Section 4. Support Documents
The applicant shall make available information, materials, or documents to facilitate the screening or review of the ad.
The following examples should guide, but are not an exclusive enumeration of acceptable support. Acceptability may depend on the claims of the material being screened and on the discretion of the Professional Screener or the Screening Panel.
Downloaded materials from the internet are generally not acceptable as support for any type of claim. However, published clinicals downloaded from known and reliable internet sites, may be used by OTC drugs provided consumerized lines/copy are pre-approved by FDA.
| Type of claim | Example of Acceptable Support |
|---|---|
| 1. Own product performance without comparative claim | Company-owned document duly signed by the relevant technical person (R&D, QA, Operations), or a high-ranking company official (Managing Director, CEO/ President). Documents signed by persons directly involved in the development of advertising of the brand, product or service are not acceptable, e.g., Brand Managers, Advertising/Sales/Marketing Managers and Directors. |
| 2. Testimonial claim that does not relate to product performance | Documents, affidavits, certifications of actual product, or service use, or preference by the person making the endorsement or testimonial. |
| 3. Testimonial claims which relate to own product performance | Published researches, clinical studies, and other data supporting the product’s claimed benefits. |
| 4.Product/Service/Event Details | Certification duly signed by the Marketing Manager/Director, e.g., certificate of product launch, suggested retail price, event details, product availability in participating stores. |
| 5. All other claims | Support documents from acceptable and reliable independent third party or any other source deemed acceptable by the Professional Screener or Screening Panel. Refer to Manual of Procedures Annex 23 for details on Research Data Support |