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
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
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
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
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
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