Pest Control Products Regulations — 17.05
Conditions — use of or reliance on test data 17.05 (1) Subject to subsection 17.1(2), an applicant who makes an application to register a pest control product or to amend a registration may, in accordance with the agreement concluded with the data holder under subsection 17.07(2), use or rely on the following test data if they pay compensation to the data holder in accordance with the negotiated settlement or arbitral award for the period provided for in subsection (2) and if the applicant provides the Minister with a copy of a letter of access: (a) compensable data that the applicant wishes to use or rely on; (b) test data for which the data holder has exclusive rights, if the test data is relevant to the pest control product of the data holder and the test data is relevant to an active ingredient that is not equivalent to the active ingredient contained in the applicant’s pest control product; and (c) test data that was considered during an evaluation or review of a pest control product by a foreign regulatory authority and that the data holder has not previously provided to the Minister, if the following conditions are met: (i) the Minister has considered for the first time the decision that results from the evaluation or review of the pest control product by the foreign regulatory authority in support of the re-evaluation or special review decision of the data holder’s pest control product, (ii) the Minister requests that the data holder provide the Minister with the following in the form and manner directed by the Minister: (A) documents demonstrating that the test data was provided to the foreign regulatory authority in support of the evaluation or review of the pest control product, or in response to a request from the foreign regulatory authority relating to the evaluation or review, (B) documents demonstrating that the foreign regulatory authority considered the test data in support of its decision of the evaluation or review, and (C) the test data, and (iii) the data holder complies with the request. Compensable period (2) The period for which compensation is payable by the applicant to the data holder commences on one of the following days and must not exceed 12 years, except in the case of the test data referred to in paragraph (d) for which the period must not exceed the period set out in section 17.03: (a) in the case of compensable data in support of an application to register a pest control product of the data holder, the day on which the Minister receives the application; (b) in the case of compensable data in support of an application to amend the registration of a pest control product of the data holder, the day on which the Minister receives the application; (c) in the case of compensable data that is considered by the Minister during a re-evaluation or special review of a pest control product of the data holder, if the test data was provided by the data holder in response to a notice initiating the process under subsection 16(3) or 18(1) of the Act or a notice requiring additional information under paragraph 19(1)(a) of the Act, the day on which the Minister receives the data; (d) in the case of test data referred to in paragraph (1)(b), the day of registration referred to in subsection 17.03(1); or (e) in the case of test data referred to in paragraph (1)(c), the day on which the Minister initiates the re-evaluation or special review. SOR/2023-104, s. 5