Veterinary Biologics Guideline 3.3
Labelling of veterinary biologics

Table of contents

• I. Introduction
• II. Legal authority
• III. Labelling requirements
  1. Labels of veterinary biologics distributed within Canada
     1. Assigned name
     2. Establishment or product identification number
     3. Directions for use
     4. Expiry date
     5. Label claims
     6. Logos and slogans
     7. Language requirements
     8. Preservatives
     9. Manufacturer identification
     10. Shipping boxes
     11. Storage temperature
  2. Labels of veterinary biologics manufactured in Canada for export only
• IV. Submission procedure
  1. Fees
  2. Requirements – Final labels
     1. Paper submissions
     2. Electronic submissions
  3. Diluent labels
  4. Requirements – Drafts
  5. Labels on containers of 50 mL or less
  6. Addition or substitution in Canada of a package insert for an imported veterinary biologic
• V. Label error identification by CCVB
  1. Major errors
  2. Minor errors
• VI. Minor changes
• VII. Standardized terminology
  1. Recommended statements
  2. Recommended translations of product claims
• VIII. Glossary – Recommended English and French terms
• Appendix – Summary of changes

I. Introduction

The following provides guidance to veterinary biologics manufacturers and importers regarding the Canadian requirements for labelling veterinary biologics manufactured and/or distributed in Canada. A label includes any legend, word or mark attached to, included in, belonging to or accompanying any veterinary biologic.

The Canadian Food Inspection Agency (CFIA) is responsible for licensing veterinary biologics, including veterinary vaccines, colostrum, antibody products and diagnostic kits, manufactured and/or used in Canada. The licensing program operates under the authority of the Health of Animals Act and Regulations, and is administered by the CFIA's Canadian Centre for Veterinary Biologics (CCVB).

II. Legal authority

Health of Animals Regulations, Part XI

130 No person shall sell a veterinary biologic or any diluent to be used therewith if the veterinary biologic or diluent has been prepared, manufactured, preserved, packed, labelled or tested otherwise than in the manner described in the product outline.

130.1 Every veterinary biologic imported, sold, advertised or offered for sale in Canada shall be stored at a temperature between 2°C and 7°C unless otherwise stated in the product outline or the labelling.

132(1) No person shall sell, advertise or offer for sale a veterinary biologic unless it is packed and labelled in accordance with these Regulations.

132(2) All information required by section 134 to be shown on the label of a veterinary biologic

1. shall be clearly and prominently displayed on the label; and
2. shall be readily visible by a purchaser under the customary conditions of purchase and use.

133 Every veterinary biologic sold, advertised or offered for sale in Canada shall carry a label.

134(1) Subject to subsection (2), every label of a veterinary biologic sold, advertised or offered for sale in Canada shall show

1. the assigned name of the veterinary biologic,
2. the name of the manufacturer of the veterinary biologic or, if there is more than 1 manufacturer of that veterinary biologic, the name of the first or the name of the final manufacturer,
3. the place where the manufacturer referred to in paragraph (b) manufactures the veterinary biologic,
4. the lot or serial number or other means of identifying the veterinary biologic,
5. the same establishment licence number, whether Canadian or foreign, on all components of the label except that the Minister may, in writing, exempt from that requirement diluents manufactured in Canada,
6. directions for use of the veterinary biologic or that directions for its use are contained inside the package,
7. the expiration date of the veterinary biologic,
8. the components of the veterinary biologic, including:
   1. viruses, bacteria, toxoids and antibodies, and
   2. antibiotics, if added during the production process as preservatives,
9. the net quantity of the veterinary biologic in the container, expressed in metric units or in doses,
10. the temperature range, expressed in metric units, necessary to maintain prescribed potency of the veterinary biologic,
11. in the case of a veterinary biologic manufactured for use in food producing animals, the cautionary statement indicating the appropriate withdrawal period as stated in the product outline on the basis of which the import permit or product licence was issued,
12. the words "For veterinary use only" or "Pour usage vétérinaire seulement" or other wording to the same effect, and
13. any cautionary information necessary to ensure the safe handling and use of the veterinary biologic.

134(2) Where the label of a veterinary biologic is too small to show all the information required by subsection (1), any such information as the Minister may permit may be shown on the directions for use inside the package.

134(3) Subject to subsection (4), the information required by subsection (1), as well as any supplemental information appearing on the label, shall be shown in both official languages, and may additionally be shown in whole or in part in any other language.

