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Switch from paper to electronic format: eCTD

EU

As from the third quarter of 2018, also purely national marketing authorization applications have to be submitted in eCTD format. For follow-up procedures (e.g.  variations, renewal applications) of these national procedures, the switch to electronic format will be adopted from the first quarter of 2019 onwards. Marketing authorization holders of purely national marketing authorizations, therefore, should switch their files to eCTD no later than by the end of 2018. According to eSubmission roadmap version 1.0, the eCTD obligation for decentralized or mutual recognition procedure will already be effective from 2018 onwards.

More information on this topic can be found here.

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