Health of Animals Regulations

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.