Guidance on veterinary drug labelling: General labelling requirements
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- Official languages
- Reference to the Act and Regulations and other advertising
- Unique labelling formats
- International context
This section covers the general requirements that apply broadly for all types of labelling and packaging for veterinary drugs.
Labelling in both official languages is to be submitted for non-prescription and prescription veterinary drugs. At the time of filing a drug submission, sponsors may choose to submit their labels only in 1 language for review. Before approval, sponsors will need to provide a complete set of labelling in both English and French, along with a signed and dated attestation by the sponsor for the accuracy of the translation.
For non-prescription drugs (sold in retail outlets to the public), the adequate directions for use must be in both English and French on the inner and outer label. The adequate directions for use include the following:
- indications for use
- intended species
- 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.
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.
To avoid problems at the time of final labelling, we strongly encourage sponsors to provide design layouts of the labels (mock-ups). We will review to ensure the requirements set out in the Regulations are met.
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:
- Therapeutic comparative advertising: Directive and guidance document
- Policy: Principles for claims relating to comparison of non-therapeutic aspects of non-prescription drug products
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.
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:
- 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 the information does not destroy or harm the integrity and legibility of the product labels (that is, 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.
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 type of international information on the Canadian label. However, we may consider these types of requests on a case-by-case basis. Contact us at email@example.com.
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