The agreed guidelines establish two formats:
A standardised set of technical specifications have also been established, the Global Harmonised Submission Transport Standard (GHSTS), to assemble electronic files for any pesticide package in a predefined manner.
The formats do not require OECD countries to make the same regulatory decisions. Rather their purpose is to facilitate registration by minimising duplication of effort for both industry and governments.
pdf - Main document
pdf - Standard terms and abbreviations
pdf - Preparation (formulation) types and codes
pdf - Guidance with respect to pagination, lay-out, tables and references
pdf - Suggested order for the preparation of each of the four levels and three annexes of the monographs to be prepared by regulatory authorities
pdf - Form for use in reporting details of intended uses (GAP information)
pdf - Format for the listing of end points to be included in the reasoned statement of the overall conclusions drawn by the regulatory authority (Level 2)
pdf - Format for the listing of test and study reports and other documentation evaluated (Annex A)
pdf - Format for the listing of test and study reports and other documentation relied on (Annex B)
pdf - Guidance Notes for Analysis and Evaluation of Particular Types of Studies
Microbials Guidance Main document
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Appendix 5
Appendix 6
Appendix 7
Appendix 8
Pheromones and Semiochemicals
Series on Pesticides No. 17 (2003)
Pheremones Monograph Main Document
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Appendix 5
Appendix 6
Appendix 7
Appendix 8
Appendix 9
DOSSIER GUIDANCE (FOR INDUSTRY)
Chemical Plant Protection Products
OECD Guidance for Industry Data Submissions on Plant Protection Products and their Active Substances -Revision 2 May 2005:
pdf - Main document
pdf - Standard terms and abbreviations
pdf - Preparation (formulation) types and codes
pdf - Forms for use in reporting: 1. details of intended uses (GAP information); 2. registered uses and actual uses; 3. maximum residue limits (MRLs)
pdf - Format for compilation of Tier I quality checks
pdf - Forms for use in reporting: 1. crop residues data from individual supervised trials in summary form; 2. individual soil dissipation studies (soil residues) in summary form
Appendix 6 - Format for the listing of test and study reports and other documentation;
Appendix 7 - Format for the compilation of Tier II summaries - active substance -
Appendix 8 - Format for the compilation of Tier II summaries - formulated product -
pdf - Format for the listing of endpoints to be included in the Tier III overall summary and assessment
pdf - Format for the compilation of Tier III overall summaries and assessments
pdf - Forms for use in checking dossiers for completeness
Microbial
OECD Guidance for Industry Data Submissions for Microbial Pest Control Products and their Microbial Pest Control Agents (Dossier Guidance for Microbials), Series on Pesticides No. 23
Microbials Dossier Main Document
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Appendix 5
Appendix 6a Parts 1,2,3
Appendix 6b Part 4
Appendix 6c Part 5
Appendix 7
Appendix 8
Appendix 9
Appendix 10
Appendix 11
Pheromones and Semiochemicals
OECD Guidance For Industry Data Submissions for Pheromones and Other Semiochemicals and their Activie Substances (Dossier Guidance for Pheromones and Other Semiochemicals)
Series on Pesticides No. 16 (2003)
Pheremone Dossier Main Document
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Appendix 5
Appendix 6 Parts 1,2,3
Appendix 6 Part 4
Appendix 6 Part 5
Appendix 7
Appendix 8
Appendix 9
Appendix 10
Appendix 11 Part 1
Appendix 11 Part 2
Appendix 11 Part 3
Appendix 11 Part 4
Appendix 11 Part 5
Pesticide producers, who are responsible for testing any pesticide they want to register, usually have to present registration submissions in different formats for different OECD countries. The OECD common format should therefore reduce redundancies in the preparation of submissions by industry.
The format for government evaluations should change the way regulatory authorities in OECD countries write their evaluation reports on the tests submitted by industry. It should help improve the quality of review reports by ensuring that they are clear, complete, well-organised and transparent. This enables governments to use each other's reports more easily than in the past, saving time and resources. However, governments continue to apply their own criteria when making decisions.
Related Documents