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RG-1 Regulatory Guidance:
Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed

1.7 Priority status and review of feed applications

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Objective

This guidance aims to provide the criteria and the process by which feed applications may be prioritized for evaluation ahead of applications already in the queue.

About the process

As a regulatory agency, the Canadian Food Inspection Agency (CFIA) must maintain an impartial role in the pre-market assessment process of livestock feeds. Feed applications are reviewed in the order in which they are received. Moving a feed application forward in the queue at the request of the applicant would be an unfair practice that disadvantages other applicants who are also waiting to market their products. However, in certain unique circumstances, the CFIA may designate "priority status" to an application that meets strict criteria to undergo an evaluation ahead of other applications already in the queue. In this scenario, once an application has been submitted and successfully screened, it will become a priority and placed at the front of the queue for evaluation by the appropriate evaluation officer(s).

The priority status designation does not alter the scientific data requirements for approval or registration, including the required quality of evidence, nor does it shorten the time required for CFIA to conduct its evaluation. All existing regulatory requirements for livestock feeds, including all the assessment end-points, must continue to be met.

Criteria

Priority status may be granted to an application provided that it meets at least 1 of the following objectives:

Considerations in priority status requests

Alternative product availability will be considered when evaluating a priority status request. The decision for a priority status request will consider whether other types of feed products have been approved or registered for the same intended purpose, and the number of alternative products available in the market. In situations when there are considered to be a sufficient number of products available to meet demand, the priority status request will most likely be declined.

In a scenario when a priority status has been granted, approvals given by select foreign regulators (for example, European Food Safety Authority, United States Food and Drug Administration) for the same specified purpose may be considered in support of an application. Please consult the Animal Feed Program (AFP) for guidance on the use of foreign decisions for livestock feed approvals in Canada.

Process for requesting a priority status review

Step 1: contact the AFP via email to request a priority status that includes details relevant to the conditions stipulated above. The AFP will determine whether or not the request meets the criteria for priority status and will inform the applicant of its decision.

Step 2: if it is determined that your request meets the criteria for priority status, proceed to contact the AFP to set up a pre-submission consultation. Follow the process outlined in R G-1 Chapter 8 – Pre-submission consultation procedures for livestock feed. The outcome of the pre-submission consultation process will determine if the feed application continues to qualify for priority status.

Step 3: if during the pre-submission consultation process, your product is confirmed as being eligible for priority status, you will be asked to submit an application for approval and registration for the product via the following steps:

  1. apply via the online service My CFIA
  2. submit the application package as outlined in RG-1 Chapter 1.3
  3. select the permission type in My CFIA: Registration or approval
  4. in the online application name field, enter "Priority status for Product Name"
    • Please note that omitting "Priority status" from the application name may result in a longer evaluation process
  5. upload the label, the completed checklist when required, data requirements, and all other required information in the appropriate sections of the application
    • The application will undergo the standard process of preliminary screening, which serves to determine if the application is complete and can be accepted for evaluation
    • During the preliminary screening of an application for priority status, the AFP may request additional information as needed to clarify or confirm the eligibility of an application for priority status
    • The CFIA will inform the applicant of its final decision to accept or reject a request for priority status upon the completion of the preliminary screening step
      The final decision for priority status is made at this step

The applicant may request to change the status of the application to "priority" while the application is already in queue for technical review. To initiate the process, the applicant should promptly contact the AFP by email, referencing the case number of the application and providing a comprehensive explanation of the circumstances necessitating priority status. The CFIA will consider the request and may suggest organizing a pre-submission consultation to support this request.

Timeframes

Priority applications are subject to the same data requirements as non-priority applications and, therefore, require the same amount of time for evaluation. However, priority status applications receive priority in the queue.

For more information

If you have questions regarding this guidance or need assistance with requesting a priority status meeting through a pre-submission consultation, please contact the Animal Feed Program at cfia.afp-paa.acia@inspection.gc.ca.

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