NeeS publishing & submission

Compile your NeeS dossiers effortlessly with immaculate precision taking into consideration all the norms as framed by the regulatory authorities.

A NeeS format application can normally be started with any initial, variation or renewal MA application. Once the switch to this electronic format is made it is expected that further applications and responses relating to the particular medicinal product are submitted in the same electronic format or in the “upgraded” full eCTD format.

Since there is no life cycle management for NeeS, there is no need to reformat the whole dossier into NeeS format when switching from paper to NeeS, but this could be done at the applicant’s discretion. It should then be clearly stated in the cover letter of the reformatted dossier that the content has not been changed, but only its format.