Health Canada Label & Artwork Regulations

Our comprehensive guide gives an overview of what Canadian Government’s – Health Canada pays attention to when evaluating pharmaceutical packaging.

Submission Considerations

Design elements will be evaluated in the first 90 days of the review to determine whether they support or impede legibility and understanding of the label.

Sponsors should include the font size and style of inner/outer label text in the Mock-up Labels and Packages Certification Form.

Sponsors should include a rationale or Note to Reviewer when they are unable to meet the minimum recommended font size or type style.

Primary Display Panel

The principal display panel is the main product display surface and must show the following information:
o The brand name, if applicable
o The proper or common name of the drug product, if applicable
o The standard for the drug product, if any
o The notation “sterile (stérile),” if required by the Regulations
o The scheduling symbol, if required
o The Drug Identification Number (DIN)
o Health Canada recommends a minimum font size of nine points for inner and outer labels, including any text in a table format. All labelling should be in Sans Serif type font.

Font & Lettering

A point size less than 6 should not be used for key information.

Use of a sans serif type style, that is not compressed, expanded, or decorative is preferred for key information.

Choose a type style with adequate spacing between letters (to enhance legibility) and between words (to enhance readability).

Avoid using all capital letters. Exceptions: brand names, headings, and warnings that are brief may be fully capitalized.

Avoid the use of italic type except to emphasize a particular portion of text.

Use TALLman lettering (the application of UPPER CASE lettering to certain syllables or groups of letters within names) on product labels only if it is intended as a risk mitigation strategy not as a marketing strategy


To enhance the readability of information, use bullet lists, with items in point form instead of complete sentences

When providing stepwise directions, use numbered lists and keep all text for each individual step on one line, if possible.

Maximize the use of white space to avoid crowding information on the label.

Use opaque labels on clear or translucent containers to ensure that type is legible and does not show through the container.

Logos, trade dress and branding can assist in differentiating products from different manufacturers.

They have the potential to contribute to errors and impede the safe use of health products.

Trade dress may be a factor in look-alike labelling and packaging, particularly for products from the same sponsor, items across a product line, generic products, where there appears to be a tendency to create or standardize a look across all product lines. A brand (proprietary) name may be given more prominence than the proper or common name on drug labels.

Graphic elements and “branding” text may interfere with the clear presentation of information that is important to the user.

Logos and trade dress on product labels should not distract the user or impede the effective communication of key information to the user.

Strive for balance between the use of corporate trade dress and the presentation of key information on labels.

Consider the amount of space required for a logo and how much space will be available for product information on the remainder of the label.

Ensure that key information within a product line is clearly differentiated among products to avoid look-alike confusion and the potential for selection error.

Clearly distinguish different strengths of the same health product or the presentations of different health products by the same manufacturer.

Consider the use of colour, together with other elements of the label and package, such as size, shape, or features of the container closure.

When possible, avoid placing unrelated information (including graphics) between the product name and its strength.

To ensure that key information is legible and not subject to misinterpretation, avoid superimposing text and images (or logos).

While trade dress and logos can assist in the selection process, care must be taken to appropriately differentiate products within a product line to decrease the potential for confusion.

Logos and trade dress on product labels should not distract the user or impede the effective communication of key information to the

Consider the amount of space required for a logo and how much space will be available for product information on the remainder of the label

Logos and trade dress on product labels should not distract the user or impede the effective communication of key information to the

Express the dose strength in an appropriate metric unit, except in situations where other units of measure are accepted and required, such as units of potency for biological medicinal products and percentage strength for topical

Numbers without units of measure should not be used to express product

Use “mcg” rather than “μg” for “micrograms.

For numbers with five digits or more, separate the digits into groups of three by a thin space to help prevent misreading. (e.g., 1000 mg but 10 000 mg)

Leave sufficient space around the slash character (“/”) to optimize legibility, given that this character could be misinterpreted as the number “1” (one) or the letter “l” (L).

Do not use the slash character (“/”) to denote the word “or”, and avoid its use for separating different pieces of information.

Avoid the use of trailing zeros (e.g., “2.0”, “2.50”) and naked decimals (e.g., “.2”).

Units expressing the product strength and the units used for dosing instructions should be consistent.

Avoid placing expressions of strength near other numeric information, such as the number of units in the package.

Avoid using both metric units and other units (e.g., milligrams combined with international units) to express the strength on the principal display

Equivalencies may be better expressed and presented on a side or back

For dosage forms such as transdermal patches, implants, and inhalers or inhalators include the total quantity of the medicinal ingredients and the dose delivered per unit of time and the duration of use on both the inner and outer

Label the dosage form or delivery unit itself with the delivery rate of the drug (e.g., “x mg / day”).

Where the total quantity in the delivery unit does not correspond to the delivered dose, the to- tal amount of drug in the unit may be presented on a side or back panel of the package, rather than on the principal display panel.

For liquids intended for oral administration, declare the quantity of each medicinal ingredient per millilitre (e.g., 5 mg / mL).

