bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus agalactiae / staphylococcus aureus / haemophilus influenzae

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: 11 Jan 1974
PSUR frequency: 5 years
Data lock point: 31 Mar 2026
Submission date: 29 Jun 2026
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

PRAC representative was updated on 01/03/2023 DLP was updated on 22/12/2021 Entry name and EURD were amended on 31/01/2018 Next DLP was amended on 20/12/2016 DLP was corrected on 04/02/2016. Active Substance and DLP was amended on 21/12/2015. PRAC representative name was amended on 31/07/2015 Active Substance name amended on 16/07/2015 Lead MS was added on 04/02/2015

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The next three reports

Data lock point 31 Mar 2031Submission by 29 Jun 2031
Data lock point 31 Mar 2036Submission by 29 Jun 2036
Data lock point 31 Mar 2041Submission by 29 Jun 2041

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
bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus agalactiae / staphylococcus aureus / haemophilus influenzae — every 5 years, data lock point 31 Mar 2026
EMA/630645/2012 Rev.156 · published 4 Feb 2026
bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes, streptococcus pneumoniae / streptococcus agalactiae / staphylococcus aureus / haemophilus influenzae — every 5 years, data lock point 31 Mar 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

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