Canadian Food Inspection Agency - Veterinary Biologics Guideline 3.3E - Guidelines for Labelling of Veterinary Biologics

These labelling guidelines have been prepared as a reference for those persons concerned with the manufacture, importation, distribution and sale of veterinary biologics in Canada.

The authority for the regulation of veterinary biologics in Canada is the Health of Animals Act and Regulations. The Health of Animals Act and Regulations are available though the web site of the Canadian Food Inspection Agency (CFIA): www.inspection.gc.ca

1. Establish a uniform standard for the review and approval of the labelling of products from various manufacturers;
2. Provide a reference source to the veterinary biologics industry to facilitate compliance;
3. Assist the Veterinary Biologics Section (VBS) in maintaining complete and current label files for licensed products and registered products.

Labelling: includes any legend, word or mark attached to, included in, belonging to or accompanying any veterinary biologic or package including:

1. The final container label;
2. Cartons, wrappers and similar items;
3. Informational materials such as instructional brochures and package inserts.

Package: includes anything in which any veterinary biologic is wholly or partly contained, placed or packed.

Labelling requirements as stated in sections 132, 133, 134, of the Health of Animals Act and Regulations , are as follows:

Section 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.

Section 132. (2) All information required by section 134 to be shown on the label of a veterinary biologic (a) shall be clearly and prominently displayed on the label, and (b) shall be readily visible by a purchaser under the customary conditions of purchase and use.

Section 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.

Section 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.

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

Section 134. (1) Subject to this section every label of a veterinary biologic imported, sold, advertised or offered for sale in Canada shall show

Explanatory note: 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 shall overshadow the assigned name which must be given prominence by the location and by the style and/or size of lettering. The size of the letters of the assigned name should not be less than the size of the letters of the trade name.

(b) 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

Explanatory note: It should be clearly indicated on the labels who is responsible for the distribution of the product, and the monitoring of the adverse reactions in Canada. Only one of the four following statements can be accepted of the labels, depending on the status of the manufacturer(s) and/or distributor(s):

- To be used only for manufacturing steps involving preparation of the product, not just filling and labelling.

- To be used when Canadian distributor has arranged for contract manufacturing. Should cite the manufacturer’s Establishment Licence Number issued by the Unites States Department of Agriculture-Animal and Plant Health Inspection Services-Center for Veterinary Biologics (USDA-APHIS-CVB) or the Canadian Veterinary Biologics Establishment Licence Number. Manufacturers in the United States (U.S). require USDA-APHIS-CVB’s approval to cite the USDA Establishment Licence Number on labels. See (e) below for manufacturers outside of Canada and of the U.S.

- It is acceptable to keep the name of the manufacturer confidential as long as VBS is informed of the manufacturer’s identity through approval of the outline of production, and the firm identified on the labels is responsible for monitoring adverse reactions in Canada. US manufacturers require USDA–APHIS-CVB’s approval to cite USDA Establishment Licence Number on labels.

Note: The identification of the manufacturer with the authorized establishment number must be the same on all the labels used for the distribution of a product in Canada.

(c) the place where the manufacturer referred to in paragraph (b) manufactures the veterinary biologic

(d) the lot or serial number or other means of identifying the veterinary biologic

(e) 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.

Explanatory note 1: In order to avoid confusion with other types of Establishment Licences issued by the CFIA, the following designation has been adopted: Canadian Veterinary Biologics Establishment Licence No. (Can. Vet. Biol. Est. Lic. No.).

Explanatory note 2: The Establishment Licence Number of the facility, as issued by the country where it resides, must be on the labels unless such a system is not used by that country. CFIA or USDA Veterinary Biologics Establishment Licence Numbers can only be issued within the respective country.

(f) directions for use of the veterinary biologic or that directions for its use are contained inside the package.

Explanatory note: Such directions should include the following: the recommended dose, the route or routes of administration, recommendations in regard to the optimum age for vaccination, repeat dose instructions, precautions, the withdrawal period, the antidote, etc. The instructions for a diagnostic kit should include among other items: the test procedure, the safety precautions, results of efficacy testing (sensitivity and specificity, etc.) the disposal recommendations, etc.

