AUTH/3816/7/23: Stirling Anglian breached Clause 12.9 after omitting adverse event reporting statement from Acepiro banner ad

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Key facts

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Case number	AUTH/3816/7/23
Company	Stirling Anglian
Complainant	Anonymous, non-contactable
Product	Acepiro (acetylcysteine)
Material	Promotional digital banner advertisement on a learned society’s homepage (members-only login)
Issue	Adverse event reporting statement not included within the advertisement itself (only available via link to prescribing information)
Applicable Code	2021
Breach	Clause 12.9
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	31 August 2023
Case completed	23 September 2024
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, non-contactable complainant queried a digital banner advertisement for Acepiro (acetylcysteine) on a learned society’s website, noting the absence of a “safety statement” in the banner.
The PMCPA asked Stirling Anglian to consider Clause 12.9 of the 2021 Code (prominent adverse event reporting statement in all promotional material).
Stirling Anglian initially focused on digital prescribing information requirements (Clause 12.4/12.1 approach), stating the banner had a prominent single-click link to prescribing information.
On follow-up, Stirling Anglian apologised, confirmed the advertisement had been withdrawn, and said other digital adverts were reviewed for similar omissions.
The Panel reviewed the banner content, which included claims “Simple”, “Effective”, “Economical”, “Just one tablet daily”, “Prescribe Acepiro by brand”, a pack shot, and a prominent link to prescribing information.
The adverse event reporting statement was available only via the prescribing information link, not within the banner itself.

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Breach of Clause 12.9 (2021 Code).
The Panel ruled that providing the adverse event reporting statement only via a hyperlink to prescribing information did not meet Clause 12.9; it must appear as an integral part of the promotional material.
No appeal.

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