The submission of information to the regulatory authorities have always been very important and critical. The success of millions of dollar research depends on the successful submission as the final and most critical step. Sarjen understands the intricacies of submission process and its vital aspects and hence its web based solution abstracts the complexity of the XML backbone structure and makes submissions very user friendly.
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.
Applicants should not change from eCTD back to NeeS. In exceptional circumstances, if this should be needed, please contact the concerned NCAs in advance.
The core of Sarjen’s success lies in its intellectual approach in understanding the process of NeeS submission and helps in easy and accurate NeeS publishing
For NeeS submission the eCTD folder structure is used with the addition of TOC’s (Table of contents) as appropriate. For the folder structure and file
NeeS submission are accepted in following regions
Europe (EU NeeS): EU Module 1 Specification, version 2.0 and EU NeeS Validation Criteria, version 4.0
Australia/New zealand (AU/NZ NeeS): AU/NZ NeeS Validation Criteria, version 1.0
GCC (GCC NeeS): Module 1 Specification, version 1.2 & version 1.5 and SFDA eCTD Validation Criteria, version 1.2 & version 1.4
Support for NeeS submissions to ALMBiH (Bosnia and Herzegovina): As of 1st July 2015 ALMBiH (Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina) is mandating NeeS format for all types of regulatory submissions
NeeS software – features
System have Pre-defined NeeS Template of EU (both Medicinal and Veterinary product), Gulf Countries (GCC), Australia/New Zealand (AU/NZ) and Bosnia and Herzegovina region as per regulatory specificationOther dossier submission key features click here