Explanatory note 1: Such a date must be supported by satisfactory stability data and the product must not be sold after this expiration date. For multi-components products, the expiry date should be calculated from the initiation of the potency testing of the component with the shortest expiry date.

Explanatory note 2: If the expiry date is indicated using only year/month, it is understood that the expiry date corresponds to the last day of this month. Since the expiry date is calculated from the date of the start of the potency testing, the month that is indicated must fall within the total expiry time stipulated in the outline of production. Example: potency testing started June 14, 2004, for a product with an expiry dating of 12 months: expiry date will be "2005/05".

Explanatory note 3: The preferred format for expiry date is: "yyyy/mm/dd" (year/month/day).

(h) the components of the veterinary biologic including
(i) viruses, bacteria, toxoids and antibodies, and
(ii) antibiotics, if added during the production process as preservatives.

Explanatory note: This applies also to the list of all the components necessary to perform the test that are included in a diagnostic kit or supplied by the user.

(i) the net quantity of the veterinary biologic in the container, expressed in metric units or in doses.

Explanatory note: Since the metric system is the official measure system in use in Canada, if units of measures other than metric appear on the labels, the metric units appear first, and the other types of units are placed in brackets.

(j) the temperature range expressed in metric units necessary to maintain prescribed potency of the veterinary biologic.

Explanatory note: Wording such as "store at not over 7°C - do not freeze" would be considered acceptable where appropriate.

(k) 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,

Explanatory note: The minimal withdrawal period authorized is 21 days. The withdrawal period may be longer in accordance with the specifications in the outline of production. Example: "Do not vaccinate within 21 (or 60) days before/prior to slaughter" or "Ne pas vacciner dans les 21 (ou 60) jours précédant l'abattage" .

Note: There is no withdrawal period for antibody products administered orally.

(l) 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.

Examples of alternative wording to be used on vaccines in general: "For use in dogs only", "For use in chickens", "Recommended for use in cattle".

Section 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.

Explanatory note: See the section for containers 50 mL or less (V.C. below).

Section 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.

Explanatory note 1: All claims written on the labels must be supported by data that have been approved by VBS. The recommendations for use of a product must be consistent with the recommendations stipulated in section VI. of the outline of production.

Explanatory note 2: The distributors of veterinary biological products are required to comply with provincial laws where the products are distributed (as stipulated on the product licence or the import permit). VBS advises all the manufacturers that provincial legislation in Québec stipulates that labels of products sold in Québec must be in French or French-English. Hence, if manufacturers intend to sell their products in Québec, they are encouraged to submit bilingual labels at the time of registration of their products in Canada.

In most instances, the approval of the final labelling by VBS is the final stage in the registration (manufactured and licensed in the U.S.) or the licencing (manufactured in Canada or in another country other than U.S.) of the product in Canada.

In certain instances, manufacturers of veterinary biologics licenced for sale in foreign countries may be required to perform field trials in Canada prior to the issuance of a Canadian licence. In these instances, a gummed label containing the following statement "For investigational use only - Not for sale" must be attached to the product carton and/or final container. It is expected that manufacturers will submit field trial reports to VBS for evaluation.

IV.B. LABELS OF VETERINARY BIOLOGICS MANUFACTURED AND LICENSED IN CANADA THAT ARE ONLY DISTRIBUTED OUTSIDE CANADA (EXPORTED)

Veterinary biologics produced in Canada for commercial purpose (distribution within Canada and/or export) can only be manufactured in an establishment with a valid Canadian Veterinary Biologics Establishment Licence delivered by the VBS of CFIA under an authorized Veterinary Biologic Product Licence (H. of A. Regs., sections 123., 124., 125., and 127.). In order to obtain the product licence, the manufacturer has to submit to VBS all the supporting data for the claims on the labels as per the H. of A. Regs., regardless of the language appearing on the labels used for export only.

