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Add CC Search to your browser. Learn how to switch to or from CC Search in your Firefox search bar. The use of the Formatted Letter Template will become obsolete as of 1st January 2019. Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier. From 1 January 2019, the Formatted Letter Template will not be maintained by EMA and the document and references will be removed from EMA corporate website.
XMLdelivery file, as all attributes in the . XML delivery file are used to support important searches in the Common Repository. XML will also support EMA internal processes by significantly reducing the time required for receiving, processing, and validating incoming applications, and ensures continuous and immediate access to up-to-date dossiers. Please note that incorrect submissions may lead to procedural delays of incoming applications. Also, a Purchase Order number attribute for PASS 107 procedure was introduced.
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This is aligning with how Human procedure numbers can be linked to ASMF submission. The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. It also facilitates the assessment by ensuring that NCAs, EMA and its scientific committees have timely and secure access to all relevant documents.
The use of the PSUR Repository is mandatory as of 13 June 2016. PSURs for products authorised under Art. There should be no PSUR submissions directly to the National Competent Authorities from 13 June 2016 onwards. Web Client with the use of an XML delivery file.
The delivery files are used to provide required metadata allowing the EMA to process the submissions. You can find the link to the tool to create the delivery file here. Previous news can be found here. The main enhancements provided in PSUR Repository versions 1. Users can now view all historic versions of the Assessment Report along the submitter and date received for each version. When performing a search for any PSUSA for a particular procedure the Document Types are displayed with a hyperlink to the physical location of the document.
The PSUR Repository will be impacted by essential maintenance to SPOR data services between 08:00-18:00 hrs on Saturday, 25 August 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. MA authorisation type’ will also be unavailable during this period. The PSUR Repository will be impacted by essential maintenance to SPOR data services between 18:00-19:00hrs on Thursday, 17 May 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. The PSUR Repository will be impacted by essential maintenance to SPOR data services between Saturday and Sunday, 10-11 March 2018 for industry users sending non-EU single assessment PSURs and for NCA users performing searches in the non-EU single assessment area of the PSUR Repository. MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday 9 March, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime. PSUR and Gateway File Handler will be affected between 07:00 and 08:00 on Wednesday, 31 January 2018 due to essential maintenance to EMA’s computer systems. Previous Repository Bulletins are available here.