INTERNATIONAL COMPARISONS > KEY COMPARITIVE CRITERIA Australia New Zealand New Zealand Canada European Union Japan Brazil APVMA EPA MPI PMRA VDD FAMIC Plant Protection Products Time frame 1-25 calendar 10-100 working 40 working days 80-737 calendar 2-300 calendar 2.5 to 3.5 years Up to 2 years 120 days (min – max) months days days days (912.5-1277 days) (up to 730 (30-750 days) days) Location Statutory Statutory Statutory Policy Statutory Statutory Statutory Statutory Regulatory Registration Grower Third parties Consultants consultants consultants Requested Own Panel appointed Accredited Use (GROU) assessors Assessors Committee Performance 100% 100% 100% 90% 100% 100% 100% 100% target Recent 69% 100% 55% (approx.) Category A 87% Within service EFSA: 75% (2016) Can be up to 6 performance 2016/17 2015/16 June 2017 Category B 88% delivery standard RMS: “delays are years² Category C 95% for 7/9 application commonplace” ¹ Backlog of 6 x 2015/16 those types 2015/16 evaluated Pre- Administrative assessment and and technical technical Reporting Quarterly Annual As required Annual Annual requirements Reporting Parliament Annual Report Industry focussed Parliament Parliament mechanism newsletter Extension of time Clock stops Clock stops for Rejected if issue Clock stops Clock stops Clock stops clock for requests for Can request requests for not addressed information extensions information within 1 month Review period Risk based 15 year cycle Risk based not Risk based exceeding 15 years triggers Overview Report on a Series of Audits Carried Out In EU Member States in 2016 and 2017 in Order to Evaluate the Systems in Place for the Authorisation of Plant Protection Products 1 ² Chemlinked, Brazilian Pesticide Regulation Overview, March 13, 2017
INTERNATIONAL COMPARISONS > KEY COMPARITIVE CRITERIA Australia APVMA New Zealand EPA New Zealand MPI Canada PMRA VDD European Union Plant Protection Products Japan FAMIC Brazil Time frame (min – max) 1-25 calendar months (30-750 days) 10-100 working days 40 working days 80-737 calendar days 2-300 calendar days 2.5 to 3.5 years (912.5-1277 days) Up to 2 years (up to 730 days) 120 days Location Statutory Statutory Statutory Policy Statutory Statutory Statutory Statutory Third parties Regulatory consultants Panel appointed assessors Registration consultants Accredited Assessors Grower Requested Own Use (GROU) Committee Consultants Performance target 100% 100% 100% 90% 100% 100% 100% 100% Recent performance 69% 2016/17 100% 2015/16 55% (approx.) June 2017 Category A 87% Category B 88% Category C 95% 2015/16 Within service delivery standard for 7/9 application types 2015/16 EFSA: 75% (2016) RMS: “delays are commonplace” ¹ Can be up to 6 years² Backlog of 6 x those evaluated Pre- assessment Administrative and technical and technical Reporting requirements Quarterly Annual As required Annual Annual Reporting mechanism Parliament Annual Report Industry focussed newsletter Parliament Parliament clock Extension of time for requests for information Clock stops Can request extensions Clock stops Clock stops Clock stops Clock stops for requests for information Rejected if issue not addressed within 1 month Review period Risk based 15 year cycle Risk based not exceeding 15 years Risk based triggers 1 Overview Report on a Series of Audits Carried Out In EU Member States in 2016 and 2017 in Order to Evaluate the Systems in Place for the Authorisation of Plant Protection Products ² Chemlinked, Brazilian Pesticide Regulation Overview, March 13, 2017