Guidance on veterinary drug labelling: Overview

On this page


This guidance document provides direction to sponsors/manufacturers on how to meet the requirements of the Food and Drugs Act (Act) and Food and Drug Regulations (Regulations) for veterinary drug labelling and packaging in Canada.

Labels give key information about the safe and proper use of veterinary drugs. They also identify the product and list directions for use.

Where terms such as 'must' and 'required' are used in the guidance, labels and packages must comply with provisions in the Regulations. This is a legal requirement.

Scope and application

This guidance document outlines the requirements for labels that sponsors must submit as part of these submission types:

This guidance document focuses on the inner and outer labels and package inserts of veterinary drugs. For additional labelling information for generics, consult the Guidance for industry: Preparation of veterinary abbreviated new drugs submissions – Generic drugs.

This guidance document does not apply to:

You can find approved product labels in the format provided by the sponsor (either text-based or mock-up label) in the drug product database.


Active ingredient: see the definition for 'Medicinal ingredient'

Adverse drug reaction: as defined in the Regulations, a noxious and unintended response to a drug, which occurs at doses normally used or tested for diagnosing, treating or preventing a disease or modifying an organic function

Adverse event: any untoward medical occurrence in animals or humans involved in administering a veterinary drug to an animal and does not necessarily have to have a causal relationship with this treatment. Can therefore be any unfavourable and unintended sign (such as an abnormal laboratory finding) or disease temporally associated with the use of a drug product, whether or not it is related to the drug product

Brand name: the name, which may or may not include the name of any manufacturer, corporation, partnership or individual, in English or French:

Child resistant package: a package that meets the requirements of subsection (2) (Regulations, section C.01.001)

Close proximity: immediately next to the common name, without any intervening printed, written or graphic matter (Regulations, section B.01.001)

Common name: the name in English or French by which the drug is:

Contraindications: describes situations in which the drug should not be used because the risk outweighs any potential benefit

Distributor: see the definition for ‘Manufacturer or distributor’

Drug: includes any substances or mixture of substances manufactured, sold or represented for use in:

Drug in dosage form: 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))

Dosage forms (also called unit doses): pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of medicinal ingredients and non-medicinal ingredients, in a particular configuration (such as a capsule shell, for example), and apportioned into a particular dose

Expiration date: the earlier of:

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

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

Internal use: 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: 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: refer to 'principal display panel'

Manufacturer or Distributor: 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)

Medicinal ingredient (active ingredient): a drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect (Regulations, section C.01A.001)

Net amount: the outer label of a drug shall show the net amount of the drug in the container in terms of weight, measure or number (Regulations, subparagraph C.01.004(2)(a))

New drug:

Official drug: any drug for which

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

Package: item in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed (section 2 of the Act)

Package insert: the factual, scientific document that gives detailed information on how to use the drug safely and effectively if there is not enough space on the inner and outer labels for all the information

Parenteral use: 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: set down in the regulations (section 2 of the Act)

Principal display panel (main panel): has the same meaning as in the Consumer Packaging and Labelling Regulations, which states:

Product class: consists of drug products indicated for the same condition or range of diseases and sold under similar regulatory requirements

Product line or product line extension: 2 or more products sharing a brand name, part of a brand name or common identifier as part of a 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.

Proper name: the name in English or French that:

Monograph: lists specifications relating to nomenclature, identity, purity, potency, quality, physical properties, tests, assays, packaging, labelling and storage requirements

Withdrawal period: the length of time (in days) between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for use as food contain a level of residue of the drug that would not likely cause injury to human health (Regulations, section C.01.001)

Withholding time: the length of time, specified in 12-hour milking intervals, up to a maximum of 8 intervals (96 hours) that must elapse after treating a lactating animal with a veterinary drug before milk can be collected for human use

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents do not replace the regulations. Alternate approaches to the principles and practices described in this document must be supported by adequate justification. They 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 always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We must make sure that such requests are justifiable and that decisions are clearly documented.

Related links

Page details

Date modified: