GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Health of Animals Regulations — (a)
environment means the components of the Earth and includes (a) air, land and water, (b) all layers of the atmosphere, (c) all organic and inorganic matter and living organisms, and (d) the interacting natural systems that include components referred to in paragraphs (a) to (c); ( environnement )
Health of Animals Regulations — Health of Animals Regulations
live genetically modified veterinary biologic means a live veterinary biologic that contains or is made from an organism and is produced by recombinant DNA technology; ( produit biologique vétérinaire vivant et génétiquement modifié )
Health of Animals Regulations — Health of Animals Regulations
release means any discharge or emission of a veterinary biologic into the environment. ( dissémination )
Health of Animals Regulations — 120.2
120.2 (1) In this section, organism includes a part or product of an organism. (2) Sections 120.3 to 120.6 do not apply in respect of (a) a veterinary biologic (i) in respect of which a product licence has been issued, or (ii) that contains only organisms that are (A) the same as organisms contained in a veterinary biologic referred to in subparagraph (i), or (B) of a species that is substantially equivalent to a species of organisms contained in a veterinary biologic referred to in subparagraph (i), in terms of pathogenicity, host specificity, potential impact on non-target organisms, on biodiversity and on biogeochemical cycles, mode of action, persistence and dispersal in the environment and gene flow; and (b) the release of a veterinary biologic, that contains organisms, under containment or in accordance with confinement procedures in a manner that prevents the dissemination of any genetic material from the veterinary biologic into the environment. SOR/97-8, s. 2; SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 120.3
120.3 (1) Subject to subsection (2), no person shall release a veterinary biologic unless the person (a) submits an application for a permit for the proposed release to the Minister, accompanied by sufficient information, including the information referred to in section 120.4, to enable the Minister to determine whether the proposed release is (i) unlikely to result in the introduction into Canada or the spread within Canada of any vector, disease or toxic substance, and (ii) unlikely to pose a risk of harm to the environment or to human or animal health; and (b) is issued a permit for the proposed release under section 160. (2) Where the accompanying information that is required to be provided to the Minister pursuant to paragraph (1)(a) in respect of the proposed release of a veterinary biologic is the same as information that has already been provided to the Minister before the coming into force of sections 120.1 and 120.2, this section and sections 120.4 to 120.6, or that is provided on or after the coming into force of sections 120.1 and 120.2, this section and sections 120.4 to 120.6 in relation to an application for another permit, the information is not required to be provided again. SOR/97-8, s. 2; SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 120.4
120.4 (1) The accompanying information that is required to be provided by a person to the Minister pursuant to paragraph 120.3(1)(a) includes the following: (a) the name of the person or body responsible for the proposed release and the name of the person who will be in charge of carrying out the release; (b) in the case of a live genetically modified veterinary biologic (i) a description of the donor organism and the methods of incorporation of the genes from the donor organism into the host, and (ii) a description of the live genetically modified veterinary biologic, including details relating to expression of the new gene and the stability of the incorporation of the new gene, and a comparison of the characteristics of the live genetically modified organism with those of the unmodified organism; (c) the protocol followed in preparing the veterinary biologic and any diluent to be used with it; (d) the procedures to be followed in handling, storing, administering, testing, releasing and disposing of the veterinary biologic and any diluent to be used with it; (e) the tests used to establish the purity, safety, potency and efficacy of the veterinary biologic and the purity and safety of any diluent used with it, and the results of all the tests; (f) the proposed starting date, time period and site of the release; (g) the proposed measures to mitigate any risk of harm to the environment or to human or animal health; and (h) any other information in respect of the veterinary biologic that is relevant to identifying any risk of harm to the environment or to human or animal health. (2) The information required by paragraph (1)(h) or any part of that information may be omitted if the Minister determines, on the basis of a written scientific rationale provided by the person referred to in subsection (1), that the information or part is not relevant or cannot practicably be obtained and is not required for the issuance of a permit under section 120.5, and notifies the person of that determination. SOR/97-8, s. 2; SOR/2002-438, ss. 10(F), 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 120.5
120.5 (1) The Minister may issue a permit for the release of a veterinary biologic under section 160 where the Minister, in addition to being satisfied that the proposed release meets the criteria set out in subsection 160(1.1), is satisfied that, to the best of the Minister’s knowledge and belief, the proposed release is unlikely to pose a risk of harm to the environment or to human or animal health. (2) In evaluating the risk of harm to the environment and to human and animal health for the purposes of subsection (1), the Minister shall (a) consider such matters as (i) the effects of the proposed release on the environment and on human and animal health, and (ii) the magnitude of the exposure to the environment of the veterinary biologic involved in the proposed release; and (b) assess whether the veterinary biologic will enter or may enter the environment in a quantity or concentration or under conditions (i) having or that may have an immediate or long-term harmful effect on the environment or on human or animal health, (ii) constituting or that may constitute a danger to the environment on which human or animal life depends, or (iii) constituting or that may constitute a danger in Canada to human or animal life or health. (3) In addition to the conditions referred to in paragraph 160(2)(b), a permit for the release of a veterinary biologic shall contain such conditions as the Minister considers advisable to prevent harm to the environment or to human or animal health. (4) In addition to any of the reasons set out in any of paragraphs 160(3)(a) to (c), the Minister may cancel or suspend a permit for the release of a veterinary biologic if the Minister has reason to believe that failure to do so could result in harm to the environment or to human or animal health. SOR/97-8, s. 2; SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 120.6
