carry all the information required on the inner and outer labels (section C.01.006).

A shipping carton, unless such a container is also the immediate container, or the outside of the package unit distributed to the consumer or health professional, is not subject to the labelling provisions of the Part C, Division 1, of the Regulations. However, manufacturers should note that shipping cartons must be labelled in such a manner as to ensure compliance with the Good Manufacturing Practices (GMP) requirements of Part C, Division 2, of the Regulations and associated guidance documents (see Appendix B). Health Canada recommends that manufacturers label the shipping carton with sufficient information to enable product identification (e.g., brand name, common or proper name, strength, and manufacturer's name).

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3.4 Main Panel

This subsection describes in further detail the information to be included on the main panel of an inner or outer label.

3.4.1 Brand Name

The brand name is the name assigned by the manufacturer and approved by Health Canada in connection with a product at the time of market authorization. In the case of a new drug, the brand name is the name that appears on the Notice of Compliance. If the drug product is not a new drug, the brand name is the name appearing on the notification form issued for the drug product and signed by the manufacturer. The brand name must be consistent on all labelling. Note that a brand name is not required. A manufacturer may choose to use a common or proper name instead of a brand name as the product name (e.g., acetylsalicylic tablets).

Any alteration of the brand name from that originally filed with Health Canada requires the submission and approval of a Supplemental New Drug Submission (SNDS) for a new drug, pursuant to paragraph C.08.003(2)(b) of the Regulations, or a new application for a Drug Identification Number (DIN) for a drug product that is not a new drug, before the new name can be used. For further information, see the Health Canada policy document, Changes in Manufacturer's Name and/or Product Name.

The Health Canada approved brand name must be presented in a continuous, uninterrupted fashion on the label, and be clearly evident to consumers and patients.

3.4.2 Proper or Common Name

Pursuant to paragraph C.01.004(1)(a) of the Regulations, when a product has a proper or a common name, this name must appear on the main panel of the inner and outer labels. In the case of official drugs labelled with a brand name, the lettering of the proper name must be in type not less than half the size of the brand name and must immediately precede or follow the brand name. Proper or common names should not be abbreviated.

For products labelled without a brand name , the proper or common name must be shown on the main panel.

3.4.2.1 Proper Name

The proper name for an ingredient is considered to be the name:

  1. assigned to that ingredient in section C.01.002 of the Regulations;
  2. that appears in boldface type in other sections of the Regulations; or
  3. assigned to the ingredient in the titles of monographs of Schedule B publications.

Where a proper name for an ingredient appears both in the Regulations and in one or more Schedule B publication, the name appearing in the Regulations takes precedence.

The proper name for a drug product in final dosage form is the name assigned to that final product in one of the Schedule B publications (e.g., Ferrous Sulfate Tablets).

Official synonyms for proper names listed in some Schedule B publications may be used instead of the title of the monograph, except where the synonyms are abbreviations or are in a language other than French or English. For example, the British Pharmacopoeia (BP)lists acceptable synonyms in Appendix XXI and these may be used in place of the non-abbreviated name. This practice is not allowed in the United States Pharmacopoeia (USP).

Some illustrative examples of proper names for ingredients versus products in final dosage form include the following:

  • Proper name of ingredient: Acetaminophen;
  • Proper name of drug product in final dosage form:Acetaminophen Capsules;
  • Proper name of a drug product combination: Acetaminophen; and Pseudoephedrine Hydrochloride Tablets.

The standard of manufacture (United States Pharmacopoeia [USP], BP, European Pharmacopoeia [EP], etc.)should be shown in close proximity (see Appendix A, Definitions) to the proper name (e.g., Acetaminophen Capsules USP, Acetaminophen and Pseudoephedrine Capsules USP) .

Note: Although in the USP the term "aspirin" appears as a proper name for an ingredient and as a proper name for a drug product in final dosage form (Aspirin Tablets), the proper name of the ingredient, as outlined in section C.01.002 of the Regulations, is acetylsalicylic acid. In this case, the name in the Regulations takes precedence and if it meets USP requirements, the final product is labelled in Canada as Acetysalicylic Acid Tablets USP.

3.4.2.2 Common Name

A common name is used in the case where there is no proper name . The common name of a drug ingredient is a name chosen by a respected body responsible for drug nomenclature, often with international recognition (e.g., International Non-proprietary Name [INN], British Approved Name [BAN]). The common name of a drug product consists of the medicinal ingredient and the dosage form.

For drugs in the form of a salt where there is no existing common name for the drug product, the naming conventions outlined in the USP Nomenclature Policy (See Appendix C) are used to determine the name:

  1. Where the strength is expressed in terms of the salt, the same salt is used as the common name for the drug.
  2. Where the strength is expressed in the terms of free acid or base, the same acid or base is used in the common name, and the name of the complete salt is also shown near this common name, on the main panel of the label. Example: Brand X Antibacterial Agent, moxifloxacin tablets 400 milligram (mg) (as moxifloxacin hydrochloride).

As the Regulations require that the proper or common names must appear on the main panel of the label, the USP Nomenclature Policy and the additional provision above, ensure that the complete salt is also shown on the main panel. These provisions ensure that the product identity is clear and they prevent inappropriate substitutions of one salt for another, where there are differences in the pharmaceutical or pharmacological properties of different salts and these differences may cause adverse effects.

3.4.2.3 Pharmaceutical Form

Where a proper or common name for a drug product in final dosage form does not exist (e.g., for a multiple ingredient product), the pharmaceutical form should be shown on the main panel of the inner and outer label.

3.4.3 Standard of Manufacture

This section refers to the standard to which a drug is manufactured and represented. The term standard can be applied to a finished product or to an ingredient.

Pursuant to subsection C.01.004(1) of the Regulations, where a standard prescribed by the Regulations exists (see Section 3.4.3.1, "Prescribed Standard") and it applies to the specific drug product, it shall be included on the main panel of the inner and outer labels. Where no standard has been prescribed, but a pharmacopoeial standard exists (see Section 3.4.3.2, "Pharmacopeial Standard") and it applies to the specific drug product, the main panel of the inner and outer labels shall name the publication containing the standard used or by indicating that a manufacturer's standard is used.

3.4.3.1 Prescribed Standard

The Act states:

Where a standard has been prescribed for a drug, no person shall label, package, sell or advertise any substance in such a manner that is likely to be mistaken for that drug, unless the substance complies with the prescribed standard. (subsection 10(1))

A prescribed standard is a standard prescribed by the Regulations. A list of Canadian Standard Drugs (CSD) can be found in Division 6 of the Regulations.

Products containing these drugs as single ingredients may be sold only if they are labelled with the CSD standard and if they conform in all aspects to that standard. In other words, no pharmacopeial or manufacturer's standard may be used for these products.

3.4.3.2 Pharmacopeial Standard

The Act states:

Where a standard has not been prescribed for a drug, but a standard for the drug is contained in any publication referred to in Schedule B, no person shall package, label, sell or advertise any substance in such a manner that is likely to be mistaken for that drug, unless the substance complies with the standard. (subsection 10(2))

Pharmacopoeial standards are those for drugs contained in the publications listed in Schedule B to the Act and for which no standard has been prescribed in the Regulations.

Products for which a standard exists must declare the standard of manufacture. A manufacturer may choose to manufacture a product to the pharmacopoeial standard (e.g., USP) or to the manufacturer's own standard and label the product as a house standard (e.g., manufacturer's name standard). The manufacturer's standard must at least meet the pharmacopoeial standard, but may exceed it (e.g., tighter specifications).

If a manufacturer declares a standard on a label, it implies that the product complies fully with that standard. A manufacturer's use of a house standard on a label indicates that the product may differ in some respect from the pharmacopeial standard. (See paragraph C.01.011 (4) of the Regulations.) Sponsors can refer to their own standards as house, firm, or manufacturer's standard.

The following expressions are considered acceptable to describe a manufacturer's standard:

  • House Standard, or House Std.
  • Manufacturer's Standard, or Mfr. Std.
  • Firm X Standard, or Firm X Std.

Products that differ from the official standard only by their colour, flavour, shape, or size may be labelled with the standard, if such differences do not interfere with the assay methods prescribed in the official compendia.

When a pharmacopoeial standard is declared on the drug label, the labelling provisions that are included in the section of the official monograph and those that are required by the general notices of the pharmacopoeial standard should be met.

When a standard is declared, it means that the product meets the current, most up-to-date version of the pharmacopoeia. A manufacturer cannot claim to meet a previous version of the pharmacopoeial standard.

3.4.3.3 Professed Standard

The Act states:

Where a standard for a drug has not been prescribed and no standard for the drug is contained in any publication referred to in Schedule B, no person shall sell the drug, unless:
(a) it is in accordance with the professed standard under which it is sold; and
(b) it does not resemble, in any manner likely to deceive, any drug for which a standard has been prescribed or is contained in any publication referred to in Schedule B. (subsection 10(3))

This section refers to non-official drugs for which no standard prescribed in the Act or Regulations or pharmacopoeial standard exists. The "professed standard" refers only to the label claims for quality and potency, and manufacturers are required to set their own standards within certain limits outlined in the Regulations.

The label of such products should not carry any standard (e.g., the expression "house standard" or "name of company standard" are unacceptable) as this may give the misleading impression that the product meets a prescribed or pharmacopoeial standard . There is no objection to the words "professed standard" on the labels of these products.

It is not mandatory to declare a standard for the product's ingredients. However, if a manufacturer chooses to do so, the manufacturer must ensure that the ingredient is contained in the current edition of the pharmacopoeoia compendium that is referred to and should not be shown on the main panel of the label, as it might be mistaken for a pharmacopoeial standard for the product in final dosage form.

3.4.3.4 Placement of Standard on Label ling

Where a standard of manufacture is to be shown on a label (see subsections 10(1) and (2) of the Act), this standard should be declared near the proper name of the product. The quantitative amounts may be indicated before or after the proper name (e.g., Acetaminophen Tablets USP, 325 mg).

3.4.3.5 Updating Standards

Where a pharmacopoeial standard has been updated and the manufacturer has been declaring that standard for that drug product or ingredient, it is the manufacturer's responsibility to update the processes and specifications of that product or ingredient, and to submit the appropriate submission where required.

3.4.3.6 New Pharmacopoeial Standards

Where no standard existed previously and a new pharmacopoeial standard has been created for an ingredient or drug product in final dosage form, and where the standard applies to the manufacturer's product, it is the manufacturer's responsibility to adjust the product or specifications to meet or exceed the standard and to revise the labelling if required.

3.4.3.7 Pharmacopoeial Standards for Prolonged Release Capsules or Tablets

These types of products have been regarded by Health Canada as being intrinsically different from ordinary capsules and tablets. If only ordinary capsules or tablets of a drug are described in any Schedule Bpublication and a manufacturer offers for sale a sustained release version, such a product should not be labelled with any standard .

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3.4.4 Sterility

Where a drug is required to be sterile by the Regulations (section C.01.065), then the notation "sterile" (stérile) should be shown on the principal display panel of the inner and outer label in accordance with subparagraph C.01.004(1)(a)(v).

3.4.5 Scheduling Symbols

Pursuant to paragraph C.01.004 (1)(b) of the Regulations, the appropriate symbol for drugs listed in the Schedule to Part G to the Regulations, Schedule F of the Regulations, and the schedules to the Narcotic Control Regulations and the Benzodiazepines and Other Targeted Substances Regulations must appear in the upper left corner of the main panel of the label. Refer to the appropriate regulation for specific requirements concerning size, colour, and shape of the symbols.

When a product contains a combination of ingredients from two or more of the schedules, only the scheduling symbol corresponding to the more stringent control is required on the label. In these instances, the Narcotic Control Regulations are the most stringent, followed by the Controlled Drug and Substances Regulations, the Benzodiazepines and Targeted Substances Regulations, and the Regulations concerning Schedule F drugs.

The one exception to the above interpretation is when the narcotic present in the combination is codeine in an amount that does not require a prescription. In this instance, the symbol "N" is required and, depending on the other ingredients, possibly a "C" symbol or the "Pr" symbol.

3.4.6 Drug Identification Number

The principal display panel of the inner and outer label of a drug sold in dosage form (a form in which it is ready for consumer use without requiring further manufacturing) should clearly show the DIN assigned to it preceded by the words "Drug Identification Number" or "Drogue identification numérique," or both, or the letters "DIN" (Regulations, section C.01.005(1)).

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3.5 Any Panel

This subsection describes in further detail the information to be included on any other panel of an inner or outer label.

