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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

04-06-2018

Mandatory use of the Common Repository for veterinary submissions

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions is now mandatory since the 1st of June 2018. Please see further details in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)

And

The Common Repository has been extended to include EMA coordinated procedures from 8 March 2018. The use of the Common Repository for EMA coordinated procedures will become mandatory on 1st September 2018.

There should be no EMA coordinated procedures submissions sent directly to any NCAs from 1st of September 2018 as these will be considered to have been delivered to the NCAs. Please see the Statement of Intent on the mandatory use of Common Repository for EMA coordinated submissions for human medicinal products.

09-04-2018

Stepwise implementation towards mandatory use of the Common Repository for veterinary submissions

The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions will be mandatory from 1st June 2018. Until this time, a transition period is ongoing, whereby the use of the Common Repository is being implemented in a stepwise approach, as indicated in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)

08-03-2018

Common Repository (User Interface and API) is now extended to include the following types of submissions related to procedures for Human Medicinal Products: Signal Detection, PASS 107 NAPs, Work share NAPs and Ancillary products for new submissions from the 8th of March 2018 onwards. This will be followed by a transitional period of 6-9 months, during which all NCAs will have time to adapt their systems and business processes in order to switch to the sole use of the Common Repository. During the transitional period, NCAs can still receive submissions directly from applicants, but they will also have the opportunity to switch to the sole use of the Common Repository during this period as and when they are ready to do so. Following the transitional period, the use of the Common Repository for above submissions will become mandatory for all NCAs. The date for the mandatory use is not yet decided.

23-02-2018

A new version of the Common Repository will be available in March 2018 extending the system to other EMA led EU procedures submissions.
Common Repository will extend and/or add new Cabinets to include the following types of submissions related to Human procedures:

    • Signal Detection
    • PASS 107 NAPs
    • Work share NAPs
    • Ancillary Products

Relevant for NCAs only:

  • The acceptable usage policy defines a set of rules for the 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 the 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 (jsimarro@aemps.es) 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 updated Q&A document. (08.11.2016) Updated

Statements of Intent and announcements

Statement of Intent on the mandatory use of Common Repository for EMA coordinated submissions for human medicinal products New

Statement of Intent on the mandatory use of Common Repository for human Referral submissions (14.09.2017)

Statement of Intent on the extension of the Common Repository for all Veterinary submissions in Centralised Procedure (25.11.2016)

Who to Contact

NCA User registration https://servicedesk.ema.europa.eu
Common Repository related technical issues https://servicedesk.ema.europa.eu

 

 

 

 

 

 

 

 


 

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