Boehringer Ingelheim voluntary admission: MIMS issue carried Spiolto Respimat advertising on more than two pages

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Key facts

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Case number	AUTH/3223/7/19
Case reference	Voluntary admission by Boehringer Ingelheim
Complainant	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Respondent/company	Boehringer Ingelheim Limited
Product(s)	Spiolto Respimat (tiotropium and olodaterol)
Material/channel	Print journal advertising in MIMS (June 2019 issue): one-page abbreviated advertisement and double-sided bookmark insert
Key issue	Advertising for a particular product appeared on more than two pages in a single print journal issue (bookmark counted as two pages)
Dates (received/completed if stated)	Complaint received 12 July 2019; case completed 19 December 2019
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 6.1
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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Boehringer Ingelheim Limited voluntarily admitted that the June 2019 issue of MIMS bore advertising for Spiolto Respimat (tiotropium and olodaterol) on more than two pages.
The June 2019 MIMS contained a one-page abbreviated advertisement (outside back cover) and a bookmark insert printed on both sides for the same product.
A third-party agency alerted Boehringer Ingelheim that the combination might exceed the allowable page limit for journal advertising in a single issue.
Boehringer Ingelheim contacted its media buyer (which placed the advertisement and bookmark) to understand how both appeared in the same edition.
The bookmark was double-sided and, per supplementary information to Clause 6.1, counted as two pages; together with the one-page advertisement this totalled three pages.
Boehringer Ingelheim stated that both items were certified in May 2019 within two days of each other as standalone items for use in MIMS, but there was no alert to the certifier that they would appear in the same edition.
The Panel noted there did not appear to be any journal publication schedule provided to the certifier in the copy approval system and considered there to be a general lack of company oversight.
Boehringer Ingelheim began a formal internal investigation and initiated corrective and preventative actions (CAPA), including proposed updates to its material approval SOP and internal oversight steps.

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The Panel ruled that the June 2019 edition of MIMS bore advertising for Spiolto Respimat on three pages.
A breach of Clause 6.1 was ruled.
Complaint received: 12 July 2019.
Case completed: 19 December 2019.

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