The Food Directorate of Health Canada is proposing a new scheme of management for pre-market submissions of Food Additives, Infant Formulas and Novel Foods. Timelines and activities are being proposed, influencing the time to market and other food marketing considerations.
On October 7th 2014, the Food Directorate of Health Canada opened a consultation period for their proposal on how they intend to manage Pre-Market Submissions for Food Additives, Infant Formulas, and Novel Foods pursuant to the requirements of the Food & Drug Regulations in the future. The Food Directorate’s aim is to increase improve the timeliness, predictability and transparency of the submission process through the proposed management of pre-submission process. The timelines and activities of the proposed Pre-Market Submission Management process are outlined in a Consultation Document which has to be requested directly from the Food Directorate to view. The Food Directorate is hoping through having an open consultation to acquire feedback from industry on their proposed management process.
All Pre-Market Submissions for Food Additives, Infant Formulas and Novel Food Review Process are structured with the same three steps:
1. Administrative Verification
2. Scientific Review
The Pre-Market Submission Management Process also includes Performance Standards for increased accountability. The Food Directorate is aiming to have a decision to applicants within 410 calendar days of receiving a food additive, infant formula or novel food submission 90% of the time. The other 10% of the time when a licensing decision could not be reached with 410 calendar days may be attributed to complexity or quality of the submission, but not limited to those, according to the Food Directorate. Please note the Food Directorate state that the 410 day performance standard does not include the time the submission is with the applicant to address deficiencies.
The Consultation period for comments and feedbacks is open from October 7, 2014 to December 5, 2014.
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