Language selection

Government of Canada / Gouvernement du Canada

Search

Draft guidance on veterinary drug labelling: Specific requirements for label content and format

On this page

Inner and outer labels

This section covers the content requirements for inner and outer labels, as well as information about the format.

For more information, refer to the Annexes:

The inner label is on the drug's immediate container. The outer label is any label on the outside of the drug packaging, such as a box.

There may be more than 1 outer label if there are multiple packages. Examples include a vial packaged in a pouch, pouch enclosed in a carton and several cartons enclosed in a larger carton.

For a package that has only 1 label, that label must carry all the information required on the inner and outer labels.

Note: A shipping carton is not subject to the labelling requirements of the Regulations unless it is the package unit that's distributed to the user or veterinarian. For labelling requirements for transportation and storage, refer to the good manufacturing practices guide for drug products.

Principal display panel

The principal display panel (PDP), or main panel, must be visible to the user under normal or customary conditions. The PDP of the inner and outer label must display the information outlined below.

Product name

This section provides guidance on brand names and proper or common names for veterinary drugs.

We do not recommend including non-medicinal ingredients (NMIs) in the product name.

Brand name

For drugs regulated under Part C, Division 8 of the Regulations, the brand name is the name that appears on the notice of compliance (NOC). For drugs not regulated under Division 8, the brand name is the name that is on the drug notification form issued for the drug product.

Do not translate the brand name. It should be the same on all labelling.

Note: A brand name is not required. You may choose to use a common or proper name as the product name instead of a brand name (for example, acetylsalicylic acid boluses).

Look-alike, sound-alike (LA/SA) drug product names

LA/SA refers to names of different health products that have either orthographic similarities when written or similar phonetics when spoken. These similarities may pose a health risk by causing errors in prescribing, dispensing or administering a drug product. It's the sponsor's responsibility to ensure that a proposed drug product name will not cause potential confusion with another drug product name or be misleading.

Proper or common name of the product

The proper name of the drug product must be shown on the PDP of the inner and outer labels. Use the common name if there's no proper name.

For drugs with a brand name, the proper name or common name must immediately follow the brand name. The type size cannot be less than one-half the size of the brand name.

The proper name for a drug product consists of the medicinal ingredient as outlined in the Regulations or one of the Schedule B publications and the dosage form. When the name appears both in the Regulations and one of the Schedule B publications, the Regulations take precedence.

The common name for a drug product (if there is no proper name) consists of the medicinal ingredient and the dosage form. For drugs with medicinal ingredients in a salt form, the common name should follow the naming conventions outlined as follows:

Detailed instructions for the proper or common names of medicinal ingredients are outlined in the ingredients section.

Standards of manufacture (quality standards)

The standard to which a drug may be manufactured and represented can be applied to a finished product or an active ingredient. A standard of manufacture for a specific drug product must be included after the proper/common name of the product on the PDP of the inner and outer labels. The quantitative amounts may be indicated before or after the proper name (Amprolium Soluble Powder USP, X mg/mL).

Further information on standards is available in the Guidance for industry preparation of veterinary new drug submissions.

If a standard has been updated or a new one exists, please refer to the Post-notice of compliance (NOC) guidance document – Quality document. This document provides more information on changes regarding the standard claimed for the drug substance or drug product.

Sterility

For ophthalmic or parenteral use drugs, "sterile" and "stérile" must be shown in both official languages on the main panel of the inner and outer labels. Include the sterility statement on the labels of veterinary drugs where Health Canada has received supporting data for review (for example, the data with a sterility assurance level of 10-6).

The label should clearly identify the presence or absence of a preservative for ophthalmic or parenteral use drugs, either by reference in the brand name or directly and prominently on the label. For parenteral preparations, you must also declare the quantity of the preservative.

Drug symbols

If applicable, the inner and outer labels of a drug must show on the upper-left quarter of the PDP. The following schedules and corresponding symbols are to be listed in decreasing order of stringency:

When a product contains a combination of ingredients from 2 or more of the schedules and/or ingredient(s) listed in the prescription drug list, only the symbol corresponding to the most stringent control is required on the label.

