What happened

• 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.

Outcome

• 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.

Clauses

• Clause 6.1 (Limitations on number of pages of print advertising): no issue of a print journal may bear advertising for a particular product on more than two pages; inserts count towards the limit and a double-sided insert counts as two pages.

Sanctions

• No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report.

ABPI signatory lens

Why this matters: Print-journal page limits are a bright-line rule. Even compliant, certified pieces can become non-compliant when combined in the same issue, creating avoidable Code risk and undermining confidence in the certification system.

Where teams typically slip up (interpretation):

• Certifying items as “standalone” without documenting the intended placement plan (same issue vs different issues) and without linking related materials in the approval system.
• Relying on third parties (media buyers/publishers) to interpret Code requirements, rather than applying internal controls to placements and formats (e.g., double-sided inserts counting as two pages).
• Lack of a single source of truth for publication schedules and booked placements, meaning reviewers/certifiers cannot see cumulative exposure in a given issue.

The control that would have prevented it: A mandatory “journal placement reconciliation” step before sign-off/booking that checks (1) all booked items for the product in that issue, (2) insert formats (single vs double-sided), and (3) total page count against Clause 6.1, with linked job-bags in the copy approval system.

What I’d check in an audit:

• Whether the copy approval system supports linking multiple materials intended for the same journal issue and whether teams use that functionality in practice.
• Evidence of a pre-publication check that reconciles media bookings, publisher offers (e.g., inserts/bookmarks), and certified materials against the two-page limit.
• Training/working instructions for brand teams and agencies on how inserts are counted (including double-sided inserts counting as two pages).
• CAPA records: SOP updates, implementation dates, and evidence of companywide learning (e.g., presentation at the Code Review Forum).

What the sanctions tell you (interpretation):

• The ruling focused on a specific, objective breach (page-count limit) rather than content claims, so remediation is primarily process/control-based.
• The case highlights that certification alone is insufficient if placement context is missing; governance over media placement is part of compliance.
• Expect scrutiny on oversight of third parties acting on the company’s behalf and on how publication schedules are controlled and communicated.

3 questions to ask your team this week:

1. For each print placement, do we have a documented view of everything else for that product appearing in the same issue (including inserts/bookmarks) and how it is counted under Clause 6.1?
2. Can our certifiers/reviewers see the publication schedule and linked job-bags in the approval system before certification/booking?
3. What is our final “pre-flight” check with media buyers/publishers to confirm formats (e.g., double-sided) and cumulative page totals before print?

Key facts

Download the full case report (PDF)

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