Chapter 1 - Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed
1.4 The Assessment Process
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Your submission will be assigned to one or more evaluators depending on the submission type and type of assessment that is required for your feed. Submissions are placed into the review queue based on the date they are received, and are assessed in the order in which they are received. After reviewing the submission, the evaluator(s) will determine whether the approval criteria have been met or if additional information is necessary in order to make the assessment decision.
In the event that additional information or clarification is needed by the evaluator(s), you will receive a deficiency letter putting your application on hold and advising you in writing what additional information or clarification is needed in order to proceed with the assessment. It should be noted that the hold period is not indefinite, and that you must provide all the requested information back to the evaluator within the time-lines identified in the deficiency letter.
1.4.1 Assessment Outcomes
At the conclusion of the assessment process, the evaluator will advise you in writing of the outcome of the assessment. There are three possible outcomes of the assessment process: favourable, unfavourable and temporary registration.
1.4.2 Favourable Assessment
If the assessment process allows for a positive conclusion, the evaluator will identify any label changes required in order to complete the assessment process. You will need to submit a final label to the Pre-market Application Submissions Office (PASO) within 90 days of the date of approval which includes all the changes requested by the evaluator. If accepted, this label is kept on file for post-market verification, as well as for comparison at renewal. The label that you provide must be a complete and accurate representation of the information that appears in the marketplace.
1.4.3 Unfavourable Assessment (closed)
If the evaluation process cannot conclude on the safety or efficacy of your product, if you fail to address any deficiencies identified during the assessment, or if you miss the deadline for response without receiving an extension, the assessment will be considered to be complete and your submission will be closed. Your application form will be returned to you with a closing letter outlining the items that were not addressed, and what you must do should you wish to re-apply. The data submitted with your submission may be destroyed by shredding. If you wish to have the submission data returned to you, you will need to provide the PASO with a valid courier account in order to return the data. It should be noted that the fees associated with your application are assessed for the review, and not for a successful registration of the product.
1.4.4 Temporary Registration
Upon concluding the assessment of a submission, the AFD may issue a temporary registration for a product that has demonstrated both safety and potential usefulness, but requires additional evidence in support of efficacy or validation of an analytical method. A temporary registration cannot be granted to a product that has not satisfied the regulatory requirements related to product safety, as stated in Section 9(5) of the Feeds Regulations.
It is important to note that it is not possible to submit an application requesting a temporary registration. The issuance of temporary registrations is an interim measure that allows companies to adequately comply with the conditions outlined in their approval letter. Only one temporary registration will be granted per product and the maximum duration for a temporary registration will be three (3) years.
Products bearing a temporary registration number on the label will be identified by the letter "T" in front of the registration number. Normally no claims are permitted on product labels, as the desired claims and/or label guarantees remain to be substantiated.
To gain permanent registration status, you must submit the supporting information or data with a completed "Application for Feed Registration CFIA Form 0009" before the expiry of the temporary registration. The application fees are the same as those for a new application for registration for category 2 (New Feed).
If the product has not been proven to be efficacious and the desired product claims have not been supported by acceptable scientific data by the end of the temporary period, and/or if other registration criteria have not been met as outlined in the approval letter granting temporary registration status, the temporary registration will expire and the product will not receive a full registration. Upon expiry of the temporary registration, the product will be considered non-compliant with Section 3 of the Feeds Act, and no longer permitted to be marketed or otherwise distributed within Canada.
1.4.5 Private Labelled Products
Private label registration is a process that has been put in place to allow companies to commercialize a product that is already registered by another company under a different brand name. Such applications are considered standard feeds as they do not require any additional safety or efficacy evaluations.
Applications for registration of private labels must include:
- a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) - PDF (98 kb)
- the application fee for a standard feed (category 1)
- three copies of the proposed product label, including the name and address of the private label registrant
- an accompanying cover letter
- a letter from the company holding the original registration, signed by a person having signing authority for this company, allowing the private label applicant to use the information on file to register their product as a private label.
As the formulation of the private label product must correspond exactly to the formulation originally approved for the parent product, any mandatory information present on the original label (e.g. list of ingredients, guaranteed analysis, directions for use, caution statements) must be present on the private label. If the private labelling company also manufactures the feed, the formulation is required and certificates of analysis may be requested.
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