allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)
As the list published 4 Feb 2026 has it, binding since 6 Apr 2026. 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 Sept 2015
- PSUR frequency
- 3 years
- Data lock point
- 22 Sept 2025
- Submission date
- 21 Dec 2025
- 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?
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
PSUR frequency amended and DLP updated on 03/05/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 28/04/2022 DLP was updated on 28/04/2021 DLP was updated on 06/05/2020 PSUR frequency and DLP were updated on 20/11/2019 Next DLP was updated on 05/06/2019 DLP was updated on 21/11/2018 DLP was updated on 06/06/2018 Entry name amended on 17/10/2017 Lead MS and PRAC Rapporteur name was added on 27/06/2017 New active substance added on 26/04/2017
Changing
The list published 23 Sept 2026 changes this entry. Those values bind from 27 Nov 2026, 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 | 2025-09-22 | 2028-09-22 |
| Submission date | 2025-12-21 | 2028-12-21 |
| Notes | PSUR frequency amended and DLP updated on 03/05/2023 PRAC representative was updated on 01/03/2023 DLP was updated on 28/04/2022 DLP was updated on 28/04/2021 DLP was updated on 06/05/2020 PSUR frequency and DLP were updated on 20/11/2019 Next DLP was updated on 05/06/2019 DLP was updated on 21/11/2018 DLP was updated on 06/06/2018 Entry name amended on 17/10/2017 Lead MS and PRAC Rapporteur name was added on 27/06/2017 New active substance added on 26/04/2017 | DLP was amended on 27/05/2026 |
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- Data lock point 22 Sept 2028Submission by 21 Dec 2028
- Data lock point 22 Sept 2031Submission by 21 Dec 2031
- Data lock point 22 Sept 2034Submission by 21 Dec 2034
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
allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) — every 3 years, data lock point 22 Sept 2028
EMA/630645/2012 Rev.156 · published 4 Feb 2026
allergen for therapy: dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) — every 3 years, data lock point 22 Sept 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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Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.