Electronic submission of a registration application (Checklist 6)
Effective January 30, 2020, all manufacturers of multisource drugs (generic drugs or natural health products) must send in their registration applications using only the INESSS online submission portal. The application should meet all of the requirements in Checklist 6, with one exception: the original copy and electronic copy (USB stick) are no longer required for submission.
Effective January 30, 2020, upon receipt of a hard-copy application in our offices, the manufacturer will have 48 hours to submit its online registration application. The person responsible for the submission will be advised by email.
All companies must be signed up on the INESSS electronic submission portal before they can create and submit a registration application (see Terms of sign-up for electronic submission). An “access manager” should be identified for every company requesting to sign up on the INESSS portal. This person can manage access (creation, deactivation and reactivation) for other “users” in your company.
Note that accents and special characters should not be used in the file names of attachments submitted with your application.
For information on the requirements governing your application, see the Registration application section.
For information on user management (Gestion des utilisateurs) and Online submission of an evaluation request, two guides are available in the “Base de connaissances” tab of the electronic submission portal (“Book” button). Information videos are also available.
Next steps after electronic submission
Once you have submitted a registration application through the e-portal, you will be sent an email confirming the key details of your application.
INESSS will analyze the eligibility of your application and begin an assessment if it is deemed acceptable.
Subsequent communications will, as usual, be in the form of emails.
If you have any questions, problems or suggestions for ongoing improvement of the sign-up process or electronic submission of a registration application, write to inscription@inesss.qc.ca.