It is then the responsibility of the manufacturer to demonstrate to VBS that the claims on the labels in a language other than English and/or French correspond to the claims in the support documentation of the product file approved for licensing for export only by VBS. If the government of the importing country regulates veterinary biologics, a document attesting their approval of the label claims must be submitted to VBS.

All submissions of labels for approval must be accompanied with a covering letter stating the changes, an Application for Services (CFIA 4720 Form), and the corresponding fee [as per the Regulation item 10.(2) Project Code 1376], unless it is part of the file for the registration or the licencing of a new product.

2. Each label should be affixed/mounted on a 8½"X11" sheet of paper showing the identification of the manufacturer (with the establishment licence number), the assigned name of the product, the VBS file number, the USDA Product Code (when applicable), the type of labels (container, carton, leaflet), and the date of the preparation of the version of that label. A 5 cm space minimum is required on one side of the label for the approval stamp. The labels must be affixed to the sheet of paper so that the entire label (front and back) can be read without taking it apart from the paper.

Note: In the case of diagnostic kits, it is recommended to use a separate sheet of paper for each carton label, for the insert and for any label used on a bag for a micro-titration plate or any other apparatus provided to run the test. Labels of vials of 50 mL or less can be affixed to the same sheet of paper as long as a 5 cm margin is left on one side of each label. Another sheet of paper should be used for labels of containers above 50 mL that must be bilingual for distribution throughout Canada.

3. Only original labels or computer-ready color-printed labels are accepted for final approval, with a few exceptions (see Note 2).

Note 2: In the case where the text of the labels is printed directly on plastic bottles through a silk-screen process, photocopies of these labels will be accepted for approval. However, this has to be clearly indicated in the covering letter.

Note 3: If bilingual labels are presented solely for the registration in Canada of a product licensed in the U.S., VBS must receive photocopies of the English version approved by the USDA-APHIS-CVB.

Note 4: Copies of original labels showing the approval stamp of the USDA-APHIS-CVB are not sufficient for the final approval of a product submitted for registration in Canada. Separate original copies are required in order to be stamped by the CFIA-VBS.

4. A sufficient number of each label (minimum of two copies) should be submitted so that the required number of stamped approved labels can be returned to the manufacturer for their file. One stamped approved copy is kept on file at VBS. An additional copy of each label (container, carton, package insert and diluent labels when applicable) is required for products that are tested by our Biologic Evaluation Laboratory.

5. All the different labels used in the distribution or the administration of a product (including the labels of the diluent when applicable, even if sold separately) should be submitted together for approval.

Note 1: The labels for containers of 50 mL or less (See V.C. below) usually contain less information than the labels for containers above 50 mL, and therefore both types of labels (50 mL or less, and 100 mL and above) should be submitted for approval.

Note 2: For labels of containers above 50 mL, and of carton labels, if the content and the layout of the text are identical for all the distributed formats (all volumes that could be filled must be indicated in the outline of production), only the labels of the smallest format are required to be submitted for approval. If the content and the layout of the text are variable among the distributed formats, the labels of the smallest container and carton format for each variation should be submitted for approval. The same principle applies to the instruction leaflet.

Note 3: If manufacturers wish to also supply individual self-stick labels to place in respective animal files, in the case of vaccines sold in multi-dose bottles, these labels must also be submitted to VBS for approval.

The manufacturer may submit drafts of labels and label review fees in order to have the text verified for appropriateness before the final printing (before the final approval). This would mostly apply to labels of new products submitted for registration or licencing in Canada, or to the French version of labels initially written in English. The review fee will also cover the final approval of the labels.

Note 1: The fee for review of labels or drafts of labels of new products is included in the submission fee for the registration or the licencing of the new product.

Note 2: Manufacturers may wish to find out if the French version of some labels for a product not yet submitted for licencing or registration in Canada is appropriate [example: a manufacturer in the U.S. wishes to licence the product in the U.S. with English-French or English-French-Spanish labels]. It is possible to submit to the VBS drafts of the bilingual or trilingual labels for scrutiny by paying the fee for label revision [CFIA 4720 form, item 10.(2)]. When the file of that product will be presented for registration in Canada, it will then be necessary to specify that the French version has been evaluated (refer to pertinent correspondence) in order to simplify its acceptance as long as the initial claims and text have not changed. As indicated in IV. Section 134 (3) of the H. of A. Regs., English-Spanish labels cannot be approved for distribution in Canada.

