Notification/Non-notification

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Brad Bergen
Project Manager
Review and Science Integration Division
Registration Directorate

Notification/Non-notification

• Regulatory Directive DIR2001-04 outlines process
• Certain minor changes to pest control products do not require an application for amendment and can be done via the notification/non-notification process
• Includes many of the types of changes currently done in the U.S. under their notification/non-notification process as outlined in PR Notice 98-10
• Other regulatory documents may specify notifiable changes which are not included in DIR2001-04 (e.g. DIR2006-02 Formulants Policy)

Notification Process

• Registrants submit a letter clearly identifying the type of notification and names and registration numbers of the products affected by the change
  • Note: for label changes, labels are not to be submitted
  • For changes/additions of text, the French translation is required
• The PMRA reviews the notification request for acceptability and sends a letter to the registrant indicating whether the request is acceptable
  • PMRA goal is to review notification requests within 45 days

Notifiable Changes

• Change in address of registrant or name or address of Canadian agent
• Change in site of formulation for EP or MA
• Certain changes in packaging and related labelling statements
• Product name change
• Deleting a pest
• Revising outdated disposal statements using standard statements in DIR99-04
• Addition of trade label statement

Formulation-related Notifiable Changes

• Are described in Regulatory Directive DIR2006-02, Formulants Policy and Implementation Guidance Document
  • Note: SPSFs are not to be submitted for notifiable changes
• Letter of notification should clearly outline the proposed changes, and when changes affect amounts of other formulants (e.g. when a fragrance is removed), these changes should be specified in the letter

Non-notifiable changes

• Are changes that may be made to pest control products without notifying the PMRA
• If registrants are unsure whether a particular change is non-notifiable they should contact the Pest Management Information Service for clarification.
• Change in net contents within range accepted on the SPSF
• Revision, addition or deletion of certain non-mandatory label elements
• Label format changes consistent with requirements
• Addition of symbols or graphics consistent with label text
• Removal of redundant labelling statements
• Change in a source of starting materials for TGAIs or ISPs provided the specifications remain the same

Obsolete Sections/Requirements

• Labels are not to be submitted to document notifiable label changes
• Section 3.1 with respect to registrant name change and Section 3.9 on transfer of ownership are no longer applicable as these changes are now done via an administrative process described in DIR2005-02
• Section 4.5 on warranty statements is no longer applicable based on changes to the PCPR. The portion of the statement pertaining to liability associated with use of a product has been added to the Notice to User Statement (section 26(2)(g) PCPR

Trade Label Statement

• Section 3.8 - Trade Label Statement has been revised:
  • "If this pest control product is to be used on a commodity that may be exported to the U.S. and you require information on acceptable residue levels in the U.S., visit CropLife Canada's web site at: www.croplife.ca"

Notification Challenges

• Registrants proposing changes that go beyond the bounds of the directive
  • e.g. addition of larger domestic class package sizes that are outside the range accepted on the SPSF on file
  • Changes in disposal statements that are different than the standard statements in DIR99-04
• French translation is often not submitted when changes are made to English label text, including product name
• Change of supplier of a formulant mixture where PMRA has no info on the new trade name mixture to confirm composition (registrants should first confirm that PMRA has info using the latest version of the PMRA List of Formulants (REG2007-04) and if not, ensure that information is provided before submitting a notification request.)

Revision of DIR2005-02

• PMRA will be revising the Notification/Non-notification directive involving:
  • Updating to delete obsolete sections and revise certain sections based on changes in the PCPR
  • Clarifying changes that are acceptable via notification/non-notification
  • Examining possible areas for expansion of notification process, considering processes in other countries, e.g. U.S., UK, Australia
  • Developing a notification form