For small-volume parenteral products (100 mL or less), declare the quantity of each medicinal ingredient per millilitre (e.g., 5 mg / mL), as well as the total amount per total volume. (e.g., 20 mg / 4 mL).When the total quantity per total volume is present on the principal display panel of a label, ensure that this information is more prominent than other expressions of

The total amount per total volume should be the primary expression followed by the strength per mL presented in close

For example, display “400 mg / 4 mL” more prominently than “100 mg / mL”, presenting the less prominent expression within parentheses or in smaller

For containers with less than 1 mL total volume, express the strength as the quantity of active ingredient in the volume provided (e.g., 3 mg / 0.5 mL).

Avoid using percentages to express concentration or strength when usual dosing is based on a weight or volume calculation of the amount to be

The expression of strength should match the units of measure described in the prescribing information to avoid

The following must normally be displayed on any panel of the inner and outer labels:
o The name and address of the manufacturer/sponsor and of the distributor if the manufacturer/ sponsor is not Canadian;
o The lot number;
o The expiration date;
o Adequate directions for use of the drug product
o A quantitative list of the medicinal ingredients of the drug product.
o Declaration of Non-medicinal Ingredients
o Net Amount (Net Contents).
o Preservatives

The following information is to be displayed on any panel of the outer label:
o The net amount of the drug product in the container in terms of weight, measure or number [for example (e.g.) number of tablets].
o A quantitative list of all preservatives in parenteral preparations and of all mercurial preservatives in any drug product containing mercury or a salt or derivative thereof as a preservative.

The labelling of small containers is exempt from many of these requirements.

The adequate directions for use 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.

Prescription drugs products, drugs products available in hospitals and clinics only, or drug products for professional use only do not require bilingual labelling.

Health Canada recommends a font size of ten points for the consumer information and package insert text and a minimum of nine points for inner and outer labels and tables for the labelling of the consumer information and package inserts.

Preferably all labelling in Sans Serif type font, to avoid any problems in legibility.

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

Standard units of measure and abbreviations (e.g., ounces, oz.) may be included on the label pro- vided that the metric units are also present.

The abbreviation “mcg” be used instead of “μg” for microgram.

Bar codes may be used provided that all regulatory requirements concerning the label have been met and the bar code information does not
o change the terms of market authorization for the product
o obscure or displace the required and approved information on the label

Use color to draw attention to important label information, such as the name of a health product and its strength, to bring attention to or enhance the prominence of warning statements to differentiate one product from another or to differentiate between strengths within a product line.

To enhance differentiation among product strengths, avoid using different shades of blue for various strengths, and instead use distinctly different colors.

As a general principle, color-coding of health products is not recommended. Consider using more than just colour to distinguish between products

When selecting colors for labeling and packaging, consider the potential implications of colorblindness.

Match the styles of inner and outer package labels so that the visual appearance, including use of colour, is identical or related.

Maximize the legibility of text by ensuring good contrast between text and background.

For multiple-dose packs and single-dose packs consideration should be given to the color of the text and the use of non-reflective or coloured foils that may enhance the legibility.


Text should be a minimum font size of ten points

Text in tables should be a font size of nine points

All labelling should be in Sans Serif type font.

Font size and type style of package inserts should be included in the Mock-up Labels and Packages Certification Form

Include a rationale or Note to Reviewer if they are unable to meet the minimum recommended font size or type style.

A point size of less than 6 will not be accepted.

To enhance readability, use flush left, ragged right alignment of multiple lines of text.

Package Insert

A package insert is not required to be included.

If not included, should include a label statement such as “Product Monograph, package insert or prescribing Information available on request”

You may choose to voluntarily include a package insert or as a convenience to the healthcare professional, if special directions are required to prepare the product for dispensing

If the package insert is included in the package, a separate consumer information document can be included in the insert or distributed separately

If the Part I (professional information) and Part III (consumer information) are included together in a package insert, then the label should indicate “See enclosed 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.

If the Part III (consumer information) is not part of the package insert and is distributed separately, then the following two statements should appear on the label: “See package insert” and “Pharma- cist: Dispense with consumer information (leaflet)”.

It is expected that sufficient copies of the consumer information included in the packaging for distribution to the consumer/patient at the time of dispensing.

Product monograph

Health Canada requires a product monograph which is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be compared.

A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug.

A product monograph also to serve as a standard against which all promotion and advertising of the drug can be compared.

A copy of the product monograph should be provided to health professionals prior to, or coincident with, the first direct promotion or marketing of a new drug, and to any health professionals to whom the sponsor sells a new drug before it is generally available.

Product monograph formatting

A product monograph should be prepared with the following guiding principles:

Avoid duplication of information

Key information should be easy to locate.

Information in the monographs should be presented in a consistent format to facilitate ease of retrieval, particularly in an electronic environment.

Paper: 8½ x 11” portrait orientation

Margins: 1” top, bottom and sides

Line spacing: single

Font: Parts I, II and III: Times New Roman, 12 – point

Patient Medication Information leaflet: Sans Serif type fonts, text – 10 point, tables – 9 point.

Justification: left

Page numbers: on bottom right hand side

Start each Part on a new page

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