During the course of its evaluation process for the registration of drug products, INESSS offers the opportunity of a post-submission appointment with the drug manufacturers, if they didn’t avail themselves of a presubmission appointment.
The evaluation or re-evaluation requests for a new drug or a new indication for a drug already registered are targeted. More specifically, this corresponds to requests submitted to INESSS in accordance with checklist 1, 2 or A.
The specific objectives of the post-submission appointment are to:
- Give the opportunity to manufacturers to present to the Direction du médicament the primary items of the submitted request for evaluation, more specifically the information concerning the severity of the illness, healthcare provisions, principal clinical studies as well as pharmacoeconomic analyses and budgetary impact.
- Allow INESSS to take note of primary items of the request for evaluation and discuss with manufacturers about certain issues that may be identified.
Terms and conditions
Following a favourable decision by INESSS concerning the admissibility of the request for registration and an invitation to a post-submission meeting (information present in the admissibility decision letter sent to the manufacturer), a manufacturer may accept or not this offer of a meeting with the Direction de l'évaluation des médicaments et des technologies à des fins de remboursement. To maximize the advantages, the meeting may be held according to the arrangements communicated in the decision letter.
- The request for the meeting must be sent quickly by email to email@example.com. Please note that the manufacturer must justify its request when a presubmission meeting on the same issue has already been held.
- The Direction du médicament approves the request for the meeting and schedules it with the manufacturer.
- At least 72 hours prior, the manufacturer must provide the name and the title of people who will be present at the meeting as well as the agenda by email to firstname.lastname@example.org
For the manufacturer, a maximum of four people including, if applicable, an external consultant for clinical and pharmacoeconomic aspects. For INESSS, up to four representatives, including professionals and scientific coordinators.
- Introduction and summary of the indication of medication.
- Presentation of epidemiological and clinical data.
- Presentation of economic data (pharmacoeconomic model, budgetary impact)
- Discussion period.
It is to be noted that during re-evaluations, discussions are centered on new data from the submission that consider the reasons for which INESSS has recommended a refusal of registration.
During the meeting, INESSS asks that invited participants report situations of actual conflict of interests, potential or apparent, to ensure objectivity and credibility to the evaluation process. Examples of conflicts of interests include, but not limited to, financial support from a pharmaceutical company (research or education grant, fees, gifts, salary), an affiliation, personal or business relationships with a manufacturer or other interest groups. This step is required for the sake of transparency.
- Six printed copies of the presentation and a copy of the conflict of interest declaration of people who are present at the manufacturer’s request. A USB key, holding all necessary documents to the presentation must be remitted at the end of the meeting.
Duration of meeting
45 minutes maximum, including discussion period.
For any questions relating to the post-submission appointment process, you may communicate with the secretariat of the Direction du médicament, by phone at 418 643-1339 or by email to email@example.com.
The presence of people not expected at the meeting may compromise it being held. All participants must be physically present. In case of force majeure only, a person’s participation by teleconference may be authorised, but must be approved in advance.
Any additional documentation, following up on a request by INESSS at the time of the meeting, must be submitted to INESSS by no later than five business days after (before 4:30 p.m.). Anything received after said delay may postpone the evaluation.