chlorquinaldol (vaginal tablet) / promestriene
As the list published 23 Sept 2026 has it, binding since 3 Dec 2020. 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
- 13 Jun 1977
- PSUR frequency
- 13 years
- Data lock point
- 30 Sept 2032
- Submission date
- 29 Dec 2032
- 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
PRAC representative was updated on 31/03/2021 PSUR frequency and CLP were updated on 03/06/2020 PSUR Frequency amended and DLP updated on 23/05/2017 EURD date amended on 22/09/2016 PSUR Frequency amended and DLP updated on 03/06/2016 Lead MS added on 12/05/2015
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- Data lock point 30 Sept 2032Submission by 29 Dec 2032
- Data lock point 30 Sept 2045Submission by 29 Dec 2045
- Data lock point 30 Sept 2058Submission by 29 Dec 2058
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
chlorquinaldol (vaginal tablet) / promestriene — every 13 years, data lock point 30 Sept 2032
EMA/630645/2012 Rev.156 · published 4 Feb 2026
chlorquinaldol (vaginal tablet) / promestriene — every 13 years, data lock point 30 Sept 2032
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.