arnica montana / arum triphyllum / belladonna, bromum / bryonia / mercurius solubilis / phytolacca decandra / pulsatilla / spongia testa
New in the list published 29 Jul 2026; binds from 29 Jan 2027.
What the list says
- EU reference date
- 24 Mar 2009
- PSUR frequency
- 18 years
- Data lock point
- 24 Mar 2044
- Submission date
- 22 Jun 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 29/07/2026
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- Data lock point 24 Mar 2044Submission by 22 Jun 2044
- Data lock point 24 Mar 2062Submission by 22 Jun 2062
- Data lock point 24 Mar 2080Submission by 22 Jun 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
arnica montana / arum triphyllum / belladonna, bromum / bryonia / mercurius solubilis / phytolacca decandra / pulsatilla / spongia testa — every 18 years, data lock point 24 Mar 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.