Questions and Answers
Submission Management and Information Unit (SMIU)
Q1. What is the Submission Management and Information Unit?
A1. The Submission Management and Information Unit hereafter referred to as the Unit or SMIU, is a new unit within the Food Directorate. It has been established as part of the modernization of pre-market submission review process project. This unit will provide coordination and administrative support to program Bureaux and serve as the single contact point for submissions received directly from stakeholders. Packaging, incidental additives and natural health products in food format submissions will not be dealt with by the SMIU.
The SMIU is mainly responsible for:
- assisting program Bureaux in the management of pre-submission consultations;
- conducting an administrative verification of food additive, infant formula and novel food submissions received;
- managing communication and correspondence with petitioners;
- managing the centralized tracking system;
- analyzing data collected for performance measurement and producing reports for Food Directorate management;
- assisting program Bureaux in the management of the dispute resolution process.
This Unit is intended to be of a modest size initially. However, there will be adjustments made to the size of the unit in keeping with the FD's intent to apply the new submission management process to all the other type of submissions the FD receives.
Q2. Why was the SMIU created?
A2. Consistent with best practices adopted in other Directorates within Health Products and Food Branch, the Food Directorate established the Unit primarily to facilitate the coordination and communication among and between the Food Directorate's staff and petitioners. With the SMIU taking over the more administrative tasks, staff involved in the technical review of submissions will be able to place all their efforts in completing the safety assessment in a more timely and efficient manner.
Furthermore, SMIU will use a centralized tracking system which will allow data entry to be consistent across program Bureaux, thereby facilitating performance reporting. The Unit will, as a result, also be in a position to assist the Food Directorate in identifying bottlenecks, submissions meeting proposed timelines and in planning the submission workload.
Q3. What type of information will the SMIU communicate to the petitioner?
A3. The Unit will provide information to petitioners regarding the new submission management process and associated timelines and the status of their submission. The SMIU will also refer petitioners to relevant guidelines available on Health Canada's website should they need specific information on data requirements to prepare their submission as well as inform petitioners of the possibility to meet with the FD's staff in a pre-submission consultation. Finally, the Unit will respond to any enquiries concerning the dispute resolution process and inform petitioners of the procedures to follow if the initiation of such a process is requested.
The SMIU however won't communicate any scientific/technical information to petitioners such as clarification on submission requirements or any information on data and product-specific issues. These enquiries will be forwarded by the SMIU to the Bureaux.
Q4. Who should I contact if I have more questions?
A4. The SMIU should be contacted if you have additional questions. The Unit can be reached at the following:
Phone: (613) 960-0552
Fax: (613) 946-4590
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