paracetamol (IV formulation)

As the list published 23 Sept 2026 has it, binding since 2 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: Not stated
PSUR frequency: 5 years
Data lock point: 7 May 2026
Submission date: 5 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?

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

DLP and PSUR frequency were updated on 02/02/2022 PRAC representative was updated on 29/07/2020 PRAC representative was updated on 03/06/2020 PSUR frequency amended and DLP updated on 19/12/2018 DLP was updated on 19/12/2017 PRAC Rapporteur name updated on 21/07/2017 Next DLP was amended on 20/12/2016 PRAC Rapporteur name was amended on 28/07/2016 Next DLP was updated on 21/12/2015. Lead MS was added on 06/03/2015

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The next three reports

Data lock point 7 May 2031Submission by 5 Aug 2031
Data lock point 7 May 2036Submission by 5 Aug 2036
Data lock point 7 May 2041Submission by 5 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
paracetamol (IV formulation) — every 5 years, data lock point 7 May 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
paracetamol (IV formulation) — every 5 years, data lock point 7 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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