The mandatory use of the PSUR xml delivery file is introduced to harmonise the submission mechanism for all PSURs and it applies to all types of PSURs and any related submissions. Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure has posed a number of challenges that are specific to the assessment of nationally authorised medicinal products.

The European Commission is currently revising EMA's fees system.

To further facilitate the check and assessment, the MAH should present clean and tracked changes Word versions of the RMP in the submission.If an RMP is incorrectly submitted with a PSUR, this will be identified at the start of the procedure and both the MAH and The assessment of a PSUR may result in a recommendation to update the content of the RMP through a subsequent The PSUR should provide comprehensive information on the findings of all PASS, both interventional and non-interventional, in PSUR sections 7 and 8 respectively as an integrated summary.The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities. Holders of authorisation under Art 126a of Directive 2001/83/EC are not subject to the obligation to submit PSURs with regards to such authorisation.Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non-The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation.In this context “case narrative” refers to clinical evaluations of individual cases rather than the CIOMS narratives included in the During the assessment of the PSUR, line listings for adverse reactions of special interest may be requested by the It should be presented as a tracked change version of each EU SmPCs and This can result in having to submit a large number of sets of tracked change Where the proposed changes are not based on the data submitted within the PSUR, these will not be considered and a If the above does not apply, the updated RMP should be submitted as a stand-alone As an interim measure, submission of RMP updates cannot be accepted with PSURs subject to a PSUSA of:In these cases, MAHs should submit the updated RMPs as part of another procedure affecting the RMP, if one such procedure is foreseen. Explanatory note on pharmacovigilance fees payable to EMA (as of October 2018) Advice notes. This person will be the sole recipient of any communication from EMA throughout this procedure, including the The EMA levies a fee for the assessment of PSUR(s) since 26 August 2014.For the PSUR assessment under a PSUSA procedure involving more than one MAH, the total amount of the fee will be divided among all the MAHs concerned proportionately to the number of chargeable units.The MAHs concerned will be established on the basis of the obligation to submit the PSUR(s) and not on the basis of the actual PSUR submission(s) received by the EMA.The total of chargeable units in the procedure will be identified from the Art. The explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the Periodic Safety Update Single Assessment (PSUSA) process. No specific template needs to be followed for the responses to the The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs. If a Summary Bridging Report is also to be provided then this should be included in Module 5.3.6 as well. 32.

Explanatory Note to GVP Module VII. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure has posed a number of challenges that are specific to the assessment of nationally authorised medicinal products.The following explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the PSUSA process.

MAHs should translate all relevant Annexes for each procedure.Depending on the type of outcome and whether a Commission Decision is required irrespective whether the procedure includes CAPs and/or NAPs, the timelines for the translation process vary depending on the need for a linguistic review as illustrated below:Translations of the adopted Annexes in EN and in all other EU languages(Including Icelandic and Norwegian) are to be provided electronically (in one Eudralink package if applicable) to the Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure has posed a number of challenges that are specific to the assessment of nationally authorised medicinal products.