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PMCPA Case

Colonis Pharma: promotional letter for Melatonin Oral Solution misleadingly implied product-specific support from general guidance

📅 8 March 2026 | 🖉 Anzal Qurbain
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Key facts

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Case numberAUTH/3221/6/19
Case referenceUK-CPL-121-008 (promotional letter reference)
ComplainantMedicines information pharmacist in an NHS trust
Respondent/companyColonis Pharma Limited
Product(s)Melatonin 1mg/ml Oral Solution
Material/channelPromotional letter
Key issueClaims implying Melatonin 1mg/ml Oral Solution should be preferred over unlicensed alternatives/specials were misleading and not substantiated by cited general references and “data on file”.
Dates (received/completed if stated)Complaint received 29 June 2019; Case completed 20 December 2019
AppealNot stated
Code yearNot stated
Breaches/clauses7.2, 7.4, 9.1
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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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  • An NHS trust medicines information pharmacist complained about a promotional letter (ref UK-CPL-121-008) sent by Colonis Pharma Limited promoting Melatonin 1mg/ml Oral Solution.
  • The product was indicated for the short-term treatment of jet-lag in adults.
  • The letter included prominent claims that: (1) “Melatonin 1mg/ml Oral Solution should be prescribed over unlicensed alternatives” and (2) “Specials should not be supplied on the basis of cost or convenience if Melatonin 1mg/ml Oral Solution satisfies the patient’s clinical need”.
  • Both claims were referenced to a named NHS CCG document titled “Unlicensed, off-label medicines and specials”; the second claim also cited Royal Pharmaceutical Society guidance and “Colonis data on file”.
  • The complainant alleged the references did not support the claims (no mention of melatonin) and that citing “data on file” was misleading because it implied independent support.
  • Colonis said the letter was sent on 25 June 2019 to relevant pharmacy/medicines management audiences to announce availability of the now-licensed product, and argued the statements referred to licensed medicines as a group rather than melatonin specifically.
  • The Panel found the “data on file” was correspondence between Colonis and the MHRA relating to Melatonin 3mg Tablets and did not refer to Melatonin 1mg/ml Oral Solution; the MHRA correspondence noted there may still be reasons to use an unlicensed product after a licensed equivalent becomes available.
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Outcome

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  • The Panel ruled the claim “Melatonin 1mg/ml Oral Solution should be prescribed over unlicensed alternatives” was misleading because, in context and with the cited reference, it implied the named CCG document specifically supported preferential use of that product, which it did not.
  • The Panel ruled this claim could not be substantiated by the reference cited.
  • The Panel ruled the claim about “Specials” was misleading because the cited references (CCG document, Royal Pharmaceutical Society guidance, and MHRA email trail) were general and/or not product-specific, yet were presented in a way that implied robust, product-specific support for Melatonin 1mg/ml Oral Solution.
  • The Panel ruled the “Specials” claim was not substantiated by the cited references.
  • The Panel ruled Colonis failed to maintain high standards.
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