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There are many formats for submission of a registration dossier. One of these formats is the Computer Aided Dossier and Data Supply (CADDY) format.

SGS’ Regulatory Team has experienced staff and the latest accepted version of the software for compilation of dossiers in CADDY format.

CADDY is an industry accepted concept, providing all the necessary information in electronic form for the regulatory authorities to review the submission of an Active Substance (a.s.) or Plant Protection Product (PPP) dossier in the EU, using the CADDY-xml format. Its use is also recommended in USA and Canada as ePRISM and e-Index respectively.

The submission of a CADDY dossier enables considerable savings in resources – paper, copying materials, shipping and storage costs. Some countries now offer a reduction in their registration fees if dossiers are submitted using the CADDY format.

The CADDY dossier includes the draft Registration Reports (dRR) parts A, B and C; tier I, II and III; document O, label, MRLs, GAPs, BAD, SDS, confidential data, and all the studies, both for the a.s. and the PPP.

REGULATORY SERVICES

Our regulatory team has:

  • The capability to produce a.s. and PPP specific CADDY dossiers.
  • Experience with the preparation, handling, and submission of CADDY dossiers. The dossiers can either be generated in parallel to the standard paper form dossiers, or subsequent to the submission of the dossier.

Read more articles of our Seed and Crop Newsletter - February 2014.

For further information, please contact:

Dr. Sue McMillan-staff BSC., PHD., c.
Chem. M.R.S.C.
Regulatory Affairs Manager
SGS United Kingdom Limited
The Meadows, Alkerton Oaks
Business Park
Upton Estate, Stratford Road
Banbury OX15 6EP United Kingdom
t: +44 (0)1295 671933