AUTH/2950/4/17: Health professional v Tor Generics — pack shot of unlicensed injectable in public magazine | PMCPA Case

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Key facts

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Case	AUTH/2950/4/17
Complainant	Health professional
Company	Tor Generics Ltd
Material	Advertisement in The Big Issue (20–26 March 2017)
Product referenced	Tor-Bac 5ml (“Bacteriostatic saline solution for injection”) plus Vitamin D3 capsules and Vitamin A capsules
Main issue	Pack shot of an injectable product included in a public magazine ad prior to marketing authorisation; alleged public advertising of a POM
Applicable Code year	2016
Complaint received	01 April 2017
Case completed	09 June 2017
Appeal	No appeal
No breach	Clause 26.1
Breaches	Clauses 2 and 9.1
Sanctions	Undertaking received; Advertisement

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

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A health professional complained about a Tor Generics advertisement in The Big Issue (20–26 March 2017), a magazine sold to the general public.
The ad included pack shots of Vitamin D3 capsules, Vitamin A capsules and Tor-Bac 5ml, described as “Bacteriostatic saline solution for injection”.
The complainant alleged this was advertising an injectable medicine (therefore a prescription only medicine (POM)) to the public, breaching Clause 26.1.
Tor Generics said Tor-Bac’s MHRA licence was pending; it was due to launch June 2017 and would be a POM once licensed.
The company said the Tor-Bac pack shot was included by oversight when image files were sent for compilation; it asked the typesetter (email dated 4 April) to remove pack shots and provided a revised ad with no product references.

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No breach of Clause 26.1 (on a narrow technical point: Tor-Bac was not classified as a POM at the time the ad was published because the licence was pending).
Breach of Clause 9.1 (high standards not maintained).
Breach of Clause 2 (brought discredit upon and reduced confidence in the pharmaceutical industry).
No rulings under Clause 3.1 because it was not raised with the company and the Panel therefore made no rulings in that regard.

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