3.5.1 Name and Address of Manufacturer

According to section A.01.10 of the Regulations, the manufacturer is the "person," including an association or partnership (which can also mean business or corporation under that name), that sells a drug (i.e., owns the DIN). The manufacturer is not necessarily the fabricator. Where more than one name appears on the label, each person mentioned may be held responsible for compliance with the requirements of the Act and Regulations.

The Regulations require that the label display the name and address of the manufacturer or manufacturers (section C.01.004). If the drug is imported, the name and address of the Canadian importer or distributor must be added (section C.01.004.1).

The address should be sufficiently complete that Canada Post could deliver a letter mailed to that address. For Canadian manufacturers, it may suffice to have the name of the city and province. For distinct cities, the province may be omitted and "Canada" used instead. The postal code should be included in all cases. Any non-Canadian addresses that appear on the label should include the name of the country. Refer to the Canada Post Addressing Guide for more information.

Any non-Canadian addresses that appear on the label should include the name of the country. The address must be sufficient to ensure delivery of a letter through the various postal systems involved in the delivery.

3.5.2 Lot Number

The lot number may be any combination of letters, figures, or both (section A.01.010 of the Regulations) by which a drug can be traced to the manufacturer and, if applicable, to the distributor or importer. This number should be preceded by the words "Lot Number" or a suitable abbreviation (i.e., Lot no, Lot, L), and should appear on any panel of the inner and outer labels (subparagraph C.01.004. (1)(c)(ii)).

3.5.3 Expiration Date

The expiration date must be on the inner and outer labels of all drug products (subparagraph C.01.004. (1)(c)(v)). The Regulations currently do not specify a particular wording or expression for expiry date. However, for guidance, some acceptable terms include "Expiration" or "Expiration date" in English, and "Expiration" or "Date d'expiration" in French. The term "Expiration" or its abbreviation "EXP." is acceptable as a bilingual expression.

The expiration date should be expressed in full or in any manner that the general public will clearly understand. To provide consistency, the use of the pattern year‑month‑day established in the food section of the Food and Drug Regulations is suggested. An acceptable abbreviationis the last two digits of the year, two letters for the month, and two digits for the actual day of the month, if required. Unless the actual day of expiration is required, the declaration year‑month is sufficient, with the last day of the month assumed.

As provided in section B.01.007of the Regulations, the following two-letter abbreviations for the months are acceptable in both official languages: JA, FE, MR, AL, MA, JN, JL, AU, SE, OC, NO, DE.

Examples: 2009 April 30, 09AL30, or 09AL.

3.5.4 Adequate Directions for Use

Subparagraph C.01.004(c)(iii) of the Regulations requires that that the inner and outer labels show "adequate directions for use of the drug."This is interpreted to include:

  1. indications for use or pharmacological classification;
  2. recommended single and daily dose;
  3. route of administration , when the route is not obvious; and
  4. any warning or cautions specifically required by the Regulation.

More detailed information that may be necessary for the proper use of the drug by the consumer, but for which there is no room on the label, must be provided in some additional labelling such as a consumer information document.

For a prescription drug, this consumer information may be a package insert or a document provided to the patient at the point of dispensing . The prescription label should include a statement regarding the availability of this guide, such as, "See consumer information [leaflet]," or "Pharmacist: Dispense with consumer information [leaflet]."

For a nonprescription drug , the consumer information should be provided as a package insert. The label should include an instruction to consult the package insert for further directions, such as, "See consumer information [leaflet]."

For a new drug, subject to the requirements of Part C, Division 8, of the Regulations, the inner and outer labels should also carry a statement regarding the availability of the Product Monograph, such as, "Product Monograph available on request".

For prescription drugs that are not considered new drugs subject to Part C, Division 8, of the Regulations, and where the health care professional may require more detailed information, but for which there is no room on the label, a separate prescribing information document should be available. The label should bear a statement describing the availability of this document, such as, "Prescribing Information available on request" (see also Section 5.4.5 of this guide).

For any prescription drug where substantial product preparation may be required by the health care professional before dispensing (e.g., reconstituting parenterals), sponsors should consider including the prescribing information as a package insert . In this case the label should bear a statement such as, "See package insert " (see also Section 5.4.2 of this guide).

Concerning adequate directions for use on a label showing a claim or indication for a Schedule A disease, or any other reference to a Schedule A disease, see Section 2.7 of this guide.

Health Canada recommends that positive statements should be used on labels to avoid ambiguity. For example, "For subcutaneous use only" is preferred to the negative statement "Not for intravenous use".

3.5.4.1 Storage Conditions

Storage conditions are considered to be part of adequate directions for use , where applicable, and must be shown on the inner and outer labels (subparagraph C.01.004(c)(iii)). Guidance on appropriate storage conditions benefits patients and consumers by helping maintain product quality and safety.

3.5.4.2 Limit Dose Drugs

For those drugs that carry a recommended single or daily dose or statement of concentration above the limits provided by section C.01.021 of the Regulations, the inner and outer labels should caution that the product is to be used only on the advice of a physician (section C.01.025).

3.5.4.3 Warnings and Precautions

The Regulations require several cautionary statements, such as those for acetylsalicylic acid and salicylic acid. Cautions shown within quotation marks in the Regulations should be printed verbatim. If the caution or warning does not appear within quotation marks, the wording may be altered but the meaning must be retained. Additional warnings and cautions outside the Regulations and specific to the product or product class may also be required on labels to help ensure safe use of the product.

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3.5.5 Declaration of Medicinal Ingredients

Except as otherwise provided in the Regulations, pursuant to subparagraph C.01.004(1)(c)(iv), the quantities of all medicinal ingredients should be declared on the inner and outer labels with the ingredients listed by their proper names or, if there are no proper names, by their common names. The standards of each individual ingredient should not be declared on the label of a multi-ingredient product. However, when a standard exists for the combination, then this standard should be declared.

Except as otherwise provided in the Regulations, the method of declaring the quantities of active ingredients should be as described in the following table.

Table 3.1: Method of Declaring Quantities of Active Ingredients

Table 3.1: Method of Declaring Quantities of Active Ingredients
Pharmaceutical Form Appropriate Declaration
Tablets, capsules, suppositories and other discrete dosage forms gram or milligram per dosage form
Powders for oral use gram or milligram per gram, and per specific dosage unit (e.g., level teaspoonful)
Liquids for parenteral use* milligram per millilitre, or % weight per volume (w/v)
Liquids for oral use gram or milligram per dosage unit, or per millilitre
Creams, lotions, ointments milligram or millilitre per gram, or millilitre, or % weight per weight (w/v)

* Refer to Section 5.4, "Prescribed and Parenteral Drugs," for further information.

Leading and Terminal zeroes

The use of terminal (trailing) zeroes following a quantitative declaration of the medicinal ingredient should be avoided. Use 2 gram (g) rather than 2.0 g. and 2.5 g instead of 2.50 g to avoid confusion.

Similarly, when a quantitative amount is expressed as a decimal number less than 1, then the declaration should be preceded by a leading zero, such as 0.5 mg.

3.5.5.1 Non-parenteral Products Requiring Dilution

For non-parenteral products that must be diluted prior to use (e.g., powders for reconstitution), the labelling should indicate the:

  1. quantity of medicinal ingredients per container;
  2. final concentration after reconstitution (e.g., mg per millilitre [mL]); and
  3. identity of the diluent and the quantity to be added for reconstitution.

Where percentages are used, they should be specified as % w/w, w/v, or v/v, as applicable.

3.5.5.2 Single Ingredient Preparations

When a drug product contains a single medicinal ingredient, a declaration of the quantity of medicinal ingredient immediately following or preceding the proper or common name is acceptable, provided that the amount refers to the medicinal ingredient in the form mentioned in the name. Examples: Acetylsalicylic Acid Tablets 300 mg; Hydrocortisone Acetate Ointment 1% w/w. In the second example, the product is understood to contain 1% w/w Hydrocortisone Acetate and not 1% w/w Hydrocortisone.

The declaration of the medicinal ingredient in terms of the active moiety is also permissible, provided that both are identified. For example, if the proper name is Chloramphenicol Palmitate Oral Suspension, then an acceptable quantitative declaration could be "Chloramphenicol 30 mg/mL as Chloramphenicol palmitate." In such cases the dosage should also be specified in terms of the active moiety.

3.5.5.3 Combination Immediate Release/Extended Release Ingredients

A combination drug product may contain an immediate release medicinal ingredient along with an extended release medicinal ingredient in the same pharmaceutical form (e.g., tablet). In these instances, the dosage form should be clearly labelled to reflect the combination.

3.5.5.4 Transdermal Patches

The inner and outer labels (e.g., pouch and carton) of transdermal patches should include a declaration of the total quantity of the medicinal ingredients per patch, the mean dose delivered per unit of time (e.g., X mg/day, X mg/hour), and the duration of patch use (e.g., Y hours, Y days).

To avoid potential hazards of fallen or discarded patches to children and pets, the patch itself should be labelled with the following minimum information:

  1. Brand name;
  2. Common or proper name;
  3. Quantitative declaration of the medicinal ingredients;
  4. DIN; and
  5. Delivery rate of the drug (e.g., X mg/hour).
3.5.5.5 Implants

Labelling for implants (e.g., wafers, capsules, pellets, etc.) should include the total quantitative declaration of the medicinal ingredients per implant, the mean dose delivered per unit of time (e.g., X mg/day), and the duration of use (e.g., Y days).

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3.5.6 Declaration of Non-medicinal Ingredients

Until recently, the Regulations did not require the declaration of most non-medicinal ingredients on package labels, although there are some limited exceptions (e.g. preservatives in parenterals).

Recent amendments to the Food and Drug Regulations, published May 13, 2010, (see Appendix B) and to be in effect 2 years from the date of this publication, modify section C.01.004 of the Regulations to state:

  • (1.1) "....when a drug is intended for human use, its outer label must contain a list of all nonmedicinal ingredients, or, if the outer label is too small, the list must appear on a tag, tape or card that is attached to the package."
  • (1.2) "The nonmedicinal ingredients must be listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients."

The above is intended to apply to nonprescription drugs and does not apply to:

  1. prescription drugs
  2. drugs not required to be sold pursuant to a prescription but are administered under the supervision of a practitioner.
  3. veterinary drugs and hard surface disinfectants, both of which are outside the scope of this label guidance.

For further important details on the regulations concerning flavours, fragrances and variable formulations, please refer to the regulatory amendments of May 13, 2010 (Appendix B).

In the interim period before this becomes a regulatory requirement and in the interest of patient safety and to better inform the decision- making of consumers and health care professionals, Health Canada recommends that sponsors provide a complete listing of all non-medicinal ingredients on the label.

A non-medicinal ingredient should be clearly identified as a non-medicinal or inactive ingredient or for a specified non-therapeutic purpose (e.g., cosmetic, moisturizing, flavour, etc.) in the text or the brand name, unless the purpose is obvious (e.g., flavour).

Lists of non-medicinal ingredients should be clearly separated from the medicinal ingredients with a heading such as "non-medicinal (inactive) ingredients."

Non-medicinal ingredients should be excluded from the product name. Exceptions include labelling for flavour, colour, or for non-therapeutic, cosmetic purpose such as, "X Sunscreen SPF 30 with moisturizing aloe".

3.5.6.1 Different Flavours, Colours, or Fragrances

A single DIN is assigned for products varying in flavour, colour, or fragrance, provided that all other product characteristics, including formulation, route, dosage form, product name, manufacturer's name, and labelling, except for the identification of the fragrance, flavour, or colour, are identical. Refer to the Health Canada policy document, Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours, for more information.

3.5.6.2 Colouring Agents

The use of colouring agents in drugs is restricted to those listed in section C.01.040 of the Regulations. If a manufacturer wishes to use a new colouring agent not listed in section C.01.040, the manufacturer is required, prior to approval, to submit information to Health Canada regarding the safety of the ingredient. Showing colouring agents on the label is optional. If a manufacturer wishes to show them, only the names listed in the Regulations may be used (section C.01.040).

3.5.6.3 Nomenclature for Non-medicinal Ingredients

Health Canada's policy Non-medicinal Ingredients Nomenclature outlines the accepted nomenclature used in naming the non-medicinal ingredients in drug product formulations. The list is not all-inclusive and does not imply acceptability for use in the labelling of all drugs; therefore, it should be used as a guide only. Many other non-medicinal ingredients may also be acceptable, consistent with good manufacturing practices in the selection of appropriate ingredients.

3.5.7 Net Amount (Net Contents)

Net contents should be declared on the outer label as outlined in paragraph C.01.004(2)(a) of the Regulations. In some cases, however, it may be desirable to have this information on the inner label also. Manufacturers should consider whether repeating the information would be useful in administration of the drug. Standard units of measure and abbreviations (e.g., ounces, oz.) may be included on the label if metric units are also present.