Labels affixed to containers of vaccines of 50 mL or less (with a packaging carton and/or package insert) must provide the following minimal information.

1)   The assigned name of the product. This is not to be confused with the trade name, which may appear if space is available.
2)   The volume of the contents, and/or the number of doses.
3)   The manufacturer's name and address.
4)   The establishment number.
5)   The serial, or lot number.
6)   The expiration date.
7)   Directions to consult the package insert, or the carton label for complete directions for use.

An example of the minimum information required on a vial label for a container of 50 mL or less is shown below. When such a label is used, it is understood that the accompanying package insert and/or carton label, as well as any other labelling components, will be bilingual when applicable for distribution throughout Canada.

Assigned Name
Trade Name

Container Volume (Doses or mL)

See insert (Voir dépliant) or See Carton (Voir boîte)

Manufacturer
City, Province
Est. Lic. No:

Ser: Exp:

If bilingual labelling is to be used, labels for final containers of 50 mL or less (with a packaging carton and/or package insert) may be entirely in one, or both official languages, depending on the space available. If such labels are in one language only because of space shortage, a brief statement in the other language instructing the user to see the package insert or carton for complete directions for use of the product must be present (with some exceptions allowed: see Notes 6, 7, 8, 9, and 10 below). It is recommended to emphasize the statement "See insert" ("Voir dépliant") or "See carton" ("Voir boîte"), or any equivalent statement, in either bold letters or on a separate line.

Note 1: Other information found acceptable may be added, but not at the expense of clarity and legibility, since the regulations state that the labelling must be readily visible under the customary conditions of purchase and use.

Note 2: The manufacturers are required to provide legible labels. When the assigned name of the product includes numerous components, the available space left for the other essential information is limited. Hence, manufacturers are encouraged to provide a packaging carton and/or package insert where all the required information can be written in more than one language. It is possible to use vial labels with a pouch containing a small insert or vial labels with an overlap.

Note 3: The identification of the manufacturer with the authorized establishment number must be the same on all the labels used for the distribution of a product in Canada (Example: Re-packaging in Canada with bilingual carton label and insert of single-dose vaccine vials already labelled in the United States with English-only labels).

Note 4: In the case of vaccines, if there are no packaging carton and/or package insert, the requirements for complete information in the two official languages apply to the labels of containers of 50 mL or less if the products are distributed throughout Canada.

Note 5: When single dose vials (example: vaccines for dogs and cats), or concentrated multiple dose (1,000 -10,000) in vials of 20 mL or less (example: poultry vaccines) are packaged in a multi-dose carton, the directions for use and precautions may be stated on the carton label or a package insert, since there is insufficient space on the individual container labels.

Note 6: In the case of single dose vials or concentrated multiple dose vials (see Note 5 above) of vaccines distributed throughout Canada, if the carton label clearly states "See insert/Voir dépliant", then the container labels of such vaccines do not require the statement "See insert/Voir dépliant", provided the individual containers are not sold separately.

Note 7: In the case of a regular multiple dose vaccine distributed throughout Canada with only vials of 50 mL or less, if the carton label of such vaccine includes the complete bilingual product information and instructions for use, it is not necessary to include the statement "See carton/Voir boîte" for instructions in the other official language on the vial label(s). This will mainly be observed with less frequently used vaccines distributed in smaller quantity (example: 20 mL-10 dose vial) to vaccinate pregnant animals to induce the production of maternal antibodies.

This will allow the packaging with a bilingual carton and subsequent distribution throughout Canada of such vaccines with an English-only vial label that has been approved by USDA-APHIS-CVB as long as this unilingual version meets all the Canadian requirements, the bilingual instructions are present on the carton label and the vials are not sold separately.

