Skip to content
Kreastel
Opening soon

paraffin liquid / paraffin yellow soft

As the list published 23 Sept 2026 has it, binding since 25 Dec 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
1 Aug 1977
PSUR frequency
12 years
Data lock point
28 Dec 2032
Submission date
28 Mar 2033
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?

Yes — the list requires 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 corrected on 25/06/2025 New entry added on 02/04/2025

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 28 Dec 2032Submission by 28 Mar 2033
  • Data lock point 28 Dec 2044Submission by 28 Mar 2045
  • Data lock point 28 Dec 2056Submission by 28 Mar 2057

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

    paraffin liquid / paraffin yellow soft — every 12 years, data lock point 28 Dec 2032

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

    paraffin liquid / paraffin yellow soft — every 12 years, data lock point 28 Dec 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.

Kreastel