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budesonide (nationally authorised products only)

As the list published 23 Sept 2026 has it, binding since 22 Jun 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
30 Apr 1992
PSUR frequency
5 years
Data lock point
30 Apr 2026
Submission date
29 Jul 2026
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 Rapporteur name was amended on 28/04/2022 DLP updated on 22/12/2021 PRAC Rapporteur name was amended on 21/11/2018 Entry name was corrected on 07/05/2018 Next DLP updated on 30/01/2017 Next DLP and Submission deadline were corrected on 04/03/2016 PSUR Frequency amended and DLP updated on 04/02/2016 PRAC Rapporteur and Lead Member State added on 27/11/2015. 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 PRAC Rapporteur name updated on 05/11/2018

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The next three reports

  • Data lock point 30 Apr 2031Submission by 29 Jul 2031
  • Data lock point 30 Apr 2036Submission by 29 Jul 2036
  • Data lock point 30 Apr 2041Submission by 29 Jul 2041

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

    budesonide (nationally authorised products only) — every 5 years, data lock point 30 Apr 2026

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

    budesonide (nationally authorised products only) — every 5 years, data lock point 30 Apr 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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