The use of the Common Repository for Human Centralised Procedure submissions is now mandatory 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 they should no longer send 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 will apply to all types of Human Centralised Procedure eCTD submissions, including PMF submissions and ASMF submissions related to centrally authorised products submitted in eCTD format.
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 introduction of the Common Repository on 28th February 2014 enables National Competent Authorities (NCAs) to search, browse and download centralised procedure eCTD submissions for human products. The introduction of this solution in all NCAs will reduce significantly the time required for receiving and validating incoming applications and will ensure continuous and immediate access to up-to-date dossiers. It will also significantly reduce the number of submissions sent by the applicants/MAH thereby reducing time and costs related to submissions.
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.
For further information please see the Q&A document.