magnesium hydroxide

As the list published 23 Sept 2026 has it, binding since 27 Aug 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: 9 Nov 1970
PSUR frequency: 5 years
Data lock point: 31 Oct 2026
Submission date: 29 Jan 2027
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 was updated on 29/06/2022 DLP was updated on 21/07/2017 Lead MS and PRAC Rapporteur name was added on 03/06/2016

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The next three reports

Data lock point 31 Oct 2026Submission by 29 Jan 2027
Data lock point 31 Oct 2031Submission by 29 Jan 2032
Data lock point 31 Oct 2036Submission by 29 Jan 2037

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 hydroxide — every 5 years, data lock point 31 Oct 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
magnesium hydroxide — every 5 years, data lock point 31 Oct 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.

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