3.5.8 Preservatives

For product lines containing ophthalmic or parenteral drug product formulations, and where 2 products differ only in the presence or absence of a preservative, the label should clearly identify the presence or absence of a preservative, either by reference in the brand name or directly and prominently on the label. Health Canada will issue separate DINs to emphasize the differences in product identity between the 2 products.

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3.6 Special Packaging

The following subsections cover labelling requirements for special types of packaging.

3.6.1 Co-packaged Products

Co-packaged products containing two different drugs, or a drug and a non-drug item (e.g., cosmetic and device), should comply with the regulatory requirements for each product. As the co-packaging of certain drugs may imply certain unapproved claims, pose a safety concern, or require the filing of a New Drug Submission (NDS), manufacturers should consult with Health Canada prior to marketing co-packaged products.

The labelling of co-packaged drug products should include only those claims and indications that have been authorized for the individual drugs. If claims for the drug product exceed the authorized claims for the components, or new claims are made on the concomitant administration of the drug and non-drug product, then the sponsor should file another drug submission for the new material.

3.6.2 Labelling of Drugs in Small Containers

The labelling requirements for drugs generally apply to all container sizes. However, some containers are too small to carry all the information required by the Act and Regulations. The Regulations address this issue as follows:

Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations, the inner label requirements of these Regulations do not apply to the drug in that container if

  1. there is an outer label that complies with the labelling requirements of these Regulations; and
  2. the inner label shows
    1. the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than one medicinal ingredient, the brand name of the drug,
    2. the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug,
    3. the net content of the drug if it is not in a discrete dosage form,
    4. the route of administration of the drug if other than oral,
    5. the lot number of the drug,
    6. the name of the manufacturer of the drug,
    7. the expiration date of the drug, and
    8. the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii).
      (section C.01.004(3))
3.6.3 Labelling of Special Containers

Drugs may be packaged in special containers that are too small to accommodate an inner label that conforms to the requirements of subsection C.01.004(3) of the Regulations. This inner label may contain even further abbreviated labelling, provided there is an outer label that meets all regulatory requirements.

The packages concerned fall into two groups:

  1. Multiple-dose packs, such as blister packs, strips, push-through cards, ampoules, vials attached by a plastic strip, etc.; and
  2. Single-dose packs, such as sachets, pouch-type packs, individual dose vials of liquid, pre-packaged syringes, etc.

These packages should contain the information listed in Subsections A and B below, and as outlined in the Health Canada policy document, Labelling of Special Containers. Consideration should be given to the colour of the text and the use of non-reflective or coloured foils that may enhance the legibility of the text for these special containers.

A. Multi-dose Containers

Labels for multiple-dose packs should include, at a minimum, the following information:

  • Brand name or if no brand name, then the proper or common name plus the manufacturer's name;
  • Potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used is unique for a particular potency of the drug; and
  • Lot number and expiry date.

The above information should be presented in a way that ensures that the package can be identified after units have been removed. This can be done by printing in a repetitive manner or by embossing on the edge of each card.

B. Single Dose Containers

Labels for single-dose packs should include the same information as labels for multiple-dose packs (See A), but if there is insufficient space, the expiry date may be omitted.

For drug products containing multi-ingredients (e.g., cold product with four ingredients), the blister package label may not accommodate the quantitative amount of each ingredient as required by the Regulations, so the use of a brand name unique for a particular potency is acceptable. If a brand name is not unique for a particular potency, it is acceptable to have the brand name and the DIN appear on the blister package label (e.g., Cough/Cold Tablet, DIN 12345678), which clearly identifies the drug product.

3.6.4 Security Packaging

Pursuant to section A.01.065 of the Regulations, drugs intended for ingestion, inhalation, or insertion into the human body, mouthwashes, or drugs intended for ophthalmic use, must be contained in a security package if the product is available to the general public in an open selection area. The labels on these products must draw attention to the security feature of the package. For further information, refer to the Regulations, paragraph G.02.019 (c) for controlled drugs and section J.01.030 for restricted drugs.

3.6.5 Drugs in Pressurized Containers and Flammability

Drugs packaged in a disposable metal container designed to release pressurized contents by the use of a manually operated valve should show the cautionary statements, hazard symbols, and signal words as outlined in sections A.01.061 to A.01.063 of the Regulations.

Drugs packaged in unpressurized containers operated by a manual pump spray device or any other containers that contain flammable ingredients should bear a cautionary warning indicating flammable contents and appropriate directions for use (e.g., "do not use near an open flame").

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3.7 Technical Information and Language

Technical information should be presented in terminology that is easily understood by the consumer. The amount of information provided should not exceed that required to arrive at a proper conclusion. Technical information is more likely to mislead or deceive the consumer in controversial areas where scientific opinions diverge. Technical or complicated language should not be used to purposely obscure, disguise, or exaggerate product benefits.

However, with the new requirement for a consumer information document for all new drugs in the New Product Monograph format (see the Guidance for Industry: Product Monograph), much technical information has to be explained to consumers. A balance is required between exposure to sufficient information for safe, effective, and informed use of a medication and too much information, which could overwhelm the consumer. For some prescription drug products there is no accurate consumer language to describe some conditions, and the original technical language must be maintained, while attempting to explain as best as possible, even in general terms, the condition in consumer language.

Technical information should be:

  1. in consumer information written at no greater than a Grade 8 reading level;
  2. in simple, clear, and easy to read language; and
  3. presented with numerous headings and bulleted points.

Manufacturers may wish to refer to the Canadian Public Health Association's voluntary guidance, Good Medicine for Seniors: Guidelines for Plain Language and Good Design in Prescription Medication.

3.8 Labelling of Professional Samples

Subsection 14(1) of the Act prohibits the distribution of any drug as a sample, which is considered to be a package of drug provided at no cost. However, subsection 14(2) allows the "distribution, under prescribed conditions, of a sample to physicians, dentists, veterinary surgeons, or pharmacists." The conditions that must be met are provided in sections C.01.048 and C.01.049 of the Regulations.

A sample of a drug given to a health care worker and intended for subsequent distribution to a consulting patient must be labelled with all directions required for safe and effective use, as required for regular package sizes of prescription and nonprescription drugs. All labelling that is normally distributed with the regular package sizes should be distributed with samples, including the consumer information document for all new drugs in the new Product Monograph format.

It is understood that the labelling detail required for a nonprescription drug may be greater than that required for a prescription drug. Refer to the Health Canada policy document Labelling of Professional Samples of Drugs.

3.9 Harmonization with International Labels

Labels for drugs authorized for sale in Canada may include additional information approved by other regulatory jurisdictions provided that the label:

  • meets Canadian regulatory requirements;
  • is consistent with applicable Health Canada guidance documents and policies; and
  • does not cause confusion.

4. Claims and Text Content

Subsection 9(1) of the Act prohibits the representation of a 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." Drug manufacturers can ensure product labelling complies with the Act by providing accurate and concise information to assist health care professionals in choosing the correct medication for patients, and consumers in identifying the availability and effects of therapeutic agents for self-medication.

Drug products, due to their potential risk, should be labelled in an informative manner. It is the manufacturer's responsibility to periodically update product labels to be consistent with current scientific information and medical treatment.

4.1 Misrepresentation of Classification

Labelling should clearly indicate that the product is a drug. Sponsors should avoid describing the drug, its purpose, or method of use in a way that implies it is another product type, most commonly food or cosmetic. Misrepresentation of classification can create an erroneous impression regarding the character, merit, and safety of a preparation (e.g., medicated versus cosmetic shampoo).

4.2 Absence of Ingredients

Consumers and patients may be concerned about the health implications of certain medicinal and non-medicinal ingredients in drug product formulations (e.g., sugars, salts, sulfites, etc.). In the absence of a requirement for complete disclosure of all ingredients in a drug product formulation (see subsection 3.5.6), manufacturers may selectively refer to the absence of certain ingredients under particular conditions (e.g., no ingredient X, no X, non-X, X-free, etc.).

When an ingredient has been removed from drugs in Canada because of safety concerns, it is acceptable to include a statement to the effect that a drug has been reformulated to omit that ingredient or that the drug does not contain that ingredient. Such statements are considered acceptable for a limited time (e.g., one year), but after a certain period they lose meaning as the unacceptable ingredient is no longer found in other products.

For example, phenylpropanolamine as a nonprescription oral decongestant has been removed from drugs in Canada because of safety concerns. As phenylpropanolamine is no longer found in any over-the-counter oral decongestant, a "PPA-free" claim is no longer relevant or acceptable as a claim for this product class.

Because such statements are intended to reinforce consumer acceptance of drug products, such statements would be acceptable for preparations that previously contained the subject ingredient and that belong to that class of products in which the subject ingredient could be expected. For further guidance, refer to the Health Canada policy document, Absence of Ingredient Statements for Nonprescription Drugs.

4.2.1 Sugar-free , Sucrose-free, Sweetener-free

Statements such as "sugar-free" that imply that a drug contains no sugar are acceptable only for those products that contain none of the chemical classes of sugar, including sugar alcohols. If a sweetening agent is present, the drug label should include a phrase such as "sugar-free; sweetened with agent X." This accompanying statement will reduce the risk of misleading consumers.

When a sugar alcohol is used (e.g., sorbitol, xylitol, maltitol, etc.), along with an alternative sweetening agent, the label should state the name of the alternative sweetening agent so that sensitive individuals do not assume that the product has no sugar or like substance. For example, there is concern that a "sucrose-free" claim on a product that nonetheless contains other sugars may provide a false impression that the product is safe for diabetics. Therefore, all sweetening agents in the product should be declared. Health Canada suggests that drug labels claiming one of the sugar alcohols specify the number of energy calories provided per dose.

Claims such as sweetener-free, artificial sweetener-free, artificial sweetener X-free may be acceptable if true. However, claims for the absence of a particular artificial sweetener (e.g., "aspartame-free") may be misleading if it is not revealed to the consumer that the product may contain another artificial sweetener (e.g., acesulfame potassium). In these situations, the declared absence of one sweetener should be accompanied by the equally prominent declaration of the actual sweetener used.

4.2.2 Salt and Sodium-free

Products without sodium chloride may be labelled as "salt-free," while those without sodium may be labelled as "no sodium." The expression "low salt" or "low sodium" or "suitable for low sodium diets" or "suitable for restricted sodium diets," are acceptable if the daily amount of sodium provided by the drug is 25 mg or less.

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4.3 Absence of Side Effects

Some consumers wish to avoid some specific side effects that can occur with some nonprescription drug products, but not others within the same product class (e.g., some antihistamines have a likely somnolent side effect while others are non-drowsy). Statements regarding the absence of a side effect are permitted provided the following conditions are met:

  1. Scientific evidence exists to support the statement, such that the incidence of a side effect is comparable to when a placebo is taken. Scientific evidence to support the statement should be available to the manufacturer and submitted to Health Canada upon request. The evidence would consist of data from well-designed clinical trials, including sufficient sample sizes and adequate control groups, such that a significance level of 0.05 is attained and the study meets the 80 to 90% power test for excluding Type I and Type II errors. The substantiating data should include results derived from measurable, objective parameters, where feasible. If the incidence of a particular side effect exceeds that for the placebo, the statement regarding the absence of side effects should not be used.
  2. There is a widely held consumer perception that the significant side effect is associated with comparable products of that class. For example, drowsiness is a side effect perceived to be frequently associated with the use of nonprescription cough and cold products. A claim indicating the absence of this side effect for a drug product within this product class, would be acceptable provided all other conditions are met.
  3. The claim regarding the absence of a side effect provides practical consumer information such that consumers can readily identify the side effect or benefit.
  4. Statements about the presence of significant adverse effects are accorded equal prominence in the labelling material to statements about the absence of side effect. The colour, contrast, position, and spacing of the information should be considered when assessing the requirement for equal prominence.
  5. No undue emphasis on the statement about the absence of side effects is presented in labels or advertising.

Statements regarding the absence of side effects should be cleared as Notifiable Changes for new drugs. Health Canada recommends that prior approval be obtained concerning the use of these statements for products that are not new drugs.

4.4 Side Effects and Placebo Comparisons

Comparisons of the incidence of side effects on labels between the drug product and placebo are often misleading and should be avoided. Consider the following example:

In clinical studies, frequent side effects observed more often with Ingredient X than placebo (sugar pill) were headache and diarrhea. Other side effects observed about as often on Ingredient X as on sugar pill included abdominal pain, nausea, flatulence, dizziness, back pain, and influenza-like symptoms.

