Globally Harmonised Submission and Transport Standards (GHSTS) Format Specification, Second edition

The Global Harmonised Submission Transport Standard (GHSTS) is a standardised set of technical specifications for assembling electronic files for pesticide registration in a predefined manner. Once assembled according to the GHSTS, the dossier files can be transferred from a business to a regulatory authority and can be used in a regulatory process. GHSTS version 2.0, described in this document, includes changes to support the use of the GHSTS for electronic packages in other regulatory domains in addition to the pesticides domain and includes improvements in the lifecycle management of documents in a series of dossier electronic submissions by a registrant for a dossier regulatory action.