Consultation on guidance for registrants and data holders for use or reliance on test data considered in support of re-evaluation and special review decisions, Regulatory Proposal PRO2024-04

Health Canada's Pest Management Regulatory Agency (PMRA) invites stakeholders to comment on the this draft guidance document, "Guidance for Registrants and Data Holders for Use or Reliance on Test Data Considered in Support of Re-evaluation and Special Review Decisions Published before 4 December 2023".

The Pest Control Products Act and the Regulations set out a regulatory process for data compensation for pest control products. For the purpose of re-evaluations and special reviews, a data holder's test data can be used or relied on by other registrants, as per Pest Control Products Act subsections 16(5) and (5.1) for re-evaluations, and subsections 18(3) and (3.1) for special reviews. As per section 17.8 of the 2010 Regulations, the PMRA will make available to registrants and data holders the list of test data considered by the Minister in support of the final re-evaluation or special review decision for which they will need to enter into an agreement regarding compensation that may be payable.

The final guidance would be used in conjunction with the Pest Control Products Act and the Pest Control Products Regulations (Canada Gazette, Part II publication SOR/2010-119 on 23 June 2010) and also as amended on 21 September 2017 with the Canada Gazette, Part II, publication SOR/2017-169 (2017 Amendments), and the Consultation on Proposed Agreement for Test Data Compensation under Section 66 of the Pest Control Products Act for Re-evaluation and Special Review Decisions Published before 4 December 2023.

How to get involved

Health Canada's Pest Management Regulatory Agency (PMRA) invites the public, stakeholders, and partners to submit written comments on the Regulatory Proposal PRO2024-04, Consultation on Guidance for Registrants and Data Holders for Use or Reliance on Test Data Considered in Support of Re-evaluation and Special Review Decisions Published before 4 December 2023.

This consultation is available for comment for 60 calendar days from the date of publication, with a closure of the comment period on 9 November 2024. Open the "Consultation Document" link to access the document.

If you would like to comment, see the Pest Management Regulatory Agency Publications Section page for contact information. Please be sure to include the title of the consultation document on which you are commenting.

Reporting to Canadians

Health Canada will make the results of this consultation available on this website. The final version of the policy will be published on PMRA's Policies and Guidelines website.

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If you have any questions, contact the Pest Management Information Service.