134(4) A person may sell, advertise or offer for sale in Canada a veterinary biologic that is labelled in only one official language if

• (a) the Minister determines that the veterinary biologic is needed for research or emergency use; and
• (b) the person undertakes to ensure its safe storage, handling and administration.

III. Labelling requirements

III.A. Labels of veterinary biologics distributed within Canada

All applicable federal legal labelling requirements prescribed in the Health of Animals Regulations, as well as any conditions or restrictions set out in a product licence or import permit, must be met before a label will be accepted for use in Canada.

The following information must appear on all components of a product's labelling unless otherwise noted below:

• assigned name – exemption for diagnostic kit reagent labels for containers less than 10 mL;
• manufacturer;
• location of manufacturer;
• serial number – exemption for package inserts;
• Establishment Licence Number, if applicable;
• directions for use, or instructions to consult a carton or package insert for full directions;
• expiry date – exemption for package inserts;
• all components, including antigens and preservatives – exemption for containers of 50 mL or less;
• quantity of veterinary biologic in the container, expressed in metric units or doses – exemption for package inserts;
• storage temperature expressed in metric units;
• withdrawal period, if applicable – exemption for containers of 50 mL or less;
• the words "For veterinary use only" or "Pour usage vétérinaire seulement" or other wording to the same effect; and
• any cautionary information necessary to ensure the safe handling and use of the veterinary biologic – exemption for containers of 50 mL or less.

Additional information may appear, provided the inclusion of such information does not affect the clarity and legibility of required text.

III.A.1. Assigned name

This is considered to be the true or proper name of the micro-organism(s) contained in the product and is not the trade or brand name. The assigned name should be identical to that shown on the Veterinary Biologics Product Licence or Permit to Import Veterinary Biologics. No other statement, design, device, or trade name should overshadow the assigned name, which should be given prominence by the location and by the style and/or size of lettering. The assigned name must appear on every component of a product's labelling.

The CCVB will approve the assigned name for each product licensed in Canada. Consistency of terminology should be maintained for all products if there is a choice of appropriate terminology. Check the CCVB website for similar licensed products prior to suggesting a new assigned name.

III.A.2. Establishment or product identification number

The Establishment Licence Number of the manufacturer, as issued by the regulatory authority of the country where the manufacturer is located, must be on the labels, unless such a system is not used by that country. The same number must be on all labels.

It is the veterinary biologics importer's responsibility to determine whether the manufacturer's Establishment Licence Number may appear on labelling applied outside the country of manufacture.

A product code, issued by the regulatory authority of the country of manufacture, may appear on the labels. This is not mandatory for labels on products distributed in Canada.

III.A.3. Directions for use

To ensure proper use and handling of the product, directions for use must appear on at least 1 component of a product's labelling.

Directions for use for all veterinary biologics, except diagnostic test kits, include the following:

• recommended dose
• route(s) of administration
• recommendations with respect to the optimum age for vaccination and repeat dose (booster) instructions
• precautions

Pertinent information for diagnostic test kits includes the following:

• test procedure
• safety precautions

III.A.4. Expiry date

The preferred format for expiry date is as follows: yyyy/mm/dd (year/month/day).

If the expiry date is indicated by using only the year and month, it is understood that the expiry date corresponds to the last day of this month. The month that is indicated must fall within the total expiry time stipulated in the outline of production (OP). For example, if potency testing started June 14, 2012, for a product with an expiry dating of 12 months from the date of initiation of the potency test, the expiry date would be written 2013/05.

III.A.5. Label claims

All claims written on the labels must be supported by data that have been approved by the CCVB. The recommendations for product use must be consistent with the recommendations stipulated in Section VI of the OP, unless otherwise approved by the CCVB.

In the case of labels approved under the US Department of Agriculture (USDA)'s single tier label claim approach, where labels direct users to a USDA website for animal safety and efficacy data, the CCVB will facilitate the posting of French versions of the Product Compilation Summaries on the USDA's website. Refer to CCVB Memorandum 2017-04: Submission of French-language product compilation summaries for posting on the USDA website for more information.

III.A.6. Logos and slogans

Company logos and other artwork may appear on labels, provided they are discreet and do not overshadow required information. Slogans and taglines should not ordinarily appear on container and carton labels, except for large containers and cartons where there is sufficient space to include this information without displacing the other text.

Slogans and company taglines may appear on the package insert, provided claims by the slogan or tagline are consistent with data filed with the CCVB. All claims are subject to approval by the CCVB.

