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ferric ferrocyanide

New in the list published 29 Jul 2026; binds from 29 Jan 2027.

What the list says

EU reference date
15 May 2009
PSUR frequency
5 years
Data lock point
15 May 2030
Submission date
13 Aug 2030
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

New entry added on 29/07/2026

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The next three reports

  • Data lock point 15 May 2030Submission by 13 Aug 2030
  • Data lock point 15 May 2035Submission by 13 Aug 2035
  • Data lock point 15 May 2040Submission by 13 Aug 2040

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

    ferric ferrocyanide — every 5 years, data lock point 15 May 2030

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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