Veterinary Biologics Guideline 3.3
Labelling of Veterinary Biologics

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Table of Contents

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. Labelling includes any legend, word or mark attached 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 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.

131.1 (1) Where an emergency exists with respect to the availability of and need for a veterinary biologic, the Minister may exempt that veterinary biologic from the application of any of the provisions of these Regulations during the period of the emergency.

(2) An exemption referred to in subsection (1) shall be in writing and shall state the veterinary biologic that is exempted, the provision or provisions of these Regulations from which it is exempted and the reasons for that exemption.

(3) The Minister may at any time cancel the exemption referred to in subsection (1).

132.(1) No person shall import, 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.(1) Subject to subsection (2), every veterinary biologic sold, advertised or offered for sale in Canada shall carry a label on or attached to every container in which the veterinary biologic is packed.

133.(2) Subsection (1) does not apply to a single dose of a killed veterinary biologic packed in a ready to use syringe if the syringe is in a sealed pouch that carries a label.

133.(3) Every veterinary biologic imported into Canada shall carry a label on or attached to every outer container and shipping container.

134.(1) Subject to this section, every label of a veterinary biologic imported, 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 one 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, and
  12. in the case of modified live virus rabies vaccines, the cautionary statement

    "In the event of accidental human exposure to the vaccine virus, the possible hazard to health should be considered and public health officials or a physician should be consulted" or "En cas d'exposition accidentelle d'une personne au vaccin viral, il faut prendre en considération le risque sanitaire et consulter les responsables de la santé publique ou un médecin,"

    and shall be marked with the words "For veterinary use only" or "Pour usage vétérinaire seulement" or alternative wording approved by the Minister.

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) The information contained on the label of a veterinary biologic imported into or sold, advertised or offered for sale in Canada shall be shown in its entirety in either or both official languages and, if both official languages are shown, may additionally be shown in whole or in part in any other language.

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.

Note that some provincial/territorial regulations may apply to the labelling of veterinary biologics. It is the responsibility of the manufacturers and the importers to ensure that all applicable legal requirements are met before a veterinary biologic is distributed in Canada.

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

  1. assigned name – exemption for diagnostic kit reagent labels for containers less than 10 mL;
  2. manufacturer;
  3. location of manufacturer;
  4. serial number – exemption for package inserts;
  5. Establishment Licence Number, if applicable;
  6. directions for use, or instructions to consult a carton or package insert for full directions;
  7. expiry date – exemption for package inserts;
  8. all components, including antigens and preservatives – exemption for containers of 50 mL or less;
  9. quantity of veterinary biologic in the container, expressed in metric units or doses – exemption for package inserts;
  10. storage temperature expressed in metric units; and
  11. withdrawal period, if applicable – 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 one component of a product's labelling.

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

  1. recommended dose
  2. route(s) of administration
  3. recommendations with respect to the optimum age for vaccination and repeat dose (booster) instructions
  4. precautions

Pertinent information for diagnostic test kits includes the following:

  1. test procedure
  2. 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.

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 imported into or sold, advertised, or offered for sale in Canada must bear labels in English, French, or English and French. Only when information is available in both English and French can other languages appear. In accordance with the CFIA's responsibility to ensure that health and safety information is available to Canadians in their official language of choice, the CCVB recommends the use of bilingual labels for all veterinary biologics distributed in Canada.

Since 'labelling' includes all labelling components distributed with the veterinary biologic, a product with unilingual English or French container and carton labels that is distributed with a bilingual package insert where all information on the container and carton is also present in the insert, is considered to have bilingual labelling.

Veterinary biologics imported for emergency use (i.e. to control a disease outbreak and no effective licensed veterinary biologic is available in Canada) may be exempted from Section 134.(3) of the Health of Animals Regulations, in accordance with Section 131.1 (1).

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 listed on the label. 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 one 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:

  1. product assigned name;
  2. volume and quantity of individual containers (e.g. 10 × 250 mL bottles);
  3. serial number(s);
  4. expiry date(s);
  5. name and address of manufacturer; and
  6. 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.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 (e.g. 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 (e.g. 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. 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 one product, the diluent labels may be submitted together in one package, with one fee, as long as the Form CFIA/ACIA 5761 identifies all of the vaccines with which the diluent is normally distributed. 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 (e.g. if the diluent is distributed with five products, at least six copies of the diluent labels must be submitted).

