PLEASE NOTE: All materials submitted as part of an application for drug scheduling must be submitted in English. The National Drug Scheduling Advisory Committee (NDSAC) meetings are conducted in English.
The following is intended to assist in the preparation of scheduling applications, and is a summary of the provisions set out in Bylaw No. 2 and the Rules of Procedure. In the event of any inconsistency or conflict between the provisions of the By-law or Rules of Procedure and these guidelines, the provisions of the Rules of Procedure or By-law, as applicable, shall prevail.
The Committee strives to expedite scheduling decisions and to avoid unnecessary delays to manufacturers and other interested parties. Accordingly, parties contemplating a future scheduling recommendation request are advised to contact NAPRA as early as possible so that a specific processing timetable can be planned and Committee time appropriated.
Drug Scheduling Applications are due at least 60 days before the Committee meeting is scheduled. NAPRA must receive a digital copy of the submission documents in PDF format, along with payment of the drug scheduling fee via electronic funds transfer (EFT). For more information on the EFT process or to request an invoice for payment, please contact the NDSAC Secretariat at least 3 weeks prior to the submission deadline.
Please see the NDSAC Meeting Schedule section of the website for the meeting dates and submission deadlines.
Drug scheduling applications must be based on a specific drug rather than a drug product, and include the following components:
- Statement of the requested schedule recommendation
- A brief overview of the drug including:
- conditions for use
- safety and efficacy
- a description and incidence of adverse reactions
- experience with overdose if relevant
- Application of each of the scheduling factors, with appropriate literature citations
- copy of the appropriate literature citations including literature search parameters. In keeping with the cascading principle of drug scheduling, an application of the scheduling factors for all schedules should be included, in support of the scheduling request
- Proposed product labelling, including labelling standards or monographs prepared for the Drugs Directorate (where applicable)
- Results of consumer usage studies in a market consistent with the scheduling request regarding compliance and related issues, such as reading and comprehension studies of labels and patient information (for non-prescription drugs)
- Drug status in other countries
- Exposure assessment (market penetration)
- When the scheduling request is pursuant to a deregulatory proposal, the applicant will provide the Committee with a summary of the background information used and evaluation prepared by the Therapeutic Products Directorate reviewers.
- References section that includes:
- Literature Search Parameters used by the applicant to find the references to support the information in the submission
- List of references used to support the information in the submission
- Copies of all references cited in the submission
- The submission should be in PDF format, ideally in 1 document with links from the Table of Contents to the appropriate sections.
- All material must be submitted in English.
- The submission must be readable and concise
- The majority of submissions are between 50-150 pages, excluding references – the appropriate length depends largely on the nature of the drug to be reviewed.
- Information packages that are not completely legible will be rejected.
- The NDSAC Secretariat will communicate with any applicant whose submission appears excessively long to discuss options.
Sample Drug Scheduling Application Template
Drug Scheduling Applications – Submission Instructions
Note: The NAPRA Drug Scheduling Applications Submission Portal is under development. Please check back soon.
Drug Scheduling Fees
The National Drug Scheduling Advisory Committee and the national drug scheduling review process are funded on a cost-recovery basis.
For 2022, the cost of conducting a review of a submission is set at $45,000 (+HST). Payment in the full amount is required when the application is submitted to NAPRA.
There is a limit of two submissions reviewed at any given meeting.
Contact the NDSAC Secretariat to request an invoice for payment or for more information on the EFT process.