Introduction
The CADDY (Computer Aided Dossier Design and supplY) system provides a framework for the submission of a regulatory dossier in an electronic format.
Electronic submission of active substance dossiers is strongly encouraged as this
- allows rapid access to the studies supporting the submission and supports the efficiency of the evalution process;
- reduces the costs involved with the associated copying, storage, transport and handling both by industry and regulatory authorities;
- allows a stable long term archive of submissions to be maintained and easily accessed.
What is CADDY ?
CADDY is an electronic interchange and archiving format for pesticide registration application documents (dossiers) using CD-ROM as the storage medium for the submission. CADDY defines the format and structure for files to be written to the CD-ROM and defines the indices used by the retrieval software to read the submission.
Creation of the compilation software is the responsibility of those compiling CADDY submissions. Companies may choose to do this 'in house' or approach contract houses and consultancies which offer compilation of CADDY-compliant dossiers.
Although submission of EU dossiers using the CADDY system is not mandatory, CRD strongly encourages CADDY submissions as they provide cost savings in terms of transport and storage of dossiers and facilitate efficient retrieval of information. Our requirements for new and renewal active substance submissions are given in the tables below.
Where to find more information on CADDY
The CADDY site hosted by the European Crop Protection Association (ECPA) provides a repository of information on CADDY for those who would like to learn more about the system. As well as contact information the site provides the following documentation.
CADDY Information Brochure
This document gives an overview of CADDY and is recommended if you are new to CADDY and need initial information on the system.
Format Specification
Provides the technical specification for the CADDY system. Defines the format and structure of the files to be written to the CD-ROM.
Application guide
A more detailed guide to the use of CADDY.
Conformity test software
Downloadable from the site. This software allows those compiling and receiving CADDY submissions to check if they conform to the format specification. Only submissions conforming to the CADDY specification are accepted.
CRD's requirements for EU regulatory submissions
New active substances if dossier is available on CADDY | No. of complete paper sets of the full dossier. | No. of CADDY CD-ROM sets for the dossier. |
| Acting as rapporteur | 0 | 2 |
| Not rapporteur | 0 | 2 |
New active substances if dossier is not available on CADDY | No. of complete paper sets of the full dossier. | No. of CADDY CD-ROM sets for the dossier. |
| Acting as rapporteur | 2 | |
| Not acting as rapporteur | 1 | |
Renewal of Approved active substances if Dossier is available on CADDY | No. of complete paper sets of the full dossier. | No. of CADDY CD-ROM sets for the dossier. |
| Acting as rapporteur | 0 | 2 |
| Not acting as rapporteur | 0 | 2 |
Revewal of Approved active substances if dossier is not available on CADDY | No. of complete paper sets of the full dossier. | No. of CADDY CD-ROM sets for the dossier. |
| Acting as rapporteur | 2 | |
| Not acting as rapporteur | 1 | |
