Changes in the submission of marketing authorisation documentation

08.07.2015.

European Medicines Agency (EMA) informs that from 1 July 2015 marketing authorisation holders should send their centralised procedure applications for human medicines to the EMA via eSubmission Gateway/Web Client only. These applications companies should not sent to national agencies of European Union, including the State Agency of Medicines (SAM), on CDs/DVDs or via the Common European Submission Platform (CESP).

This applies to all human centralised procedure applications in the electronic Common Technical Document (eCTD) format. The CESP remains in use for other procedure types as previously.

SAM also informs that, when submitting additional documentation via CESP, it is not necessary to submit a signed cover letter. More information is available in the section “eSubmission/CESP“ of the SAM website.

For further information, please see the eSubmission website and the section “Register” of the SAM website.