Blood System Products (BSPs) Pending a Notice of Compliance

A request for registration of a blood system product on the Liste des produits du système du sang du Québec [blood products list] can be evaluated before Health Canada issues a Notice of Compliance.In this way, the recommendation can be forwarded to the Minister of Health and Social Services without undue delay. The evaluation can begin if, in INESSS’s estimation, the following condition has been satisfied:

• Issuance of the Notice of Compliance is expected in the next 180 days.

Before this evaluation can take place, you must ensure that the files you submit are tentatively complete. Please refer to the “Requesting an Addition” section for a list of the documents required. INESSS will begin the scientific evaluation of requests it considers admissible. We will, however, need to have a copy of the Notice of Compliance issued by Health Canada and the official product monograph in order to finalize and forward the recommendation to the Minister.