EMA announces full availability of electronic application forms; udpated eSubmission gateway Q&A

After succesfully completing the previous pilot phase, the European Medicines Agency (EMA) has recently announced the full availability of the electronic application forms for marketing authorisation applicants and holders. 

The electronic forms were developed in a co-production by the European Commission, the Agency and national regulatory authorities in the EU Member States.  The electronic forms are available for initial marketing authorisations, variations or renewals for human and veterinary medicines.

Applicants are advised to download the latest versions from the Agency's eSubmission website .

In addition, the EMA has released a recent update of the "EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation". This Q&A document aims to address the commonly-asked questions and provide guidance regarding technical and practical aspects of the Agency’s eSubmission Gateway for electronic submissions as part of the Centralised Procedure and can be downloaded here.

[Source: EMA]

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