Attachment 1 AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 S78B – PERIOD WITHIN WHICH APVMA IS TO CONCLUDE RECONSIDERATIONS A + B + 2E + 3C + J + D + X A = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 3.1 Toxicology Level 1 13 – 3.2 Toxicology Level 2 9 – 3.3 Toxicology Level 3 5 – 4.1 Toxicology (requiring poison schedule classification) 13 7.1 Environment Level 1 13 – 7.2 Environment Level 2 7 – 7.3 Environment Level 3 4 – TOTAL A 7 TIME FOR B = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 2.1 Chemistry Level 1 13 – 2.2 Chemistry Level 2 9 – 2.3 Chemistry Level 3 6 – 5.1 Residues Level 1 13 – 5.2 Residues Level 2 8 – 5.4 Residues Level 4 4 – 6.1 Occupational Health and Safety Level 1 13 – 6.2 Occupational Health and Safety Level 2 7 – 6.3 Occupational Health and Safety Level 3 4 – 9 Non-food trade 6 10.1 Special data Level 1 13 – 10.2 Special data Level 2 7 – 10.3 Special data Level 3 7 – TOTAL B 7 TIME FOR 2E = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 8.1 Efficacy and safety Level 1 6 – 8.2 Efficacy and safety Level 2 4 – 8.3 Efficacy and safety Level 3 3 – TOTAL E 2 x 0 = 0 TIME FOR 3C = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 11.1 Finalisation type 1 3 – 11.2 Finalisation type 2 2 – 11.3 Finalisation type 3 2 – TOTAL C 3 x 2 = 6 TIME FOR J = whichever is relevant Consultation with jurisdictional coordinator 3 In any other case 0 TOTAL J 3 TIME FOR D TOTAL D 4 TIME FOR X = whichever is relevant Appointment of an arbitrator under s.64 3 In any other case 0 TOTAL X 0 TIME FOR TOTAL TIMEFRAME 27 months
Attachment 1 AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 – S78B PERIOD WITHIN WHICH APVMA IS TO CONCLUDE RECONSIDERATIONS A + B + 2E + 3C + J + D + X A = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 3.1 Toxicology – Level 1 13 3.2 Toxicology – Level 2 9 3.3 Toxicology – Level 3 5 4.1 Toxicology (requiring poison schedule classification) 13 7.1 Environment – Level 1 13 7.2 Environment – Level 2 7 7.3 Environment – Level 3 4 TOTAL TIME FOR A 7 B = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 2.1 Chemistry – Level 1 13 2.2 Chemistry – Level 2 9 2.3 Chemistry – Level 3 6 5.1 Residues – Level 1 13 5.2 Residues – Level 2 8 5.4 Residues – Level 4 4 6.1 Occupational Health and Safety – Level 1 13 6.2 Occupational Health and Safety – Level 2 7 6.3 Occupational Health and Safety – Level 3 4 9 Non-food trade 6 10.1 Special data – Level 1 13 10.2 Special data – Level 2 7 10.3 Special data – Level 3 7 TOTAL TIME FOR B 7 2E = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 8.1 Efficacy and safety – Level 1 6 8.2 Efficacy and safety – Level 2 4 8.3 Efficacy and safety – Level 3 3 TOTAL TIME FOR E 2 x 0 = 0 3C = the longest of the following periods (in months) relevant to the scope of the reconsideration Item Module level or type Period for completion Scope 11.1 Finalisation – type 1 3 11.2 Finalisation – type 2 2 11.3 Finalisation – type 3 2 TOTAL TIME FOR C 3 x 2 = 6 J = whichever is relevant Consultation with jurisdictional coordinator 3 In any other case 0 TOTAL TIME FOR J 3 D TOTAL TIME FOR D 4 X = whichever is relevant Appointment of an arbitrator under s.64 3 In any other case 0 TOTAL TIME FOR X 0 TOTAL TIMEFRAME 27 months