On October 12, 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 mandatory notification required for submissions. As of November 1, 2017, manufacturers are required to inform INESSS at least 2 months in advance of their intention to file an application for registration.
The mandatory notification applies to requests for evaluation of a new drug, a new indication of a listed drug, a new biosimilar drug or a new non-biologic complex drug. Specifically, this corresponds to the applications for registration that will be filed with INESSS as of January 3, 2018 according to the requirements listed in Checklists 1, 2, 5 or A.
The mandatory notification allows INESSS to plan for the evaluation work to be carried out. It will also allow for the consultation of citizens, patients, their caregivers and health professionals, and their associations and groups. It is expected that the manufacturer will inform INESSS as soon as possible of any changes made to the target date for the submission of its evaluation request. A manufacturer who does not respect the minimum 2 months’ notice is will be subject to delays in the evaluation of their application. Failure to comply with the notice could, for example, interfere with the timely alignment of INESSS’ recommendation with the recommendations provided by the Canadian Agency for Drugs and Technologies in Health (CADTH).
The following information and documents are expected from the manufacturer. Those with an asterisk will be made available on the INESSS website for the consultation process; INESSS considers that this information is of a public nature:
- *Target Submission Date (YYYY/MM/DD)
- *Type of Evaluation Requested
- *Name of Manufacturer
- *Brand Name and Generic Name
- *Requested Indication
- For a drug with a Health Canada Notice of Compliance: Date of Issue and Approved Indication
- For a drug awaiting a Health Canada Notice of Compliance: Anticipated Date of Issue and Indication
- Pharmaceutical Form and Strength
- Other Characteristics (i.e. Companion Test)
- Target RAMQ List of Medications
- Request for Priority Review
- Official Product Monograph or Draft Product Monograph
Lastly, information relating to the preparation and filing of the mandatory notification is available on the INESSS website under the following section “Préavis obligatoire demandé aux fabricants”.