riociguat
As the list published 23 Sept 2026 has it, binding since 25 Nov 2022. 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
- 19 Mar 2013
- PSUR frequency
- 3 years
- Data lock point
- 19 Sept 2027
- Submission date
- 18 Dec 2027
- Next data lock point
- Not stated
- Next submission date
- Not stated
- 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 updated on 25/05/2022 PSUR frequency was amended on 01/10/2019 PRAC Rapporteur name was updated on 03/07/2019 DLP was updated on 30/04/2019 Lead MS and PRAC Rapporteur name updated on 23/10/2018 DLP was updated on 07/05/2018 Next DLP was amended on 26/04/2017 PSUR frequency and following DLP updated on 18/11/2016 Next DLP was amended on 19/10/2016 DLP and next DLP were amended on 03/05/2016 The Next DLP was amended on 29/10/2015. Next DLP was amended on 12/05/2015 EURD was amended on 04/11/2014
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- Data lock point 19 Sept 2027Submission by 18 Dec 2027
- Data lock point 19 Sept 2030Submission by 18 Dec 2030
- Data lock point 19 Sept 2033Submission by 18 Dec 2033
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
riociguat — every 3 years, data lock point 19 Sept 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
riociguat — every 3 years, data lock point 19 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.