Description: In the session will be discussed about eSubmissions of medicines, becoming mandatory for all types of Applications. Regional regulatory aspects are moving towards global electronic submissions/eCTD (electronic common technical dossier). “Paper” CTD format is accepted in Montenegro and Albania. In Serbia partial electronic submission is accepted from 20.12.2016, although “paper” CTD format is inforce. In Bosnia & Herzegovina NeeS (non-eCTD format) is mandatory starting from 01.07.2015. In Kosovo electronic submission is mandatory for new MA from 01.04.2018. In Macedonia eSubmission is mandatory starting from 18.09.2018. Regional National Agencies have developed customized-softwares for electronic submissions, but also documents in NeeS and eCTD format can be used for eSubmissions. Get an indepth look at regulation compliance from the emerging markets and steps to keep up to date on global products within country-specific environments.
Learning Objectives:
Upon completion, participants will get knowledge about the trend how electronic submissions are slowly becoming mandatory also in regional countries.
Upon completion, participants will be able to learn and get deeper knowledge about regulatory submissions of medicinal products in concerned countries.
Upon completion, participants will be able to get indepth look at regulation compliance from the emerging markets and steps to keep up to date within country-specific environments.
