glucose (apart from glucose1- phosphate), glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride and/or sodium acetate (intravenous or parenteral use except haemodialysis, hemodiafiltration), potassium phosphate / sodium chloride / glucose / lactic acid / magnesium chloride / sodium lactate / potassium chloride

As the list published 23 Sept 2026 has it, binding since 17 Jun 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: 22 Mar 1971
PSUR frequency: 10 years
Data lock point: 2 Sept 2034
Submission date: 1 Dec 2034
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 amended on 17/12/2025 Active substance name was amended on 05/06/2024 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?", PSUR frequency and DLP were amended on 26/07/2023 Active substance name, PSUR frequency and DLP were amended on 03/05/2023 Active substance name was amended on 23/10/2018 New active substance added on 21/12/2015

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The next three reports

Data lock point 2 Sept 2034Submission by 1 Dec 2034
Data lock point 2 Sept 2044Submission by 1 Dec 2044
Data lock point 2 Sept 2054Submission by 1 Dec 2054

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
glucose (apart from glucose1- phosphate), glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride and/or sodium acetate (intravenous or parenteral use except haemodialysis, hemodiafiltration), potassium phosphate / sodium chloride / glucose / lactic acid / magnesium chloride / sodium lactate / potassium chloride — every 10 years, data lock point 2 Sept 2034
EMA/630645/2012 Rev.156 · published 4 Feb 2026
glucose (apart from glucose1- phosphate), glucose in combination with calcium chloride and/or sodium chloride and/or magnesium chloride and/or sodium citrate and/or potassium chloride and/or sodium acetate (intravenous or parenteral use except haemodialysis, hemodiafiltration), potassium phosphate / sodium chloride / glucose / lactic acid / magnesium chloride / sodium lactate / potassium chloride — every 10 years, data lock point 2 Sept 2034

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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