Drug identification number (DIN)

The PDP of the inner and outer labels of a drug sold in dosage form must clearly show the DIN assigned to it. It must be preceded by the words "Drug Identification Number" or "Drogue : identification numérique" or both, or the letters "DIN".

Veterinary use only

The statement "Veterinary Use Only" or "For Veterinary Use Only" should appear on the PDP of all veterinary drug labels. It must appear in the following instances:

The statement should be in both official languages: "For Veterinary Use Only/Pour usage vétérinaire seulement" or "Veterinary Use Only /Usage vétérinaire seulement". This statement should appear either before the brand name or immediately following the proper name or common name. The type size should be at least half the size of the largest type on the label.

Therapeutic classification

The PDP of the inner and outer labels of a drug should contain the applicable therapeutic classification (for example, antibiotic, antifungal, anticoccidial). It should be placed below or close to the statement "For Veterinary Use Only/Pour usage vétérinaire seulement" or the product name, and may be part of the product's description/indication. Health Canada also recommends including the anatomical therapeutic chemical code (ATCvet code) for the classification of veterinary drugs.

Warnings

Warning statements provide information on potential human health risks associated with the use of veterinary drugs. These health risks include the following:

The PDP of the outer and inner labels and package insert must carry a warning statement on specified withdrawal periods/withholding times for drug products that are administered in food-producing animals.

For example, for antibiotic preparations for treating lactating animals (whose milk will be consumed as food), the warning statement would be:

"Milk taken from treated animals during treatment and within... hours after the latest treatment must not be used as food" [the hours must be filled out in the space indicated by the ellipsis based on the approved milk withholding time]

The following warning statement must appear on both inner and outer labels of an antibiotic preparation containing chloramphenicol, its salts or derivatives, which are given to animals that do not produce food and that are not intended for consumption as food:

"Federal law prohibits the administration of this preparation to animals that produce food or animals that are intended for consumption as food/En vertu des lois fédérales, il est interdit d'administrer cette préparation aux animaux qui produisent des aliments ou aux animaux destinés à être consommés comme aliments"

The above warning statement only applies to chloramphenicol. However, you should display a similar statement (the use of lower case letters and selective bolding may improve the visibility of the warning) on both the inner and outer labels of the following drugs banned for use in certain species:

The warning statement "Keep out of reach of children" should be on the PDP of the inner and outer labels and the package insert.

Where warnings cannot be displayed in full on the PDP, we recommend the following:

If serious adverse events are associated with a veterinary drug found post-market, we may request additional labelling (such as a new or updated warning statement).

Any panel

Any panel of the inner and outer labels must include the information outlined below.

Name and address information

The label must display the name and complete mailing address of the manufacturer(s) to ensure Canada Post can deliver a letter to that address. If the drug is imported, include the name and address of the Canadian importer or distributor.

When addresses for separate entities are on the labelling, you must also include the licensable activity that each entity is responsible for (manufacturer, distributor and importer). The manufacturer is not necessarily the fabricator, but is understood to be the authorization holder (DIN holder/NOC holder).

If there is more than 1 name and address on the label, statements such as the following may be used:

You may use logos or symbols as long as the required labelling information is clear and prominent. The image cannot be false or misleading. For example, if there is a logo of a drug's distributor on the label, it must still be clear to the consumer who to report adverse events to. In other words, they must be able to identify the manufacturer.

You may place the distributor's logo on a PDP if the logo appears close to where the manufacturer and distributor are identified. We recommend that you submit a mock-up to us beforehand.

You may add a statement such as "Product of Canada" or "Made in Canada". However, you must make sure that any country-of-origin claims comply with the provisions of the Competition Act, Consumer Packaging and Labelling Act and Textile Labelling Act.

