Health of Animals Regulations

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  • (iii) [Repealed, SOR/80-428, s. 11]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