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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 413 - If the URL for a PAAB approved HCP portal (which contains gated product information - PAAB approved) is included on the back of a sales representative’s business card, does the business card now require PAAB approval?
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413 - If the URL for a PAAB approved HCP portal (which contains gated product information - PAAB approved) is included on the back of a sales representative’s business card, does the business card now require PAAB approval?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Provided there is no additional information about the portal or about a product, there are no other resources provided, and the URL does not include a claim, PAAB review is not required. But even in such cases, it is important that the manufacturer pauses to consider whether this creates any linkages which violate the advertising regulations. For example, a business card identifying the sales rep as the specialist for drug X while also containing a URL for an unbranded website containing off-label disease information would link product to off-label information thus contravening section 3.1 of the PAAB code. Some manufacturers have elected to submit a business card template for a written opinion (no PAAB logo required) when adding URLs or other information on business cards. If you are unsure, feel free to employ our opinion service. See the fee schedule on our website.

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