120.6 (1) Where, at any time after the applicant submits an application for a permit referred to in paragraph 120.3(a) or is issued a permit for the release of a veterinary biologic under section 160, the applicant becomes aware of any new information regarding the risk of harm to the environment or to human or animal health, or the risk of introducing into Canada or spreading within Canada any vector, disease or toxic substance, that could be caused as a result of the release, the applicant shall immediately provide the new information to the Minister. (2) Where the Minister, on the basis of the new information provided by an applicant pursuant to subsection (1), re-evaluates the risk of harm to the environment and to human and animal health posed by the release and determines that there is (a) a risk that is less than was apparent at the time that information was first provided or at the time any new information was subsequently provided, the Minister may (i) where the release has already been authorized, maintain the existing conditions respecting the release, (ii) change the conditions respecting the release, or (iii) remove any conditions respecting the release; (b) a risk that is greater than was apparent at the time that information was first provided or at the time any new information was subsequently provided, the Minister may amend the permit for the release by (i) imposing additional conditions respecting the release, or (ii) changing the conditions respecting the release; or (c) an unacceptable risk, the Minister shall (i) refuse to issue a permit for the release, or (ii) where a permit for the release has already been issued, cancel the permit and require the applicant to stop the release and to take any appropriate action necessary to eliminate or minimize the risk. (3) In re-evaluating the risk of harm to the environment and to human and animal health on the basis of new information for the purposes of subsection (2), the Minister shall consider the matters referred to in paragraph 120.5(2)(a) and make the assessment referred to in paragraph 120.5(2)(b). SOR/97-8, s. 2; SOR/2002-438, s. 18(F); SOR/2012-286, s. 58(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 121
121 (1) No person shall import a veterinary biologic into Canada unless the person does so under and in accordance with a permit issued by the Minister. (1.1) Where a permit referred to in subsection (1) has been issued, the veterinary biologic shall be shipped directly to Canada from the manufacturer’s premises or from such other premises, in which veterinary biologics may be lawfully manufactured under the applicable foreign laws, that were designated in the application for the permit. (2) [Repealed, SOR/95-475, s. 4] SOR/80-428, s. 8; SOR/95-475, s. 4; SOR/2002-438, s. 11(F) SOR/2018-79, s. 4(F) SOR/2025-47, s. 19
Health of Animals Regulations — 122
122 (1) Subject to subsection (2), every applicant for a permit to import a veterinary biologic into Canada shall include with his application (a) when requested by the Minister, such samples of the veterinary biologic and any diluent to be used therewith as will enable the Minister to analyse the veterinary biologic; (b) a product outline; (c) the results of such tests of the veterinary biologic as will enable the Minister to analyse the veterinary biologic; (d) a sample of each package and container used or to be used for packing the veterinary biologic and any diluent to be used therewith; (e) a copy of the instructions or other written material to be included with each package or container of a veterinary biologic; (f) a copy of every label, tag or other marking to be attached to, marked on or contained in every package or container in which a veterinary biologic is to be packed; (g) the names of all persons to be employed in the manufacture or testing of the veterinary biologic and information with respect to the education, qualifications and experience of such persons; and (h) any information the Minister may require in order to determine, in the course of assessing the safety of the veterinary biologic, whether the introduction of the veterinary biologic into the environment could result in the spread within Canada of a vector, disease or toxic substance that would have a harmful effect on human or animal health. (2) Where the Minister has issued a permit to a person to import a veterinary biologic into Canada, he may issue a permit (a) to that person to import the veterinary biologic into Canada in any subsequent year, and (b) to any other person to import the veterinary biologic into Canada, and that person is exempt from any of the requirements of subsection (1) as the Minister may specify. (3) The Minister shall furnish the applicant referred to in subsection (1) with a report showing the result of any test performed on the sample supplied pursuant to paragraph (1)(a). (4) Every person to whom a permit is issued to import a veterinary biologic shall (a) keep and make available for inspection by a veterinary inspector a record in a form approved by the Minister with respect to the importation, sale and distribution of the veterinary biologic and retain that record for at least two years following the expiration date of the veterinary biologic to which the record relates; and (b) furnish the Minister with such samples of the veterinary biologic as the Minister may require from time to time. SOR/78-597, s. 14; SOR/82-590, s. 6; SOR/95-54, s. 5; SOR/2002-438, ss. 12(F), 18(F) SOR/2018-79, s. 4(F) SOR/2019-99, s. 18(F)
Health of Animals Regulations — 123
123 No person shall prepare, manufacture, preserve, pack, label or test a veterinary biologic for use in Canada or for export unless the person does so under and in accordance with an establishment licence issued by the Minister. SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F) SOR/2025-47, s. 20
Health of Animals Regulations — 124
124 No person shall manufacture a veterinary biologic for use in Canada or for export unless the person does so under and in accordance with a product licence issued by the Minister. SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F) SOR/2025-47, s. 20
Health of Animals Regulations — 126
126 Subject to section 127, every applicant for a product licence shall include with his application the material and information referred to in subsection 122(1).
