caffeine / dimenhydrinate, dimenhydrinate
As the list published 4 Feb 2026 has it, binding since 15 Jul 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
- 10 Feb 1950
- PSUR frequency
- 8 years
- Data lock point
- 1 Dec 2025
- Submission date
- 1 Mar 2026
- 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
Active substance name, PSUR frequency and DLP were amended on 18/10/2023
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 29 Jan 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| Data lock point | 2025-12-01 | 2033-12-01 |
| Submission date | 2026-03-01 | 2034-03-01 |
| Notes | Active substance name, PSUR frequency and DLP were amended on 18/10/2023 | DLP was amended on 29/07/2026 |
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- Data lock point 1 Dec 2033Submission by 1 Mar 2034
- Data lock point 1 Dec 2041Submission by 1 Mar 2042
- Data lock point 1 Dec 2049Submission by 1 Mar 2050
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
caffeine / dimenhydrinate, dimenhydrinate — every 8 years, data lock point 1 Dec 2033
EMA/630645/2012 Rev.156 · published 4 Feb 2026
caffeine / dimenhydrinate, dimenhydrinate — every 8 years, data lock point 1 Dec 2025
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.