Draft guidance on veterinary drug labelling: General labelling requirements

Official languages

Labelling in both official languages is strongly encouraged for non-prescription and prescription veterinary drugs. Sponsors who choose to submit their labels only in 1 language for review must attest that the labels in the second language are accurate.

For non-prescription drugs (sold in retail outlets to the public), the adequate directions for use must be in both French and English on the inner and outer label. The adequate directions for use include the following:

indications for use
intended species
dosage
route of administration
instructions on how to reconstitute the drug when applicable
duration of treatment
safety information (contraindications, cautions and warnings)
recommended storage conditions

Note: Some provincial/territorial regulatory requirements may go beyond existing federal regulations and specify further language labelling requirements (for example, in Quebec).

Consult the English-French lexicon for standard labelling statement for translations of terms that often appear on veterinary drug labels.

Legibility

All information that must appear on a veterinary drug label must be visible and prominent. Consumers must also be able to easily read and understand the information.

Colour, contrast, position and spacing of the information on labels are all important considerations. Use the largest type size possible and a font type that can be read easily.

You may use logos or symbols (such as images of animals or the antimicrobial prudent use logo) as long as the required labelling information is clear and prominent.

Claims

A claim is a statement made about the expected benefits of the veterinary drug. It must align with the product's approved purpose or indication for use.

The Act prohibits representing a drug "in a manner that is false, misleading, deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety." This covers logos or symbols, brand name, as well as claims in text and any product-related information referred to on the product label.

A claim cannot :

misrepresent the drug or its classification
reflect misleading promotional terms
compare with other drugs or the properties of other drugs
- avoid using words that compare (for example, stronger, better, safer)

For more information on claims, consult the following documents:

Section 3 of the Act states that no person shall advertise any food, drug, cosmetic or device to the public as a treatment, prevention or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1. For more information, refer to Guidance document: Schedule A and Section 3 to the Food and Drugs Act.

Abbreviations

The following types of abbreviations are acceptable:

names of pharmacopoeial compendia as indicated in Schedule B of the Act
units of weight, volume or potency according to the Weights and Measures Act or where that abbreviation is commonly used and understood by the veterinarian and user
standard units of measure and abbreviations (for example, millilitres, mL)

Use the full form of an abbreviation at least once before using the abbreviated form.

For small containers, inner labels may contain an abbreviation (for example, "IM") only when the outer labelling indicates the term in full.

Do not abbreviate the proper or common name of the drug and any ingredients in the drug. Abbreviations used to describe routes of administration (for example, "IM" for intramuscular) or other product attributes such as weight are discouraged.

We recommend using the abbreviation "mcg" for microgram, rather than "μg" to reduce confusion or any potential errors.

Reference to the Act and Regulations and other advertising

Labelling and advertising must not refer directly or indirectly to the Act or Regulations, unless the reference is a specific requirement of the Act or Regulations.

They must also not carry the following:

Health Canada endorsement
for example, authorized, registered or accepted by Health Canada
Health Canada logo

Only health products (including veterinary drugs) that Health Canada authorizes for sale in Canada may be advertised. For more information, consult the regulatory requirements for advertising.

Unique labelling formats

Sponsors may use unique formats for their drug labels or package inserts. Examples include:

tags
booklet
peel-back
collar labels
accordion labels
labels on the inside of cartons
labels on the bottom of containers

Such formats may be acceptable provided that:

users are alerted to the location of the labelling information
the placement of information does not contravene the Regulations
gaining access to these labels does not destroy or harm the integrity of the product's labelling (it can be read after opening)

Information that must be on the outer label should be visible. Users should not need to manipulate the label.

Unique label formats should be clearly identified and explained in the drug submission and are subject to Health Canada approval.

International context

Labels for drugs authorized for sale in Canada may include additional information approved by other regulatory jurisdictions (for example, codes, logos, artwork, text in a foreign language). This information must:

not cause confusion
meet Canadian regulatory requirements
be consistent with applicable Health Canada guidance documents and policies
be consistent with the terms of the Canadian market authorization (for example, a prescription symbol required in another country should not appear on the Canadian label of a product which is non-prescription in Canada)

For the above reasons, Health Canada does not encourage this. However, we may consider these types of requests on a case-by-case basis. Contact us at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

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Date modified:: 2022-03-07

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