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    Changes in Centralised Procedure submissions from 1.4.2014

    07.04.2014
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    State Agency of Medicines will no longer accept Centralised Procedure submissions for human medicinal products on CD or DVD or via CESP. This will apply to all types of Centralised Procedure eCTD procedures, including ASMF submissions related to centrally authorised products submitted in eCTD format.

    It is mandatory to submit Centralised Procedure eCTD submissions to the EMA via the eSubmission Gateway/Web Client. The submissions are made available to National Competent Authorities (NCAs) via the Common Repository removing the need for additional copies of the submission.

    It is essential that applicants only use one method of submission to EMA and do not submit duplicate submissions to the selected NCAs on a physical media (CD/DVD) or via CESP as these might cause a delay in the processing of the application.

    Further information: Common Repository