Skip to content
Kreastel
Opening soon

sacubitril / valsartan

As the list published 4 Feb 2026 has it, binding since 5 Sept 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
7 Jul 2015
PSUR frequency
2 years
Data lock point
31 Jul 2026
Submission date
29 Oct 2026
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 amended and DLP updated on 05/03/2025

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 23 Mar 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.

Changing
FieldApplies todayFrom the date above
NotesPSUR frequency amended and DLP updated on 05/03/2025Reference to NAP added on 23/09/2026 PSUR frequency amended and DLP updated on 05/03/2025

Track dates like these for your own products: a sample workspace, read-only, no account needed.

Try the demo

The next three reports

  • Data lock point 31 Jul 2026Submission by 29 Oct 2026
  • Data lock point 31 Jul 2028Submission by 29 Oct 2028
  • Data lock point 31 Jul 2030Submission by 29 Oct 2030

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

    sacubitril / valsartan — every 2 years, data lock point 31 Jul 2026

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

    sacubitril / valsartan — every 2 years, data lock point 31 Jul 2026

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 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.

Kreastel