anagrelide
As the list published 23 Sept 2026 has it, binding since 30 Nov 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
- 16 Nov 2004
- PSUR frequency
- 5 years
- Data lock point
- 13 Sept 2027
- Submission date
- 12 Dec 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
PSUR frequency amended and DLP updated on 31/05/2023 Correction: Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 21/10/2022 PSUR frequency and DLP were updated on 28/04/2021 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 DLP was updated on 06/05/2020 DLP was updated on 30/04/2019 DLP was updated and information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was updated on 07/05/2018 PRAC Rapporteur name updated on 21/07/2017 Next DLP was amended on 26/04/2017 PRAC Rapporteur name was amended on 28/07/2016 PRAC Rapporteur name updated on 03/06/2016 Next DLP was amended on 03/05/2016 "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No" was amended on 16/07/2015 Rapporteur name amended on 04/11/2014
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- Data lock point 13 Sept 2027Submission by 12 Dec 2027
- Data lock point 13 Sept 2032Submission by 12 Dec 2032
- Data lock point 13 Sept 2037Submission by 12 Dec 2037
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
anagrelide — every 5 years, data lock point 13 Sept 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
anagrelide — every 5 years, data lock point 13 Sept 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.