Note 8: For vaccines packaged in cryovac ampules and stored in liquid nitrogen that are distributed throughout Canada, the vial labels do not require the statement "See insert/Voir dépliant", provided the package insert accompanying the product clearly states the bilingual directions for use.

Note 9: If the carton label for a diagnostic kit clearly states that the directions for use are in a package insert, the individual reagent containers do not require the statement "See insert/Voir dépliant".

Note 10: In the case of diagnostic kits that are distributed throughout Canada, the labels of reagent vials for volumes below 50 mL could be entirely in one of the two official languages as long as they can easily be recognized by a mode of identification (color, number, letter, etc.) as specified on the carton label or in the insert.

Note 11: The commercial name of a diagnostic kit can be used without the complete assigned name on the vial labels of reagents with very small volumes (10 mL or less).

a. Any claim not supported by submitted data results in the rejection of the labels.

b. When bilingual labels are used, the English and French versions must be equivalent. The assigned name, the claims, the recommendations for use and the precautions of the product must be free of terminology/typographical/spelling errors in either official language. Any errors in these parts are considered major errors and result in the rejection of the labels.

Note 1: When bilingual labels (for distribution in Canada) are submitted for approval, all the information present on the labels has to appear in the two official languages. See V.C. above for the exceptions that apply to labels of vials of 50 mL or less.

Note 2: Labels in a foreign language for export (See V.E. below) could also be rejected if VBS is aware that the claims indicated are not supported by the submitted data.

Terminology/spelling/typographical errors (in either of the Canadian official languages) in the explanatory text other than parts identified in V.D.1.b. above are considered minor errors. Labels can be approved for interim use. Corrected labels must be submitted for final approval within a limited time frame (see V.F. below).

Manufacturers can make minor cosmetic changes to labels and implement them without pre-approval as long as copies of the modified labels are submitted to VBS within two months of the change. See V.A.. above for the details on submission.

- change in the commercial logo of the company
- change in the background picture
- change in the colors
- minor change in the shape of the labels (including new peel-off format)
- introduction or removal of patent number or registration logo/number (examples: ®, ©, ™)
- modification to the lay-out of the already approved text
- corrections to existing minor spelling/typographical errors in the explanatory text (V.D.2. above)
- addition of a new "800" telephone number
- change in the mailing address

Labels of all products destined for exportation that are manufactured at facilities with a Canadian Veterinary Biologics Establishment Licence Number must be presented to VBS for approval, in conformity with Sections 123., 124. & 126. (see the CFIA web site), and Sections 132. & Section 134. (1) of the Health of Animals Regulations [see above].

The Canadian manufacturer is required to supply a proof of acceptance of the product by the regulatory authorities of the importing country if there are regulations pertinent to veterinary biologics in that country. If the regulations of the importing country require information on the labelling that differs from the approved Canadian labels, the Canadian manufacturer is required to supply a proof of their acceptance of the labelling.

b. Manufacturers are required to supply one version in either French or English of all labels in order to verify their conformity.

c. Manufacturers are required to supply a certificate from the translation firm stipulating that the version in the foreign language is equivalent to the French or English version. However, the VBS may also contact a third party to verify the compliance of the version in foreign language.

Approval for interim use applies to the cases described below. Manufacturers wishing to have labels approved for interim use (V.F.2. and V.F.3.) should follow the instructions for submission of labels described in V.A. above.

If the errors identified by VBS are considered minor (see V.D.2. above) and would not interfere with the prescribed use of the product, final labels are "approved for interim use until the next printing revision (that is when a new lot of labels is due to be printed) with corrections". This allows the distribution of the registered or licensed product by the manufacturer until the supply of the printed labels is exhausted.

Photocopies of the labels with the required corrections are returned to the manufacturer. The final corrected labels should be submitted for review and approval at the next printing of the labels.

Note 1: In all cases, the manufacturer must indicate the time required for the submission of the corrected labels. However, a maximum of one year is normally allowed after the approval for interim use. The VBS may shorten this delay in the case of recurrent errors on labels of the same products previously approved for interim use.

