Use eCTD for all regulatory activities in National Procedures (NP) by 1 January 2019

MA applicants are reminded that following the revision of the European eSubmission roadmap, as of January 1, 2019, every file for the acquisition of a license to market a drug for human use must be submitted in eCTD format.

18th January 2019

The NeeS submission format will be discontinued for all applications submitted under the EU national procedures (NP), i.e. applications for variations, renewals etc.

This step has previously been added to the updated version of the eSubmission Roadmap to have the same stepwise approach as for MRP submissions and applies to all submission types for a dossier such as variations, renewals, PSURs, ASMFs and so on.

MA applicants are requested to to ensure that relevant dossiers are in the eCTD format. Cambridge Regulatory Services can help you to upgrade your existing formats such as NeeS or paper-based NtA submissions to eCTD. Please contact us via website or office phone to discuss your requirements. 

For more information or an estimate, contact us »

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