Otsuka Europe voluntary admission: unclear SPC update communications for Jinarc and out-of-date package leaflet (AUTH/3169/3/19)

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Key facts

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Case number	AUTH/3169/3/19
Company	Otsuka Pharmaceuticals Europe Ltd
Product	Jinarc (tolvaptan)
Issue	Unclear affiliate communications and SOP non-compliance around parallel SPC revisions; temporary inconsistency on eMC; out-of-date package leaflet packaged at manufacturing site
Complaint type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Complaint received	12 March 2019
Case completed	5 July 2019
Applicable Code year	2016
No breach clauses	2; 29
Breach clauses	2; 9.1; 29
Sanctions	Undertaking received; Additional sanctions: Advertisement
Key timing detail	eMC SPC inconsistency period: 15 February 2019 to 1 March 2019
Regulatory engagement	EMA and MHRA notified 17 January 2019; EMA confirmed 6 February 2019 no DHPC required

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

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Otsuka Pharmaceuticals Europe Ltd made a voluntary admission that it might have breached the Code regarding updates to the Jinarc (tolvaptan) SPC.
There were two parallel SPC revisions processed separately at EMA: (1) addition of blister wallet cards with new marketing authorisation numbers; (2) addition of gout as a common adverse drug reaction.
Affiliate communications about these revisions (notably an email on 14 February 2019) were not clear enough, and a later communication on 26 February 2019 did not follow the relevant SOP (eg, missing required attachments; sent from Global Regulatory Affairs Region Europe only), causing confusion.
As a result, the SPC on eMC from 15 February to 1 March 2019 included the gout update but omitted the preceding blister wallet cards revision, creating inconsistency with the UK prescribing information in use at the time.
Separately, Otsuka identified that an out-of-date package leaflet had been packaged with Jinarc at a UK manufacturing site (the site mistakenly used the previous leaflet version from 30 November 2018).
Otsuka notified EMA and MHRA (DMRC) on 17 January 2019; EMA ultimately confirmed on 6 February 2019 that no DHPC letter was required, and agreed batches should not be recalled to avoid out-of-stock risk.
Otsuka was concerned the situation might breach undertakings given in earlier cases AUTH/3041/6/18 and AUTH/3123/11/18.

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Breach found: Clause 9.1 (failure to maintain high standards) for unclear affiliate communications and inconsistent SOP application regarding SPC updates.
No breach: Clause 29 and Clause 2 in relation to the undertaking from AUTH/3041/6/18 (Panel found the subject matter sufficiently different).
Breach found: Clause 29 (breach of undertaking) in relation to the undertaking from AUTH/3123/11/18, because the current Clause 9.1 breach reflected the same type of process/communication weakness.
Breach found: Clause 2 (bringing discredit upon and reducing confidence in the industry) linked to the breach of undertaking (AUTH/3123/11/18).
Breach found: Clause 9.1 for the out-of-date package leaflet being packaged with product (failure to maintain high standards).
No breach: Clause 2 was not ruled in relation to the package leaflet issue, on balance, given liaison and agreed actions with EMA/MHRA.

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