AstraZeneca Zoladex journal advertisement: prohibited reference to the MHRA

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Key facts

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Case number	AUTH/2204/1/09
Case reference	Medicines and Healthcare products Regulatory Agency v AstraZeneca
Complainant	Medicines and Healthcare products Regulatory Agency (MHRA)
Respondent/company	AstraZeneca UK Limited
Product(s)	Zoladex (goserelin)
Material/channel	Journal advertisement in The Pharmaceutical Journal (17 January 2009); ad ref AZ-CZ000261b-ZOLU
Key issue	Reference to the MHRA in promotional material (prohibited unless specifically required by the licensing authority)
Dates (received/completed if stated)	Complaint received 27 January 2009; case completed 24 February 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breach of Clause 9.5
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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The MHRA complained about a Zoladex (goserelin) journal advertisement (ref AZ-CZ000261b-ZOLU) issued by AstraZeneca UK Limited.
The advertisement appeared in The Pharmaceutical Journal on 17 January 2009.
The advertisement stated that the MHRA had reviewed the licence for goserelin 3.6 mg and 10.8 mg and updated the SmPC, and that Section 5.1 of the goserelin SmPC detailed survival data from randomised controlled trials.
The MHRA alleged that referencing the MHRA in the advertisement breached Clause 9.5 of the Code.
AstraZeneca accepted the reference was a genuine error, apologised, and said it did not intend to suggest MHRA endorsement.
AstraZeneca said it took measures to stop further publication where possible, would amend the text (including removing direct reference to the MHRA), would address the case at internal quarterly Code awareness training days, and would write to the MHRA to ensure it agreed with the proposed amendments.

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The Panel ruled the advertisement breached Clause 9.5.
The Panel found the Code prohibited reference in promotional material to, among others, the MHRA, unless specifically required by the licensing authority.
The Panel noted the MHRA had not specifically required AstraZeneca to include such a reference in the promotional material.

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