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

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Key facts

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Case number	AUTH/3240/8/19
Case reference	Voluntary admission from Colonis
Complainant	Colonis Pharma Limited (voluntary admission treated as a complaint under Paragraph 5.5)
Respondent/company	Colonis Pharma Limited
Product(s)	Melatonin 1mg/ml Oral Solution; Melatonin 3mg film-coated tablets (prescribing information supplied in error)
Material/channel	Promotional letter (ref UK-CPL-121-008)
Key issue	Wrong prescribing information included (tablets PI used for Oral Solution), omitting important safety information; concerns also raised about incomplete/inaccurate information provided to the Panel regarding MHRA-required corrective statement
Dates (received/completed if stated)	Voluntary admission received 15 August 2019; Undertaking received 20 December 2019; Appeal Board consideration 22 January and 26 February 2020
Appeal	Appeal Board consideration of case report; additional sanctions considered; public reprimand imposed; no further sanctions
Code year	Not stated
Breaches/clauses	Clauses 2, 4.1, 9.1
Sanctions	Public reprimand (Paragraph 11.3 of the Constitution and Procedure); no further sanctions required

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

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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.

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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.

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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.

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