GovWire

It has been mandatory to submit applications using electronic application forms (eAFs) for marketing authorisations through the centralised procedure from 1 July 2015. It will become mandatory for all other procedure types, including national procedures, from the beginning of 2016. All other Medicines and Healthcare products Regulatory Agency (MHRA) submission requirements remain unchanged.

If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF. If you are submitting your application through the Common European Submission Portal (CESP) you will only need to submit the eAF.

Further guidance is available on the European Medicines Agency eSubmissions website.

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