IV.C. Requirements – Final Labels

  1. Ensure that a separate Form CFIA/ACIA 5761 for each product accompanies the labels.
  2. 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.
  3. Submit a minimum of two copies for each label. One copy is kept on file at the CCVB. One original copy should be kept by the manufacturer and one by each designated importer, if applicable. There is no maximum number of copies that can be submitted.
  4. Submit all the different label formats (bottle labels, cartons, inserts, etc.) and dose sizes together for approval:
    1. 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.
  5. Each label should be mounted on an 8½" by 11" sheet of paper.
  6. Include for each mounting sheet the following information:
    1. identification of the manufacturer (including the Establishment Licence number, if applicable);
    2. product assigned name;
    3. CCVB file number;
    4. product code, issued by the country of manufacture (if applicable);
    5. type of label (container, carton, insert), including dose size; and
    6. date of preparation and/or the version number of that label.
  7. Leave (at a minimum) a 5-cm blank space at the bottom of the mounting sheet for the approval stamp.
  8. 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.
  9. Mount the labels of co-packaged vials on the same mounting sheet, provided there is enough room for the approval stamp.
  10. Ensure that over-stickers are approved by CCVB prior to use.
  11. 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.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:

  1. product assigned name
  2. volume of the contents and/or the number of doses
  3. manufacturer's name and location
  4. establishment number (if applicable)
  5. serial or lot number
  6. expiry date
  7. instructions to consult the package insert or the carton for complete directions

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 (e.g. 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:

  1. The applicant is an approved designated Canadian importer of veterinary biologics.
  2. The veterinary biologic is licensed for use in Canada, or authorized by the CCVB for restricted use.
  3. The importer's facilities where the package inserts are added or substituted are inspected regularly by a member of the CFIA-Veterinary Biologics Operations or the CCVB.
  4. 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:
    1. submission to CCVB of at least two copies;
    2. the location of the designated Canadian importer where the package insert will be added or substituted;
    3. the position titles of the importer personnel who are responsible for adding or substituting the insert to the product;
    4. 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);
    5. all quality control steps to verify that the correct insert is included with each product;
    6. a description of the product:
      1. assigned name,
      2. product identification from country of manufacture (e.g. USDA Product Code),
      3. CCVB Product File number, and
      4. manufacturer's identification (e.g. U.S. Veterinary Biologics Establishment License number);
    7. the last page of the Special Outline signed by the Regulatory Affairs person who is responsible for its preparation.
  5. The package insert is stamp-approved by the CCVB.
  6. The Special Outline is kept up to date.

Importers 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.

Photocopies of the labels with the required corrections are returned to the manufacturer. 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 within60 days of the change.

The following are considered minor label changes:

  1. commercial logo of the company
  2. background picture
  3. colour scheme
  4. minor change to the shape of the labels (including new peel-off format)
  5. introduction or removal of patent number or registration logo/number (e.g. ®, ©, ™)
  6. modification to the layout of the already approved text
  7. addition of, or change to, a toll-free telephone number
    1. 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

  1. Vaccination: Applies to the administration of a veterinary biologic to an animal regardless of the route of administration. Term to avoid: inoculation.
  2. Withdrawal period: "Do not vaccinate within [X] days before/prior to slaughter."
  3. "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.
  4. "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

