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Previous News

17-08-2018

Reminder concerning the Common Repository for Veterinary medicinal products: applicants are reminded that for procedures involving only Centrally Authorised products, submission should be done only once, via the EMA eSubmission Gateway. No additional submission should be done via CESP, CD or DVD, as National Competent Authorities have now access to the Common repository. For further details, please consult 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)

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)

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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

08-11-2017

From 1 December 2017, the use of Common Repository for Referral submissions replaces the use of CESP and CD/DVD for sending the Referral submissions to the National Competent Authorities (NCAs). All human referral submissions sent to the EMA will be considered delivered to all NCAs representatives and alternates.

Submissions for all referrals should be made using the EMA eSubmission Gateway/Web Client only. Additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. The Dossier requirement document will be updated shortly.

22-11-2017

A new version of the Common Repository, extending the system to all EMA coordinated veterinary submissions is available from Thursday 23rd of November 2017. The new system can be accessed by all National Competent Authorities (NCAs) and committee members to search, view and download veterinary submissions.

The dossier requirements for veterinary submissions remain in place until the use of the system becomes mandatory in Q2 2018. Applicants should continue sending applications to EMA via the eSubmission Gateway and to the NCAs via CESP or CD/DVD as listed the dossier requirements document until it is announced by the EMA that the NCA is using the system exclusively.

20-11-2017

The use of the Common Repository for Referral submissions becomes mandatory for all member states on 1st of December 2017. Please note that there should be no Referral submissions (including CAPs and NAPs) to any of the member states after 1.12.2017. Meanwhile, prior to the mandatory use the following member states have communicated the exclusive use of the Common Repository; Croatia, Estonia, Finland, Norway, Latvia and Romania.

22-09-2017

Romania is now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Croatia, Estonia, Finland, Norway, Latvia and Romania, as these types of submissions are now retrieved via the Common Repository.

15-09-2017

Croatia and Finland are also now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Croatia, Estonia, Finland, Norway and Latvia, as these types of submissions are now retrieved via the Common Repository.

14-09-2017

Estonia and Norway are now using the Common Repository to receive Referral submissions. Please do not send any Referral submissions (including CAPs and NAPs) to Estonia, Norway and Latvia, as these types of submissions are now retrieved via the Common Repository.

01-09-2017

The Common Repository has been extended to contain all human Referral submissions. The use of the Common Repository for referral submissions will become mandatory for all NCAs after a transitional period. The date for the mandatory use for Referral submissions by all NCAs will be announced shortly. The MAHs are advised to review the Dossier Requirements for referral, NAP and ancillary medicinal substances in medical devices document.

Latvia is now using the Common Repository to receive Referral submissions, in addition to all CAP submissions, from 1 September 2017. Please do not send any Referral submissions (including CAPs and NAPs) to Latvia as these are now retrieved via the Common Repository.

The Common Repository will be extended to all veterinary submissions in the centralised procedure. The Statement of Intent is available here.

The introduction of the Common Repository on 28th February 2014 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 using the Common Repository as their only source of Centralised Procedure submissions in compliance with the HMA eSubmission Roadmap.

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.

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.

 

 

 
 

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