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glatiramer

As the list published 23 Sept 2026 has it, binding since 31 Jan 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
23 Dec 1996
PSUR frequency
3 years
Data lock point
30 Nov 2026
Submission date
28 Feb 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?

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 was amended on 31/07/2024

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The next three reports

  • Data lock point 30 Nov 2026Submission by 28 Feb 2027
  • Data lock point 30 Nov 2029Submission by 28 Feb 2030
  • Data lock point 30 Nov 2032Submission by 28 Feb 2033

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

    glatiramer — every 3 years, data lock point 30 Nov 2026

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

    glatiramer — every 3 years, data lock point 30 Nov 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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