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simvastatin

As the list published 23 Sept 2026 has it, binding since 16 Jun 2021. 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
6 Apr 1988
PSUR frequency
5 years
Data lock point
5 Apr 2030
Submission date
4 Jul 2030
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 16/12/2020 Lead MS and PRAC Rapporteur name amended on 19/12/2018 DLP was updated on 19/12/2017 Lead MS and PRAC Rapporteur name was added on 19/10/2016 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 5 Apr 2030Submission by 4 Jul 2030
  • Data lock point 5 Apr 2035Submission by 4 Jul 2035
  • Data lock point 5 Apr 2040Submission by 4 Jul 2040

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.

Combinations containing this substance

In earlier versions of the list

  • EMA/630645/2012 Rev.164 · published 23 Sept 2026

    simvastatin — every 5 years, data lock point 5 Apr 2030

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

    simvastatin — every 5 years, data lock point 5 Apr 2030

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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