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

• 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.

Information Requirements

• 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.

Issuance of Permits

• 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.

New Information Requirements

• 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).

Permits to Import

• 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]

• 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.

Establishment Licence and Product Licence

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.

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.

125 [Repealed, SOR/97-85, s. 72]

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).

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.

Requirements of Operation in a Licensed Establishment

• 128 (1) No person shall prepare, manufacture, preserve, pack, label, store or test a veterinary biologic in a licensed establishment unless

  • (a) the establishment and the equipment therein is sound in construction, clean, in good repair and equipped with means to maintain it in a sanitary condition;

  • (b) the area immediately adjacent to the establishment is clean and protected against the incursion of animals;

  • (c) animal wastes, effluents from processing or testing, contaminated matter and dead animals are decontaminated before being removed or discharged from the establishment;

  • (d) the floors and walls of every room and area in which a veterinary biologic is prepared, manufactured, preserved or tested are of a hard finish suitable for cleaning;

  • (e) the establishment has drainage, plumbing and sewerage that are

    • (i) adequate to handle all wastes, and

    • (ii) equipped with suitable traps and vents;

  • (f) the establishment has dressing rooms, lavatories and showers that are

    • (i) adequate in size and equipment for the number of persons using them, and

    • (ii) well lighted and ventilated to the outside;

  • (g) eating rooms, if provided, are separate from, and do not lead directly into, any room used for preparing, manufacturing, preserving, storing, testing, packing or labelling a veterinary biologic;

  • (h) rooms or areas are provided, where required, that are capable of being maintained at a uniform and constant temperature within any desired range and are equipped with thermometers that provide a continuous permanent record of temperature;

  • (i) means are provided for warning of any failure of power or equipment or any change in the required temperature;

  • (j) rooms, areas and equipment are provided, where required, that are capable of being maintained free of air-borne contaminants to any desired degree and preventing the escape of micro-organisms therefrom;

  • (k) animals being used in a testing program or for any special purpose are segregated from all animals not being used in such program or for such purpose;

  • (l) a separate room is provided for animals being examined or tested

    • (i) ante mortem, and

    • (ii) post mortem; and

  • (m) every person employed therein is qualified to perform the task assigned to him.

• (2) Every holder of a licence issued under these Regulations shall without delay inform the Minister of any change or addition to the material or information furnished to the Minister for the purpose of obtaining the licence.

• (3) Every person employed in a licensed establishment shall

  • (a) [Repealed, SOR/97-85, s. 73]

  • (b) be immunized against diseases likely to be encountered therein; and

  • (c) wear clothing and use equipment adequate to protect him against all hazards likely to be encountered therein.

• (4) Unless otherwise permitted by a veterinary inspector, no veterinary biologic shall be tested in a licensed establishment except in a separate room or building that is used exclusively for testing veterinary biologics.

• (5) No diagnostic examination or procedure involving the use of

  • (a) a dead or diseased animal,

  • (b) diseased animal matter, or

  • (c) an unidentified culture of micro-organisms, fungi or moulds

  shall be conducted in a licensed establishment except in a room or area separate from and not leading into any room or area used for preparing, manufacturing, preserving, storing or testing a veterinary biologic.

• (6) Unless otherwise permitted by a veterinary inspector, no research or experimentation shall be conducted in a licensed establishment except in a room or area separate from and not leading into any room or area used for preparing, manufacturing, preserving, storing or testing a veterinary biologic.