Sandoz: POM ad visible to the public after journal mailed in transparent wrapper (AUTH/3389/9/20)

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Key facts

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Case number	AUTH/3389/9/20
Company	Sandoz Ltd
Product(s)	Reletrans (buprenorphine 7-day transdermal patch); Mezolar Matrix (fentanyl transdermal patch)
Issue	Promotion of a prescription only medicine to the public via exposed mailing (transparent wrapper)
Material/channel	Bound outsert on Guidelines in Practice journal; mailed copies in polywrap
What went wrong	Printer ran out of bespoke opaque polywrap and used transparent polywrap, making the front-cover promotion visible
Scale	~3,300 of nearly 18,000 copies (about 18%) affected
Complaint received	30 September 2020
Case completed	12 March 2021
Applicable Code year	2019
Breach clauses	9.1, 9.8, 26.1
Sanctions	Undertaking received
Appeal	No appeal

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

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Sandoz made a voluntary admission that copies of the September 2020 edition of Guidelines in Practice were sent in transparent wrappers instead of the usual opaque polywrap.
A bound outsert (wrapped around the journal) contained advertisements for Reletrans (buprenorphine 7‑day transdermal patch) and Mezolar Matrix (fentanyl transdermal patch).
Because the wrapper was transparent, the Reletrans promotional material on the front cover was visible to the general public during postal handling/delivery.
Out of nearly 18,000 copies printed, around 3,300 (about 18%) were wrapped in transparent polywrap.
The publisher used a third-party printer/distributor. The printer reportedly ran out of the bespoke opaque polywrap and completed the run using transparent polywrap, despite instructions to use the opaque version.
Sandoz initiated an internal investigation after being informed by the publisher on 22 September 2020; a recall was considered but not pursued due to concern it could increase exposure during retrieval.
Sandoz stated the advertisement itself had been certified as compliant and that there was no intention to advertise to the public.

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Breach of Clause 9.8 was ruled (acknowledged by Sandoz).
Breach of Clause 26.1 was ruled (acknowledged by Sandoz).
Breach of Clause 9.1 was ruled (Panel did not accept Sandoz’s position that high standards had been maintained).
No appeal.

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