secale cereale L., phleum pratense, zea mays L. single or mixes (genitourinary therapy)
New in the list published 27 May 2026; binds from 27 Nov 2026.
What the list says
- EU reference date
- 28 Oct 2004
- PSUR frequency
- 5 years
- Data lock point
- 28 Oct 2030
- Submission date
- 26 Jan 2031
- 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
New entry added 27/05/2026
Track dates like these for your own products: a sample workspace, read-only, no account needed.
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- Data lock point 28 Oct 2030Submission by 26 Jan 2031
- Data lock point 28 Oct 2035Submission by 26 Jan 2036
- Data lock point 28 Oct 2040Submission by 26 Jan 2041
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
secale cereale L., phleum pratense, zea mays L. single or mixes (genitourinary therapy) — every 5 years, data lock point 28 Oct 2030
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.