zonisamide
As the list published 23 Sept 2026 has it, binding since 21 Jun 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
- 10 Mar 2005
- PSUR frequency
- 3 years
- Data lock point
- 31 Mar 2028
- Submission date
- 29 Jun 2028
- 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 and DLP were updated on 21/12/2022 DLP was corrected on 03/03/2021 PSUR frequency and DLP were updated on 18/11/2020 DLP was updated on 20/11/2019 DLP was updated on 21/11/2018 PRAC Rapporteur name was amended on 23/10/2018 Reference to NAP added on 31/07/2018 DLP was amended on 15/11/2017 DLP was updated on 18/11/2016 DLP was amended on 29/10/2015 Requirement to submit generics changed on 31/01/2014
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- Data lock point 31 Mar 2028Submission by 29 Jun 2028
- Data lock point 31 Mar 2031Submission by 29 Jun 2031
- Data lock point 31 Mar 2034Submission by 29 Jun 2034
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
zonisamide — every 3 years, data lock point 31 Mar 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
zonisamide — every 3 years, data lock point 31 Mar 2028
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.