1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / orthophenylphenol
As the list published 23 Sept 2026 has it, binding since 4 Aug 2026. 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
- 23 Oct 1980
- PSUR frequency
- 10 years
- Data lock point
- 23 Oct 2029
- Submission date
- 21 Jan 2030
- 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 was amended on 04/02/2026 PSUR frequency and DLP were updated on 01/07/2020 Lead MS and PRAC Rapporteur name added on 03/04/2019 Entry name changed and Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes/No was updated on 07/05/2018 New substance added on 27/11/2015
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- Data lock point 23 Oct 2029Submission by 21 Jan 2030
- Data lock point 23 Oct 2039Submission by 21 Jan 2040
- Data lock point 23 Oct 2049Submission by 21 Jan 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
1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / orthophenylphenol — every 10 years, data lock point 23 Oct 2029
EMA/630645/2012 Rev.156 · published 4 Feb 2026
1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / orthophenylphenol — every 10 years, data lock point 23 Oct 2029
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.