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sulfamethizole

As the list published 23 Sept 2026 has it, binding since 1 Sept 2023. 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
15 Jun 1955
PSUR frequency
10 years
Data lock point
15 Jun 2032
Submission date
13 Sept 2032
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?

Yes — the list requires 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 01/03/2023 PRAC Rapporteur name was amended on 28/04/2022 PRAC Rapporteur name was amended on 21/11/2018 DLP was updated on 28/02/2018 Lead MS and PRAC Rapporteur name was added on 26/04/2017 New entry added on 30/01/2017 PRAC Rapporteur name updated on 05/11/2018

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The next three reports

  • Data lock point 15 Jun 2032Submission by 13 Sept 2032
  • Data lock point 15 Jun 2042Submission by 13 Sept 2042
  • Data lock point 15 Jun 2052Submission by 13 Sept 2052

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

    sulfamethizole — every 10 years, data lock point 15 Jun 2032

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

    sulfamethizole — every 10 years, data lock point 15 Jun 2032

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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