Post-publication meeting with manufacturers

Context

INESSS offers the possibility of a post-publication meeting with drug manufacturers as part of its process of evaluating drugs for listing purposes.

This meeting may take place after the publication of a recommendation to the Minister, in the case of a refusal to register for therapeutic reasons only, or when follow-up is indicated in the conditions of registration.

For the sake of efficiency, only one meeting is permitted per drug concerned.

The meeting may be requested within two months of the date of publication of the notice to the Minister.

Questions on significant issues should be identified by the manufacturer in preparing his request for a meeting and submitted, in the form of questions, with his request for a meeting.

Terms and conditions

• The meeting request must be sent by email and include the name of the product, the indication, the date of publication of the notice to the Minister and the significant reasons to be discussed with INESSS, formulated as questions.
• The manufacturer must provide a proposed agenda (time allotted per question) and the names of two people who will represent the manufacturer.
• The request must be sent by email to the following address: inscription@inesss.qc.ca.
• INESSS will evaluate whether this meeting is appropriate and will notify the manufacturer as soon as possible. If necessary, INESSS will schedule the time of the meeting. The invitation for the meeting will be sent by INESSS.
• Issues not included in the initial application will not be addressed.
• French remains the preferred language for all meetings.

Participants
For the manufacturer, a maximum of two people.

Duration of meeting 
30 minutes maximum, including discussion period.

Other details 
If you have any questions about the post-publication meeting process, you can contact the secretariat of the Direction de l’évaluation des médicaments et des technologies à des fins de remboursement by sending an email to inscription@inesss.qc.ca.