The introduction of the Common Repository on 28th February 2014 has enabled all National Competent Authorities (NCAs) to search, browse and download Centralised Procedure eCTD submissions for human products. The use of the Common Repository for Human Centralised Procedure submissions is mandatory since July 2015 and all NCAs are now using the Common Repository as their only source of Centralised Procedure submissions in compliance with the HMA eSubmission Roadmap.
The Common Repository has been extended to include all human Referral submissions from 1st September 2017. The use of the Common Repository for human Referral submissions became mandatory for all NCAs on 1st of December 2017. There should be no referral submissions directly to any NCAs as these will be considered to have been delivered to the NCAs.
The Common Repository has been extended to include all submissions for veterinary products from 23rd November 2017. The use of the Common Repository for veterinary submissions became mandatory for all NCAs on 1st of June 2018. There should now be no veterinary submissions for Centrally Authorised Products directly to any NCAs as these will be considered to have been delivered to the NCAs.
The Marketing Authorisation Holders submit applications only once to the European Medicines Agency and there should be no further submissions of any CDs/DVDs or CESP submissions to any individual Member States as this will take place electronically between the European Medicines Agency and the National Competent Authorities. Submissions sent to EMA via eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities’ representatives and alternates. This applies to all types of Human Centralised Procedure eCTD submissions, including PMF submissions and ASMF submissions related to centrally authorised products submitted in eCTD format, and to all submissions for Veterinary Centralised procedures, including Referrals, MRL and ASMF submissions related to centrally authorised products.
The introduction of Common Repository has significantly reduced the time required for receiving and validating incoming applications and ensures continuous and immediate access to up-to-date dossiers. It has also significantly reduced the number of submissions sent by the applicants/MAH thereby reducing time and costs related to submissions.
It is essential that applicants only use one method of submission to EMA (via eSubmission Gateway/Web Client) and do not submit duplicate submissions to any NCAs on a physical media (CD/DVD) or via CESP as these might cause a delay in the processing of the application. Please see the updated CAP Dossier Requirements document for details on Human procedures, and the CAP Dossier requirements document for details on Veterinary procedures.
News
Previous news can be found here
04-12-2024
Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5
December 2024,
between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common
Repository Web-UI
and API, PSUR Repository Web-UI (both NCA and industry access) and API.
The maintenance includes various improvements and implementations:
- Common Repository Web-UI - technology modernisation
- Gateway XML delivery file user interface - various improvements and integrations for retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
- Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g. renaming of the submission mode from "IG" to "super-grouping")
Updated documentation will be published on the relevant pages of the
eSubmission website.
For any further information, please contact EMA Service Desk.
11-06-2024
Planned maintenance of the eSubmission systems on 19 June 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on
Wednesday, 19 June 2024, between 18:00 and 21:00: Common Repository Web-UI (relevant for NCAs
only) and Common Repository API (relevant for NCAs only). During the same interval, the
Gateway Filehandler will experience short delays in sending the acknowledgements of the processed
submissions.
20-03-2024
Planned maintenance of the eSubmission systems on 25 March 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Monday 25 March 2024, between 18:00 and 21:00: Gateway XML delivery file user interface and Common Repository Web-UI (relevant for NCAs only).
The maintenance includes the introduction of a new field in the eSubmission Gateway XML delivery file user interface (EPITT number for pam-sda submissions), and other small bug fixes and improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.
Updated documentation will be published on the relevant pages of the eSubmission website.
For any further information, please contact EMA Service Desk.
15-03-2024
Planned maintenance of the Common Repository Torrent in the evening of 21 March 2024
Due to planned maintenance, the use of the Torrent files via client to download the content will not be possible on Thursday 21 March 2024, between 18:00 and 21:00. For any further information, please contact EMA Service Desk.
11-07-2023
Common repository Go-live (relevant for NCAs only)
We are pleased to inform you that the next version of the Common Repository introducing the 'Basic Authentication' is going live on the 18th July 2023.
This release improves security by modifying access to the Common Repository requiring all users to log in to the system to view/download submissions. Additionally, this release provides usability improvements mainly related to procedures containing Nationally Authorised Products.
For the completion of the deployment, Common Repository UI and API and eSubmission Delivery File UI will be unavailable on Tuesday evening, 18th of July 2023 between 18:00 and 19:30 (CET).
Relevant for NCAs only:
For further information please see the Q&A document. (08.11.2016)
Statements of Intent and announcements
Who to Contact
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
|
