Draft guidance on management of rolling reviews for drug submissions: Fees

As with other drug submissions, sponsors of a new drug submission (NDS) or supplement to a new drug submission (SNDS) that has been granted rolling review status must comply with either of the following:

• Guidance on evaluation fees for human drugs and disinfectants: Invoicing, fee payment and mitigation
• Guidance document: Fees for the review of veterinary drug submissions and applications

Sponsors will be issued an invoice for the full fee related to examining the NDS or SNDS once Health Canada has accepted the submission for review and issued the screening acceptance letter.

Payment of the fee in full is required even if the missing information is not provided and the submission is cancelled or withdrawn.