Guidance on veterinary drug labelling: Specific requirements for label content and format
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- Inner and outer labels
- Principal display panel
- Any panel
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:
- Annex A – Regulatory labelling requirements checklist
- Annex B – Sample veterinary drug label (outer label)
- Annex C – Requirements for particular product types
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.
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.
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, section C.01.002 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:
- where the strength is expressed in terms of the salt, the same salt is used in the common name for the drug
- where the strength is expressed in terms of free acid or base, the same acid or base is used in the common name and the name of the complete salt should be shown in the medicinal ingredients section on the label
- on PDP: brand X antibacterial agent chlortetracycline premix XX mg/g
- on any panel (medicinal ingredients section): chlortetracycline (as chlortetracycline hydrochloride), XX mg/g
- for different solvated forms (for example, including hydrates), the complete common name, including the solvated form, should be on the label (does not have to appear on the PDP)
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 a medicinal 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 (for example, Amprolium Soluble Powder USP, X mg/mL).
If a non-medicinal ingredient meets a pharmacopeial standard, it can be declared on the label, but cannot appear on the principal display panel (PDP).
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.
- Prescribed standard
A prescribed standard is a standard prescribed by the Regulations. A list of Canadian standard drugs (CSD) is in Part C, Division 6 of the Regulations. Drug products containing these drug substances as single ingredients may be sold only if they are labelled with the CSD standard and if they conform in all aspects to that standard.
Example: Conjugated Estrogen Tablets CSD, 1.25 mg
Pharmacopoeial standards are for those drugs contained in the publications listed in schedule B of the Act and for which no standard has been prescribed in the Regulations. Products for which a standard exists in the pharmacopeia must declare the standard of manufacture on the label. The labelling provisions in the official monograph and the general notices of the pharmacopoeial standard should be met.
Example: Amprolium Soluble Powder USP, X mg/mL
Where a pharmacopeial standard exists but the manufacturer chooses to use their own standard and label the product as such, it must at minimum meet the most stringent purity and potency of the pharmacopeial standard(s). A manufacturer's standard can be described on the labelling as "Mfr." or "Mfr. Std.".
Example: Drug Product X Mfr. Std., XX mg
A professed standard is declared when no prescribed (in the Act or Regulations) or pharmacopeial standard exists. The product labelling for such products do not carry any standard claim.
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.
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.
If applicable, the inner and outer labels of a drug must show the appropriate symbol on the upper-left quarter of the PDP. The following schedules and corresponding symbols are listed in decreasing order of stringency:
- Narcotic - "N" in a colour contrasting with the rest of the label or in type not less than half the size of any letters used thereon
- Controlled - "" (C in a ◊) in a clear manner and a conspicuous colour and size
- Targeted substance - "" T\C in a □ in contrasting colour and in a type not less than half the size of any other letters on the label
- Prescription - "Pr" (either on its own or within a box)
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 all veterinary drug labels. It must appear on the PDP in the following instances as per the Regulations:
- non-prescription veterinary drugs
- a vitamin in a form suitable for human use
- antibiotic for parenteral use
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 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.
Warning statements provide information on potential human health risks associated with the use of veterinary drugs. The warning statements include 3 aspects: food safety, user safety and microbiological safety. These warning statements may include the following:
- those related to food safety (for example, withdrawal period or milk withholding time, not for use in lactating dairy cattle) and meant to minimize potential human health risks associated with consuming food from food-producing animals treated with the drug product
- any warning statement on specified withdrawal periods/withholding times on the inner/outer label must also be included in the package insert
- those related to occupational or user health and safety hazards from handling and administering the drug product, necessary measures to reduce potential exposure or accidental direct contact with the drug, including any relevant warnings for people who may be sensitive to the drug product (for both food-producing and companion animals)
- those related to microbiological safety of the drug product, such as the hazard or risk of the development of antimicrobial resistance associated with using the drug product (as applicable to antimicrobial products)
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 any food-producing animal or in certain species (poultry):
- 5-nitrofuran compound
- 5-nitroimidazole compound
- clenbuterol or its salts or derivatives
- diethylstilbestrol or other stilbene compounds
- drugs containing any substance having oestrogenic activity (banned for use in poultry that may be consumed as food)
The warning statement "Keep out of reach of children" should be on the PDP of the inner and outer labels and the package insert.
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.
Where warnings cannot be displayed in full on the PDP, we recommend the following:
- put the title Warnings on the PDP with a statement directing the user to the side panel/package insert for complete warnings
- use condensed or shortened warnings for inner/outer labels with a statement directing the user to the side panel/package insert for more information
Warnings: Withdrawal periods:
Cattle: Meat: 20 days – Milk: 96 hours
For complete warnings, see side panel.
If serious adverse reactions associated with a humans administering a veterinary drug to an animal are reported post-market, we may request additional labelling (such as a new or updated warning statement).
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. You may also include a generic email and/or a toll-free number. The manufacturer is not necessarily the fabricator, but is understood to be the authorization holder (DIN holder/NOC holder). If the address shown is not Canadian, include the name and address of the Canadian importer and distributor.
When addresses for separate entities are on the labelling, you should indicate the address with statements such as the following:
- Manufactured by / Imported by / Distributed by (preferred)
- Manufacturer: / Importer: / Distributor:
- Manufactured by: / For:
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.
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:
- indications for use
- intended species
- directions for use
- dosage, duration of treatment, route of administration, instructions to reconstitute the drug (as applicable)
- safety information
- contraindications, cautions and warnings (as applicable)
- the order of the warning statements should follow a logical sequence, taking into consideration the species, withdrawal periods and withholding times (as applicable)
- storage conditions
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".
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:
- assigned to that ingredient in the Regulations, section C.01.002
- appearing in boldface type in other sections of the Regulations or
- assigned to the ingredient in the titles of monographs of schedule B publications
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:
- international non–proprietary name (INN)
- British-approved name (BAN)
- United States-adopted name (USAN)
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.
|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 (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.
However, for ophthalmic or parenteral use drugs, a preservative must be clearly identified on the label. For parenteral use drugs, the quantity of the preservative must also be declared on the label.
Note that the use of colouring agents in drugs is restricted to those listed in the Regulations, section C.01.040.2.
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.
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.
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:
- all regulatory requirements concerning the label have been met and the bar code information does not change the terms of market authorization of the product
- the codes don't obscure or displace the required and approved information on the label, especially on smaller product labels
Ensure that any product-related information referred to is in line with the approved product label and is kept up-to-date.
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