Lot number

The words "Lot Number" or a suitable abbreviation (such as Lot no., Lot, L) should go before the lot number. The lot number should appear on any panel of the inner and outer labels. It may be any combinations of letters, figures or both by which a drug can be traced in manufacture and identified in distribution.

Adequate directions for use

Inner and outer labels must have "adequate directions for use of the drug product" in both official languages, if the drug is available for sale without a prescription. For veterinary drugs, the "adequate directions for use" include:

Use positive statements on labels. For example, "For subcutaneous use only" is preferred to "Not for intramuscular use" (does not apply to the sections for cautions and contraindications).

If there isn't enough space on the labels, provide a statement that users should consult the package insert for more detailed directions. For example, you could state "Consult package insert for complete directions for use" or "Consult package insert for complete product information".

Ingredients

This section outlines the requirements for proper names and common names when listing the medicinal ('active') and non-medicinal ('inactive' or 'excipient') ingredients of a drug on the label.

The proper name for an ingredient is the name:

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

You may use official synonyms for proper names listed in some schedule B publications instead of the title of the monograph. The exception is where the synonyms are abbreviations or are in a language other than French or English. For example, you may use the British Pharmacopoeia's synonyms, which are listed in Appendix XXI B, instead of the non-abbreviated name. However, this practice of using synonyms is not allowed for products claiming the USP standard.

A common name is used when there's no proper name. The common name of a drug ingredient is chosen by a body responsible for drug nomenclature, often with international recognition, such as:

Medicinal ingredients

You must declare the quantities of all medicinal ingredients on any panel of the inner and outer labels and list the ingredients by either their proper or common names. For a salt medicinal ingredient, indicate its salt information in parentheses with "equivalent to" or "as". Refer to Table 1 on how to declare the quantities for different pharmaceutical forms.

Do not declare the standards of each individual ingredient on the label of a multi-ingredient product. The exception is when a standard exists for the combination.

Table 1: Method of declaring quantities of medicinal ingredients
Pharmaceutical form Appropriate declaration

Tablets, capsules, boluses and other discrete dosage forms

g or mg per dosage form

Powders for parenteral use

Powders for oral use

mg/vial or mg/g

g or mg per g, and per specific dosage unit

Liquids for parenteral use

mg per mL or % w/v

Liquids for oral use

g or mg per dosage unit or per mL

Creams, lotions, ointments

mg per g (or % w/w) or mg per mL (or % w/v)

Refer to Annex C for further information on the declaration of medicinal ingredients for particular product types.

Terminal and leading zeroes

Avoid using terminal (trailing) zeroes following a quantitative declaration of the medicinal ingredient. Use 2 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, put a leading zero, such as 0.5 mg, before the declaration.

Non-medicinal ingredients

Non-medicinal ingredients (NMIs) are to be used at a level that doesn't exceed the amount required to accomplish the intended effect. NMIs include binders, preservatives, antioxidants, carriers, colouring agents, fragrances and flavours.

If you choose to provide a list of NMIs, provide a complete listing. Identify this list with a heading such as "Non-medicinal Ingredients" or "Inactive Ingredients." Use units such as mg/mL when appropriate.

Note that the use of colouring agents in drugs is restricted to those listed in the Regulations.

Expiration date

The expiration date must be on both the inner and outer labels. You may use terms such as "Expiration" or "Expiration date" or "EXP". For consistency, use the pattern year-month-day established in the food section of the Regulations. The following 2-letter abbreviations for the months are acceptable in both official languages: JA, FE, MR, AL, MA, JN, JL, AU, SE, OC, NO and DE.

Net contents

The net contents is the amount of drug in terms of weight, measure or number. Display net contents (or net amounts) on any panel of the outer label. It may be useful to put this information on the inner label as well. We recommend putting the net content first, followed by the term "Net".

Identifying codes and URLs

You may use bar codes, QR (quick response) codes or URLs (such as that for the sponsor's website) on a drug label for appropriate purposes providing that:

Ensure that any product-related information referred to is in line with the approved product label and is kept up-to-date.

Page details

Date modified: