eWAY-eCTD Solutions

NeeS / VNeeS

Non-eCTD electronic Submissions- (NeeS)
Veterinary Non eCTD Electronic Submission (VNeeS)

NeeS has been used as a bridge format until the adoption of eCTD as the only acceptable format, and is now only accepted in a few limited circumstances.

A NeeS differs from an eCTD in that it does not contain an XML backbone or the quantity of MD5 checksum values as defined by the ICH – it is in essence, a collection of electronic files organised in folders.

eWAY-eCTD SOLUTIONS support Nees Format for following Regulatory authority and compliant software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

Europe– EU Nees

  • EU NeeS Module 1 Specification, version 4.0
  • EU NeeS Validation Criteria, version 4.3

Gulf Corporation Council (GCC)– Nees/VNeeS

  • GCC NeeS Module 1 Specification, version 1.2/ version 1.5
  • GCC NeeS Validation Criteria, version 1.2/ version 1.4
  • GCC VNeeS Validation Criteria, version 4.1

Australia/NZ– AU/NZ Nees

  • AU/NZ NeeS Module 1 Specification, version 2.0
  • AU/NZ NeeS Validation Criteria, version 2.0

Bosnia and Herzegovina- BIH NeeS (ALMBIH)-Nees

  • ALMBiH NeeS Module 1 Specification, version 1.0
  • ALMBiH NeeS Validation Criteria, version 1.0


  • EU VNeeS eSubmission for a Veterinary Medicinal Product, version 2.6
  • EU VNeeS Validation Criteria, version 2.6 We fulfills the following NeeS validation criteria