iron in any combination with multivitamins and/or minerals and/or aminoacids (except for combinations with folic acid)

As the list published 23 Sept 2026 has it, binding since 11 Dec 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: 9 May 1969
PSUR frequency: 13 years
Data lock point: 3 Nov 2032
Submission date: 1 Feb 2033
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 23/10/2024 Active substance name was amended on 23/10/2024

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The next three reports

Data lock point 3 Nov 2032Submission by 1 Feb 2033
Data lock point 3 Nov 2045Submission by 1 Feb 2046
Data lock point 3 Nov 2058Submission by 1 Feb 2059

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
iron in any combination with multivitamins and/or minerals and/or aminoacids (except for combinations with folic acid) — every 13 years, data lock point 3 Nov 2032
EMA/630645/2012 Rev.156 · published 4 Feb 2026
iron in any combination with multivitamins and/or minerals and/or aminoacids (except for combinations with folic acid) — every 13 years, data lock point 3 Nov 2032

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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