Regulatory information

Mandatory use of common repository for human centralised procedures.

As of 1 July 2015 companies should send centralised procedure applications to the European Medicines Agency’s (EMA) via eSubmission Gateway/Web Client only. These applications will automatically be made available to all national competent authorities via a common online repository. 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.

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