III.A.7. Language requirements

Veterinary biologics sold, advertised, or offered for sale in Canada must bear labels that present all information in both English and French. Label information may additionally appear, in whole or in part, in other languages

For products with small vial labels, where space is limited, the CCVB may allow the use of English-only or French-only vial labels, provided all information on the vial label is repeated in both English and French on a package insert and/or carton label. The CCVB may also allow the use of a bilingual insert as a substitute for fully bilingual component labels in certain other situations where it is not feasible to require Canadian-specific bilingual labels, such as for minor-use, minor-species products where enforcing this requirement would impact product availability in Canada.

Veterinary biologics imported for research or emergency use are exempt from the bilingual labelling requirement, provided the person responsible for this restricted use undertakes to ensure its safe storage, handling and administration.

III.A.8. Preservatives

These include all substances added to prevent spoilage of the final product. Preservatives that may be present in the final product, including those added at the cell culture stage, must be identified in the product labelling. For diagnostic test kits, all preservatives included in the components that are necessary to perform the test should be listed in the labelling.

III.A.9. Manufacturer identification

The name of the company that is responsible for the manufacture of the product must be clearly indicated on the labels. If more than 1 company is responsible for this process, the company that is responsible for the first or last stage should must be identified.

III.A.10. Shipping boxes

Approval of outer shipping container labels by the CCVB is not mandatory. However, shipping boxes should include the following information:

• product assigned name;
• volume and quantity of individual containers (for example, 10 × 250 mL bottles);
• serial number(s);
• expiry date(s);
• name and address of manufacturer; and
• other information as necessary:
  • trade name(s);
  • Global Trade Item Number(s) (GTIN);
  • above information in the language of the country importing the product, provided the information is also available in English and French;
  • storage temperature (wording such as "store below 7°C – do not freeze" would be considered acceptable, where appropriate); and
  • World Customs Organization (WCO) Harmonized Commodity Description and Coding System (HS) Codes.

III.A.11. Storage temperature

The storage temperature must be presented as an acceptable range (for example, between 2-8°C, less than −60°C) rather than a single temperature value. In accordance with international standards, the temperature range for veterinary biologics needing to be stored refrigerated is typically 2°C to 8°C. It is not sufficient to advise users to store at "room temperature"; a numerical temperature range must be given.

III.B. Labels of veterinary biologics manufactured in Canada for export only

"For export only" (FEO) product labels that are stored and applied in a manufacturing establishment regulated by the CCVB must be approved by the CCVB prior to use, and must be acceptable for use in the destination country. It is up to the manufacturer to decide whether the labels are first submitted for approval to the CCVB, or to the relevant regulatory authorities of the destination country.

The information required to be displayed on the labels is determined by the relevant regulatory authorities of the importing country. It is the manufacturer's responsibility to ensure that all information displayed on the labels is consistent with information provided to the CCVB, and that the labels and supporting information are acceptable to the relevant regulatory authorities of the importing country.

Minor differences between the supporting documentation filed with the CCVB and information presented on the labels of FEO products (for example, target animal characteristics, withdrawal period, expected level of efficacy) may be accepted, provided the labels are acceptable to the relevant regulatory authorities of the importing country. In cases of significant differences between the information displayed on the labels and supporting documentation filed with the CCVB, written confirmation of the acceptance of such information by the relevant regulatory authorities of the importing country may be required.

IV. Submission procedure

It is the applicant's responsibility to proofread labels before their submission to the CCVB.

IV.A. Fees

All label submissions must be accompanied by a Form CFIA/ACIA 5761 – Canadian Centre for Veterinary Biologics (CCVB) – Product Label Submission, a Form CFIA/ACIA 4720 – Application for Services, and the corresponding cost recovery fee.

Fees for label reviews, conducted as part of a new product submission, are included with the fees for the new product submission review.

Fees are waived for approval of corrections to label errors identified by CCVB. However, a new fee is required if any changes are made to the labels other than those corrections requested by CCVB.

A single cost recovery fee is charged when all the modified labels of all the affected products are submitted together and the same change (for example, modification of a toll-free telephone number) is made to all of the labels. An individual Form CFIA/ACIA 5761 is required for each product file. Any change to the content of the text present on the labels, other than the requested change, requires a full review of the labels, and a revision fee for each product will then apply to the label review.

