cladribine (apart from products with multiple sclerosis indication)
As the list published 23 Sept 2026 has it, binding since 20 Apr 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
- 26 Feb 1993
- PSUR frequency
- 3 years
- Data lock point
- 25 Feb 2027
- Submission date
- 26 May 2027
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally and nationally authorised (CAP and 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
DLP was updated on 20/10/2021 PRAC representative was updated on 31/03/2021 PRAC representative was updated on 25/09/2019 LMS and PRAC representative were updated on 05/06/2019 DLP was updated on 21/11/2018 Entry name amended on 19/12/2017 PRAC Representative was amended on 28/03/2017 next DLP was amended on 29/10/2015
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- Data lock point 25 Feb 2027Submission by 26 May 2027
- Data lock point 25 Feb 2030Submission by 26 May 2030
- Data lock point 25 Feb 2033Submission by 26 May 2033
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
cladribine (apart from products with multiple sclerosis indication) — every 3 years, data lock point 25 Feb 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
cladribine (apart from products with multiple sclerosis indication) — every 3 years, data lock point 25 Feb 2027
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.