NeeS/VNeeSSave as PDF
Application dossiers submitted for the national, mutual recognition (MRP) and decentralised procedures (DCP), can also be compiled in a Non-eCTD electronic Submission (NeeS)/Veterinary Non-eCTD electronic Submission (VNeeS) format according to requirements by the National Competent Authorities (NCA).
The NeeS format is very similar to the eCTD with the exception that the relevant XML backbone files are not present. Therefore navigation through a NeeS is based on electronic tables of content, bookmarks and hypertext links.
A NeeS format application can normally be started at any stage in the product development lifecycle (e.g. initial submission, variation or renewal of a MAA), but NCA-specific requirements have to be considered.
ERA can support you in the compilation of your NeeS according to relevant guidelines as well as in the submission of your electronic application to NCA(s).
How can ERA's eCTD group help?
- Provision of country-specific requirements for NeeS submissions
- Compilation and submission of a new NeeS for Europe and Australia
- Conversion and submission of NeeS previously submitted in paper format (baseline submission)
- Interaction with regulatory agencies, pre- and post-submission
Are you looking for other product development consulting services independent of eCTD?
- Preparation/Authoring of NeeS
- Support with your list of questions received from NCA
- Preparation of variations
- Advice on your filing strategy
- And other consulting services regarding biotechnological and biological products as specified on our website
For further information on other consulting services please see: www.eraconsulting.com