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cemiplimab

As the list published 23 Sept 2026 has it, binding since 3 Nov 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
28 Sept 2018
PSUR frequency
2 years
Data lock point
27 Sept 2026
Submission date
26 Dec 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

PSUR frequency amended and DLP updated on 03/05/2023 PSUR frequency corrected on 21/12/2022 DLP was updated on 25/05/2022 PSUR frequency corrected on 30/03/2022 DLP was updated on 17/11/2021 PSUR frequency and DLP were updated on 26/05/2021 DLP was updated on 18/11/2020 DLP was updated on 06/05/2020 New CAP authorised on 28/06/2019

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The next three reports

  • Data lock point 27 Sept 2026Submission by 26 Dec 2026
  • Data lock point 27 Sept 2028Submission by 26 Dec 2028
  • Data lock point 27 Sept 2030Submission by 26 Dec 2030

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

    cemiplimab — every 2 years, data lock point 27 Sept 2026

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

    cemiplimab — every 2 years, data lock point 27 Sept 2026

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.

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