Health Products Preclearance Appeal Procedure
Advertising Standards Canada (“Ad Standards”) is recognized by Health Canada as an advertising preclearance agency for consumer-directed health product advertising and information pieces. Ad Standards’ Clearance Service Analysts help provide confidence that the submissions comply with applicable legislation and guidelines. Each submission to our Health Products team is reviewed by two analysts to help ensure completeness and consistency of our assessment.
If a submitter disagrees with the decision of Ad Standards’ analysts, the submitter and/or advertiser may seek clarification, reconsideration, or appeal Ad Standards decision in the following ways.
1. Request for Clarification / Reconsideration
Any submitter may request clarification of the comments received from Ad Standards Clearance Services on their submission. Any request for clarification must be sent by email to: firstname.lastname@example.org Please include in your email the Order Number and the question(s) that you have about the analysts’ comments or directional suggestions. You will receive a response as soon as possible (typically within three to five business days) to answer your questions by email, or to set up a call to discuss if determined by the analyst to be the most efficient and effective way to reply.If you do not agree with the initial advisory opinion, and would like the analysts to reconsider their assessment, send your written rationale along with any supporting documentation as a resubmission on the applicable file through the Clearance Services online submission portal for the analysts to re-evaluate.
2. Appeal to Clearance Services
If a request for reconsideration does not resolve the matter to the satisfaction of the submitter, and a submitter still disagrees with the advisory opinion by Ad Standards Clearance Services, the submitter may make a request for Appeal to Clearance Services. This request for appeal must be made by email to the Director, Clearance Services (Health Products). Please include in your email the Order Number, any further rationale for reconsideration, and any additional supporting documentation not already provided as a resubmission. Your request for Appeal to Clearance Services will be reviewed and we will do our best to consider and get back to you in writing within five (5) business days following receipt of the request for an Appeal to Clearance Services.
3. Final Appeal to Ad Standards
If an Appeal to Clearance Services is not successful in the opinion of the submitter, then the submitter may request a Final Appeal to Ad Standards. The request for a Final Appeal to Ad Standards must be sent without unreasonable delay after receipt of Ad Standards’ response to the Appeal to Clearance Services. The submission, again in writing, must set out the reasons for requesting reconsideration, grounded in the applicable provisions of the Food and Drugs Act, the relevant regulations thereunder and any applicable Health Canada guidelines. The request for Final Appeal to Ad Standards must be submitted by email to Ad Standards’ Chief Legal Officer, copying the CEO of Ad Standards. If the entity submitting the Final Appeal is not the advertiser, then a senior member of the advertising or regulatory team of the advertiser must be copied on the request, to acknowledge and agree that the information about their submission, appeals and Ad Standards’ assessment will be sent to Health Canada. If either the Chief Legal Officer or the CEO of Ad Standards was involved in a previous assessment or appeal, then whenever possible the Final Appeal will be considered by the other individual to allow for a fresh perspective on the matter.After consideration of the complete file, including the initial advisory opinion, the prior Appeal to Clearance Services, all submissions made by the submitter, and the request for the Final Appeal, a written decision will be provided within a target of five business days of receipt. The fact of this Final Appeal, and the decision, will be submitted to Health Canada’s Marketed Health Products Directorate.