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PMCPA Case

Janssen voluntary admission: Trevicta journal ads missing PI location reference and incomplete hardcopy certification (AUTH/2870/8/16)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2870/8/16
CompanyJanssen-Cilag Ltd
ProductTrevicta (paliperidone palmitate 3 monthly)
Material typeTwo-page journal advertisements (PI overleaf)
Ad referencesPHGB/XEP/0516/0022; PHGB/XEP/0516/0022a; PHGB/XEP/0516/0022b; PHGB/XEP/0616/0015
Where placedThe Commissioning Review; BMJ; Nurse Prescribing; Prescriber; British Journal of Mental Health Nursing; British Journal of Psychiatry; Progress in Psychiatry
IssueMissing reference on first page to where PI could be found (PI was overleaf); final hardcopy form not certified
Root cause (as described)Job bags incorrectly uploaded into Zinc as digital-only, leading to electronic-only certification and missed final hardcopy check
Complaint received10 August 2016
Case completed23 August 2016
Applicable Code year2016
Breach clausesClause 4.7; Clause 14.1
SanctionsUndertaking received
AppealNo appeal

Download the full case report (PDF)

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

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What happened

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  • Janssen-Cilag Ltd placed four two-page Trevicta (paliperidone palmitate 3 monthly) journal advertisements during July and August 2016.
  • The prescribing information (PI) appeared overleaf on the second page, but the first page omitted the required reference stating where the PI could be found.
  • The omission was not detected during Janssen’s copy approval/certification process.
  • An internal review found the job bags had been incorrectly uploaded into Zinc as “digital” job bags, even though the ads were both digital and hard copy.
  • As a result, the ads were electronically certified only and were not also certified in their final hardcopy form.
  • Janssen proactively notified the PMCPA (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure).
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Outcome

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  • Breach of Clause 4.7 was ruled (as acknowledged by Janssen).
  • Breach of Clause 14.1 was ruled (as acknowledged by Janssen).
  • No appeal.
  • Sanction recorded: Undertaking received.
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