The fees cover remuneration of These activities directly benefit marketing-authorisation holders by reducing administrative burden, simplifying reporting and streamlining processes.The chargeable unit is a unique combination of the following dataset derived from information on all medicines authorised in the European Union held by the Agency:This is consistent with the obligation of marketing-authorisation holders referred to in points (b) and (c) of Article 57(2) of For guidance on how 'chargeable units' are derived from Please note that, for PASS procedures, a flat amount to be paid in two instalments is applied.Prior to issuing an invoice, the Agency provides marketing-authorisation holders with an opportunity to review the information recorded in the Article 57 database by supplying the qualified person for The advice note contains the line listing of the chargeable units and a reference to the related products (as recorded in the Article 57 database) as well as regulatory background and electronic submission guidance.For information on general fees charged for services for obtaining and maintaining a The PSUR should be located in Module 5.3.6, Reports of Post-Marketing Experience. The Agency will inform the MAH of the insufficient quality of the translations and the transmission to the Commission will be delayed until receipt of the amended translation (which would be expected within 1 week). 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. Here is my attempt to provide most relevant practical information in a readable format. The recommendations aim to reduce the number of issues and requests for clarification that are currently being raised with PRAC during the assessment period. As it complements GVP Module VII, both documents should be consulted in conjunction. The MAH should be aware that any non-compliance detected will be highlighted in the evaluation of the PSUR and further actions will be discussed at EU level. 32. • Addressing the challenges encountered during the two years of running the PSUSA process • The explanatory note will serve as the basis for the update of GVP Module VII, which will eventually replace it. The P-RMS should comment on the signals classified by the MAH as new, ongoing and closed during the reporting interval. You should type the full details of your query in the appropriate space.

For the submission of responses to the PSUR Repository, the xml delivery file is filled in the same way as the original PSUR submission apart from the selection of 'response' as a regulatory activity (submission unit). The share payable by each For MAHs already qualified as an SME (i.e. This note should be read in conjunction with GVP Module VII; where appropriate, references to ICH E2C (R2) are made; it should be used for the preparation of PSURs subject to single assessment.In order to preserve the content that is agreed by international consensus, all European Union (EU) specific information should be provided in the EU regional appendix of the PSUR (GVP Module VII section VII.C.5. For explanatory notes, please refer to GVP Module VII on PSURs, Section VII.B.5.15 and appendix 2. See also Question ‘How will my PSUR be handled’ about section ‘Other considerations’ of the PSUSA assessment report. MAHs should consult the following information when preparing a PSUR:As of 13 June 2016, MAHs are required to submit all PSURs in the EU to the central For more information on how to use the PSUR repository, see:Further information on the PSUR repository, guidance on how to register and multimedia tutorials for MAHs on Before submitting a request, EMA encourages stakeholders to carefully consult the introductory cover note.