IV.B. Requirements – Final labels

IV.B.1. Requirements – Final labels – Paper submissions

• Ensure that a separate Form CFIA/ACIA 5761 for each product accompanies the labels.
• Verify that submitted labels are originals or legible printer-ready colour copies. Whenever possible, printer-ready copies should accurately depict the size of the final labels.
• Submit a minimum of 2 copies for each label. 1 copy is kept on file at the CCVB. 1 original copy should be kept by the manufacturer and 1 by each designated importer, if applicable. There is no maximum number of copies that can be submitted.
• Submit all the different label formats (bottle labels, cartons, inserts, etc.) and dose sizes together for approval.
  • If the layout and text of the labelling is identical for different product dose sizes, submit for approval only the labelling of the smallest dose size, using that layout and text.
• Each label should be mounted on an 8½" by 11" or larger sheet of paper.
• Include for each mounting sheet the following information:
  • identification of the manufacturer (including the Establishment Licence number, if applicable);
  • product assigned name or trade name;
  • CCVB file number;
  • product code, issued by the country of manufacture (if applicable);
  • type of label (container, carton, insert), including dose size; and
  • date of preparation and/or the version number of that label.
• Leave (at a minimum) a 5-cm blank space at the bottom of the mounting sheet for the approval stamp.
• Mount the labels in such a way that allows all text on the label to be read without removing the label from the mounting sheet.
• Mount the labels of co-packaged vials on the same mounting sheet, provided there is enough room for the approval stamp.
• Ensure that over-stickers are approved by CCVB prior to use.
• Indicate, if not otherwise indicated, the location of the serial number and expiry date on the labels with an asterisk and a corresponding description.

IV.B.2. Requirements – Final labels – Electronic submissions

• Ensure that a separate Form CFIA/ACIA 5761 for each product accompanies the labels.
• Label files should preferably be in PDF format. Files should present printer-ready colour label artwork on a white backdrop (analogous to a mounting page), and whenever possible indicate the actual size of the final labels once printed.
• Submit a single copy of each label. Generally each label is submitted in a separate file. The labels of co-packaged vials can be included in the same file, provided there is enough room for the approval stamp
• Each label file should include the following identifying information on the mounting page:
  • identification of the manufacturer (including the Establishment Licence number, if applicable);
  • product assigned name or trade name;
  • CCVB file number;
  • product code, issued by the country of manufacture (if applicable);
  • type of label (container, carton, insert), including dose size; and
  • date of preparation and/or the version number of that label.
• Submit all the different label formats (bottle labels, cartons, inserts, etc.) and dose sizes together for approval.
  • If the layout and text of the labelling is identical for different product dose sizes, submit for approval only the labelling of the smallest dose size, using that layout and text.
• Leave (at a minimum) a 5-cm blank space at the bottom of the page for the approval stamp.
• All text (panels) associated with a particular label should be contained within the same file.
• Ensure that over-stickers are approved by CCVB prior to use.
• Indicate, if not otherwise indicated, the location of the serial number and expiry date on the labels with an asterisk and a corresponding description.

IV.C. Diluent labels

Up-to-date labels for diluents distributed with vaccines should be submitted at the same time as the vaccine labels.

If a particular diluent is distributed with more than 1 product, the diluent labels may be submitted together in 1 package (for paper submissions), with 1 fee, as long as the Form CFIA/ACIA 5761 identifies all of the vaccines with which the diluent is normally distributed. For paper submissions, the minimum number of copies of diluent labels that should be submitted is X + 1 where X is the number of products distributed with that diluent (for example, if the diluent is distributed with 5 products, at least 6 copies of the diluent labels must be submitted). For electronic label submissions, only 1 diluent label file needs to be submitted, identifying all the different product files for which the diluent is used.

IV.D. Requirements – Drafts

Draft label text may be submitted to the CCVB for review prior to the presentation of final labels. The label review fee should accompany the draft text, and this fee will also cover the review of the corresponding final labels.

If the draft label text is part of a new product submission, no fee is required to accompany the text, as it is already included with the fees for the review of the new product submission.

IV.E. Labels on containers of 50 mL or less

Because space on the labels of containers of 50 mL or less is restricted, only the following information is required:

• product assigned name
• volume of the contents and/or the number of doses
• manufacturer's name and location
• establishment number (if applicable)
• serial or lot number
• expiry date
• instructions to consult the package insert or the carton for complete directions

Whenever possible, the text "for veterinary use only", or other wording that would indicate that the product is intended for animals, should additionally appear.

Other information may be added to the vial label, but not at the expense of clarity and legibility. The labelling must be easily read under the customary conditions of purchase and use.

Directions for use (including precautions) must appear on multi-vial cartons or package inserts when the individual vials are too small to legibly carry all necessary information.

A diagnostic kit's trade name can be used without the complete assigned name on the vial labels of reagents with very small volumes (10 mL or less).

