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Health of Animals Regulations (C.R.C., c. 296)

Regulations are current to 2021-06-03 and last amended on 2021-06-01. Previous Versions

PART XIVeterinary Biologics (continued)

[
  • SOR/95-54, s. 4(F)
  • SOR/2018-79, s. 4(F)
]

Requirements of Operation in a Licensed Establishment (continued)

  •  (1) Every holder of a product licence shall

    • (a) keep and make available for inspection by a veterinary inspector records with respect to the preparation, manufacture, preservation, storage, testing, sale and distribution of every veterinary biologic manufactured under the product licence and any diluent to be used therewith; and

    • (b) furnish the Minister with such samples of the veterinary biologic as the Minister may require from time to time.

  • (2) Every record referred to in paragraph (1)(a) shall be retained by the licensee for at least two years following the expiration date of the veterinary biologic to which it relates.

 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.

 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.

 Where the Minister is satisfied from tests of a veterinary biologic, or otherwise, that a veterinary biologic is unsafe to use, is likely to cause communicable disease in animals or is contaminated or ineffective, he may, by order, prohibit the importation, manufacture, sale or distribution of the veterinary biologic.

  •  (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).

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

  • (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.

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

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

    • (a) the assigned name of the veterinary biologic,

    • (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,

    • (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,

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

    • (g) the expiration date of the veterinary biologic,

    • (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,

      • (iii) [Repealed, SOR/80-428, s. 11]

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

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

    • (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, and

    • (l) the words “For veterinary use only” and “Pour usage vétérinaire seulement” or other wording to the same effect, and

    • (m) any cautionary information necessary to ensure the safe handling and use of the veterinary biologic.

  • (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.

  • (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.

  • (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.

 No person shall sell or offer for sale a veterinary biologic after its expiration date.

  •  (1) Except as provided in subsection (2), no person shall sell or offer for sale a rabies vaccine to anyone other than a veterinarian of the Department of Agriculture of Canada or a veterinarian who holds a valid licence to practice veterinary medicine issued by the veterinary licensing body of a province.

  • (2) Subsection (1) does not apply in respect of rabies vaccine that is sold or offered for sale in accordance with the written permission granted by the Minister for its use

    • (a) in a temporary emergency veterinary clinic; or

    • (b) in a remote area where veterinary services are not readily available.

  • SOR/85-81, s. 1
 
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