Note 2: The submission fees paid for the approval of the labels that require corrections (approved for interim use) are still valid for the submission of the corrected labels for final approval.

Note 3: Manufacturers have the responsibility to do the proof-reading of the corrected labels before submitting them to the VBS.

a. English only labels approved by USDA-APHIS-CVB, but not conforming to the Canadian requirements, can be approved for interim use for the registration of the product in Canada. The manufacturer is required to conform with the metric system at the next printing of the labels, and submit the corrected final labels for approval.

b. If there is a delay in the printing of the final version of the bilingual labels (drafts of the bilingual labels found acceptable by VBS), English-only labels approved by USDA-APHIS-CVB, or the English only version found acceptable by VBS, can be approved for interim use.

Note 1: In all cases, the manufacturer must indicate the time required for the submission of the revised labels. However, a maximum of one year is normally allowed after the approval for interim use.

Note 2: The submission fees paid for the approval of the labels that require revision (approved for interim use) are still valid for the submission of the revised labels for final approval.

Note 3: Products with English-only labels may not be distributed in the province of Québec, and the manufacturer and/or distributor must indicate in the correspondence that they will comply to this rule.

If there is a delay in the assembly of a serial with approved labels (usually bilingual), English-only labels approved by USDA-APHIS-CVB can be approved for interim use to allow the distribution in Canada of a serial already released according to the USDA-APHIS-CVB specifications, provided that the label claim is identical to the label claim approved by VBS.

The manufacturer must then specify the serial number and the quantity to be distributed, as the approval for interim use will only cover this serial and the stipulated quantity.

Note 1: Submission fees are required for the interim approval of English-only labels to be used until the shortage of product with approved bilingual labels is resolved.

Note 2: It is recommended that, during the period of that type of shortage, the manufacturer and/or the distributor should reserve any remaining inventory of the product with bilingual labels for the distribution in Québec.

In order to extend the expiry date of a serial of a product that has already been serial-released, the manufacturer must submit the data in support of the extension, and the sticker labels required for the change affixed to the labels bearing the serial number involved, with the applicable fee.

When the name and address of the manufacturer of a licensed product change, the manufacturer should notify VBS and indicate the time frame required for the submission of the new labels showing the new identification of the manufacturer.

The previously approved labels showing the identification of the former manufacturer can be used for the distribution of the product for a period not exceeding one year after the transfer of ownership of the product. Registered products already imported (licensed in the U.S.) and/or released (licensed in Canada) with previously approved labels can be distributed until their expiry.

a. When the only change is the identification of the manufacturer, manufacturers are then encouraged to submit the revised labels for all their products together in one package, to streamline the review and approval procedure.

Note: A single fee is required when all the modified labels of all the affected products are submitted together. However, an individual covering letter is required for each product file.

b. The covering letter clearly states that no other changes have been done to the claims and text of labels.

Note: Any change to the content of the text present on the labels other than the change of the identity of the manufacturer requires a full review of the labels, and a revision fee for each product will then apply to the review of the labels.

If the scientific name of a product changes, it can change the assigned name on the product licence. Submission of the revised labels of all affected products is then required with the related fee. A copy of the revised USDA Product License is also required for products manufactured in the U.S.

Note 1: If all the labels of all the related products affected by the name change are submitted together, only one submission fee is required. However, an individual covering letter for each product file is required.

Note 2: The released products labelled with the old assigned name can be distributed until the inventory is exhausted.

If the manufacturer makes minor changes to the labels (see V.D.3. above) to all his products or a set of products, all the labels for the affected products can be submitted together to simplify the approval and filing. The covering letter must clearly state that there is no other change to the content of the labels.

Note: If all the labels of all the related products affected by the minor change are submitted together, only one submission fee is required. However, an individual covering letter for each product file is required.

- "Vaccination": It applies to the administration of a veterinary biological product regardless of the route of inoculation. The term "immunization" refers to the immune status of the animal. Vaccination does not guarantee the immunization of 100% of the vaccinees, therefore, "vaccination" is the appropriate term for the administration of a veterinary biologic.

