Periodic Safety Update Reports (PSURs)
A Periodic Safety Update Report is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits.
The legal requirements for submission of PSURs are established in Regulation (EU) No 1235/2010, Directive 2010/84/EU and in Commission Implementing Regulation (EU) No 520/2012. The format of PSURs follows the structure described in the Implementing Regulation Article 35 and Module VII of the Guidelines on Good Pharmacovigilance Practices (GVP) provides guidance on the preparation, submission and assessment of PSURs. This format is a legal requirement for both Nationally Authorised Products (NAPs) and Centrally Authorised Products (CAPs).
Who should submit PSURs?
The 2010 legislation introduces the principle of EU single assessment where a substance is authorised in more than one Member State. The European Medicines Agency maintains a list of EU reference dates and frequency of submission of PSURs (EURD list) for active substances contained in medicines in the EU and is updated on an ongoing basis.
Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list. The legislation introduces derogation for routine PSUR reporting for certain products. Unless there is a specific condition in the authorisation, or it is indicated otherwise in the EURD list, routine PSUR reporting is not required for medicinal products authorised under the following articles of Directive 2001/83/EC:
• Article 10.1 generics
• Article 10.a well-established use
• Article 14 homeopathic medicines
• Article 16a traditional herbal medicines
Further information on GVP and the EURD list may be found on the European Medicines Agency website. Please note that the EURD list is a living document which will be amended whenever considered necessary by the PRAC, the CHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances and requests received from MAHs. Substances can be added or removed as appropriate. MAHs should therefore maintain an awareness of the current status of the list which is reviewed on a monthly basis.
Guidance on PSUR Submission
Mandatory submission of PSURs via the EU PSUR Repository
As of 13th June 2016, it is mandatory for all MAHs to submit PSURs for human medicines authorised in the EU directly to the PSUR repository. The repository will act as the single point for all submissions (including responses and supplementary information). This is mandatory for both centrally authorised and nationally authorised medicinal products whether they follow the EU single assessment or a purely national assessment procedure. As a consequence, no further PSUR submissions should be made to the HPRA from this date onwards and the CMDh document “Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Procedures, MRP and DCP (NAPs)” is no longer applicable. PSURs not sent to the PSUR repository are considered as not submitted and will not fulfil the MAH’s legal obligation to submit PSURs.
All PSURs should be submitted to the PSUR repository using the eSubmission Gateway/Web Client: http://esubmission.ema.europa.eu/esubmission.html
Information on the repository, guidance on how to register and multimedia tutorials for MAHs on how to submit a PSUR, as well as on the correct structured electronic formats, can be found on EMA’s PSUR repository web pages here: http://esubmission.ema.europa.eu/psur/psur_repository.html
Further information for MAHs on changes to submission of PSURs for human medicines is available here: PSUR repository mandatory use: Q&A
Users of the repository should direct any questions on use of the EMA PSUR repository and/or the eSubmission Gateway/Web Client to the EMA Service Desk portal: https://servicedesk.ema.europa.eu.
For further information on submission dates, PSUSA procedure number and requirements for submission of products referred to in articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended please refer to the EURD list.
Detailed guidance on procedural aspects of the EU single assessment is available on the EMA website: PSURs: questions and answers