Effective March 30, 2020, manufacturers of innovative drugs will be able to submit their registration applications to INESSS electronically. A temporary submission solution has been deployed using the secure ShafeFile platform of the Ministry of Health and Social Services. The purpose of this temporary solution is to help limit the spread of coronavirus in the population.
This temporary submission method can be used to file registration applications for drugs that comply with the requirements listed in Checklists 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, A, B and C.
In the case of multisource drugs (generic drugs or natural health products), you must continue to submit applications through INESSS’s electronic submission portal (Checklist 6).
The registration application submission procedure is as follows
- On the business day preceding your planned submission of a registration application to INESSS, please send an email to email@example.com requesting electronic submission access and stating the name of the product involved (trademark or generic name) and the number of the registration checklist used.
- INESSS will email you a unique and confidential hyperlink directing you to an electronic submission file. This link will be valid for a maximum of 24 hours.
- You will be able to submit all your documents electronically via this link.
- Please avoid using any accents, apostrophes or special characters in your file titles because they will prevent submission of your documents.
- Please take care to separate your documents according to the various evaluation components described in the registration checklists.
- Please make sure the documents you submit meet INESSS’s requirements as described in the registration checklists because they will not be returned to manufacturers at this stage.
- INESSS will be notified when a registration application is submitted via ShareFile. The date and time of the last document submitted will be used to establish the application processing order for eligibility purposes.
- Your registration application will then be considered in accordance with our usual procedures.
- You do not need to contact INESSS to confirm that your documents have been successfully submitted.
For registration applications that have already been reviewed for eligibility and for which additional documents are required, or for registration applications reviewed for eligibility after March 30, 2020 and deemed ineligible (incomplete), you must send your documents by email to firstname.lastname@example.org. However, if your documents are too large to be sent by email, you may request electronic submission access as described above.
If you have any questions, please email them to us at email@example.com.