- Withdrawal period: «Do not vaccinate within 21 days (or 60 days) before/prior to slaughter», and «Ne pas vacciner dans les 21 jours (ou 60 jours) précédant l'abattage».

- "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 animals", or "Do not vaccinate pregnant females". In French, only "Ne pas vacciner les femelles gestantes" is acceptable. The same principle applies to "Do not vaccinate calves/piglets nursing pregnant animals" that translates in French to "Ne pas vacciner les veaux/porcelets allaités par des femelles gestantes".

- Abbreviations of measure units. In Canada, it is recommended to use "L" as abbreviation of "litre" in veterinary publications. However, VBS will accept either "L" or "l" for "litre" and "mL" or "ml" for "millilitre" as long as the manufacturer is consistent throughout all labels. In the case of "gram", the abbreviation is always "g". None of these abbreviations take a "s" regardless of the amount.

Note: Please note that labels of concentrated vaccines manufactured in the U.S. that require dilution prior to administration (example: avian vaccine administered in drinking water) must clearly indicate that the non-metric units are U.S units. One U.S. gallon contains 3.8 L as compared to a Canadian gallon that contains 4.5 L.

- Some multivalent vaccines are distributed with two vials: one contains a lyophilized fraction and the other contains a liquid fraction or a plain diluent. Since the lyophilization only removes water from the first fraction of the vaccine, the liquid in the second vial is used to "rehydrate" the lyophilized fraction. The English verb "rehydrate" is them recommended.

The list of products that have been licensed or registered for sale in Canada is available in French and English on our web site:

Whenever a French name is not listed because the product is not yet available in Canada or distributed in Québec, please communicate with the VBS to verify the pertinence of the proposed French assigned name.

Note: There are frequently two acceptable French versions for the same English assigned name. Our web site shows the most frequently used French version with the other possibility in brackets. The choice is left to the manufacturer. However, the same French version of the assigned name should be used on all related products containing the same fraction.

a. To use the name of the disease to designate the causal agent in the explanatory text of the labels. Example: "the disease caused by infectious bovine rhinotracheitis and bovine virus diarrhea". To be corrected to "the disease caused by infectious bovine rhinotracheitis and bovine viral diarrhea viruses".

b. To use capitalized letters for the second part of the latin name of micro-organisms in the explanatory text of the labels. Example: "Leptospira Canicola". To be corrected to "Leptospira canicola" (italics). Please note that the second part never takes a capitalized letter in French, with the exception of the Salmonella group.

c. To use capitalized letters for the name of diseases in French or English in the explanatory text of the labels. Example: "Canine Hepatitis". To be corrected to "canine hepatitis". Only names of persons (example: Glässer disease) or geographic locations (example: Newcastle disease) take capitalized letters.

d. To use capitalized letters for all the words in a French title or heading. Only the first word takes a capitalized letter with a few exceptions (see V.H.3.c. above).

VI. REFERENCES AVAILABLE FOR CONSULTATION ON APPROPRIATE TERMINOLOGY IN FRENCH AND ENGLISH

1. Dictionnaire des termes vétérinaires et animaliers/Veterinary and Animal Science Dictionary. Roy Mack - Étienne Meissonnier. Éditions du Point Vétérinaire. Maisons Alfort. 1991.

2. Dictionnaire anglais-français des sciences médicales et paramédicales/English-French Dictionary of Medical and Paramedical Sciences. William J. Gladstone. Maloine. Paris. Third edition 1990.

3. Manuel Vétérinaire Merck. Clarence M. Fraser, editor. Merck & Co., Inc. Rathway, N.J., U.S.A. First French edition of the 7^th edition of Merck Veterinary Manual. 1996.

4. Vocabulaire de l’agriculture/Vocabulary of Agriculture. Bulletin de terminologie 197/Terminology Bulletin 197. Pierre Dermine. MInistère des approvisionnements et services Canada/Ministry of Supply and Services Canada. Ottawa, Canada. 1990.