This text requires an ability to evaluate two different comparisons and assess their significance, which may be difficult for some consumers. The message should be as simple and straightforward as possible, limited to the side effects that are reasonable to expect. More appropriate wording would be, "Frequent side effects were headache and diarrhea." Manufacturers may also opt to include the other side effects, without citing the comparison with the placebo.

4.5 Look-alike, Sound-alike Drug Product Names

Look-alike, sound-alike (LA/SA ) refers to names of different health products that have orthographic similarities when written or similar phonetics when spoken. These similarities may pose a risk to health by causing confusion in prescribing, dispensing , or administration of a drug product. It is the manufacturer's responsibility to ensure that any proposed drug product name (brand name , common, or proper name ) will not cause potential confusion with another drug product name. The manufacturer should perform an analysis and risk assessment for any proposed product name to support its use. See Appendix B for several guidance documents developed by Health Canada to outline the criteria for manufacturers and regulators to consider when evaluating a name.

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4.6 Comparisons

Manufacturers are encouraged to promote drugs on their own merits in a positive manner instead of by comparison with other products. Comparisons with other drugs or with the selected properties of other drugs are potentially misleading. The consumer, while competent to evaluate comparisons of taste, flavour, colour, and appearance, generally lacks the expertise and access to the supporting data required to evaluate the implications of comparisons about the therapeutic properties of drugs. Sponsors should exercise caution when presenting comparative statements to the public to avoid violating subsection 9(1) of the Act.

Comparisons may be misleading for several reasons:

  • Comparisons are generally incomplete. Usually, only the advantages of the advertised product and the disadvantages of the competitive product are mentioned. Special benefits or advantages of the competitive product are generally ignored.
  • Comparisons exaggerate the importance of the alleged advantages of the product (e.g., speed of action, quantity of medicinal ingredient, or extent or duration of action). Failure to disclose the lack of real therapeutic advantage is often deceptive.
  • Differences of opinion between experts regarding the truth and impact of the compared qualities are often undisclosed.
4.6.1 Implied Comparisons

Some terms and phrases used to describe the composition of drug products imply comparisons that convey an erroneous impression regarding a product's merit. The terms "better," "richer," and "stronger" indicates an unidentified comparison and may be misleading. Describing a product as "better" or "richer" implies superiority and may create an erroneous impression regarding the value and merit of the drug. Where a product has been reformulated to be significantly more effective or to provide an additional therapeutic advantage over a previous formulation, the use of "better" may be acceptable, if carefully explained. However, it should be clearly indicated that the products being compared are the old and new formulations. To avoid violating subsection 9(1) of the Act, sponsors should describe such a product as a "new" or "improved" formulation. The use of such terms to describe novel or modified products is acceptable for one year.

4.6.2 Therapeutic Comparative Claims

Therapeutic claims are those related only to the therapeutic aspects of the product (e.g., therapeutic actions, efficacy, speed of action, symptom relief, etc.). For manufacturers wishing to consider labelling or advertising that includes therapeuticcomparisons to other drug products for human use, Health Canada's Therapeutic Comparative Advertising: Directive and Guidance Document provides:

  1. broad principles applicable to all drugs for human use regardless of the intended audience (health professionals or consumers);
  2. detailed data requirements necessary to support consumer-directed non-prescription drug advertising and labelling;
  3. roles and responsibilities of Health Canada and the sponsor concerning labelling; and
  4. roles and responsibilities of Health Canada, the sponsor, and the independent advertising preclearance agency concerning advertising.

The purpose of Therapeutic Comparative Advertising: Directive and Guidance Document is to provide a framework for supporting evidence and presentation of comparative therapeutic claims in labelling and advertising, such that these claims will not be false, misleading, or deceptive to the intended user.

Manufacturers wishing to add therapeutic comparisons to labelling, which is generally discouraged if the overall effect is considered promotional, should seek pre-approval of the label claims through the submission and approval of an appropriate change to labelling. Refer to the Health Canada guidance document, Management of Drug Submissions, or the Health Canada policy document, Changes to Marketed New Drug Products, for further information.

4.6.3 Non-therapeutic Comparisons

The Therapeutic Products Directorate (TPD) is not responsible for the review of the comparative, non-therapeutic qualities claimed for drug products in labelling (e.g., taste, fragrance, colour, physical, sensory, cosmetic benefit, market share, cost effectiveness, etc.), provided these claims do not conflict with the therapeutic understanding of the product.

The purpose of the existing Health Canada policy, Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products, is to define the conditions under which such comparisons will not be considered false, misleading, or deceptive as to the therapeutic character, value, quantity, composition, merit, or safety of the drug product to the intended audience. This measure is to aid sponsors and the industry to create labelling and advertising in compliance with the Act and Regulations, particularly subsection 9(1) of the Act.

The sponsor is responsible for ensuring that the applicable non-therapeutic, comparative claims meet the requirements of Health Canada's policy. Health Canada does not accept complaints concerning overall impression of comparative, non-therapeutic claims unless these claims interfere with the therapeutic aspects of the product. Advertising complaints concerning these non-therapeutic comparative claims can be forwarded to the sponsor, the courts (for complaints brought under the Competition Act) or may be considered by industry, voluntary pre-clearance agencies.

4.6.4 High, Low

The terms "high" and "low" generally imply unidentified comparisons and standards against which a product must be measured. For most product classes, these standards do not exist and these terms are unacceptable. To avoid misleading the consumer about the benefits of a product, more specific terminology should be used.

In some specific product areas, such as sunscreens, where a measurable standard of comparative performance is available (i.e., SPF), these terms may be tolerated in a product line to assist the consumer in product choice, in addition to the principle measure of effectiveness, the SPF, and this is outlined in the appropriate Health Canada labelling standards and monographs (see Section 5.2.1).

4.7 Endorsements, Testimonials , and Quotations

The following subsections provide guidance for the use of endorsements, testimonials, and quotations from the media or medical literature.

4.7.1 Endorsements, Seals of Approval

Endorsements of drug products (e.g., "doctor recommended") by health professionals, celebrities, and others are acceptable in labelling provided that the endorsements are consistent with the expected actions of the drug and the terms of market authorization for the product, supporting data is available where necessary, and they do not otherwise violate the Act and Regulations. The endorsements should also be consistent with related guidance documents and policies.

Seals of approval on the labelling of certain products issued by independent professional bodies (e.g., Canadian Dental Association) may be acceptable if TPD has been provided the written material explaining the exact nature of the endorsement and has analyzed the criteria that the product must meet to obtain the independent product recognition. This recognition must be consistent with the terms of market authorization of the product. TPD will usually evaluate the criteria used by the attesting organization once, and it is the manufacturer's responsibility to ensure that the product continues to meet the attesting organization's criteria. The manufacturer should have the documentation on file showing that the product has obtained the recognition. Product-specific data showing that a product meets this seal of approval is not expected with a submission but must be available on request.

4.7.2 Testimonials

Testimonials or quotations from individuals on drug labels frequently constitute an unfair and biased advantage. There may be no acceptable way of indicating on the labelling how such cases compare with the frequency of failure or success of that treatment. It may be misleading to build unwarranted expectations in the consumer's mind by the use of success stories. However, if such testimonials are consistent with the expected benefits of the product and the terms of market authorization, they can be accepted following critical review, provided the testimonial does not otherwise violate the Act and Regulations.

4.7.3 Quotations from Media, Journals, or Texts

Quotations from scientific journals, papers, authoritative texts, magazines, newspapers, or any other media source may create an erroneous impression regarding the character, value, merit, or safety of a drug product. This material may not reflect the entire data package supporting the drug product and may represent the isolated opinion of the author or a biased selection of data. Therefore, sponsors should avoid using quotations on drug labels.

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4.8 Cosmetic Claims

Cosmetic claims or any description of the cosmetic, non-therapeutic attributes of the product (fragrance, texture, colour etc.) are acceptable for therapeutic products provided that they:

  1. do not directly or indirectly imply therapeutic activity;
  2. are not otherwise misleading as to therapeutic merit, identity, composition, and character of the drug product, or otherwise in violation of the Act and Regulations (e.g., prohibited substance); and
  3. the manufacturer has evidence to support the cosmetic claim.

TPD will comment on any claim purported to be "cosmetic" that is actually considered to be a direct or indirect therapeutic claim that may be misleading as to the merit of the product. TPD may consult Health Canada's National Capital Region Consumer Product Safety Bureau, Cosmetics Program, concerning uncertain claims that may be difficult to classify as cosmetic versus therapeutic.

Manufacturers are encouraged to consult the Guidelines for Cosmetic Advertising and Labelling Claims, available through Advertising Standards Canada (ASC), for guidance concerning acceptable cosmetic claims. Any cosmetic claim attributed to a specific ingredient (e.g., "with moisturizing aloe vera") must be supported by data on file and available to Health Canada upon request.

4.8.1 Cooling

The term "cooling" may be used in a therapeutic sense, if the product is appropriately medicated, such as for cooling relief of sunburn (e.g., topical anaesthetic with menthol or camphor). The term may also be use in a non-therapeutic sense if adequately explained (e.g., antiseptic mouthwash with a cooling sensation flavour such as menthol).

4.9 Conditionally Positive Promotional Terms

The following subsections discuss conditionally positive promotional terms that may be used under certain conditions on product labels.

4.9.1 Market Share and Consumer Preference

Claims for market share, sales, and consumer and patient use, choice, or preference on labelling must be supported by adequate studies. Manufacturers should have this material on file. Although Health Canada does not review these label claims, where advertising disputes arise there are self-regulatory industry bodies that may deal with complaint resolution.

4.9.2 Clinically Proven or Tested
A. For a Product

The terms "clinically proven"or "clinically tested" can be used on labelling with regard to a product when:

  • adequate clinical efficacy* data pertaining to the product has been reviewed and found acceptable by the Therapeutic Products Directorate; or
  • it contains only one medicinal ingredient whose efficacy in a given dosage form and for the indication is well recognized and documented in the literature (e.g., Category I ingredient- United States Federal Register).

An example would be dextromethorphan syrup in product X: "Product X is a clinically proven cough relief" or "clinically prove" would be acceptable on the label.

[*Note: Adequate clinical efficacy data is defined as statistically significant clinical efficacy data, obtained from a minimum of two separate, well controlled studies that reflect a representative population and are of sufficient duration. Survey data and anecdotal results are unacceptable for this purpose].

B. For an Ingredient

"Clinically proven" can be used on labelling for an ingredient when a product contains more than one medicinal ingredient, including one or more whose efficacy in a given dosage form and for the given indication is well recognized and documented in the literature.

An example would be Product Y containing dextromethorphan and other ingredients that are not Category I: "dextromethorphan provides a clinically proven cough relief" would be acceptable. The following statement would not be acceptable: "Product Y is clinically proven."

Another example would be a combination product containing only dextromethorphan and pseudoephedrine hydrochloride, the benefits of both of which are documented in the literature: "Product Y provides clinically proven cough/nasal congestion relief" would be acceptable. The following statement

would not be acceptable: "Product Y is a clinically proven cold relief" because the product is likely to alleviate only two cold symptoms, not the whole range of cold symptoms that may be present.

4.9.3 New

The word "new" may be used to describe a drug product that is marketed under its present brand name for the first time in Canada, or in a different version of an existing preparation (e.g., a new pharmaceutical form or strength). The use of the term "new" for more than one year of product sale is considered to be misleading.

If reformulating a product has changed one or more medicinal ingredients , manufacturers are encouraged to indicate the modification by phrase such as "new formula" to alert the consumer. Similarly, when a dosage regimen has been modified, manufacturers should indicate the change to the consumer.

4.9.4 Improved

It is considered acceptable to describe, for a period of one year, a drug product as being "improved," if the drug has been modified in a manner that provides a significant therapeutic advantage (e.g., oral powder formulation that is faster dissolving in water, smaller tablet that is easier to swallow, etc.) over a previously marketed product of the same name. Sponsors should clearly explain the therapeutic advantage. This type of claim requires prior review and acceptance as part of the market authorization for the product.

In cases where the improvement refers to some non-therapeutic aspect of the formulation (e.g., taste, colour, texture), this should be specified, and it is the manufacturer's responsibility to determine the acceptability and veracity of the claim. See also Section 4.8, "Cosmetic Claims."

4.9.5 Advanced

Few drugs that can be advertised to the general public can be considered advanced. Most drugs are part of a product class with similar product attributes, where it would be difficult to identify any particular drug as advanced, compared to another in that class. To be considered advanced, a drug product would require some new or added therapeutic benefit, which is clinically significant, meaningful, and easily identified by the consumer, compared to others in its therapeutic class.

