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human coagulation factor viii / human von willebrand factor (centrally authorised product only)

As the list published 23 Sept 2026 has it, binding since 28 Oct 2022. 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
12 Aug 2013
PSUR frequency
5 years
Data lock point
12 Aug 2026
Submission date
10 Nov 2026
Next data lock point
Not stated
Next submission date
Not stated
Products covered
Centrally authorised (CAP)

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 28/04/2022 PSUR frequency amended and DLP updated on 03/04/2019 PRAC Representative updated on 26/09/2018 DLP was updated on 27/03/2018 DLP was updated on 28/03/2017 Next DLP was updated on 22/09/2016 PSUR Frequency amended and DLP updated on 07/04/2016 Next DLP was updated on 30/09/2015 Next DLP was amended on 01/04/2015 Correction of PSUSA number (Next DLP) on 06/10/2014 Correction of submission date on 31/01/2014 Name of active substance was amended on 30/11/2013

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The next three reports

  • Data lock point 12 Aug 2026Submission by 10 Nov 2026
  • Data lock point 12 Aug 2031Submission by 10 Nov 2031
  • Data lock point 12 Aug 2036Submission by 10 Nov 2036

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

    human coagulation factor viii / human von willebrand factor (centrally authorised product only) — every 5 years, data lock point 12 Aug 2026

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    human coagulation factor viii / human von willebrand factor (centrally authorised product only) — every 5 years, data lock point 12 Aug 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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