Initial Product/Private Label Registration Process (DIR93-21)

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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

• Initial Product status is a regulatory designation that allows a fully registered product to be used as a precedent for the registration of Private Labels.
  • Shorter review timeline (10 business days)
  • No data or statement of product specification form required to register the Private Label
• Initial Product status may be requested in the initial submission for registration or through amending a currently registered product.
• Initial Product status can only be granted to fully registered products that are not manufacturing concentrates or technical active ingredients.
• It is the responsibility of the Initial Product registrant to assign consecutive registration numbers to the Private Label products using the Initial Product registration number and a decimal point followed by two digits.
• Example:
  • Registration number for the Initial Product 12345
  • Registration number for Private Label product A 12345.01
  • Registration number for Private Label product B 12345.02

Private Label Registration

• Application package must include:
  • E-Index
  • Cover letter
  • An application for registration of Private Label Product form (form 6012)
  • Proposed text label in PDF normal format in either English or French
  • Fee Form and appropriate fee of $154

Allowable Differences

• The Private Label may only differ from the Initial Product label in the following ways:
  • Registrant name and address
  • Product name
  • Registration number (as outlined previously)

Limitations on the Private Label Product

• Must be identical in formulation and must be formulated on the same production line as the Initial Product.
• The container size and type must be selected from the approved sizes and types of the Initial Product.
• The label format and layout must be identical.
• The label text must be identical (other than the allowable differences outlined on the previous slide).

Limitation on the Initial Product

• Amendments to the Initial Product can only be made if the changes do not affect the Private Label product
• (e.g. formulation changes that do not affect label statements) or the Initial Product in question has no Private Labels registered.
• If the Initial Product/Private Label registration process does not provide enough versatility for your needs, the Master Product/Master Copy registration process may be more suitable.
• A product can have both Master and Initial Product status.