The term "advanced" in a product name is acceptable in a therapeutic sense if the advanced product treats a wider range of symptoms or has an additional medicinal ingredient compared to a reference product in the same product line. Consistent with the extra strength policy (Section 4.9.6), the list of medical ingredients on the product label should clearly identify the additional ingredients responsible for use of the term "advanced."

In some cases, qualified claims concerning advanced non-therapeutic aspects (e.g., cosmetic aspects) may be acceptable, if the non-therapeutic benefit is clearly explained. The manufacturer is responsible for having data available to support these non-therapeutic claims.

4.9.6 Extra Strength

Use of terms such as "strong" or "extra strength" may be erroneous. Drug products are formulated to provide an amount of medicinal ingredient in an effective therapeutic range. The inclusion of a greater amount in a particular preparation or the marketing of more than one product to provide varying amounts of a medicinal ingredient within an acceptable range is undertaken at the manufacturer's discretion.

Use of this wording may imply that the product is therapeutically more effective, when in most cases data is unavailable to support a difference in product effectiveness within an acceptable dosage range and within a population.

However, descriptions such as "regular strength" and "extra strength" are acceptable to describe products within a product line where various quantitative amounts of medicinal ingredient are provided. In most cases, the term "extra strength" can be used only if there is a regular strength reference product on the market containing the same medicinal ingredients. However, exceptions are described in the following two subsections.

4.9.6.1 Single Ingredient Analgesics

Division 9 of the Regulations outlines standard dosage units for nonprescription analgesics, for example, 325 mg acetaminophen (APAP) per dosage unit. Since dosage units for some analgesics are standardized by regulation, the use of the term "extra strength" to describe higher strength dosage unit products will be permitted. Health Canada considers that the expression "extra strength" provides useful information to the purchaser during product selection. Although there will not necessarily be a regular strength version of the same product by the same manufacturer on the market, dosage units containing 500 mg acetaminophen (or ASA, acetylsalicylic acid) or more, are considered "extra strength" within the context of the established standards.

For single ingredient ASA or APAP products in strengths greater than 500 mg, terms other than extra strength should be used to distinguish them. For example, 500, 650, and 1000 mg acetaminophen products could be progressively described as "extra strength," "super strength," and "ultra strength" to differentiate these products.

In the case of children's dosage units, 160 mg acetaminophen products may be described as "extra strength," even in the absence of an 80 mg formulation in the product line.

4.9.6.2 Multiple Ingredient Drug Products

A multi-ingredient nonprescription drug product in a specific product line may claim "extra strength" in the brand name provided there is a regular strength product that contains the same ingredient or ingredients at the recognized "regular" therapeutic strength available on the Canadian market.

The specific extra strength ingredient or ingredients must be identified with a qualifier in the list of medicinal ingredients on the label (e.g., "extra strength acetaminophen for pain relief"). Ingredients clearly recognized to be extra strength such as 500 mg acetaminophen per single dose must declare "extra strength" as part of the product name. As noted in Section 4.9.6.1 of this guide, a series of multiple ingredient products containing analgesics such as acetylsalicylic acid in 500, 650, and 1000 mg strengths should use different brand name descriptors such as "extra strength," "super strength," and "ultra strength" to differentiate the brand names in a product line of multi-ingredient products or product line extension (see Appendix A: Definitions).

For example, Manufacturer A submits a Drug Identification Number (DIN) application to market Panacette Cough and Cold Tablets:

  • Acetaminophen: 500 mg (analgesic/antipyretic)
  • Phenylephrine hydrochloride: 10 mg (nasal decongestant)
  • Diphenhydramine hydrochloride: 25 mg (antitussive)

There is no regular strength (325 mg acetaminophen) in Manufacturer A's product line. However, the Manufacturer A provides evidence that there are regular strength products with the same ingredients marketed by different manufacturers available to the Canadian consumer. Manufacturer A is asked to rename the product to Extra Strength Panacette Cough and ColdTablets and to identify the extra strength ingredient in the list of medicinal ingredients as follows:

Extra Strength Panacette Cough and Cold Tablets:

  • Acetaminophen (extra strength): 500 mg (analgesic/antipyretic)
  • Phenylephrine hydrochloride: 10 mg (nasal decongestant)
  • Diphenhydramine hydrochloride: 25 mg (antitussive)

Products with undefined standard strengths will be evaluated on a case-by-case basis with data submitted to support the extra strength status. The following list is of products that have defined standard strengths.

Ingredient Regular Strength Extra or Ultra Strength
acetaminophen 325 mg 500 mg or 1000 mg
acetylsalicylic acid 325 mg 500 mg or 1000 mg
acetaminophen pediatric 80 mg 160 mg
dextromethorphan hydrobromide 10-20 mg 30 mg
pseudoephedrine hydrochloride 30 mg 60 mg
phenylephrine hydrochloride 10 mg N/A
ibuprofen 200 mg 300 mg or 400 mg
4.9.7 Complete, Total

Reference to a therapeutic action as "complete" or "total" (e.g., complete relief) implies 100% efficacy, which is generally considered misleading for a drug. No drug product works 100% of the time or is completely effective and to imply this is unacceptable, unless specific product data supports the claim.

However, the words "complete" or "total" have been accepted in the brand names of products to indicate that they treat several symptoms of a temporary condition (e.g., cough/cold products treating several symptoms of a cold), treat a wider range of symptoms, or have an additional medicinal ingredient than the reference product in the same product line.

Consistent with the extra strength policy (Section 4.9.6), the specific additional ingredients referred to or responsible for the use of the term "complete" or "total" must be clearly identified in the list of medicinal ingredients on the product label, to clearly differentiate this from the reference product.

Health Canada reminds manufacturers that product line extensions should not create name confusion with respect to other products in the line. See Section 4.5, "Look-alike, Sound-alike Drug Product Names."

4.9.8 Plus

The use of the term "plus" in the brand name or as a label descriptor is acceptable in a product line containing a reference product and where the "plus" product contains an additional amount of one or more ingredients or an additional medicinal ingredient providing an additional therapeutic benefit.

Consistent with the extra strength policy (Section 4.9.6) the specific additional ingredient or ingredients referred to as "plus" must be clearly identified (e.g., plus phenylephrine) in the list of medicinal ingredients on the product label.

The term is also acceptable in the brand name of a product to the formulation of which an additional non-medicinal ingredient has been added and this is clearly identified (e.g., Product X Antiperspirant Plus Talc).

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4.10 Potentially Misleading Promotional Terms

The following subsections discuss potentially misleading promotional terms that should not be used on product labels unless specific data, rationale, or circumstances support such a claim or the addition of appropriate qualifying statements justify the wording , in some limited cases in this section.

4.10.1 Therapeutic Superlatives and Undue Emphasis

Descriptive wording and phrases to describe drugs and their activity, effects, attributes, formulation, or development should be chosen to ensure that the consumer can appreciate the actual situation. Terms such as "amazing," "astounding," "fantastic," "remarkable," "wonderful" and other superlative terminology are considered inappropriate in drug labelling.

Any undue emphasis , highlighting , or unbalanced presentation of one ingredient, attribute, claim, or feature of a multi-ingredient drug product at the expense of the other ingredients and attributes may be misleading as to the merit of the product. Examples include highlighting:

  1. one ingredient in a multi-ingredient product;
  2. one indication in a product treating several symptoms;
  3. a secondary attribute (e.g., non-drowsy); and
  4. a non-therapeutic aspect at the expense of the therapeutic purpose (e.g., cleansing ability of a medicated shampoo).

Labels should represent the product identity and benefits fairly and completely. For example, a combination cough/cold product containing acetaminophen, pseudoephedrine hydrochloride, and chlorpheniramine maleate should indicate at least one symptom treated by each of these ingredients.

There is no objection to inclusive statements, for instance on the main panel of the label, such as Brand X Cough Cold Product with Acetaminophen. Also, there is no objection to highlighting a non-medicinal ingredient if the non-therapeutic purpose is clearly identified (e.g., Brand X first aid cream with moisturizing aloe). See also Section 4.8, "Cosmetic Claims").

4.10.2 Maximum Strength

The term "maximum strength" is usually considered to be misleading with respect to the composition and therapeutic merit of a drug product and is considered to be unacceptable in most cases. The term must be examined in the total context of the labelling and advertising.

This term is considered to be indefinable for most drugs. This may be understood to mean the single or total daily dosage or both. Although certain regulatory limits may exist for the nonprescription availability of certain drugs, (e.g., ibuprofen, benzoyl peroxide), regulatory limits for a maximum dosage of prescription drugs are generally not defined. New scientific evidence may increase or decrease acceptable dosages depending on circumstances, and each drug is evaluated on its own merits and for the specific conditions indicated. The concept of absolute maximum limits for a drug is difficult to maintain due to the variation of patient circumstance, product use, and the constantly changing scientific environment.

Moreover, the term "maximum strength" may create an erroneous impression of a greater (or maximum) therapeutic benefit to the consumer. This impression may encourage the consumer to believe that only a high dosage of medication can provide adequate relief of symptoms. Often the regular strength product will provide equivalent relief. More meaningful terms, if used as outlined in this guidance document, are preferred when describing a product in a product line containing various concentrations of an ingredient.

Where regulatory limits for nonprescription availability exist, qualified statements such as "the highest level of X that you can buy without a prescription" have been accepted as statements of fact (e.g., benzoyl peroxide). Similarly, the overall context of the use of such qualified statements would be evaluated on a case-by-case basis.

4.10.3 Concentrated, Potent , Strong

Descriptions of drug products as "concentrated," "potent," or "strong" are often erroneous. Drug products are formulated to provide an amount of medicinal ingredient within an effective therapeutic range. The inclusion of a greater amount of a drug in a particular preparation or the marketing of more than one product providing varying amounts of medicinal ingredient within an acceptable range is undertaken at the manufacturer's discretion and does not justify implying a concentrated product.

The use of such wording may imply that the product is therapeutically more effective when in most cases the data is not available to support a difference in product effectiveness within a given acceptable dosage range and within a population. Where such data may exist, and this material has been reviewed and forms part of the market authorization for the product, the manufacturer would be able to consider promoting products within a dosage range as being more effective.

4.10.4 Unique, Special

The term "unique" is generally not considered acceptable on the labelling of drug products unless it refers to products that possess a unique therapeutic action or formulation of medicinal ingredients. Few drugs could be considered unique or exclusive in terms of action, effect, or formulation, particularly in classes of drugs where actions and attributes are quite similar.

Use of the terms "unique" or "special" is not acceptable if it implies that the drug product in question is singular in its action or effect, unless of course this is the case. An unqualified statement describing a product as unique or special could be perceived by the consumer to refer to the therapeutic effect.

The use of "unique" to describe a product is acceptable under the following terms:

  • If a drug is the only product on the market with a particular formulation of medicinal ingredients, " unique" could be an accurate description of that formulation, but not necessarily of the therapeutic class or effect of the product. If the difference is only in the concentration of the medicinal ingredient, the consumer would be less likely to perceive this difference, therefore, the term "unique" would not be acceptable in this case.
  • The terms "unique" and "special" should be reserved for those products that are singular or exclusive in terms of action or effect and that offer a distinct advantage to the consumer in terms of effect, lack of side effects, onset, duration, or other therapeutic benefit. This therapeutic benefit should be specified in the labelling or advertising whenever this term is used. The use of "unique" would require justification and documentation to demonstrate the therapeutic advantage and would be evaluated on a case-by-case basis. The manufacturer would be responsible for ensuring the continued suitability of the term as applied in the labelling of a particular drug product, especially in response to similar products entering the market.
  • "Unique" and "special" may be acceptable when used to accurately describe the cosmetic or non-therapeutic aspects of a product. For instance, phrases such as "contains a unique combination of moisturizing ingredients" and "with a unique fragrance" could be used as they describe cosmetic elements, or "in a unique package design" to describe non-therapeutic factors provided the manufacturer has the data on file to support these claims. See Section 4.8, "Cosmetic Claims."
4.10.5 Guarantee

As no drug product can guarantee that it will be effective 100% of the time, the use of this term without qualifying it or in the context of safety, efficacy, or any other therapeutic aspect is generally considered misleading and unacceptable. In some circumstances, manufacturers may include an offer or guarantee of product quality (e.g., consistency, flavour, colour, etc.) or other non-therapeutic benefit, provided that this is clearly worded.

