aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin / bovine aprotinin, calcium chloride / human fibrinogen / factor xiii / fibronectin / human thrombin / bovine aprotinin, human fibrinogen / calcium chloride dihydrate / plasma fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / calcium chloride dihydrate / plasma protein fraction / fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / plasminogen / human thrombin / bovine aprotinin / human coagulation factor xiii / human fibronectin

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: Not stated
PSUR frequency: 5 years
Data lock point: 30 Nov 2026
Submission date: 28 Feb 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

PRAC representative was updated on 01/03/2023 DLP was updated on 27/07/2022 Next DLP was amended on 25/09/2017 Lead MS and PRAC Rapporteur name was added on 28/07/2016 The name of the active substance was amended on 06/10/2015

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The next three reports

Data lock point 30 Nov 2026Submission by 28 Feb 2027
Data lock point 30 Nov 2031Submission by 28 Feb 2032
Data lock point 30 Nov 2036Submission by 28 Feb 2037

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
aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin / bovine aprotinin, calcium chloride / human fibrinogen / factor xiii / fibronectin / human thrombin / bovine aprotinin, human fibrinogen / calcium chloride dihydrate / plasma fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / calcium chloride dihydrate / plasma protein fraction / fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / plasminogen / human thrombin / bovine aprotinin / human coagulation factor xiii / human fibronectin — every 5 years, data lock point 30 Nov 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / plasma protein fraction / plasminogen / thrombin, aprotinin / human fibrinogen / thrombin / calcium chloride, aprotinin / calcium chloride / factor xiii / human thrombin / human clottable protein containing mainly fibrinogen and fibronectin, calcium chloride / human fibrinogen / factor xiii / fibronectin / plasminogen / human thrombin / bovine aprotinin, calcium chloride / human fibrinogen / factor xiii / fibronectin / human thrombin / bovine aprotinin, human fibrinogen / calcium chloride dihydrate / plasma fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / calcium chloride dihydrate / plasma protein fraction / fibronectin / thrombin / bovine aprotinin / human coagulation factor xiii, human fibrinogen / plasminogen / human thrombin / bovine aprotinin / human coagulation factor xiii / human fibronectin — every 5 years, data lock point 30 Nov 2026

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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