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	Promotional material included a reference to the MHRA, which is 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 Medicines and Healthcare products Regulatory Agency (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 Summary of Product Characteristics (SmPC) to reflect survival benefits, and that Section 5.1 of the goserelin SmPC detailed survival data from randomised controlled trials.
Zoladex was described as a luteinising hormone releasing hormone analogue (LHRHa) indicated for certain types of cancer.
The MHRA alleged that referencing the MHRA in the advertisement breached the Code (Clause 9.5).
AstraZeneca accepted the reference was a genuine error, apologised, sought to stop further publication where possible, and proposed amending the text to remove direct reference to the MHRA and to write to the MHRA about the proposed amendments.

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

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