4.10.6 Safe, Non-toxic

As no drug is completely safe and without potential for an adverse effects, the unqualified terms "safe" and "non-toxic" are considered to be generally misleading and unacceptable for drug labels. However, in the context of providing adequate directions for use, the word "safe" may be part of the directions (e.g., "for safe use, do not exceed two tablets daily").

4.10.7 Healthy, Healthful

While drugs are intended to treat unhealthful conditions or to assist in maintaining good health, general unqualified descriptions of a drug as restoring general health or promoting healthful conditions are false. Manufacturers should be more specific in identifying the therapeutic benefits of a particular drug.

4.10.8 Natural, Natural Action, Natural Source

The term "natural" to describe a drug may imply some special benefit or added safety to consumers, which could be misleading as to the merit of the product. A drug may be described as "natural" only when it is sold in its original state without processing or refinement by humans. Where the original state of an ingredient is altered or changed, the use of the term "natural" in describing such a drug would be false, misleading, deceptive, and likely to create an erroneous impression regarding the character, composition, merit, or safety of the drug, which would be in violation of subsection 9(1) of the Act. Few drugs are so devoid of processing as to justify the description "natural."

Drugs of animal or vegetable origin, obtained with a minimum of processing in order to retain most of the original constituents, may be described as "natural source." Although most of these products under this description may be natural health products subject to the Natural Health Products Regulations, combination products containing drugs and natural health products are considered pharmaceutical drug products, and this interpretation would apply. These combination products could not be considered "natural source" due to the content of a synthetic drug.

Because all drugs act by artificially stimulating or modifying the chemical functions of the body, the description of the pharmacological effect of a drug as "natural" or "natural action" is false.

4.10.9 Antioxidant

The unqualified term "antioxidant," when used in labelling, is considered to imply some vague, therapeutic benefit of the product that is usually misleading, generally unsupported by available product data, and should not be used. Manufacturers wishing to use the term "antioxidant" should use adequate wording to make a more specific, therapeutically meaningful claim and provide substantiating data to support the claim.

In some narrow circumstances, manufacturers may wish to refer to formulation ingredients that have an antioxidant function that helps preserve the product formulation from degradation. This reference may be acceptable in terms of Good Manufacturing Practices, if it is clearly explained.

4.10.10 Free

Subsection 14(1) of the Act prohibits the distribution of any drug as a sample. Subsection 14(2) allows sampling to certain health professionals and further Regulations apply to this activity. Although the Act and Regulationsdo not define the sample, it has been defined in the Health Canada policy document Labelling of Professional Samples of Drugs as "a package of drug provided free of charge."

Therefore, it is generally inappropriate to refer to any nonprescription drug product in labelling or advertising as "free." However, in a combination offer, where with the purchase of another nonprescription drug or non-drug product, the purchaser will receive another drug product, (e.g., co-packaged product in package containing both the non-drug and drug product) "free" can be acceptable with appropriate labelling such as, "Product Y free with the purchase of Product X." Co-packaged products should be appropriately labelled, as outlined in Section 3.6.1, "Co-packaged Products."

4.10.11 False Representation

False representation is a presentation that contradicts current medical or scientific knowledge and is unsupported by clinically valid and statistically reliable data conforming to current standards. Such presentations may be considered in violation of section 9(1) of the Act. Due to the constant evolution of medical and scientific knowledge, claims that were once acceptable for a drug may become invalid. Such claims include the use of outmoded therapeutic concepts (e.g., stomach acidifier). These claims may be significant in the labelling of older products that have not been recently updated. It is the manufacturer's responsibility to update labelling when label text is no longer valid.

4.10.12 Fortified, Enriched

The terms "fortified" and "enriched" are difficult to employ without creating an erroneous impression, when the actual operation carried out is the addition of an ingredient to a formulation or to increase the quantity already present. These terms may imply that the product is therapeutically better because it contains more of a certain ingredient, whereas the formulation remains within an effective therapeutic range to accomplish the same effect and data does not likely exist to show differentiation in effect based on different strengths.

4.11 Negative Statements and Terminology

Drugs should be promoted in a positive fashion to provide the consumer with useful information. Negative statements may be derogatory, implying that another drug has a negative effect. A negative statement of this kind is considered to be misleading because it requires an interpretation of the implications of the statement by the consumer.

The following subsections discuss types of negative terminology.

4.11.1 Non-toxic and Non-narcotic

Negations such as "non-toxic," "non-poisonous" or "non-allergenic" create an erroneous impression regarding the safety of a drug. No drug is completely harmless, especially if abused or misused.

"Non-narcotic" is also a misleading and deceptive term. Only those preparations sold under section 36 of the Narcotic Control Regulations are available to the general public without a prescription, because their potential for abuse or misuse is limited. The term "non-narcotic" may suggest that the drug in question has narcotizing effects, that other drugs that are freely available contain narcotics, or that the drug has no potential for misuse or abuse.

Some consumers are concerned with the intake of certain non-medicinal ingredients in drug formulations, such as salt and sugar, and informative, negative, qualifying statements about these ingredients may be acceptable. Additional information is provided in Section 4.2, "Absence of Ingredients," and Section 4.3, "Absence of Side Effects."

4.11.2 Fear-inducing Text

Label text should not exaggerate the condition the drug is meant to treat in such a way that will induce fear in the possible consequences of not treating the condition and thereby encourage the purchase of a medication. It is improper to suggest that the health of a consumer will suffer or that full health cannot be obtained unless a particular drug is used. Most nonprescription products treat symptoms of self-limiting conditions, not the condition itself, and most resolve on their own, with or without the use of medication.

Describing the possible consequences of not treating a disorder or describing more serious diseases or effects that may result from the original condition is likely to create an erroneous impression of the merit of many drug products. This includes fear of social embarrassment that may result from the consequences of a condition that may occur without the use of the medication (e.g., anti-diarrheal medications). Therefore, terms such as "dangerous," "violent," "harsh," "hazardous," and "acute," are generally unacceptable when describing symptoms.

However, in the consumer information documents for products listed in Schedule F of the Regulations that treat serious conditions (e.g., cancer) the realities of the condition must be explained to fully inform the patient and this text may well be disturbing. A balance between fully informing the patient of the risks and benefits, and avoiding any unnecessary fear-inducing copy should be maintained for these products.

Similarly, for some nonprescription drug products that do treat the condition (e.g., vaginal antifungals) and where lack of treatment could have adverse consequences, a balance must be maintained between fully informing the patient of risks and benefits, and avoiding unnecessary fear-inducing text.

4.11.3 Acute, Severe , Chronic , Dangerous

Few conditions suitable for self-diagnosis and self-treatment in the non-prescription area would be considered acute, severe, chronic, or dangerous. In situations of a chronic or severe nature, the care and attention of a doctor or other health professional is usually required. The use of these terms is generally considered misleading and unacceptable for non-prescription drugs. Similarly, such terms may not be appropriate in the consumer labelling of prescription drugs, if considered to be unduly alarming or an exaggeration of the medical condition.

4.11.4 Need

Using the word "need" in labelling statements (e.g., "you need this drug") often conveys the erroneous impression that a particular drug is essential to an individual's well being. This term is inappropriate for most nonprescription drugs that treat self-limiting conditions that resolve on their own. Most consumer-available nonprescription drugs treat the symptoms of a condition and may relieve the discomfort. Exceptions to this general statement for nonprescription drugs include vaginal antifungal preparations.

For prescription drug products, a doctor may decide a patient needs a particular drug to treat a serious condition and wording in this context (e.g., "your doctor has determined that you need Product X to treat your blood infection Y") may be appropriate in the consumer information section of a prescription drug monograph. Similarly, for certain nonprescription drugs (e.g., vaginal antifungals), a doctor's previous diagnosis is necessary for self-treatment of the same condition or symptoms and the term "need" could be considered for these product labels.

4.11.5 Tamper Resistant

The use of the term "tamper resistant" to describe the security feature of a drug package should be avoided, as this language may tend to encourage or incite tampering behaviour in some individuals. More neutral language should be chosen to draw attention to the security feature (e.g., security feature, security band).

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4.12 Product Cross-promotion

Cross-promotion of drug products with another drug, natural health product, medical device (e.g., toothpaste, electric toothbrush), cosmetic, food, consumer good (e.g., drug product, movie) should be labelled using the following criteria:

  1. There should be no direct or indirect safety concern, including suggestions of inappropriate drug/drug, drug/natural health product, drug/cosmetic, or drug /food combinations.
  2. There should be no direct or implied new therapeutic use for the cross-promoted products that may exceed the terms of market authorization for each of the individual products.
  3. The cross-promoted products are not otherwise in violation of any Regulations applicable to any of the products.

See also Section 3.6.1, "Co-packagedProducts."

4.13 Imagery, Symbols , Illustration

Using pictures, charts, graphs, statistics, and symbols such as representations of the heart, EEG recordings, medical equipment, scientific reports, medical lab test results, and other symbolism in labelling can often be misleading as to the use, merit, and character of a drug product. Such misleading presentations should be avoided. Often these additions to labelling may imply some therapeutic benefit that is unauthorized for that product. For example, the picture of a heart on a package of acetylsalicylic acid tablets may imply some vague, undefined therapeutic benefit for the heart, which is misleading as to the merit of the product. All graphics must be shown on the draft label included in the original drug submission (see Section 2.10, "Final Labels").

5. Additional Considerations for Specific Product Types

5.1 New Drugs

All new drug submissions filed in the new Product Monograph format, as outlined in the Guidance for Industry: Product Monograph, must have a consumer information section in the Product Monograph regardless of the type and location of use for these products, including new drug products for hospital use only. The requirement applies to prescription and non-prescription new drugs.

Guidance for Industry: Product Monograph describes the information that should be provided to consumers for all new drug products respecting the use of the products (the entire Part III of the Product Monograph). The Consumer Information (CI) should be provided to the consumer at the point of dispensing or sale:

For a prescription product, the CI is handed directly to the patient by the pharmacist or is already an integral part of the package given to the patient /consumer.

For a non-prescription product, the CI is an integral part of the package purchased by the consumer.

A packaged drug product may remain in the distribution chain for some time after manufacture, depending on the expiry date and turnover at the retail level. Therefore, the revision date on consumer information may not reflect the most recent revision of the information. There is no objection to manufacturers adding a statement to the consumer information to the following effect:

Although the information shown in this document is current as of the date of production and the last revision date shown below, more current consumer information may be available at the manufacturer's website or by contacting the manufacturer at 1‑800-XXX-XXXX.

In addition, labels for these products should indicate the availability and distribution of this consumer information, by wording such as:

  • Pharmacist: Distribute/dispense consumer information for [prescription product];
  • See enclosed consumer information for [prescription or non-prescription product]; or
  • Doctor (Physician): Distribute consumer information for professional samples of [prescription product].

Please note that for New Drugs in the old PM format and where there is an Information for the Consumer (Information for the Patient) section, then the same label information as per above is expected.

It is the manufacturer's and pharmacist's responsibility that the consumer information document is distributed to the patient, in the case of the regular trade packages of a drug. Doctors are responsible for distributing this information for samples given to patients.

5.2 Consumer-available nonprescription medicines

There are 3 basic sub-categories of nonprescription drugs:

  1. those that may be sold freely to the general public without the intervention of a health care professional (e.g. consumer-available nonprescription drugs);
  2. those that may not be sold to the general public without the intervention of a health professional (e.g. nitroglycerin);
  3. those that are sold directly to health professionals and intended for professional use. (e.g. contrast media, some anesthetics...).

For those in category a) consumer-available nonprescription drugs where there is no requirement for professional intervention, then wording of the product labelling is especially important to ensure safe and effective use. Special labelling considerations are made for these products as explained in this section.

5.2.1 Labelling Standards and Monographs

Numerous labelling standards and monographs for general product classes have been developed to cover the common consumer-available nonprescription drugs, and these are available on the Health Canada website. These standards and monographs provide basic information on acceptable indications, uses, medicinal ingredient identities, strengths, dosages, warnings, and precautions to help ensure the safe and effective use of products that fall within the standards. These standards and monographs should be consulted in conjunction with the Act and Regulations, and all appropriate Health Canada guidance and policy documents.

5.2.2 Directions for Use

According to subparagraph C.01.004(1)(c)(iii) of the Regulations drugs must carry adequate directions for use on the labels Consumer-available nonprescription drugs, intended for self-treatment by the general public, must carry sufficient information on the labels for an individual to use the medication properly without consulting a health professional. Furthermore, the terminology used should be explicit and easy to interpret.

