teriparatide
As the list published 23 Sept 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
- 10 Jun 2003
- PSUR frequency
- 3 years
- Data lock point
- 12 Sept 2027
- Submission date
- 11 Dec 2027
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally and nationally authorised (CAP and 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
New CAP authorised on 27/04/2026 Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" was amended on 28/05/2025 DLP was amended on 28/05/2025 New CAP authorised on 12/01/2023 New CAPs authorised on 18/11/2022 DLP and Information included in column "Are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended?" were amended on 25/05/2022 New CAP authorised on 24/03/2022 PRAC representative was updated on 26/05/2021 New CAPs authorised on 27/08/2020 DLP updated on 05/06/2019 Lead MS and PRAC Rapporteur name amended on 06/02/2019 Lead MS and PRAC Rapporteur name amended on 21/11/2018 Reference to NAP added on 31/01/2018 PSUR Frequency amended and DLP updated on 03/05/2016
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- Data lock point 12 Sept 2027Submission by 11 Dec 2027
- Data lock point 12 Sept 2030Submission by 11 Dec 2030
- Data lock point 12 Sept 2033Submission by 11 Dec 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
teriparatide — every 3 years, data lock point 12 Sept 2027
EMA/630645/2012 Rev.156 · published 4 Feb 2026
teriparatide — every 3 years, data lock point 12 Sept 2027
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.