linaclotide
As the list published 4 Feb 2026 has it, binding since 2 Oct 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
- 30 Aug 2012
- PSUR frequency
- 1 year
- Data lock point
- 29 Aug 2025
- Submission date
- 7 Nov 2025
- Next data lock point
- 29 Aug 2026
- Next submission date
- 7 Nov 2026
- Products covered
- Centrally authorised (CAP)
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 amended on 02/04/2025
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 27 Nov 2026, 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 |
|---|---|---|
| PSUR frequency | 1 year | 3 years |
| Data lock point | 2025-08-29 | 2028-08-26 |
| Submission date | 2025-11-07 | 2028-11-24 |
| Next data lock point | 2026-08-29 | Not stated |
| Next submission date | 2026-11-07 | Not stated |
| Notes | DLP was amended on 02/04/2025 | DLP was corrected on 27/05/2026 PSUR frequency amended and DLP updated on 29/04/2026 |
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Try the demoThe next three reports
- Data lock point 29 Aug 2026Submission by 7 Nov 2026
- Data lock point 29 Aug 2027Submission by 7 Nov 2027
- Data lock point 29 Aug 2028Submission by 7 Nov 2028
Counted from the data lock point the list gives, on the cycle it states: the submission date is 70 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
linaclotide — every 3 years, data lock point 26 Aug 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
linaclotide — every 1 year, data lock point 29 Aug 2026
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.