Draft guidance on veterinary drug labelling: Overview

On this page

• Purpose
• Scope and application
• Definitions
• Note about guidance documents in general

Purpose

This guidance document gives 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:

• pre-market submissions
  • new drug submission (NDS)
  • abbreviated new drug submission (ANDS)
  • drug identification number (DIN) application
• post-market submissions, as certain changes to an approved product label require a review (refer to the guidance documents on post-notice of compliance (NOC) changes in related links)
  • administrative NDS
  • administrative ANDS
  • administrative DIN application
  • supplemental new drug submission (SNDS)
  • supplemental abbreviated new drug submission (SANDS)
  • notifiable change (NC)

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:

• drugs requested through the emergency drug release program
• veterinary health products
• drugs used in veterinary experimental studies or investigational new drugs
• medicated feeds for livestock

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.

Definitions

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

• that's assigned to the drug by its manufacturer
• under which the drug is sold or advertised and
• that's used to distinguish the drug (Regulations, section C.01.001)

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:

1. commonly known and
2. designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act (Regulations, section C.01.001)

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

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

1. diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
2. restoring, correcting or modifying organic function in human beings or animals or
3. disinfecting premises where food is manufactured, prepared or kept (section 2 of the Act)

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:

1. the date, expressed at minimum as a year and month, up to and including the date in which a drug maintains its labelled potency, purity and physical characteristics
2. the date, expressed at a minimum as a year and month, after which the manufacturer recommends that the drug not be used (Regulations, section C.01.001)

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)

• interpreted to include inner labels, outer labels and package inserts

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 (also referred to as 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:

• contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug
• a combination of 2 or more drugs, with or without other ingredients, and that has not been sold in combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug
• a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action and that has not been sold for that use or condition of use in Canada, for a sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug (Regulations, section C.08.001)

Official drug: any drug for which

• a standard is provided in these Regulations or
• no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act (Regulations, section C.01.001)

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)

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:

• container mounted on a display card: part of the label applied to all or part of the principal display surface of the container or to all or part of the side of the display card that's displayed or visible under normal or customary conditions of sale or use or to both such parts of the container and the display card
• ornamental container: part of the label applied to all or part of the bottom of the container or to all or part of the principal display surface or to all or part of a tag that's attached to the container
• other containers: part of the label applied to all or part of the principal display surface

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:

• is assigned to the drug in section C.01.002
• appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this part, the name of the dispensing form
• is specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act or
• is assigned to any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c) (Regulations, section C.01.001)

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

• Veterinary drugs - Management of regulatory submissions guidance
• Guidance for industry – Preparation of veterinary new drug submissions
• Guidance document: Schedule A and Section 3 to the Food and Drugs Act
• Guidance document for industry – Review of drug brand names
• Guidance Document: Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
• Drug Product Database: Access the database
• Therapeutic comparative advertising: Directive and guidance document
• Regulatory requirements for advertising
• Policy: Principles for claims relating to comparison of non-therapeutic aspects of non-prescription drug products
• Antiseptic teat solution monograph
• English-French lexicon for standard labelling statement