human fibrinogen

As the list published 23 Sept 2026 has it, binding since 6 Apr 2026. 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: 4 Jan 1966
PSUR frequency: 5 years
Data lock point: 30 Jun 2029
Submission date: 28 Sept 2029
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

PSUR frequency amended and DLP updated on 05/03/2025

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The next three reports

Data lock point 30 Jun 2029Submission by 28 Sept 2029
Data lock point 30 Jun 2034Submission by 28 Sept 2034
Data lock point 30 Jun 2039Submission by 28 Sept 2039

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.

Combinations containing this substance

In earlier versions of the list

EMA/630645/2012 Rev.164 · published 23 Sept 2026
human fibrinogen — every 5 years, data lock point 30 Jun 2029
EMA/630645/2012 Rev.156 · published 4 Feb 2026
human fibrinogen — every 5 years, data lock point 30 Jun 2029

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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