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.
The Common Repository will be extended to all veterinary submissions in the centralised procedure. The Statement of Intent is available here.
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 (email@example.com) 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
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