English French
Act Loi
adjuvant; oil-based adjuvant adjuvant; adjuvant huileux / à base d'huile
adjuvanted adjuvanté; adjuvé
administer administrer
adverse event / reaction évènement / réaction indésirable
advertisement publicité / annonce publicitaire
albumin (egg white) albumen (blanc d'oeuf)
ampule / ampoule (liquid nitrogen) ampoule (azote liquide)
anaphylaxis
- anaphylactic reaction
- anaphylactic shock
anaphylaxie
- réaction anaphylactique
- choc anaphylactique
animals under X weeks of age
- X-week / month-old animals
animaux âgés de moins de X semaines
- animaux âgés de X semaines / mois
antibody anticorps
antibody test kit trousse de détection / dépistage d'anticorps
anticoagulated blood sang traité à l'anticoagulant / anticoagulé
antigen antigène
antigen test kit trousse de détection / dépistage d'antigènes / des antigènes
antitoxin antitoxine
assigned name nom attribué
autogenous
- a. bacterin
- a. vaccine
autogène
- a. bactérine
- a. vaccin
bacteria; bacterium bactéries; bactérie
bacterial bactérien
bacterin bactérine
biohazardous waste matières biologiques dangereuses
biotechnology biotechnologie
bluetongue fièvre catarrhale du mouton
breeder flock (poultry) troupeau reproducteur (volaille)
breeding accouplement, saillie
bring to room temperature amener à la température ambiante
brucellosis brucellose
buffer (diagnostic kit) tampon (trousse diagnostique)
Canadian Food Inspection Agency (CFIA) Agence canadienne d'inspection des aliments (ACIA)
Canadian Veterinary Biologics
Establishment License Number
(Can. Vet. Biol. Estab. Lic. No.)
Numéro de permis canadien
d'établissement de produits biologiques vétérinaires
(Perm. can. établ. prod. biol. vét. No / no)
cattle bovins
cautionary statement mise en garde
cell line lignée cellulaire
challenge provocation
chicken; chicks; pullets; laying hens poulet; poussins; poulettes; poules pondeuses
chimera chimère
coated microtiter plates microplaques sensibilisées
coccidia; coccidium coccidies; coccidie
competitive enzyme-linked immunosorbent assay (cELISA) épreuve immuno-enzymatique de compétition (cELISA)
confidence limit (CL) limite de confiance (LC)
contraindication contre-indication
components composants; composantes
cut-off (diagnostic kit) seuil de détection (trousse de diagnostic)
degree-days (fish) degrés-jours (poissons)
device (diagnostic kit) dispositif (trousse de diagnostic)
diagnostic kit trousse diagnostique / trousse de diagnostic
disclaimer déni de responsabilité
disease maladie
dispense (reagents) distribuer (réactifs)
disposal; to dispose / discard élimination; éliminer
Dispose according to local regulations. Éliminer conformément aux règlements locaux en vigueur.
dissolved dissous
Do not vaccinate pregnant animals. Ne pas vacciner les femelles gestantes / gravides.
Do not vaccinate pregnant cows or calves nursing from pregnant cows. Ne pas vacciner les vaches gestantes / gravides ou les veaux allaités par des vaches gestantes / gravides.
Do not vaccinate pregnant sows or piglets nursing from pregnant sows. Ne pas vacciner les truies gestantes / gravides ou les porcelets allaités par des truies gestantes / gravides.
Do not vaccinate within 21/40/60 days prior to / before slaughter. Ne pas vacciner dans les 21/40/60 jours précédant l'abattage.
dosage of oral administration (rate) dosage d'administration orale (taux)
dot; spot (diagnostic kit) pastille (trousse de diagnostic)
drinking water eau potable
droplet spray nuage de gouttelettes
egg antibody anticorps dans les œufs
egg inoculation machine vaccinateur d'œufs
egg powder poudre d'œufs
egg white (albumin) blanc d'œufs (albumen)
embryonated eggs œufs embryonnés
emulsion émulsion
enterotoxigenic entérotoxigène
enzyme-linked immunosorbent assay (ELISA) épreuve immuno-enzymatique (ELISA)
excretion excrétion
expiry date; Exp.; EXP. date de péremption/pér.; Pér.; EXP.
fetal fœtal
fetus fœtus
field trial; field test essai sur le terrain
fingerling (fish) alevin (poisson)
flock troupeau
flock / herd of origin troupeau de provenance
food animal animal destiné à l'alimentation
food-producing animal animal producteur de denrées alimentaires
For investigational use. Pour usage en recherche.
For emergency use. Pour usage en cas d'urgence.
formalin-inactivated cultures cultures inactivées au formol
For use in animal only. Destiné aux animaux seulement.
For veterinary use only. Pour usage vétérinaire seulement.
fry (fish) alevin (poisson)
fungi; fungus champignons; champignon
gilt cochette
heifer génisse
herd troupeau
high incidence state état à forte incidence
hindquarter arrière-train
homogenizer homogénéisateur
hyperimmunized hyperimmunisé
In case of accidental human injection, seek immediate medical attention. En cas d'injection accidentelle chez l'humain, consulter immédiatement un médecin.
Incubate at room temperature Incuber à la température ambiante.
incubator étuve
injection site point / site d'injection
insert; leaflet notice; dépliant
