hydrocortisone (for centrally authorised products for adrenal insufficiency, congenital adrenal hyperplasia, modified-release formulations)
As the list published 4 Feb 2026 has it, binding since 28 Dec 2023. 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
- 3 Nov 2011
- PSUR frequency
- 3 years
- Data lock point
- 3 Nov 2025
- Submission date
- 1 Feb 2026
- Next data lock point
- Not stated
- Next submission date
- Not stated
- Products covered
- Centrally authorised (CAP)
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 amended on 28/06/2023 PRAC representative was updated on 19/10/2022 Active substance name was amended on 30/06/2021 New CAP authorised on 27/05/2021 DLP was updated on 01/07/2020 PRAC Representative updated on 26/09/2018 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 Next DLP was amended on 03/06/2016 DLP was amended on 16/06/2015 Next DLP was amended 08/01/2014 and 08/08/2014 Name of active substance was amended on 01/08/2013
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 1 Jan 2027, six months after the change was published (Article 107c(7) of Directive 2001/83/EC). Until then, what is above applies.
| Field | Applies today | From the date above |
|---|---|---|
| Data lock point | 2025-11-03 | 2028-11-03 |
| Submission date | 2026-02-01 | 2029-02-01 |
| Notes | DLP was amended on 28/06/2023 PRAC representative was updated on 19/10/2022 Active substance name was amended on 30/06/2021 New CAP authorised on 27/05/2021 DLP was updated on 01/07/2020 PRAC Representative updated on 26/09/2018 PRAC Rapporteur name was amended on 31/07/2018 Next DLP was amended on 27/06/2017 Next DLP was amended on 03/06/2016 DLP was amended on 16/06/2015 Next DLP was amended 08/01/2014 and 08/08/2014 Name of active substance was amended on 01/08/2013 | DLP was amended on 01/07/2026 |
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- Data lock point 3 Nov 2028Submission by 1 Feb 2029
- Data lock point 3 Nov 2031Submission by 1 Feb 2032
- Data lock point 3 Nov 2034Submission by 1 Feb 2035
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
hydrocortisone (for centrally authorised products for adrenal insufficiency, congenital adrenal hyperplasia, modified-release formulations) — every 3 years, data lock point 3 Nov 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
hydrocortisone (for centrally authorised products for adrenal insufficiency, congenital adrenal hyperplasia, modified-release formulations) — every 3 years, data lock point 3 Nov 2025
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
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