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5 fluorouracil / salicylic acid

As the list published 23 Sept 2026 has it, binding since 17 Aug 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
25 May 1994
PSUR frequency
5 years
Data lock point
25 May 2026
Submission date
23 Aug 2026
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

DLP and PSUR frequency were updated on 02/02/2022 PRAC representative was updated on 22/12/2021 PRAC representative was updated on 06/05/2020 DLP was updated on 06/02/2019 Next DLP was updated on 04/02/2016 Lead MS was added on 06/03/2015

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The next three reports

  • Data lock point 25 May 2031Submission by 23 Aug 2031
  • Data lock point 25 May 2036Submission by 23 Aug 2036
  • Data lock point 25 May 2041Submission by 23 Aug 2041

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

    5 fluorouracil / salicylic acid — every 5 years, data lock point 25 May 2026

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

    5 fluorouracil / salicylic acid — every 5 years, data lock point 25 May 2026

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.

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