What happened

• An anonymous, non-contactable individual describing themself as a “concerned UK health professional” complained about Vifor Pharma UK Limited’s corporate website pages for IV irons.
• The complainant alleged the inverted equilateral triangle symbols on product webpages were shown in different colours (blue, grey, or white) rather than black, including on the Ferinject page and similarly for Venofer and Velphoro.
• The complainant also said it was unclear whether the website was intended for the public or health professionals because it included links to download leaflets for patients and for clinicians.
• Vifor said it deactivated the corporate site immediately after being informed of the complaint and removed all brand information from the site.
• Vifor stated the site had included the correct black triangle until late June and that the issue appeared to occur when a website update was uploaded incorrectly; it said it was investigating root cause and would amend its internal approval process.
• On the Ferinject webpage, Vifor provided five downloadable UK documents: four were described by Vifor as non-promotional risk management materials requested by EMA/MHRA (including an Article 31 letter dated 31 October 2013, a “Dear Dr” letter dated January 2015, and IV iron leaflets for clinicians and patients). The fifth was a Scottish Medicines Consortium (SMC) document (2011) assessing Ferinject and stating it was accepted for restricted use in NHS Scotland.
• The Panel considered the SMC document, while non-promotional per se, had been used for a promotional purpose because it was placed by Vifor on its corporate website and contained claims for Ferinject; overall, the Panel considered the website was promotional.

Outcome

• Breach of Clause 4.10 was ruled (as acknowledged by Vifor) because the product webpages were considered promotional and the inverted black triangle symbol was not shown in black.
• Breach of Clause 28.1 was ruled (as acknowledged by Vifor) because the website presented promotional information for health professionals and information for the public together, without clear separation and identification of intended audience.
• The Panel noted Vifor had deactivated the website when informed of the complaint and removed all brand information from the site.

Clauses

• Clause 4.10 (inverted black triangle requirement when required by the licensing authority) – breached.
• Clause 28.1 (Internet/website requirements; separation of public information and HCP promotion unless access restricted) – breached.

Sanctions

No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

ABPI signatory lens

Why this matters: The black triangle is a regulatory safety symbol associated with additional monitoring; incorrect presentation on promotional pages can undermine patient safety messaging and create confusion. Mixing public and HCP promotional content without clear separation increases the risk of the public accessing HCP-directed promotion.

Where teams typically slip up (interpretation):

• Assuming a “corporate” site is automatically non-promotional even when it hosts product claims or third-party assessments that function as promotion.
• Treating UI/branding elements (icons, colours, hover states, CSS) as “design” rather than regulated content requiring compliance review.
• Publishing mixed-audience resources (patient and clinician materials) without robust audience gating and clear segmentation/labels.

The control that would have prevented it: A release management and compliance sign-off control that includes (1) automated checks for required safety symbols/colour rendering across templates and states, and (2) mandatory audience segregation (or access restriction) before any product-related content goes live.

What I’d check in an audit:

• Website approval packs showing what was certified/approved, including screenshots of the live-rendered pages (not just design comps) and evidence of checks after deployment.
• Change control records for the “late June” update, including who deployed it, what QA was performed, and whether compliance re-approval was triggered.
• Information architecture: whether public vs HCP content is clearly separated, labelled, and/or access-restricted, and whether product pages are treated as promotional assets.
• Governance for hosting third-party documents (e.g., HTA/SMC materials): criteria for when inclusion becomes promotional and how context/placement is controlled.

What the sanctions tell you (interpretation):

• The case outcome focused on ruling breaches and noting corrective actions (deactivation/removal), suggesting remediation was expected promptly rather than escalation to additional published sanctions in the text provided.
• Regulators/PMCPA treat presentation details (like symbol colour) as substantive compliance issues when tied to promotional material and patient safety.
• Website audience separation is a recurring compliance expectation; failure can trigger breach even if the company characterises the site as “corporate”.

3 questions to ask your team this week:

1. Which parts of our “corporate” web estate could be considered promotional because they contain product claims, assessments, or HCP-directed materials?
2. Do we have a documented, tested control that verifies black triangle (and other mandatory elements) render correctly across browsers, devices, and hover/dropdown states after deployment?
3. Is our public vs HCP content clearly separated and labelled (or access-restricted), and can we evidence this in our approval and QA records?

Key facts

Download the full case report (PDF)

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