inspector inspecteur
isolates isolats
keep / store out of direct sunlight entreposer / garder à l'abri de la lumière directe du soleil / protéger du soleil
killed virus virus tué
kit (diagnostic) trousse (de diagnostic)
label étiquette
laboratory test épreuve en laboratoire
leaflet; insert dépliant; notice
licence / license (U.S.) permis
licensed homologué
licensed establishment établissement agréé
licensing homologation
liquid nitrogen tank réservoir d'azote liquide
livestock animaux de ferme / bétail
local swelling enflure / inflammation localisée
lot lot
manufacture manufacture
manufactured for; manufactured by fabriqué pour; fabriqué par
manufacturer; man. fabricant; fabr.
master seed; master seed virus (MSV) souche mère; virus de la souche mère (VSM)
master cell cellules de souche mère
medicators distributeurs de médicaments
micro-organism micro-organisme
microtiter plates; microplates microplaques
midline (fish) ligne médiane / du centre (poissons)
minister ministre
mix well bien mélanger
modified live virus virus vivant atténué
mouth gueule (carnivore); bouche (herbivore)
multichannel pipet / pipette pipette à canaux multiples
nares; nostrils narines (chien, chat, oiseau); naseaux (grands animaux)
needle aiguille
Not for human consumption. Non destiné à l'alimentation humaine.
oocyst (coccidia) oocyste; ookyste (coccidies)
outline of production / production outline protocole de production / données générales sur le produit
package emballage
parr (fish) tacon (poisson)
patent pending brevet en instance
permit permis
Permit to import veterinary biologics Permis d'importation de produits biologiques vétérinaires
Permit to release veterinary biologics Permis de dissémination de produits biologiques vétérinaires
peroxidase peroxydase
phosphate buffer saline solution saline dans un tampon phosphate
pipet; pipette pipette
pipet / pipette tip embout de pipette
pouch; sachet pochette; sachet
poult (turkey) dindonneau (dindon)
precaution mise en garde
pregnancy gestation
pregnant animals (cows; sows; mares; bitches; queens) animaux (vaches; truies; juments; chiennes; chattes) gestantes / gravides
preservative agent de conservation, conservateur
product code code de produit
product licence permis de fabrication
production outline / outline of production données générales sur le produit / protocole de production
progeny descendance
quarantine quarantaine
rate (dosage of oral administration) taux (dosage d'administration orale)
ratio (interpretation of ELISA) ratio (interprétation de l'ELISA)
reagents réactifs
records; keep a record registre; Tenir un registre
registered enregistré
registration enregistrement
regulations règlement
rehydrate réhydrater
room temperature température ambiante
salmonids salmonidés
sample échantillon
screening test test de dépistage
serial série
serial number; ser. no.; ser.; SER. numéro de série; No de sér.; sér.; SER.
serial release mise en circulation d'une série
shake well bien agiter / secouer
smolts (fish) saumoneaux (poisson)
specific pathogen-free exempt d'organismes pathogènes spécifiques
spot; dot (diagnostic kit) pastille (trousse de diagnostic)
spray administration; sprayer administration par vaporisation / nébulisation;
vaporisateur / nébuliseur
spray-dried whole egg powder poudre d'œuf entier séchée par pulvérisation
standard deviation écart type
store at room temperature entreposer à la température ambiante
store below conserver / entreposer en-dessous de
stored entreposé
strip (microplate) barrette (microplaque)
strip (electrophoresis) languette (électrophorèse)
subunit vaccine vaccin sous-unitaire
susceptible animals animaux susceptibles
suspected adverse event / reaction événement indésirable soupçonné / réaction indésirable soupçonnée
swab écouvillon
syringe seringue
test (laboratory); field test test, analyse (laboratoire); essai au champ / sur le terrain
titration titrage
toxigenic toxigène
toxoid anatoxine
trade name nom commercial
turkey; poults dinde; dindonneaux
US Veterinary Biologics Establishment License No. Permis d'établissement de produits biologiques vétérinaires des É.-U. No / no
US Veterinary License No. Permis vétérinaire américain / des É.-U. No / no
US Vet. Biol. Est. Lic. No. Permis d'établ. de prod. bio. vét. des É.-U. No / no
using aseptic technique de façon aseptique
veterinarian
- accredited v.
- licensed v.
vétérinaire
- v. accrédité(e)
- v. licencié(e)
veterinary biologic produit biologique vétérinaire
Veterinary Biologics Product Licence Permis de fabrication de produits biologiques vétérinaires
veterinary inspector vétérinaire-inspecteur
Veterinary License (Vet. Lic.) Permis vétérinaire (Perm. vét.)
vial fiole / flacon
virus virus
well (microplate) puits; cupule (microplaque)
whole blood sang total / complet / entier
wing web (chicken) membrane alaire / voile de l'aile (poulet)
winter ulcers (fish) ulcères hivernaux (poisson)
withholding / withdrawal period période de retrait

