AUTH/2854/7/16: Boehringer Ingelheim voluntary admission—printed promotional materials not re-certified against approved electronic version

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Key facts

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Case number	AUTH/2854/7/16
Company	Boehringer Ingelheim Limited
Issue	Failure to certify/check and sign final printed form of promotional material against certified electronic version (job bags missing required extra signature/certificate)
How identified	Voluntary admission following internal review
Scale	Sample of ~275 hard copy job bags; 103 non-compliant (over 1 in 3)
Content mismatch found?	No; company reported final printed form matched electronically certified version in all cases checked
Applicable Code year	2016
Complaint received	06 July 2016
Case completed	08 August 2016
Breach clauses	9.1; 14.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal
Corrective actions described	SOP deviation requiring physical certificate attached to printed material; pre-use checks for hard copy job bags; interim secondary check by healthcare compliance before archiving; quarterly monitoring of job bag samples

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

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Boehringer Ingelheim conducted a review of promotional materials and identified that a number of hard copy promotional “job bags” had not received an extra signatory signature to confirm the certified electronic material matched the final printed hard copy.
The supplementary information to Clause 14.1 required that when material is printed, it cannot be used until a signatory has checked and signed the item in its final form; in such circumstances there should be two certificates and both must be preserved.
The company sampled approximately 275 hard copy job bags and found 103 that did not comply with the supplementary information to Clause 14.1 (over 1 in 3).
All affected items had been correctly certified electronically (in Zinc) and, after checking, the company found no differences between the final electronic copy and the physical printed item.
Under Paragraph 5.6 of the Constitution and Procedure, the Director treated the voluntary admission as a complaint.
The Panel was disappointed the company initially described the issue only as affecting “a number” of job bags and did not reveal the extent at the outset.

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Breach ruled of Clause 14.1 (failure to certify/check and sign the final printed form before use, as required).
Breach ruled of Clause 9.1 (high standards not maintained; robust certification underpins self-regulation).
No appeal.
Company took corrective steps including SOP changes and monitoring.

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