During the course of its evaluation process for the registration of drug products, INESSS requires that the manufacturer informs it at least two months prior to its intention to submit an evaluation request.
The evaluation requests for a new drug or a new indication of a drug already registered, of a biosimilar drug or a product analog to a complex non-biological medication are targeted. More specifically, this corresponds to requests that will be submitted to INESSS according to the requirements of Checklist 1, 2, 5, 12 or A.
The mandatory advance notice allows INESSS to plan its evaluation works to be done. It also allows the consultation with citizens, patients, caregivers and health professionals, as well as associations and groups to begin. Therefore, it is expected that the manufacturer informs INESSS, without undue delay, of any changes at the date scheduled for the submission of its evaluation request.
The evaluation request of a manufacturer not respecting the minimum two-month prior notice is subject to delays.
Terms and conditions
The following information and documents are required from the manufacturer:
- Target submission date (YYYY/MM/DD)*;
- Type of evaluation requested*; Name of manufacturer*;
- Trademark and common name*;
- Requested indications to INESSS*;
- For a drug product with a Notice of Compliance from Health Canada: date of its date of issue as well as any known indications. For a drug product pending a Notice of Compliance from Health Canada: date when it is expected as well as any indication requested by Health Canada;
- Pharmaceutical forms and concentrations;
- Other characteristics;
- Companion test (name and objective(s) of analysis);
- Lists for which the request will be done;
- Priority request contemplated;
- Monograph of official product or draft of product monograph when no final version is available for a drug product pending a Notice of Compliance from Health Canada or having just received it.
* This information of a public nature will be available on the INESSS website for the purposes of the consultation process.
Procedure for submission of mandatory advance notice
- The advance notice must be sent according to the template letter Mandatory Advance Notice;
- The official product monograph or the draft drug monograph must be attached there to;
- These documents must be sent by email to the following address: email@example.com;
- Any change made to the targeted date for the submission of the evaluation request must be communicated to INESSS at the same email address.
For any questions relating to the mandatory advance notice process, you may communicate with the secretariat of the Direction de l’évaluation des médicaments et des technologies à des fins de remboursement, by phone at 418 643-1339 or by email to firstname.lastname@example.org.
- Letter Mandatory Advance Notice including a table entitled “Informations sur la demande d’évaluation”.