Any comments or questions should be addressed via ASK EMA. You will be able to contact the RMS throughout the procedure.For PSUR repository interface, eSubmission Gateway and/or the Web Client questions, issues, change requests and requests for services, please contact us through the The Agency aims to respond to your query within 5 working days.

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.

By analogy to the implementation of For generic products or others not directly involved in the PSUSA procedure itself, the changes have to be submitted via a - II (new data submitted; classification dependent on proposed changes)- II (new data submitted; classification dependent on proposed changes)PSURs, PSUR addendums, summary bridging reports and line listings should no longer be submitted as part of a In the web form you will be asked to provide your name, the name of your employer or organisation, contact details and the subject of your enquiry. 15/06/2016 ¼ C a l i b r i 1 Ü A revised timetable will then be prepared.The MAHs are also strongly advised to liaise directly with the Member States in case of disagreement with any of the comments made or in case further clarification on some comments is required, and to reflect the outcome in “ Ú 1 ´ ÿ� V e r d a n a 1 Ü � C a l i b r i 1 Ü � C a l i b r i 1 Ü � C a l i b r i 1 Ü � C a l i b r i 1   ÿ� C a l i b r i 1 Ü ÿ¼ V e r d a n a 1 Ü ÿ¼ V e r d a n a 1 ´ ÿ¼ V e r d a n a 1 È ÿ� A r i a l 1 È ÿ� V e r d a n a 1 ª ÿ� V e r d a n a 1 @ : � V e r d a n a 1 ğ � V e r d a n a 1 ÿ¼ V e r d a n a 1 ´ ÿ� V e r d a n a 1 ´ � V e r d a n a 1 Ü � V e r d a n a 1 È � V e r d a n a 1 Ü 4 ¼ C a l i b r i 1 Ü ¼ C a l i b r i 1 Ü ?

Product Selection ..... 16 3.1.1. Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list. 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. if it involves nationally authorised products (NAP), centrally authorised products (CAP) or a mix of both.

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).

Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding (March 2017) CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU) (July 2019) [Track version] Overview of comments received … an update of the information provided to healthcare professionals and patients).Article 35 of the Commission Implementing Regulation describes the structure of PSURs.

The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates… History and development of the EU Reference Dates list. The MAH(s) will implement the required changes, compile the translations and send it back to the EMA.In case of disagreement between a Member State and the MAH, the EMA will not interfere in the translation process at this stage.

EMA is in the process of making appropriate changes to this website. It should be noted that the PSUSA cut-off date continues to apply to procedures containing nationally authorised It is the responsibility of MAHs to ensure that they submit the necessary PSUR by the submission deadline as stated in the If you have missed the submission deadline due to technical issues with the PSUR Repository, please contact EMA as soon as possible via the The use of the PSUR Repository is mandatory for all PSUR submissions. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health (e.g. The European Union reference dates (EURD) list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates, frequencies for submission of periodic safety update reports and related data lock points. To help us deal with your enquiry, please provide as much information as possible including whether your query refers to a NAP or a CAP, the procedure number of the PSUR single assessment as per the