On June 2, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released new submission guidelines, including a pre-NOC review procedure, to be implemented immediately.

Pre-NOC Review

Moving forward, INESSS will evaluate certain drug products (see the criteria here on the INESSS website) before a Notice of Compliance (NOC) from Health Canada is received in order to provide formulary recommendations to the minister in a timely manner. For drugs meeting the criteria, manufacturers will now be able to submit to INESSS

• 180 days pre-NOC for oncology drugs
• 90 days pre-NOC for any other drugs

New Submission Guidelines

INESSS also published its new submission guidelines: Guide de Soumission d’une demande à l’INESSS. This document contains information needed to prepare an application to INESSS requesting listing of a drug product on the public drug plan formulary in Québec. The revised application forms (“Fiche” or “Record”) and letter templates are also available here.

For further information, please see the INESSS website.