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Application for Drug Scheduling

PLEASE NOTE: All materials submitted as part of an application for drug scheduling must be submitted in English. Further, the meetings of the National Drug Scheduling Advisory Committee 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 By-law 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.

 

All review applications to the National Drug Scheduling Advisory Committee (NDSAC) must be based on a specific drug rather than a drug product, and include the following components:

  1. Index
  2. Statement of the requested schedule recommendation
  3. A brief overview of the drug including: conditions for use, safety and efficacy, a description and incidence of adverse reactions, and experience with overdose if relevant
  4. Application of the scheduling factors, with a 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
  5. Proposed product labelling, including labelling standards or monographs prepared for the Drugs Directorate (where applicable)
  6. 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)
  7. Drug status in other countries
  8. 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 panel of reviewers.

The submission must be readable and concise (i.e. able to be contained in a medium-sized binder). Information packages that are not completely legible will be rejected.

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.

At least 60 days before the Committee meeting is scheduled, NAPRA must receive two printed copies of the submission and a CD-ROM containing the submission documents in PDF format. Any graphics or illustrations must be in JPEG format.

An independent validation of the submitted material and additional research may be contracted by the Committee, to supplement the individual member’s private study.

NAPRA will post notice of each review or reassessment and particulars of the submission on the NAPRA website with an invitation to any party who may be interested in the submission to become an Interested Party and have an opportunity to be heard. Notice can also be served by email, by fax, by mail, by courier, or in person. Members of the Drug Scheduling External Liaison Group will be specifically notified.

Requests for Interested Party Status must be received by NAPRA no later than 45 days prior to the NDSAC meeting. Once NAPRA has ruled on who will be granted standing as an Interested Party, a list of such parties, with contact information, shall be prepared and forwarded to all interested parties with a direction that any information or materials which they wish to file must also be sent to each of the interested parties named on the list.

An Interested Party can request information or a copy of any document related to a review or reassessment of the applicant. If a copy is not provided as requested within 10 days, the document will be refused as evidence in the review or reassessment hearing, unless NDSAC agrees with the reason(s) for not complying with the request.

These “interrogatories” and responses to these interrogatories must follow a prescribed format (see Rules of Procedure). Copies of the request and the response must be filed with the NDSAC secretariat (Manager of Professional and Regulatory Affairs) and must be received within time limits directed by NDSAC.

There are three possible negative responses to an interrogatory:

  1. The information requested is felt to be non-relevant;
  2. The information requested is not available, in which case alternative information must be provided; or
  3. The information requested is felt to be confidential (a copy of this response must be filed with the NDSAC secretariat, Manager of Professional and Regulatory Affairs).

Reasons for not providing the information requested must be stated in each instance. The validity of these reasons will be assessed by NDSAC. NDSAC can demand that an adequate response be provided.

Any document provided to NDSAC will be on the public record unless the provider requests that it be held confidential and NDSAC agrees to its confidentiality, in which case an abridged version will be made available to the public, or at the least, a record of the claim for the document’s confidentiality.

NDSAC may need to study the actual document for which confidential status is being claimed or it may arrange for the claim for confidentiality to be dealt with by other means: i.e. by conference, before a commissioner of oaths or by the Committee during the oral portion of the review or reassessment proceeding (see NDSAC Drug Scheduling Rules of Procedure re: Confidentiality).

An Interested Party may request disclosure of a confidential document by filing a request and/or any material in support of the reasons for public disclosure with NDSAC. A response to such a request must be provided within 10 days.

The applicant is entitled to present before the Committee. A delegation of up to three representatives may attend on behalf of the sponsor. Twenty minutes will be allotted for the presentation, with an additional 15 to 20 minutes for Committee questions and answers.

The Canada Evidence Act applies to all drug scheduling reviews. NDSAC may require any Interested Party or their solicitor to submit information considered necessary for a review. NDSAC can also request the attendance of any other person believed to have information relevant to the proceeding.

NDSAC may call for verification by affidavit of any information brought forward. Affidavits are to be filed with the Executive Director of NAPRA.

Non-compliance with any of NDSAC’s requests can result in delays in proceedings or even suspension of the Interested Party’s participation or dismissal of the application. NDSAC may refer issues of law to the appropriate court, during which time review proceedings could be delayed.

NDSAC’s proposed recommendations (i.e. the “initial recommendation”) and the reasons for these proposed recommendations will be published on the NAPRA website and subsequently forwarded to NAPRA’s Executive Committee within 7 days of publication.

Any request for a reassessment, deemed by NDSAC to be in the public interest, must be received in writing within 30 days of the recommendation being posted to the NAPRA website.

NAPRA’s Executive Committee will confirm or reject the proposed recommendation or direct that a reassessment be conducted within this 30-day period. The final recommendation (and the reasons) will then be published unless a reassessment has been requested.

Any Interested Party or the sponsor may request a new hearing or a review or variation to an initial recommendation prior to it becoming a final recommendation (this will generally occur within 30 days following the publication of the initial recommendation).

Unless NAPRA decides to direct a new hearing, the initial recommendation will become a final recommendation within 30 days of receipt of the initial recommendation subject to NAPRA’s exercising its discretion to re-hear, review, vary or confirm the initial recommendation or final recommendation in accordance with the Rules of Procedure and By-law No. 2.