Mandatory Advance Notice from Manufacturers

Context

As part of its evaluation process for blood system products to be added to the Liste des produits du système du sang du Québec [blood products list], INESSS requires at least two months’ prior notice from manufacturers of their intention to submit an evaluation request.

The mandatory advance notice allows INESSS to plan its evaluation work and to begin the external consultation process. Manufacturers are therefore expected to inform INESSS as soon as possible of any changes in the date scheduled for the submission of their evaluation request.

An evaluation request from a manufacturer who fails to provide the minimum two-month advance notice is subject to delays.

Procedures

The manufacturer is expected to provide the following information and documentation:

  • *Target submission date (YYYY/MM/DD);
  • *Type of evaluation requested (registration or change);
  • *Name of manufacturer;
  • *Trademark and common name;
  • *Requested indications from INESSS;
  • For stable blood products with a Notice of Compliance from Health Canada: date of issue and any indications contained therein. In the case of a BSP pending a Notice of Compliance from Health Canada: date when it is expected as well as any indication requested from Health Canada;
  • Pharmaceutical forms and concentrations;
  • Other characteristics (e.g., companion tests);
  • Official product monograph or draft product monograph when no final version is available for a BSP pending a Notice of Compliance from Health Canada or when such notice has just been received;
  • Type of economic analysis that will be presented with the submission for validation purposes.

* Information of a public nature might be published on INESSS’s website for external consultation purposes.

Procedure for Sending the Advance Notice

  • The advance notice must be forwarded by email in the form of a letter. Use the Mandatory Advance Notice template.
  • This letter must include the completed “Information concerning the evaluation request” table, together with the required documents;
  • The official product monograph or draft product monograph must be attached to the email;
  • The advance notice must be sent by email to the following address: pss@inesss.qc.ca;
  • Any change in the target date for submitting the evaluation request must be sent to INESSS at the same email address.


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