Sanofi voluntary admission: Dupixent website resource not certified (Clause 14.1)

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Key facts

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Case	AUTH/3447/12/20
Company	Sanofi
Product	Dupixent (dupilumab)
Issue	Failure to certify a downloadable HCP website resource (Sanofi document referring to Dupixent and NICE technology appraisal guidance)
Channel	Company product website (www.dupixent.co.uk) – downloadable resource for health professionals
Applicable Code year	2019
Complaint received	22 December 2020
Case completed	29 March 2021
Appeal	No appeal
Breach clauses	14.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Context	Discovered while responding to Case AUTH/3402/10/20; occurred during migration from Zinc to Veeva PromoMats

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

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Sanofi made a voluntary admission after discovering that material on www.dupixent.co.uk was not certified.
The material was a Sanofi document referring to Dupixent (dupilumab) and NICE technology appraisal guidance, available as a downloadable resource for health professionals.
The document had previously been certified on 2 August 2018 and was due for reapproval in early August 2020.
Between end March and November 2020, Sanofi transitioned materials from the Zinc system to Veeva PromoMats; materials not transitioned by final shutdown were to be treated as withdrawn, and only PromoMats-approved materials were to be “live”.
An employee did not arrange re-approval because they considered the document no longer required.
During the website transition, the job was still marked “live”, so staff did not notice it was not certified/approved at the time of webpage certification (MAT-GB-2001592 (v1.0)) in mid-August 2020.
As a result, the document appeared on the website without being certificated on Veeva PromoMats, including at the time of the related complaint in Case AUTH/3402/10/20 (October 2020).

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