Master Product/Master Copy - Registration Process (DIR93-20)

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Craig O'Keefe
A/Section Head, Label Verification Section
Submission and Information Management Division
Registration Directorate

Purpose

• To streamline product registration procedures in the interests of improving operating efficiency and service to clients.

Overview

• Master Product status is a regulatory designation that allows a fully registered product to be used as a precedent for the registration of Master Copies.
  • Shorter review timeline (42-day timeline - two 21-day review periods)
  • No data required
  • Master Product status may be requested in the initial submission for registration or through amending a currently registered product.
  • Master Product status can only be granted to fully registered products that are not manufacturing concentrates or technical active ingredients.

Master Copy Registration

• Application package must include:
  • E-index
  • Cover letter
  • An Application for New or Amended Registration Form (6005)
  • A Statement of Product Specification Form (6003)
  • Proposed text label in PDF normal format in either English or French
  • A letter of confirmation of source of supply from the registrant for each active ingredient
  • Fee Form and required fee of $154
  • A letter of authorization from the Master Product registrant giving access to the data and confirming that the Master Product is being copied

Allowable Differences

• The Master Copy may be manufactured in a different plant
• The Master Copy may contain alternative sources of non-active ingredients (i.e. formulants).
• The proportion of the formulants must remain identical.
• The label of the Master Copy may contain all or a subset of the use claims approved for the Master Product.

Pilot Project - (Registration of a Master Copy)

• The purpose of the pilot project is to further increase efficiency for both industry and the Agency.
• The pilot project differs from the standard procedure as follows:
  • The applicant can submit both English and French proposed text labels with the initial application for registration of the Master Copy
    • An applicant may refer to the public registry label collection for the most recent Master Product label (English and French)
      pr-rp.pmra-arla.gc.ca/portal/page?_pageid=34,17551&_dad=portal&_schema=PORTAL
    • The Master Product labels can be copied from the collection and used as a basis for the creation of the proposed text labels for the Master Copy
    • The applicant must use highlighting and strikethrough (colour blue) to outline the text differences (e.g. product name, claims to be deleted) on the Master Copy as compared to the Master Product label.
• An applicant may participate in the pilot project by requesting inclusion in the cover letter and submitting the required English and French labels, with the appropriate annotations, with the application.