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acetylsalicylic acid / ascorbic acid / paracetamol

As the list published 4 Feb 2026 has it, binding since 1 Apr 2013. 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 Dec 1985
PSUR frequency
23 years
Data lock point
1 Jan 2035
Submission date
1 Apr 2035
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.

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 29 Jan 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.

Changing
FieldApplies todayFrom the date above
Substanceacetylsalicylic acid / ascorbic acid / paracetamolacetylsalicylic acid / ascorbic acid / paracetamol, acetylsalicylic acid / paracetamol
PSUR frequency23 years15 years
PSURs required under Art. 10(1), 10a, 16aNoYes
NotesNot statedInformation included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 29/07/2026 PSUR frequency amended on 29/07/2026 Active substance name was amended on 29/07/2026

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The next three reports

  • Data lock point 1 Jan 2035Submission by 1 Apr 2035
  • Data lock point 1 Jan 2058Submission by 1 Apr 2058
  • Data lock point 1 Jan 2081Submission by 1 Apr 2081

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

    acetylsalicylic acid / ascorbic acid / paracetamol, acetylsalicylic acid / paracetamol — every 15 years, data lock point 1 Jan 2035

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

    acetylsalicylic acid / ascorbic acid / paracetamol — every 23 years, data lock point 1 Jan 2035

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 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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