ES 1 Key components Australia New Zealand EU US Canada Protection period for 10 years as of July 2014 10 years 10 years plant protection 10 years 10 12 – a new active under Section 34M of products exclusive use years with ingredient / Agvet Code 13 years low risk change in – constituent and products formulation associated 15 years -biocides formulated products not previously endorsed Protection period for 5 as of July 2014 5 years for new variations na na na previously endorsed or variations or new information Extensions linked to None None Additional 3 months for Up to 3 Up to 5 minor use each minor use, up to 3 additional years additional registrations additional years (plant (1 year for each years. protection products). Up to three minor (1 year for 2 years (low risk products) uses) each three minor uses) potential 10 years as of July 2014 10 years 10–13 years (plant 10–13 years 10-15 years protection products) protection period 13–15 years (low risk protection products) 15 years (biocides) Data compensation na na 30 months protection 15 years 12 years period subsequent products) compensable. compensable – data to support / 5 years (review or renewal Data with maintain registration of biocides) exclusive use of a new active protection are ingredient to support compensable for re-evaluation 5 years after exclusivity expires New legislation New legislation took New legislation took effect EC1107/2009 and na na effect from July 2014. from November 2016 528/2012 test data are The interactions of extending data protection subject to compulsory various elements of the periods for new actives and sharing for both plant Agvet Code are complex expanding scope to include protection products and relative to other variations to existing biocides. Agreement on countries. products, new products costs may be reached and reassessments through negotiation, arbitration or legal proceedings SOURCE: VARIOUS 3.1.
ES 1 Key components Australia New Zealand EU US Canada Protection period for a new active ingredient / constituent and associated formulated products not previously endorsed 10 years as of July 2014 under Section 34M of Agvet Code 10 years 10 years – plant protection products 13 years – low risk products 15 years -biocides 10 years exclusive use 10 12 years with change in formulation Protection period for previously endorsed or variations or new information 5 as of July 2014 5 years for new variations na na na Extensions linked to minor use registrations None None Additional 3 months for each minor use, up to 3 additional years (plant protection products). Up to 2 years (low risk products) Up to 3 additional years (1 year for each three minor uses) Up to 5 additional years. (1 year for each three minor uses) potential protection period 10 years as of July 2014 10 years 10–13 years (plant protection products) 13–15 years (low risk protection products) 15 years (biocides) 10–13 years 10-15 years Data compensation period – subsequent data to support / maintain registration of a new active ingredient to support re-evaluation na na 30 months protection products) 5 years (review or renewal of biocides) 15 years compensable. Data with exclusive use protection are compensable for 5 years after exclusivity expires 12 years compensable New legislation New legislation took effect from July 2014. The interactions of various elements of the Agvet Code are complex relative to other countries. New legislation took effect from November 2016 extending data protection periods for new actives and expanding scope to include variations to existing products, new products and reassessments EC1107/2009 and 528/2012 test data are subject to compulsory sharing for both plant protection products and biocides. Agreement on costs may be reached through negotiation, arbitration or legal proceedings na na 3.1. SOURCE: VARIOUS
review-ip.docx