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ATROPA BELLA-DONNA C6 / VIBURNUM OPULUS C6 / CHELIDONIUM MAJUS C6 / ACONITUM NAPELLUS C6 / CALENDULA OFFICINALIS C6 / ABRUS PRECATORIUS C6

As the list published 4 Feb 2026 has it, binding since 28 Nov 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
11 Jul 2008
PSUR frequency
18 years
Data lock point
10 Jul 2044
Submission date
8 Oct 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 active substance added on 28/05/2025

Changing

The list published 23 Sept 2026 changes this entry. Those values bind from 29 Jan 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.

Changing
FieldApplies todayFrom the date above
SubstanceATROPA BELLA-DONNA C6 / VIBURNUM OPULUS C6 / CHELIDONIUM MAJUS C6 / ACONITUM NAPELLUS C6 / CALENDULA OFFICINALIS C6 / ABRUS PRECATORIUS C6ATROPA BELLA-DONNA / VIBURNUM OPULUS / CHELIDONIUM MAJUS / ACONITUM NAPELLUS / CALENDULA OFFICINALIS / ABRUS PRECATORIUS
NotesNew active substance added on 28/05/2025Active substance name was amended on 29/07/2026 New active substance added on 28/05/2025

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The next three reports

  • Data lock point 10 Jul 2044Submission by 8 Oct 2044
  • Data lock point 10 Jul 2062Submission by 8 Oct 2062
  • Data lock point 10 Jul 2080Submission by 8 Oct 2080

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

    ATROPA BELLA-DONNA / VIBURNUM OPULUS / CHELIDONIUM MAJUS / ACONITUM NAPELLUS / CALENDULA OFFICINALIS / ABRUS PRECATORIUS — every 18 years, data lock point 10 Jul 2044

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

    ATROPA BELLA-DONNA C6 / VIBURNUM OPULUS C6 / CHELIDONIUM MAJUS C6 / ACONITUM NAPELLUS C6 / CALENDULA OFFICINALIS C6 / ABRUS PRECATORIUS C6 — every 18 years, data lock point 10 Jul 2044

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.156, published 4 Feb 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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