human coagulation factor VIII (inhibitor bypassing fraction)

As the list published 23 Sept 2026 has it, binding since 20 Apr 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: 4 Feb 1977
PSUR frequency: 3 years
Data lock point: 28 Feb 2027
Submission date: 29 May 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

PSUR frequency and DLP were updated on 20/10/2021 DLP was updated on 21/10/2020 DLP was updated on 23/10/2019 PRAC Rapporteur name was updated on 05/06/2019 DLP was updated on 23/10/2018 DLP was updated and PRAC Representative name amended on 17/10/2017 Next DLP was amended on 19/10/2016 DLP was amended on 30/09/2015. Lead MS was added on 13/07/2015 Transferred from the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised on 06/03/2015

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The next three reports

Data lock point 28 Feb 2027Submission by 29 May 2027
Data lock point 28 Feb 2030Submission by 29 May 2030
Data lock point 28 Feb 2033Submission by 29 May 2033

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 (inhibitor bypassing fraction) — every 3 years, data lock point 28 Feb 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
human coagulation factor VIII (inhibitor bypassing fraction) — every 3 years, data lock point 28 Feb 2027

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

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