Skip to content
Kreastel
Opening soon

1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / lactic acid

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
7 Sept 1981
PSUR frequency
10 years
Data lock point
7 Sept 2029
Submission date
6 Dec 2029
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 03/06/2020 LMS and PRAC representatives were added on 31/07/2019 Procedure number was corrected on 18/11/2016 New substance added on 27/11/2015

Track dates like these for your own products: a sample workspace, read-only, no account needed.

Try the demo

The next three reports

  • Data lock point 7 Sept 2029Submission by 6 Dec 2029
  • Data lock point 7 Sept 2039Submission by 6 Dec 2039
  • Data lock point 7 Sept 2049Submission by 6 Dec 2049

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) / lactic acid — every 10 years, data lock point 7 Sept 2029

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    1-propanol / isopropyl alcohol (covers other synonymous terms such as 2-propanol) / lactic acid — every 10 years, data lock point 7 Sept 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.

Kreastel