Health of Animals Regulations — 127
127 Where the Minister has issued a product licence to a person, he may issue a product licence to such person in any subsequent year and that person is exempt from any of the requirements of subsection 122(1) as the Minister may specify.
Health of Animals Regulations — 129
129 (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. SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F) SOR/2019-99, s. 18(F)
Health of Animals Regulations — 130
130 No person shall sell for use in Canada or for export a veterinary biologic or any diluent to be used with it 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. SOR/80-516, s. 12; SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F) SOR/2025-47, s. 21
Health of Animals Regulations — 130.1
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. SOR/80-428, s. 9; SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F) SOR/2025-47, s. 22(F)
Health of Animals Regulations — 131
131 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. SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 131.1
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). SOR/82-590, s. 7;SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 132
132 (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. SOR/2002-438, s. 18(F) SOR/2018-79, s. 1 SOR/2018-79, s. 4(F)
Health of Animals Regulations — 133
133 Every veterinary biologic sold, advertised or offered for sale in Canada shall carry a label. SOR/80-428, s. 10; SOR/2002-438, ss. 14(F), 18(F) SOR/2018-79, s. 2
Health of Animals Regulations — 134
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. SOR/79-839, s. 31; SOR/80-428, s. 11; SOR/82-590, s. 8; SOR/86-291, s. 2; SOR/97-85, s. 74; SOR/98-409, s. 13; SOR/2002-438, ss. 15(F), 18(F) SOR/2018-79, s. 3 SOR/2018-79, s. 4(F)
Health of Animals Regulations — 134.1
134.1 No person shall sell or offer for sale a veterinary biologic after its expiration date. SOR/82-590, s. 9; SOR/2002-438, s. 18(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 134.2
134.2 (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
Health of Animals Regulations — 135
135 (1) No person shall, in any advertisement for the sale of a veterinary biologic, make any claim with respect to the purity, safety, potency and efficacy of the veterinary biologic that is not supported by the product outline for such veterinary biologic. (2) No person shall, in any advertisement for the sale of a veterinary biologic, make any representation that is false, misleading or deceptive or that is likely to create an erroneous impression regarding the character, value, quality, composition, merit or safety of the advertised veterinary biologic. (3) [Repealed, SOR/97-85, s. 75] SOR/82-590, s. 10; SOR/97-85, s. 75; SOR/2002-438, s. 16(F) SOR/2018-79, s. 4(F)
Health of Animals Regulations — 135.1
135.1 Every holder of a licence or permit issued under this Part shall report to the Minister, in writing, any information concerning, or any evidence of, a significant deficiency in safety, potency or efficacy of a veterinary biologic within 15 days after the date on which that information or evidence is known to the holder. SOR/79-839, s. 32; SOR/2002-438, s. 17; SOR/2015-55, s. 7 SOR/2018-79, s. 4(F)
Health of Animals Regulations — 136
suffering, (iii) touches the ground when the animal is standing in its natural position, or (iv) has an open wound, ulceration or obvious infection; (q) is in the last 10% of its gestation period or has given birth during the preceding 48 hours; (r) has an unhealed or infected navel; (s) has a gangrenous udder; (t) has severe squamous cell carcinoma of the eye; (u) is bloated to the extent that it exhibits signs of discomfort or weakness; (v) exhibits signs of exhaustion; or (w) exhibits any other signs of infirmity, illness, injury or of a condition that indicates that it cannot be transported without suffering. ( inapte ) (2) For the application of this Part, (a) loading of an animal begins when the animal is handled, moved or caught for the purpose of confining it in a conveyance or a container and ends when the animal is confined in the conveyance, or if it is confined in a container, when the container is placed on the conveyance; (b) in the case of an animal that is confined in a conveyance, unloading of the animal begins when the animal is handled or moved for the purpose of removing it from the conveyance and ends when the animal is removed from the conveyance or from any ramp, gangway, chute, step or apparatus used for unloading the animal; and (c) in the case of an animal that is confined in a container, unloading of the animal begins when the container is handled or moved for the purpose of removing it from the conveyance and ends when the container is removed from the conveyance and the animal is removed from the container. (3) An animal that is both compromised and unfit as defined in subsection (1), is deemed not to be compromised. SOR/2019-38, s. 2
Health of Animals Regulations — Health of Animals Regulations
assembly centre means a place to which animals are transported for the purpose of assembly and includes an auction market, an assembly yard and a holding facility, other than a slaughter establishment, that holds, on behalf of a slaughter establishment, animals that are destined soon afterwards for slaughter at that slaughter establishment. ( centre de rassemblement )