Appendix - Summary of Changes

Section Change
Table of Contents Changed III.A.3 from "Pertinent Information" to "Directions for Use"
Changed III.A.10 from "Shipping Containers to "Shipping Boxes" Removed Section IV.G
Changed VIII.B to "Recommended Translations of Product Claims"
II Added reference to the Health of Animals Regulations, Section 131.1 (1-3), removed reference to the Official Languages Act
III.A. Replaced "provincial or local" with "provincial/territorial"
Changed "complied with" to "met"
Changed "is" to "will be"
Changed "The following information must appear on a product's labelling." to "The following information must appear on all components of a product's labelling, unless otherwise noted below:"
Added exemption for assigned names for diagnostic kit reagent labels less than 10mL
Reversed the numbering of "Establishment License Number" and "Serial Number," in order to be consistent with Section 134.(1) of the Health of Animals Regulations
Reversed the numbering of "Directions for Use" and "Expiry Date," in order to be consistent with Section 134.(1) of the Health of Animals Regulations
Removed the two last bullets "Recommended treatment in case of allergic reaction" and the disposal instructions
Added "Additional information may appear provided the inclusion of such information does not affect the clarity and legibility of required text."
III.A.1 Changed "No other statement, design, device, or trade name should overshadow the assigned name, which must be given…" to "No other statement, design, device, or trade name should overshadow the assigned name, which should be given…"
Removed "The letters of the assigned name should not be smaller than the letters of the trade name."
Changed "The assigned name should appear on every part of a product's labelling" to "The assigned name must appear on every component of a product's labelling"
Removed "The assigned name is determined by the relevant regulatory authority in the country of manufacture."
Changed "Consistency of terminology must be maintained…" to "Consistency of terminology should be maintained…"
Removed "French" from both locations in the last paragraph.
III.A.3 Changed the section title to "Directions for Use"
Added "Directions for use must appear on at least one component of a product's labelling, in order to ensure the proper use of the product."
Removed "withdrawal period," "antidote," and "disposal recommendations" from the first list
Removed "results of efficacy testing (sensitivity and specificity)" and "disposal recommendations" from the second list
III.A.4 Moved the last paragraph to the top
Removed the first paragraph that begins "Such a date…"
Reworded the second paragraph to "If the expiry date is indicated 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.7 Reworded the entire section to read "Veterinary biologics imported into or sold, advertised or offered for sale in Canada must bear labels in English, French, or English and French. Only when information is available in both English and French can other languages appear. In accordance with CFIA's responsibility to ensure that information affecting health or safety is available in both official languages, the CCVB recommends the use of bilingual labels for all veterinary biologics distributed in Canada.

Since 'labelling' includes all labelling components distributed with the veterinary biologic, a product with unilingual English or French container and carton labels that is distributed with a bilingual package insert where all information on the container and carton is also present in the insert, is considered to have bilingual labelling.

Veterinary biologics imported for emergency use (i.e. to control a disease outbreak and no effective licensed veterinary biologic is available in Canada) may be exempted from Section 134.(3) of the Health of Animals Regulations, in accordance with Section 131.1 (1)."
III.A.8 Added "… that may be present in the final product, including those…" Changed the recommendation for the inclusion of all preservatives to a requirement.
III.A.9 Changed "should" to "must" in two places.
III.A.10 Changed the title from "Shipping Containers" to "Shipping Boxes"
Changed "containers" to "boxes" in the first paragraph
Changed "volume and number of individual containers" to "volume and quantity of individual containers (e.g. 10 × 250 mL bottles)"
III.B. Reworded the entire section to read "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 (e.g. 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 Changed "manufacturer" to "applicant"
IV.A Changed "A single fee is required…" to "A single cost recovery fee is charged…"
Changed "An individual cover letter, clearly stating that no other changes..." to "An individual cover letter, clearly describing the change and stating that no other changes..."
IV.B Changed the required number of copies to be submitted from "2X + 1" to "X + 1"
Added example to end of second paragraph
IV.C Re-ordered bullets. Bullet 10 becomes bullet 4.a
Changed "vial labels" to "bottle labels"
Size requirement removed for mounting sheets
Changed the space required for the approval stamp from "5cm on each side of the label" to "5cm along the bottom of the mounting sheet"
IV.F Incorporated information from now-obsolete Veterinary Biologics Memorandum 2011-03. No change to requirements or procedure.
IV.G Removed the entire section
V.A Removed "This also applies to foreign language labels on products destined for international markets."
Added "… that may have health or safety implications" to bullets 2 and 4
V.B Added "for interim use" to the first paragraph
Added "or omissions" to the first bullet
Removed the second bullet
Removed the sentence "Corrected labels must be submitted for final approval within a limited time frame, to a maximum of one year."
VI Removed the entire section
VII Changed "two months" to "60 days"
Moved the second paragraph to the end of the section
VIII.A.1 Removed the term "immunisation"
VIII.C Removed entire section
Translations Aligned French translations of Canadian and US Veterinary Establishment License numbers with currently accepted terminology
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