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diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed)

As the list published 23 Sept 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
17 Apr 2013
PSUR frequency
3 years
Data lock point
17 Apr 2028
Submission date
16 Jul 2028
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

PRAC representative was updated on 01/03/2023 DLP was updated on 21/12/2022 PSUR frequency and DLP were updated on 20/11/2019 DLP was updated on 21/11/2018 DLP was amended on 15/11/2017 DLP was updated on 18/11/2016 DLP was updated on 27/11/2015 DLP was amended on 01/12/2014 DLP was amended on 28/05/2014

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The next three reports

  • Data lock point 17 Apr 2028Submission by 16 Jul 2028
  • Data lock point 17 Apr 2031Submission by 16 Jul 2031
  • Data lock point 17 Apr 2034Submission by 16 Jul 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

    diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) — every 3 years, data lock point 17 Apr 2028

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

    diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) — every 3 years, data lock point 17 Apr 2028

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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