Colonis voluntary admission: wrong prescribing information in promotional letter for Melatonin Oral Solution

• Colonis Pharma Limited made a voluntary admission that a promotional letter (ref UK-CPL-121-008) about Melatonin 1mg/ml Oral Solution (indicated for short-term treatment of jet-lag in adults) included the wrong prescribing information.
• The letter promoted Melatonin 1mg/ml Oral Solution but the prescribing information provided was for Melatonin 3mg film-coated tablets.
• The error was not identified at the final internal hard copy print proof sign-off stage or at the external printer QC and dispatch stage.
• Colonis stated it withdrew the single-use letter and investigated the cause; it said the error had been corrected in an early approval round but recurred and was overlooked later.
• On 23 July 2019, Colonis sent a corrective letter/mailing to recipients, pointing out and apologising for the oversight and providing the Melatonin 1mg/ml Oral Solution SPC.
• The Panel noted differences between the Oral Solution SPC and the tablets’ prescribing information that would impact prescribing information, including warnings about excipients (e.g., sorbitol/ethanol/propylene glycol for the Oral Solution vs lactose warning for tablets).
• During consideration, the Panel queried why Colonis’ submission in this case did not refer to correspondence with the MHRA about a corrective statement, noting self-regulation relied on complete and accurate responses.

• The Panel ruled breaches of Clauses 4.1, 9.1 and 2.
• The Appeal Board considered whether additional sanctions were needed due to concerns about incomplete/inaccurate information provided to the Panel.
• The Appeal Board decided Colonis should be publicly reprimanded (Paragraph 11.3 of the Constitution and Procedure) for failure to provide complete and accurate information to the Panel.
• The Appeal Board considered further sanctions but decided that, on balance, none were required.

• Clause 4.1: Breach ruled because the relevant prescribing information for the promoted product was not provided (tablets’ prescribing information was supplied instead of Oral Solution).
• Clause 9.1: Breach ruled because the incorrect prescribing information was not identified at internal sign-off or external printer QC/dispatch, meaning high standards were not maintained.
• Clause 2: Breach ruled because providing incorrect prescribing information omitted important safety information for the promoted medicine, bringing discredit upon and reducing confidence in the pharmaceutical industry; the Panel considered this a serious matter linked to potential patient safety prejudice.

• Public reprimand imposed by the Appeal Board (Paragraph 11.3) for failure to provide complete and accurate information to the Panel.
• The Appeal Board considered further sanctions but decided none were required.

Why this matters: Prescribing information is a core safety control in promotional materials. Supplying the wrong PI can omit product-specific warnings (including excipient-related restrictions) and undermines confidence in self-regulation and the approvals process.

Where teams typically slip up (interpretation):

• Re-using templates/PI blocks from a related presentation and failing to re-validate against the exact SmPC for the promoted product.
• Assuming “risk is low” because audiences are non-prescribers or because the SmPC is referenced, rather than ensuring the Code-required PI is correct in the piece.
• Relying on printer/QC as a backstop instead of treating final sign-off as the last compliance gate with explicit checks.

The control that would have prevented it: A mandatory “PI-to-SmPC reconciliation” checklist at final sign-off (and again at artwork/print proof), requiring named signatories to confirm the PI matches the promoted product, strength, formulation and current SmPC version.

What I’d check in the job bag:

• Final approved artwork and the exact prescribing information block used, with version control.
• Evidence of medical/legal/regulatory sign-off and the specific checklist steps confirming correct product/formulation PI.
• Printer proof/QC records and dispatch approval showing what was checked and by whom.
• CAPA documentation describing the remedial steps taken to the copy review approvals system.
• Corrective mailing/letter content and distribution list, including the included Oral Solution SPC.

What the sanctions tell you (interpretation):

• Clause 2 plus a public reprimand signals the regulator viewed the failure as serious and reputationally damaging, not a minor technicality.
• The focus on incomplete/inaccurate responses indicates process integrity (how you respond to the PMCPA) is treated as a compliance control in its own right.
• Even where further sanctions were not applied, escalation to public reprimand shows that transparency and completeness in case handling can materially affect outcomes.

3 questions to ask your team this week:

1. How do we prove (not assume) that the prescribing information in each promotional item matches the exact product, formulation and current SmPC?
2. What are our “two-stage” controls at final sign-off and at print proof/QC—and are they documented and auditable?
3. When responding to a complaint, how do we ensure each case submission is complete and stands alone, including relevant regulator correspondence and corrective actions?