Electronic submission of dossiers – using CADDY, GHSTS and agreed Table of contents
CADDY – Computer Aided Dossier and Data Supply
CADDY is an electronic format for the exchange, archiving and evaluation of complex dossiers, developed jointly by industry and regulatory authorities. It was developed for the interchange of plant protection products dossiers, and is currently adopted by the European Commission and Member States as the only electronic dossier interchange format. CADDY is a flexible format; it is continuously improved to follow developments in the evaluation process.
GHSTS – Globally Harmonised Submission and Transport Standard
GHSTS has been developed by the OECD Expert Group on the Electronic Exchange of Pesticide Data (EGEEPD) with significant support from ECPA. It takes CADDY to the next level by providing an extended set of metadata, lifecycle information and document identification. GHSTS is open to be used in various regulatory domains and is currently being evaluated by authorities for adoption in different continents.
Table of contents
Different table of contents (ToC) are used within the EU for different regulatory procedures, being defined in various guidance documents.
ECPA has launched a new website dedicated to esubmission topics, http://esubmission.ecpa.eu. Please see the following subsections