citrulline malate
As the list published 23 Sept 2026 has it, binding since 2 Aug 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
- 31 Oct 1991
- PSUR frequency
- 13 years
- Data lock point
- 12 Mar 2034
- Submission date
- 10 Jun 2034
- 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
Correction to PSUR frequency and DLP on 02/02/2022 DLP was updated on 17/11/2021 DLP was updated on 21/11/2018 PRAC representative and Lead Member State were added on 21/07/2017 New entry added on 28/03/2017
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- Data lock point 12 Mar 2034Submission by 10 Jun 2034
- Data lock point 12 Mar 2047Submission by 10 Jun 2047
- Data lock point 12 Mar 2060Submission by 10 Jun 2060
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
citrulline malate — every 13 years, data lock point 12 Mar 2034
EMA/630645/2012 Rev.156 · published 4 Feb 2026
citrulline malate — every 13 years, data lock point 12 Mar 2034
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.