AUTH/3015/1/18: Daiichi-Sankyo voluntary admission—medical signatories acted before MHRA/PMCPA notification

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Key facts

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Case number	AUTH/3015/1/18
Company	Daiichi-Sankyo UK Ltd
Case type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Issue	Three medical staff acted as nominated signatories before their names/qualifications were notified in advance to MHRA and PMCPA
Volume impacted	296 items certified prior to notification
Applicable Code year	2016
Breach clauses	14.1; 14.4
Complaint received	29 January 2018
Completed	30 May 2018
Appeal	No appeal
Sanctions	Undertaking received

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

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Daiichi-Sankyo UK discovered (and voluntarily admitted) that three medical staff acted as nominated signatories before their names and qualifications were notified in advance to the MHRA and the PMCPA.
The issue arose from an administrative error linked to staff departures and lack of handover; the SOP did not assign a specific role to make the external notifications.
The omission came to light during an investigation connected to an intercompany complaint about Lixiana (Case AUTH/3010/1/18) when signed certificates were requested.
The three medical signatories certified 296 items of material before notification was completed on 22 January 2018.
Daiichi-Sankyo informed the MHRA and PMCPA, submitted a voluntary admission, and initiated a CAPA plan including SOP updates and training.

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The Panel ruled that Daiichi-Sankyo breached the Code.
Failure to notify signatories in advance was a breach of Clause 14.4.
As a consequence, the materials certified by those signatories prior to notification were not certified in accordance with the Code, breaching Clause 14.1.
No appeal.

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