Bosnia and Hercegovina implemented NeeS and will be mandatory as of 1 July 2015 for all submissions
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.
