The document provides guidance to both industry and regulatory authorities in the context of pre-submission consultations prior to submission of applications for the registration of microbial biological control agents. This document describes the procedure and the information which should be submitted at a pre-submission consultation.

This document provides guidance to both industry and regulatory authorities on storage stability for different types of microbial pesticide formulations. It includes guidance on the physical and chemical parameters to be assessed for different formulation types before and/or after the storage period, and also describes specific and adequate criteria for the determination of storage stability.

This document provides guidance to national regulatory authorities in providing greater incentives to encourage applicants (manufacturers/registrants) to register agricultural pesticides (including both synthetically and naturally derived products) for minor uses.

This document provides guidance to both industry and regulatory authorities on how procedures and data requirements can be applied to facilitate the submission of a complete data package/dossier for botanical active substances used in plant protection products, and the subsequent evaluation of this data package/dossier by the regulatory authorities.

This Regulatory Directive outlines Health Canada's Pest Management Regulatory Agency (PMRA) policy on the regulation of formulants contained in pest control products. It also provides practical guidance to applicants and registrants on implementation of the Formulants Policy. The Formulants Policy applies to registration decisions in relation to formulants in manufacturing concentrates and registered end-use products, applications for research permits and in relation to the re-evaluation of products. This document replaces Regulatory Directive DIR 2004-01, Formulants Program.