A) Submission of Material
- The fee for the review of submitted materials is charged in accordance with the fee schedule published annually. Invoices are rendered after the completion of the initial review. Fees due are for preclearance review and not for the final acceptance of the material.
- All materials submitted to PAAB will be confidential unless otherwise stated by the sponsor.
- PAAB will make the final assesment of the category for billing purposes
- Each Individual Advertising / Promotion System should be submitted separately for preclearance.
B) Requirements for Preclearance
- All submitted materials are evaluated by PAAB, with appropriate consultation, when warranted.
- Preclearance is conditional upon compliance with all applicable requirements of the PAAB Code of Advertising Acceptance.
- The sponsor must provide a submission form with the indication of approval of a sponsor Company Official from the Medical, Regulatory or Compliance department prior to PAAB submission. This will confirm that the Advertising / Promotion System(s) is consistent with the approved Terms of Market Authorization and that the claims and or any direct quotes used are supported by references that meet the standards of the Code.
- Data on file must be made available to the Commissioner and may be classified as ‘Confidential’ by the advertiser or the author pending publication.
- Copies of all reference sources cited in an Advertising / Promotion Systems must be provided to the Commissioner for verification of claims and or quotations.
C) Timelines and Requirements
- PAAB endeavors to supply comments of the initial preclearance review within 10-business days of the receipt of the complete submission to the offices of PAAB. PAAB will not begin the review process until all the necessary documentation has been received.
D) Duration of Preclearance
- The maximum effective duration of preclearance for advertising is 12 months.
- All advertising scheduled for presentation beyond 12 months must be resubmitted for preclearance at least 6 weeks prior to expiry of the applicable preclearance period.
- Under special circumstances, such as an adjustment to a new 12 month advertising schedule or a delay in production of new material, the Commissioner may extend the preclearance beyond the 12 month period. Extensions at no fee charge shall be restricted to no longer than 2-consecutive months. Longer extensions shall be subject to the full fee applicable to the particular type of advertisement.
E) Accepted Advertising / Promotion Systems
- PAAB will provide written notification of acceptance of the Advertising / Promotion System to the submitting company or agency. PAAB approved Advertising / Promotion Systems are allocated an identification code comprising of the PAAB Logo, advertisement registration number, type of ad, language(s) and effective 12-month preclearance period.
- The identification code should be included in all insertion orders for the information of publishers.
- The PAAB logo must appear in both the display and product information sections of the advertisements.
F) Unaccepted Advertising / Promotion Systems
- Proposed APS Requiring Revisions
An APS found unacceptable by PAAB Reviewers, whether on first submission, resubmission after revision, or resubmission after expiry of the effective preclearance period, will be returned to the advertiser with a memorandum identifying the questionable points and portions of the APS requiring modification, and an explanation of the basis for the negative ruling.
- Clarification of Review Decisions
Further clarification of the Reviewer’s ruling will be provided on request, through correspondence or by telephone. Subject to availability and workload, Reviewers may agree to requests for meetings with advertisers at the offices of PAAB, if it will facilitate the review process. Fees may be applicable in certain instances. See Fee Schedule.
Review decisions may be escalated to the Chief Review Officer (CRO) with the following procedure: after having discussed a written review comment with the PAAB Reviewer, responding in writing and receiving a subsequent PAAB letter about the same issue, the sponsor may choose to request a teleconference with the CRO for clarification of the issue.
G) Withdrawal of Preclearance
- Conditions for Withdrawal of Preclearance
At any time, the Commissioner may withdraw PAAB preclearance and request suspension of publication of an Advertising / Promotion Systems (APS) on the following grounds: on the basis of a complaint upheld under Complaints & Appeals; cases where regulatory or independent medical advice suggest that the claims may constitute an imminent and/or significant health hazard; instruction from the Board; new information coming to light judged significant by the Commissioner; error or omission of fact. To effect the withdrawal of preclearance, the Commissioner will write to the advertiser, providing the notification that preclearance is withdrawn, along with a rationale for this action. This letter will also contain a schedule setting out by which date use of the material is to cease. The Commissioner, in consultation with the advertiser, shall determine this schedule so that the schedule is reasonable with regard to operational concerns.
- Advertisers’ Obligations when Clearance is Withdrawn
If PAAB acceptance of an APS is withdrawn during the effective preclearance period, and the ruling is not appealed under the Right of Appeal, the advertiser shall take the necessary action to withdraw the affected APS from publication or other use according to the schedule set by the Commissioner, or if none was detailed, at the earliest feasible date. Before distribution is resumed, the offending Advertising Promotion System must be revised and resubmitted for PAAB preclearance and these changes must be acceptable to the Commissioner before use.