On September 29, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing the details on the process for the admissibility of submission applications for registration. A manufacturer can submit an application for registration to INESSS only when all required documents are available at time of filing. The INESSS evaluation will commence even if other documents are filed at a later date. Ultimately, INESSS requires the Health Canada Notice of Compliance and Product Monograph before transmitting the final recommendation to the Minister of Health and Social Services.
Effective October 2, 2017, submissions will be processed on a first come, first served basis. To ensure fairness, INESSS no longer intends to communicate with manufacturers to complete the evaluation request or to offer an extension for filing documents required. INESSS will also ensure that the submitted documents are relevant to the requested type of submission application filed allowing for proper scientific evaluation.
The manufacturer will be informed of the admissibility decision for their submission application by a letter sent via e-mail to the primary contact. Paper copies will no longer be mailed. The information transmitted in this correspondence will be as follows:
- INESSS’ decision on the admissibility of the submission application;
- Documents to be sent to INESSS to complete the submission application, if necessary;
- Instructions for post-submission meetings, where applicable.
If the submission application meets all INESSS requirements and is placed on the list of submissions pending evaluation, the manufacturer will be immediately notified via e-mail. At the appropriate time, an additional electronic communication from INESSS will be sent to inform the manufacturer of scientific evaluation initiation and instructions to schedule a post-submission meeting, where applicable.
Finally, when a submission application is:
- Considered admissible for a scientific evaluation: the evaluation will commence as soon as possible.
- Considered non-admissible for a scientific evaluation: the documents submitted by the manufacturer will be retained during the transition period pending receipt of all documents required so that the file is considered admissible for a scientific evaluation.
- Considered non-admissible: the documents filed by the manufacturer will be destroyed in a secure manner.