Bosnia and Herzegovina NeeS

Full support for NeeS submissions to ALMBiH

The Agency for Medicines and Medical Devices BiH announced acceptance of documents for methods of administering / changes / renewal of the authorization in NeeS format.
ALMBIH will accept NeeS submissions for any type of submissions relating to regulatory affairs, including: granting licenses, renewal, variation, transfer or revocation / withdrawal of the license, PSUR and ASMF.

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.

As of February 2015 eCTD Office users are capable of producing valid BA NeeS submissions fully compliant with the ALMBiH NeeS regional validation criteria.

ALMBiH M1 structure

eCTD Office ALMBiH NeeS Compiler includes auto generation of TOC documents: CTD-TOC and module TOCs. Embedded validation system ensures validated NeeS sequences.

Even if you already have an eCTD/NeeS/VNeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission.
Invest only 45 minutes of your time and request a live personalized web demo of eCTD Office.

Contact us for more info…
BA NeeS e-Submissions February, 2015