Participation in National Drug Scheduling Reviews

Participation as an Interested Party

Interested Party

Any person, association or other entity that, in the opinion of the National Drug Scheduling Advisory Committee (NDSAC), has or presents a significant interest in the scheduling of a drug can request standing as an Interested Party. Interested Party status (which may be denied or revoked by the NDSAC at any time) must be obtained prior to participating in a drug scheduling review.

For more information, please refer to NAPRA’s Bylaw No. 2 and the Rules of Procedure.

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. Individuals who have subscribed to receive NDS Updates will be specifically notified.

An Interested Party is able to participate in the drug scheduling process. They can request information, or a copy of any document related to a review or reassessment, of the applicant or another Interested Party. These “interrogatories” and responses to these interrogatories must follow a prescribed format (see Pre-NDSAC Meeting Procedure and Rules of Procedure). An Interested Party is also entitled to present before the Committee.

Applications for Interested Party Status

To request Interested Party status, parties must complete the Application for Interested Party Status form and submit to the NDSAC Secretariat no later than 45 days prior to the NDSAC meeting date. Once the NDSAC 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.

Submitting Information Via the Alternate Method of Participation

Individuals, companies or organizations who chose not to pursue Interested Party status, or have been denied the status, can provide comments, in writing, related to the agenda items outlined in the meeting notice. All comments must be submitted to the NDSAC Secretariat no later than nine (9) days prior to the NDSAC meeting date.

Important Resources Related to the NDS Process

Important Resources Related to the NDS Process