IV.F. Addition or substitution in Canada of a package insert for an imported veterinary biologic

In some cases, it may be necessary or desired to add or replace the package inserts that are distributed with imported veterinary biologics (for example, information requirements differ from the country of manufacture, addition of a bilingual package insert).

Permission for designated Canadian importers to add or replace package inserts distributed with imported veterinary biologics may be granted by the CCVB, provided all of the following conditions are met:

• The veterinary biologic is licensed for use in Canada, or authorized by the CCVB for restricted use.
• The facilities where the package inserts are added or substituted are inspected regularly by a member of the CFIA-Veterinary Biologics Operations or the CCVB, and are identified on the annual import permit for the product.
• A Special Outline, describing the process has been reviewed and approved by the CCVB. The minimum information requirements for this Special Outline are as follows:
  • the location of the site where the package insert will be added or substituted;
  • the position titles of the personnel who are responsible for adding or substituting the insert to the product;
  • detailed steps, describing the labelling process (including the time required to complete the process, and the temperature for storage of the product when package inserts are being added or substituted);
  • all quality control steps to verify that the correct insert is included with each product;
  • a description of the product:
    • assigned name,
    • product identification from country of manufacture (for example, USDA Product Code),
    • CCVB Product File number, and
    • manufacturer's identification (for example, U.S. Veterinary Biologics Establishment License number);
  • the last page of the Special Outline signed by the Regulatory Affairs person who is responsible for its preparation.
• The package insert is stamp-approved by the CCVB.
• The Special Outline is kept up to date.

Importer sites whose sole labelling activity is the addition or substitution of a package insert are not required to hold a Canadian Veterinary Biologics Establishment Licence and a corresponding Canadian Veterinary Biologics Product Licence. More complicated re-labelling activities that involve manipulation of the product containers – for example, applying new bottle labels or changing cartons – will continue to require a Canadian Veterinary Biologics Establishment Licence and a corresponding Canadian Veterinary Biologics Product Licence.

V. Label error identification by CCVB

V.A. Major errors

The following are considered major errors and will result in rejection of the submitted label(s):

• label claims not supported by data approved by the CCVB;
• non-equivalence of text translation that may impact the health or safety of users, or vaccinated animals;
• illegible text or very small text that requires a magnifying glass to read; and
• terminology, typographical, or spelling mistakes that may interfere with the prescribed use of the product or have health or safety implications for end users or vaccinated animals.

V.B. Minor errors

The following are considered minor errors, and may result in temporary approval of the labels for interim use, until corrected labels can be submitted:

• spelling or typographical errors or omissions that do not interfere with the prescribed use of the product.

The length of the approval period will be determined by the CCVB reviewer. The final corrected labels should be submitted for review and approval before the end of the interim label approval period or by the next printing of the labels, whichever comes first.

The fee submitted with the original labels remains valid for the review and approval of corrected labels. This fee does not cover subsequent changes that are initiated by the manufacturer.

VI. Minor changes

Manufacturers may insert minor changes to labels, implementing without pre-approval from the CCVB, provided that the copies of the modified labels are submitted to the CCVB for approval within 60 days of the change.

The following are considered minor label changes:

• commercial logo of the company
• background picture
• colour scheme
• minor change to the shape of the labels (including new peel-off format)
• introduction or removal of patent number or registration logo/number (for example, ®, ©, ™)
• modification to the layout of the already approved text
• addition of, or change to, a toll-free telephone number
  • Companies should ensure that toll-free telephone numbers displayed on the labels of products distributed in Canada are accessible to Canadian consumers.

To streamline the review and approval procedure, manufacturers are encouraged to submit revised labels for all of their products together.

VII. Standardized terminology

VII.A. Recommended statements

• Vaccination: Applies to the administration of a veterinary biologic to an animal regardless of the route of administration. Term to avoid: inoculation.
• Withdrawal period: "Do not vaccinate within [X] days before/prior to slaughter."
• "For veterinary use only," "For use in animals only," or "For use in dogs, cats, swine, cattle, horses, chicken, turkey, salmon, etc." (or similar statement), if the animal species is stipulated.
• "Do not vaccinate pregnant females."

VII.B. Recommended translations of product claims

English

For the prevention of…
For the control of…
For the reduction of…
As an aid in…

French

Pour prévenir…
Pour contrôler…
Pour réduire…
Pour aider à…/Comme aide à la / au

VIII. Glossary – Recommended English and French Terms

Appendix – Summary of Changes

July 2021 – The Guideline was updated to reflect the amendment to the Health of Animals Regulations requiring bilingual labelling for veterinary biologic products (refer to Memorandum 2018-04). The option to make electronic submissions was also added.