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peginterferon beta-1A

As the list published 23 Sept 2026 has it, binding since 5 Aug 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
18 Jul 2014
PSUR frequency
3 years
Data lock point
18 Jul 2027
Submission date
16 Oct 2027
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 and DLP corrected on 02/04/2025 PSUR frequency amended and DLP updated on 05/02/2025 PSUR Frequency and next DLP were updated on 02/03/2022 DLP was updated on 03/03/2021 DLP was updated on 04/03/2020 Next DLP, Lead MS and PRAC Rapporteur name were amended on 06/03/2019 DLP was updated on 28/02/2018 PSUR Frequency amended and next DLP updated on 25/09/2017 Next DLP was amended on 28/02/2017 Next DLP was updated on 22/09/2016 DLP and Next DLP were updated on 04/03/2016 Next DLP was updated on 30/09/2015

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The next three reports

  • Data lock point 18 Jul 2027Submission by 16 Oct 2027
  • Data lock point 18 Jul 2030Submission by 16 Oct 2030
  • Data lock point 18 Jul 2033Submission by 16 Oct 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

    peginterferon beta-1A — every 3 years, data lock point 18 Jul 2027

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

    peginterferon beta-1A — every 3 years, data lock point 18 Jul 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

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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