Skip to content
Kreastel
Opening soon

magnesium chloride

As the list published 23 Sept 2026 has it, binding since 18 Jun 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
Not stated
PSUR frequency
20 years
Data lock point
2 Sept 2044
Submission date
1 Dec 2044
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

New entry added on 18/12/2024

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 2 Sept 2044Submission by 1 Dec 2044
  • Data lock point 2 Sept 2064Submission by 1 Dec 2064
  • Data lock point 2 Sept 2084Submission by 1 Dec 2084

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.

Combinations containing this substance

In earlier versions of the list

  • EMA/630645/2012 Rev.164 · published 23 Sept 2026

    magnesium chloride — every 20 years, data lock point 2 Sept 2044

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

    magnesium chloride — every 20 years, data lock point 2 Sept 2044

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