Adequate directions for use should include the following information:

  • Indications for use;
  • Dosage;
  • Route of administration; and
  • Warnings and precautions.
5.2.2.1 Indications for Use

In some cases, a pharmacological classification could suffice as an indication for use. However, such terminology has little meaning to the lay public and specific indications are usually necessary. For example, the pharmacological classification of a medicine as an anti-emetic would be insufficient on a consumer-available nonprescription drug label; an additional indication, such as "motion sickness," would be necessary.

Indications for use may be evident in the trade name of the product, such as Brand X Antiperspirant. In contrast, Brand Y Cough Syrup will require further clarification, such as indicating that it is an expectorant.

5.2.2.2 Dosage Directions

The dosage of consumer-available nonprescription drugs should be stated in the number of tablets or capsules per dose, or a practical household measure per dose, and should include the frequency of doses. Separate directions for adults and children should be provided and, if the product is not recommended for children, the dosage should be clearly identified as "adult dose." Some products require a qualification on repeat doses such as those normally used on analgesic labels (e.g., "may be repeated in X hours if required"). When significant, maximum single end/or daily doses, and duration of use for some conditions should be specified (e.g., treatment of fungal infection).

5.2.2.3 Routes of Administration

Labels should generally state the route of drug administration. Some consumer-available nonprescription drug products may have a brand name that includes the route of administration, or at least adequately implies it. Labels for tablets, capsules, and some liquids intended for oral administration may not require a separate statement, as the route of administration is often obvious. When the route of administration differs from the usual route associated with a pharmaceutical form, the label should specify the actual route (e.g., vaginal tablets, powder for inhalation, oral spray, ophthalmological ointment).

Qualifying statements, such as "external use only," may be required if there is a possibility that the pharmaceutical form could indicate an alternate route of administration or cause confusion with other products (e.g., camphorated oil).

5.2.2.4 Warnings and Precautions

Frequently, a specific warning or precaution statement will be required for an individual product or product category. The warning may not, in itself, be a regulated statement, but it is considered an expression of adequate directions for use based on medical or pharmacological grounds.

For example, cathartics are not to be used by children under six years of age or in the presence of nausea, vomiting, fever, or abdominal pain. As a further example, antihistamines that are known to cause drowsiness should not be used by individuals while operating machinery. See also Section 3.5.4.3, "Warnings and Precautions."

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5.3 Consumer-available Nonprescription Medicines Subject to the Narcotic Regulations

A particular subset of narcotic products can be supplied to consumers without a prescription as defined in section 36 of the Narcotic Control Regulations, which states:

36. (1) Subject to subsection (2), a pharmacist may, without a prescription, supply a preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if

  1. the preparation contains:
    1. two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half the regular minimum single dose for each such ingredient, or
    2. three additional medicinal ingredients other than a narcotic in a quantity of not less than the the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient; and
  2. there is legibly and conspicuously printed on the main panel of the label and on any outer container the full formula or true list of all active ingredients and a caution to the following effect:
    "This preparation contains codeine and should not be administered to children except on the advice of a physician or dentist."

Such products are usually pain medications containing combinations of ingredients such as acetaminophen or acetylsalicylic acid, caffeine, muscle relaxants, and codeine.

5.4 Prescribed and Parenteral Drugs

The general labelling requirements as described in Sections 2 and 3 of this guide apply to prescribed and parenteral drugs, except as otherwise noted in this section. The language used in the labelling of these products may target health professionals, provided that the fundamental goal of labelling is respected. That is, the labelling must promote safe and proper use of a product and must therefore be sufficiently complete and well understood by all users.

5.4.1 Dosage

Unlike the practice followed for consumer-available nonprescription drug preparations, dosage directions for prescription and parenteral preparations may often be expressed in terms of units of weight of medication per unit of body weight.

Although the pharmacological classification may replace specific indications on the labels, in cases where indications are specified, the dosage directions applicable to each indication or a dosage range encompassing all the indications should appear where possible. However, for complex prescription drugs with numerous indications and various dosage regimens (e.g., cancer drugs) providing complete dosage information is not possible and prescription drug labelling may be abbreviated (e.g., see package insert) or may have some general information (e.g., dosage range) accompanied by a direction to refer to the package insert or Product Monograph.

When the label provides the dosage range, the dosage specific for each indication must be detailed in the prescribing information or Product Monograph.

5.4.2 Package Insert

The package insert for prescribed drugs is the prescribing information document described above, intended for use by the health professional, or is equivalent to the Part I of the new Product Monograph template. The package insert for a new drug, in the new Product Monograph format, is Part I of the Product Monograph.

If the package insert (professional information) is included in the package of a new drug or with a product that is not a new drug, and a separate consumer information document is also included, the label should clearly indicate that the product contains both (e.g., "see package insert and consumer information"). This variation in the label statement will alert the pharmacist dispensing the drug to provide the consumer information to the patient.

Where multiple unit packages are supplied to the pharmacist, it is expected that sufficient consumer information copies are also included in the packaging or are otherwise supplied to the consumer. It is the manufacturer's and pharmacist's joint responsibility to ensure that the consumer receives this information.

5.4.3 Parenteral Preparations
5.4.3.1 Common Name Parenterals

In addition to the general labelling requirements outlined in Sections 2 and 3, more specific information applies to parenteral products. In cases where no proper name exists for a single-ingredient parenteral preparation, the common name should be derived in the following manner:

For liquids ready for injection:
Substance X Injection
(Substance X to be listed as per Section 3.4.2, "Proper or Common Name")

For dry solids or concentrated liquids requiring dilution prior to administration:
Substance X for Injection
(Substance X to be listed as per Section 3.4.2, "Proper or Common Name")

5.4.3.2 Products for Injection Requiring Dilution

If label space is available, concentrated liquid products meant for dilution before intravenous injection should bear a label warning to the effect, "concentrate - must be diluted before use." For small inner labels of these products, where space is limited, abbreviated statements such as "dilute before use" may be used.

For other injection products, such as powdered products that must be reconstituted (diluted) before use or special products (e.g., products stored in a droplet of oil under nitrogen in an ampoule), the label wording may simply be "reconstitute (dilute) before use."

For special labelling of pharmacy bulk vials, see Section 5.4.3.8.

5.4.3.3 Declaration of Medicinal Ingredients

A. Liquid preparations

  • For small-volume parenterals, the quantity of each medicinal ingredient should be declared per millilitre (e.g., 5 mg/mL), as well as total volume (e.g., 4 mL) and total amount per total volume (e.g., 20 mg/4 mL).
  • For large-volume parenterals, declarations in percentage or weight per 100 mL (e.g., 1g /100 mL, or 1% w/v) would be considered acceptable according to existing practices, as well as total volume (e.g., 250 mL) and total amount per total volume (e.g., 2.5 g/250 mL).

B. Preparations intended for reconstitution

  • The quantity of each medicinal ingredient per container should be declared.
  • The method of reconstitution, including the name and quantity of the diluent to be used, and the resulting concentration, should be declared.
  • The volume of liquid that can be withdrawn for administration after reconstitution should also be declared.

The potency of medicinal ingredients may be declared in terms of the total compound or in terms of the active moiety, provided that the whole compound is identified by name. The dosage recommendations should follow the chosen method of potency declaration. Also, for a product available in different potencies, the method of declaration should be identical for all potencies.

Manufacturers may wish to refer to the Canadian Standards Association document, Labelling of Drug Ampoules, Vials and Prefilled Syringes for further guidance.

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5.4.3.4 Declaration of Non-medicinal Ingredients

The United States Pharmacopoeia requires that the labelling of parenteral preparations list the names and quantities of all ingredients except ingredients added to adjust the pH or to make a solution isotonic, which may be declared by name with statement of their effect. Sponsors should provide the qualitative declarations of the complete formulation of parenteral preparations in all cases because such declarations provide useful information promoting safe and proper use of the products.

5.4.3.5 Declaration of Preservatives

For the purposes of paragraph C.01.004(2)(b) of the Regulations, which requires the quantitative declaration of preservatives used in parenteral preparations, the term "preservatives" refers only to antimicrobial agents.

5.4.3.6 General Directions for Use

In addition to the regulatory requirements for the labelling of injectables, including the declaration of preservatives, labelling should also state the following information:

A. Label Only

  • The route of administration (e.g., intravenous, subcutaneous);
  • If no preservatives are present, wording such as, "Single use. Discard unused portion";
  • If preservatives are present, wording such as "multiple use" as well as wording to explain duration and conditions of use and storage after first puncture of the multiple use product (e.g., use within X hours of first puncture when stored at Y-Z˚C); and
  • If dilution is required, the directions for performing the dilution.

B. Label or Insert

  • Directions to examine the solution for product integrity before use such as "mixture (solution) should be inspected visually for clarity, particulate matter, precipitation, discolouration, and leakage prior to administration whenever solution and container permit." Optional wording could include "Do not use product if mixture (solution) shows haziness, particulate matter, discolouration, or leakage."
  • Any special directions for preparation, reconstitution, administration, volume, rate and timing of infusion, mixing and incompatibilities with other medications, period of use after reconstitution, storage, special handling, and disposal.
5.4.3.7 Parenteral Salts, Salt/Sugar, Electrolytes, Parenteral Nutrition

For all parenteral electrolyte salts, or salt/sugar combinations, in addition to the quantitative declaration for each ingredient in terms of weight (per volume or per container) and final concentration after dilution, where applicable, special labelling must at a minimum show the total osmolar concentration of the ingredient or ingredients in the final formulation. The label may also need to include the declaration of the number of milliequivalents per unit final volume (mEq/volume) for each salt/electrolyte. Osmolarity is usually expressed in terms of mOsmol/L, or for volumes less than 100 mL, in terms of mOsmol/100 mL. The following table contains several examples.

Table 5.1: Additional Labelling Requirements for Parenteral Salts and Salt/Sugar Combinations
Salt, salt/sugar combination Total Osmolarity mOsmol/Litre, or mOsmol/100mL Declaration (mEq/volume)
Sodium chloride injection Yes No
Sodium chloride and dextrose injection Yes No
Potassium chloride in dextrose injection Yes Yes, potassium
Potassium chloride in dextrose and sodium chloride injection Yes Yes, potassium, sodium, chloride
Multiple electrolytes in dextrose injection Yes Yes, for all electrolytes, which may include sodium, potassium, magnesium, chloride, calcium, acetate, gluconate, phosphate, lactate, ammonium, sulfate

For parenteral nutrition products that have been assigned DINs, including those providing calories by sugars or by fat emulsions, the same requirements as above occur, with the requirement for a declaration of osmolarity. In addition, the caloric content provided per unit volume should be declared (e.g., kcal/mL) as well as a maximum daily limit of the product to be provided intravenously (e.g., 2 g fat/kg body weight).

5.4.3.8 Pharmacy Bulk Vials

Pharmacy bulk vials are large volume vials containing multiple doses and are intended for a pharmacy admixture program to create infusion mixtures or transfer to empty sterile syringes. These vials are not meant for direct injection. The closure to each vial is meant to be penetrated one time only with a sterile transfer device.

The following additional labelling is required for pharmacy bulk vials:

  1. To be shown prominently, preferably on the main panel of the label:
    • Pharmacy Bulk Package (Vial) - not for direct infusion
    • Single puncture - multiple dispensing
  2. On any panel:
    • For use in pharmacy (hospital) admixture program only
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5.4.4 Prescribed Drugs not Controlled by Schedules

Although they are not required by the Regulations to be sold on prescription (and they are held behind the counter), these drugs should not be advertised, labelled, or recommended to the general public for self-medication (e.g., drugs where the dosage exceeds the limits of section C.01.021 and drugs intended for diseases listed in Schedule A of the Act). Other drugs are available without a prescription but must be distributed by a health professional (e.g. pharmacist) so that they are more freely available in an emergency (e.g., nitroglycerin).

Schedule Adiseases may not be mentioned in those parts of the labelling available to the general public, unless the information is required for warnings and precautions (see Section 2.7, "Schedule A Claims").

In cases where a product is intended for a Schedule A disease and there is no appropriate pharmacological classification or indication other than the one that would refer to such disease, no pharmacological classification or indication should appear on the label (section 3(2) of the Act). Prescribing information that outlines the indication must therefore be made available for physicians and pharmacists, and the label should state the availability of this document. It is also essential that the label of such a drug include a statement indicating that the product should be used only on a physician's advice.

Most of the products in the categories covered by this section require that their directions for use be detailed in a document called "prescribing information" (see Section 5.4.5 of this guide). The title Product Monograph should not be used, as it is reserved for the official document issued as part of a Notice of Compliance for new drugs.

5.4.4.1 Oral Use Salts

Similarly, for oral use salts (i.e., potassium chloride for oral solution) or combinations of oral salts (e.g., oral rehydration solutions, electrolyte replenishers), in addition to the quantitative declaration in terms of weight of each medicinal ingredient per container, and weight per final volume after dilution, where applicable, the quantity should also be expressed in milliequivalents per unit of final volume for each element (ion).

