bismuth subcitrate potassium / metronidazole / tetracycline

As the list published 23 Sept 2026 has it, binding since 5 Aug 2025. Each entry binds six months after its own publication date (Article 107c(7) of Directive 2001/83/EC).

What the list says

EU reference date: 24 Nov 2011
PSUR frequency: 3 years
Data lock point: 24 May 2027
Submission date: 22 Aug 2027
Next data lock point: Not stated
Next submission date: Not stated
Products covered: Nationally authorised (NAP)

Are PSURs required for products referred to in Articles 10(1), 10a and 16a of Directive 2001/83/EC?

No — the list does not require PSURs for these products.

The list asks this as one question for Articles 10(1), 10a and 16a together, and does not answer it for Article 14 at all. A PSUR may in any case be required at the request of a competent authority or as a condition of the marketing authorisation.

Notes in the list

DLP was amended on 05/02/2025

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The next three reports

Data lock point 24 May 2027Submission by 22 Aug 2027
Data lock point 24 May 2030Submission by 22 Aug 2030
Data lock point 24 May 2033Submission by 22 Aug 2033

Counted from the data lock point the list gives, on the cycle it states: the submission date is 90 days after the data lock point — 70 days for a cycle of twelve months or less, 90 days for a longer one, as GVP Module VII sets out.

In earlier versions of the list

EMA/630645/2012 Rev.164 · published 23 Sept 2026
bismuth subcitrate potassium / metronidazole / tetracycline — every 3 years, data lock point 24 May 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
bismuth subcitrate potassium / metronidazole / tetracycline — every 3 years, data lock point 24 May 2027

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.164, published 23 Sept 2026. Open the published file

Kreastel is a planning and oversight aid for pharmacovigilance obligations. It tracks dates like these for a marketing authorisation holder's own products.

Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.

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