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.
Previous news can be found here
Reminder concerning the Common Repository for EMA coordinated procedures for Human Medicinal Products: applicants are reminded that for mentioned procedures involving both Centrally and Nationally Authorised products, submission should be done only once, via the EMA eSubmission Gateway. No additional submission should be done via CESP.
The Dossier Requirements for referral, NAP and ancillary medicinal substances in medical devices document will be updated soon.
Relevant for NCAs only:
- The acceptable usage policy defines a set of rules for Common Repository users, which give direction how to use the CR system in an optimal way, leading to good system response times, high reliability, and an efficient use of available IT resources.
- AEMPS has developed a tool to automatically download from the Common Repository via the API. The tool is available for other NCAs free-of-charge. More information can be found here. Please inform Jose Manuel Simarro from AEMPS (firstname.lastname@example.org) if you have downloaded the tool.
- Telematics website: http://euteleproj.eudra.org/
- Common Repository: https://web-cr.eudra.org/
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.