Novo Nordisk voluntary admission: GLP-1 RA supply email sent without obligatory information (AUTH/3640/5/22)

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Key facts

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Case	AUTH/3640/5/22
Company	Novo Nordisk
Type	Voluntary admission
Material	GLP-1 receptor agonist supply issue email (UK22OZM00010)
Medicines	Ozempic (semaglutide); Rybelsus (semaglutide)
Audience	Health professionals
What went wrong	Two representatives sent the promotional email without all obligatory information (including date of preparation; AE reporting info; and for one rep, working PI hyperlinks).
Volumes	Rep 1: 95 recipients; Rep 2: 8 recipients
Applicable Code	2021
Breach clauses	5.1, 12.1, 12.8, 12.9
Complaint received	02 May 2022 (case report also states 1 May 2022)
Completed	21 March 2023
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Novo Nordisk made a voluntary admission about a promotional email to health professionals stating Novo Nordisk UK had no issues with supply of Ozempic (semaglutide) and Rybelsus (semaglutide) (GLP-1 RAs).
The email template was certified as promotional material, approved for distribution in February 2022, and the certified version included all required obligatory information.
Sales representatives were instructed not to alter the template (other than adding recipient and sender names).
In March 2022, it was identified that two representatives inadvertently sent the email without all required obligatory information.
Representative 1 sent the email to 95 health professionals without: unique reference number; date of preparation; working hyperlinks to digital prescribing information for Ozempic and Rybelsus; adverse event reporting box.
Representative 2 sent the email to 8 health professionals without: unique reference number; date of preparation; adverse event reporting box in the email body (though an adverse event reporting statement was included in the prescribing information accessible via hyperlinks).

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The Panel ruled breaches of Clauses 12.1, 12.8 and 12.9 for the email sent by Representative 1.
The Panel ruled a breach of Clause 12.8 for the email sent by Representative 2.
The Panel ruled a breach of Clause 12.9 for the email sent by Representative 2 because the adverse event reporting statement did not appear within the email itself as required.
The Panel ruled a breach of Clause 5.1 because high standards had not been maintained; both representatives amended the email following certification to remove important obligatory information.
The Panel noted that inclusion of a unique reference number was referred to in the 2021 Guidelines on Company Procedures, but it was not a requirement of the Code.
No appeal.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 12.1 Failing to include up-to-date prescribing information
Breach of Clause 12.8 Failing to include the date on which the promotional material was created or last revised
Breach of Clause 12.9 Failing to include information about how to report adverse events

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