5.4.5 Prescribing Information

Prescribing information (professional information) for older new drug products not conforming to the new Product Monograph format or for products not subject to Division 8 of the Regulations, should contain at least the following:

  • Brand name, if applicable;
  • Proper or common name, and potency or quantitative list of ingredients;
  • Standard of manufacture where required by the Regulations;
  • Indications; this section must clearly indicate the function of the product in either the treatment, prevention, or diagnosis of a recognized disease entity or a significant manifestation of disease, or in the relief of symptoms associated with a recognized disease, condition, or syndrome, or as an adjunct in the treatment of some condition;
  • Contraindications, precautions, warnings, and adverse effects, drug/drug interactions, and drug/food interactions;
  • Dosage and administration instructions for each indication and age group or other patient categories, as applicable;
  • Mode of reconstitution and storage, if applicable;
  • Symptoms and treatment of overdosage;
  • Preparations available;
  • Identification of manufacturer; and
  • Date of preparation or document revision.

For manufacturers either updating old prescribing information documents or creating new prescribing information documents where none existed previously, sponsors can use the above format, if they are not required to put their information in the new Product Monograph format. Alternatively, they may follow Part I of the Guidance for Industry: Product Monograph. Where possible, the new format outlined in Part I of the Product Monograph guidance is preferred.

5.5 Notice of Compliance with Conditions

Health Canada's Notice of Compliance with Conditions (NOC/c) Guidance describes New Drug Submissions or Supplemental New Drug Submissions for serious, life-threatening, or severely debilitating disease for which promising evidence of clinical effectiveness exists. Special labelling is required to clearly identify and highlight these products and the tentative nature of their approval. See Appendix B.

5.6 Professional Use Products

A further category of unscheduled products is professional-use only products. These products are available only to health professionals and are distributed to hospitals, clinics, and directly to physicians, dentists, and other health professionals.

Professional-use only products include:

  • contrast media for MRI and other imaging agents;
  • dental-use hemostat agents to stop bleeding in dental surgery;
  • dyes for revealing dental plaque;
  • dental antiseptic solutions for administration by dental professionals; and
  • dialysis solutions.

As most of these products are distributed to health professionals only, have been long used by these professions (except contrast media), and many do not meet the criteria for a Schedule F product, the labelling of some of these products may be minimal and may not need to include a prescribing information document. To distinguish these products from similar consumer-available nonprescription products (e.g., fluoride products), and to avoid unintentional diversion to consumer markets, they usually bear labelling to the effect, "For professional use only."

Appendix A: Definitions

Adequate Directions for Use: "meansinformation necessary for the proper and recommended use of the drug, including cautionary and warning statements" (Regulations, subparagraph C.01.004(1)(c)(iii)).

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" (Regulations, section C.01.001).

Child Resistant Package: "means a package that meets the requirements of subsection (2)" (Regulations, section C.01.001).

Close Proximity: "means, with reference to the common name, immediately adjacent to the common name without any intervening printed, written or graphic matter" (Regulations, section B.01.001).

Common Name: "means, with reference to a drug, the name in English or French by which the drug is

  1. commonly known, and
  2. designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act" (Regulations, section C.01.001) See section 3.4.2 of this guide.

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 or abnormal physical state, or its symptoms, in human beings or animals,
  2. restoring, correcting or modifying organic function in human beings or animals, or
  3. disinfection in premises in which food is manufactured, prepared or kept" (Section 2 of the Act).

Drug in Dosage Form: "means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing" (Regulations, subsection C.01.005(3)).

Expiration Date: "means the earlier of

  1. the date, expressed at minimum as a year and month, up to and including which a drug maintains its labelled potency, purity and physical characteristics, and
  2. the date, expressed at a minimum as a year and month, after which the manufacturer recommends that the drug not be used" (Regulations, section C.01.001). See Section 3.5.3 of this guide."

Immediate Container: "means the receptacle that is in direct contact with a drug" (Regulations, section C.01.001).

Inner Label: "means the label on or affixed to an immediate container of a food or drug" (Regulations, section A.01.010).

Internal Use: "means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane" (Regulations, section C.01.001).

Label: "includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package" (Section 2 of the Act).

Lot Number: "means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution" (Regulations, section A.01.010).

Main Panel: see Principal Display Panel.

Manufacturer or Distributor: "means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug" (Regulations, section A.01.010). See Section 3.5.1 of this guide.

Microgram: one-millionth of a gram.

Net Amount: "in addition to the requirements of subsection (1), the outer label of a drug shall show (a) the net amount of the drug in the container in terms of weight, measure or number..." (Regulations, paragraph C.01.004(2)(a)).

New Drug: "means

  1. a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;
  2. a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or
  3. a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug" (Regulations, section C.08.001)."

Non-prescription Drug:a drug not listed on Schedule F of the Regulations and available without a prescription. This includes drugs that

  1. may be sold to the general public without the intervention of a health care professional (consumer-available nonprescription drug e. g., acetylsalicyclic acid (ASA));
  2. may not be sold to the general public without the intervention of a health care professional, usually a pharmacist (e.g., nitroglycerin, insulin, injectable epinephrine for anti-allergic purposes); and
  3. are sold directly to health professionals and intended for professional use. (e.g., contrast media, anaesthetics).

Official Drug: "means any drug

  1. for which a standard is provided in these Regulations, or
  2. for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act" (Regulations, section C.01.001).

Outer Label: "means the label on or affixed to the outside of a package of a food or drug" (Regulations, section A.01.010).

Parenteral Use: "means administration of a drug by means of a hypodermic syringe, needle, or other instrument through or into the skin or mucous membrane" (Regulations, section C.01.001).

Prescribed: "means prescribed by the Regulations" (Section 2 of the Act).

Principal Display Panel: "has the same meaning as in the Consumer Packaging and Labelling Regulations." (Regulations, section A.01.010) (CPLR). The Consumer Packaging and Labelling Regulations (CPLR) state:
"Principal display panel means

  1. in the case of a container that is mounted on a display card, that part of the label applied to all or part of the principal display surface of the container or to all or part of the side of the display card that is displayed or visible under normal or customary conditions of sale or use or to both such parts of the container and the display card,
  2. in the case of an ornamental container, that part of the label applied to all or part of the bottom of the container or to all or part of the principal display surface or to all or part of a tag that is attached to the container, and
  3. in the case of all other containers, that part of the label applied to all or part of the principal display surface."

The alternate term, main panel has the same meaning as "principal display panel."

Product Class: for the purpose of this guidance, a product class consists of drug products indicated for the same condition or range of symptoms, and sold under similar regulatory requirements.

Product Line or Product Line Extension: two or more products sharing a brand name, part of a brand name, or common identifier as part of the brand or product name that contains additional medicinal ingredients or different strengths and is intended to expand the conditions of use of the initial product. Product line extensions should not create name confusion with respect to other products in the line. See Section 4.5, "Look-alike, Sound-alike Drug Product Names."

Proper Name: "means, with reference to a drug, the name in English or French

  1. assigned to the drug in section C.01.002,
  2. that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form,
  3. specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or
  4. assigned to any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c)" (Regulations, section C.01.001).

Security Package: "means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase" (Regulations, section A.01.010). See Section 3.6.4 of this guide.

Standard: a monograph for a drug (as the medicinal ingredient or in finished dosage form) that lists specifications relating to nomenclature, identity, purity, potency, quality, physical properties, tests, assays, packaging, labelling, and storage requirements. See Section 3.4.3 of this guide.

Teaspoon: "means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres" (Regulations, section C.01.001).

Tablespoon: a volume of 15 cubic centimetres (15 cm3).

Appendix B: Applicable Health Canada Guidance Documents and Policies

Health Canada Guidance Documents

The following guidance documents are available on the Health Canada website.

  • Draft Guidance Document: Schedule A and Section 3 to the Food and Drugs Act.
  • Draft Guidance for Industry: Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names.
  • Guidance Document: Basic Product Monograph Information for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
  • Guidance Document: Disinfectant Drugs.
  • Guidance Document : Post-Notice of Compliance (NOC) Changes : Framework
  • Guidance Document : Post-Notice of Compliance (NOC) Changes : Quality Document.
  • Guidance Document : Post-Notice of Compliance (NOC) Changes : Safety and Efficacy
  • Guidance for Industry: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names.
  • Guidance for Industry: Management of Drug Submissions.
  • Guidance for Industry : Product Monograph.
  • Guidance for Industry: Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products.
  • Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUIDE-0069).
  • Guideline on Preparation of DIN Submissions
  • Issue Analysis Summary: Look-alike Sound-alike (LA/SA ) Health Product Names: The Development of a Comprehensive Policy Recommendation.
  • Non-medicinal Ingredient Nomenclature.
    Notice of Compliance with Conditions (NOC/c) Guidance.
  • Notice: Revision of the Notice of Compliance with Conditions (NOC/c) Policy and Guidance.
  • Therapeutic Comparative Advertising: Directive and Guidance Document.

Health Canada Policies

The following policies are available on the Health Canada website.

  • Absence of Ingredient Statements for Nonprescription Drugs.
  • Assignment of Drug Identification Numbers (DIN ) According to Product Name.
  • Changes in Manufacturer's Name and/or Product Name.
  • Drug Identification Number : A Brand Name Product with Different Fragrances, Flavours or Colours.
  • Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use.
  • Labelling of Professional Samples of Drugs.
  • Labelling of Special Containers.
  • Notice of Compliance with Conditions Policy.
  • Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products.
  • The Distinction between Advertising and Other Activities.

Other Applicable Legislation

  • Benzodiazepines and Other Targeted Substances Regulations
  • Controlled Drugs and Substances Act
  • Narcotic Control Regulations
  • Weights and Measures Act, 1985. (Administered by Measurement Canada, an agency of Industry Canada)
  • Regulations Amending the Food and Drug Regulations (743- Non-Medicinal Ingredients) May 13, 2010, Canada Gazette Part II, Volume 144, ( no. 11)

Appendix C: Third-party Guidance Documents

The following is a list of further labelling guidance documents from third parties or other countries that sponsors may wish to consider when creating effective labelling. Health Canada does not endorse the following documents and does not necessarily agree with their entire contents. They are presented as sources of additional, useful information should the sponsor wish to further improve labelling, providing these improvements do not conflict with the Regulations and related guidance documents.

  • Good Medicine for Seniors: Guidelines for Plain Language and Good Design in Prescription Medication. 2002, ISBN: 1-894324-23-4, Next link will take you to another Web site Canadian Public Health Association,
  • Next link will take you to another Web site Guidelines for Cosmetic Advertising and Labelling Claims. February 2006. Health Canada/Advertising Standards Canada. HC Pub: 4285, Cat H128-1/06-453, ISBN 0-662-49001-0.
  • Guidelines for Drug Packaging and Labelling for Manufacturers. 2001. Next link will take you to another Web site Canadian Society of Hospital Pharmacists.
  • Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use. 12 January 2009. European Commission, Directorate-General III Industry.
  • Next link will take you to another Web site Institute of Safe Medication Practices (ISMP).
    • ISPM's List of Confused Drug Names
    • ISMP List of Error-Prone Abbreviations, Symbols, and Dose Designations
    • Principles of Designing a Medication Label for for Intravenous Piggyback Medication for Patient Specific, Inpatient Use.
  • Labelling Code of Practice: Designing Usable Non-prescription Medicine Labels for Consumers. 2004, Next link will take you to another Web site Communication Research Institute of Australia (CRIA).
  • Labelling of Drug Ampoules, Vials and Prefilled Syringes. CAN/CSA-Z264.2-99. Next link will take you to another Web site Canadian Standards Association.
  • Part 201 - Labelling: Subpart C - Labelling Requirements for Over-the-Counter Drugs. Section 201.66 Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labelling. Code of Federal Regulations, Title 21, Volume 4. Revised as of 1 April 2008, 21CFR201.66. (US).
  • Part 201 - Labelling: Subpart B - Labelling Requirements for Prescription Drugs and/or Insulin. Section 201.56 Requirements on Content and Format of Labelling for Human Prescription Drug and Biological Products. Code of Federal Regulations, Title 21, Volume 4, Revised as of 1 April 2008. 21CFR201.56 (US).
  • USP Nomenclature Policy: Next link will take you to another Web site Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.
    USP Pharmacopeial Convention

Appendix D: Alphabetical Index

Appendix D: Alphabetical Index (see PDF)

Date Modified: 2010-10-06

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