EU processing of PSURs/ PBRERs

Today we are focusing on the processing of Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs) for medicinal products in the EU. This blog follows on from my previous blogs on this topic.

Don’t forget to check out Today’s Top Tip below!

How should I submit my PSUR in the EU?

All PSURs in the EU must be submitted to the central PSUR repository using the eSubmission Gateway/ Web Client.

What are the submission requirements and EU reference dates?

Marketing Authorisation Holders (MAHs) for active substances and combinations of active substances that are subject to assessment at EU level must submit the relevant PSURs according to the requirements set up in the list of EU reference dates (EURD).

The list does not include substances assessed at national level, although their PSURs must nonetheless be submitted via the PSUR repository. For these active substances, the frequency of submission is established at national level.

For more information, see CMDh best practice guide.

What information can be found on the EURD list?
The list provides the following information for each active substance/combination it contains:
  • frequency of PSUR submission;
  • data lock point;
  • submission date;
  • requirements for the submission of PSURs for generic, well-established use, homeopathic and traditional herbal products.
What priority does the EURD list have over the standard PSUR submission cycle?

The EURD list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.

The list is a legally binding document and MAHs are legally responsible for complying with its requirements.

How often is the EURD list updated?
The European Medicines Agency (EMA) updates the EURD list monthly*, following adoption by the Committee for Medicinal Products for Human Use (CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), after consultation with the Pharmacovigilance Risk Assessment Committee (PRAC).

*Any amendment to the EURD list becomes effective six months after its publication.

How are PSURs assessed in the EU?

PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure.

The EMA carries out PSUSA procedures to assess PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorisations and are authorised in different EU Member States. This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area.

These PSURs will be jointly assessed by the PRAC or a Member State appointed by the CMDh and result in one single assessment report, which will be shared amongst all the MAHs whose medicinal product(s) are part of the PSUR single assessment procedure.

Overall, the PRAC will issue a recommendation for the assessment of the following PSURs:
  • PSURs of centrally authorised product(s);
  • PSURs of any mix of centrally authorised products and nationally authorised products (including through the mutual recognition and decentralised procedures);
  • PSURs of nationally authorised products.

For nationally authorised medicinal products which are marketed in only one Member State and whose active substance (or combination of active substances) is included in the EURD list, the MAH should submit a PSUR as part of PSUSA procedure. A PSUSA is foreseen for each active substance or combination of active substances registered in the EURD list.

For purely nationally authorised medicinal products, containing substances or combination of actives substances not included in the EURD list, for which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level. See the CMDh best practice guide for more information on this.

For information on when and how to submit your PSUR/ PBRER in the UK please look out for the next blog in this series.

Today’s Top Tip

Don’t forget to use the PSUR repository for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure.

Don’t forget to keep an eye out for my other blogs in this series, including:
Do you have any questions/ comments or need support in this area? If so then please get in touch with us here at Fusion Pharma – we love hearing from you: or Tel: +44 (0) 203 1379 799