Temporary Marketing Authorization letters (“TMALs”) have been a critical tool, both in the transition of food-like natural health products to the food regulatory framework and to allow non-compliant products to be sold as foods while changes to the Food and Drug Regulations are considered. Health Canada has now released Guidance for the Management of Temporary Marketing Authorization Submissions for Foods to provide applicants with information on the TMAL application process and proposed timelines.
The TMAL application process is divided into three streams: 1) administrative changes to existing authorizations (e.g. change of name); 2) extensions of existing authorizations and products compliant with category-specific guidance (e.g. new flavours or sizes, or product compliant with the caffeinated energy drinks guidance); and 3) products that do not comply with the applicable guidance document.
For all applications, an initial administrative review taking up to ten calendar days will be completed to ensure the application package contains a signed TMAL application, label, complete demographic information, and, where applicable, a designated third party authorization. Following the administrative review, a screening assessment will take place to ensure the information included in the application is complete.
Generally, the performance standard for screening is thirty days, however, if additional information is required, the timeline will be extended. Screenings for Stream 1 applications are not expected to take the full thirty days. The applicant may receive a Notice – Screening Deficiency if there is missing information, in which case the applicant will have thirty days to respond in order to continue in the submission process.
In addition, if the applicant receives a request during the screen process for additional information on an ingredient(s) that Food Directorate believes may be a novel food, the applicant may receive a Notice – Novelty Review. The Food Directorate will then make a novelty determination within sixty days from the date of the Notice. A novelty review effectively stops the clock on the thirty-day target for the screening assessment.
Ultimately, the applicant will receive either a Submission Acceptance for Review Letter, or a Rejection Notice – Screening Deficiency, in which case they can re-submit the application if desired. The application then moves on to the full assessment stage.
The performance standard for full assessment depends on the stream the application falls into as follows: stream 1: 21 calendar days; stream 2: 60 days; and, stream 3: 150 days. During the full assessment additional information may be sought by Food Directorate, in which case the clock stops on the performance standard, and re-starts when the additional information is received from the applicant. When a Request for Additional Information is sent, the applicant is given 30 days from the date of the letter to provide the requested information, failing which the application will be refused. A request to extend the time for response can be requested.
Once the assessment is complete, the applicant will receive either a TMAL package or a Refusal Letter, which will include the specific reason or deficiency that led to the refusal. Applicants can request a reconsideration of a refusal within thirty days of receiving the letter, but it must be based on the information previously submitted; it cannot include any new information or material.