Operational Information - Product and Permit Evaluation

Generic information

Document title Description Last updated
Application for Approval of an Active Constituent (RTF, 272kb) Form to apply for the approval of an active constituent 21 March 2011
Evaluation - Requirements Letter - Permits (DOC, 45KB) | (PDF, 24kb)Template requirements letter for evaluation (Permits) 12 November 2012
Notice of Refusal (RTF, 137KB) | (PDF, 34kb)Template letter for a Notice of Refusal 17 August 2012
Notice of Proposal To Refuse Application (RTF, 177KB) | (PDF, 33kb) Template letter for a Notice of Proposal To Refuse Application 17 August 2012
Evaluation - Permit Renewal/Extension Application (Short Form) (RTF, 133KB) | (PDF, 43kb)Permit Renewal/Extension Application (Short Form) (Evaluation) 27 September 2010
Efficacy Administration Checklist (RTF, 37KB) | (PDF, 27kb)Checklist for Efficacy Administration29 August 2008
Efficacy Technical Report Template (RTF, 122KB) | (PDF, 35kb)Template for an Efficacy Technical Report20 April 2006
Efficacy Covering Letter Template (RTF, 118KB) | (PDF, 32kb)Template for an Efficacy Covering Letter20 April 2006
Efficacy Reveiwer External Declaration (RTF, 140KB) | (PDF, 26kb)Template for an Efficacy Reveiwer External Declaration28 September 2012
Efficacy Reviewer State Declaration (RTF, 151KB) | (PDF, 29kb)Template for an Efficacy Reviewer State Declaration28 September 2012
Efficacy Data Distribution Form (RTF, 126KB) | (PDF, 55kb)Form for Efficacy Data Distribution3 April 2006
Efficacy Work Order - Assessment Services for Technical Services (RTF, 239KB) | (PDF, 45kb)Template for an Efficacy Work Order - Assessment Services for Technical Services 8 January 2013
Confidential Commercial Information (CCI) Application Details (RTF, 94KB) | (PDF, 31kb)Template for Confidential Commercial Information (CCI) Application Details27 September 2010
Notice Not to Suspend Consideration (RTF, 134KB) | (PDF, 27kb)Template letter for a Notice Not to Suspend Consideration17 August 2012
Notice of Application Treated as Withdrawn (RTF, 134KB) | (PDF, 27kb)Template letter for a Notice of Application Treated as Withdrawn17 August 2012
Early Release of Reviewer Assessment (RTF, 133KB) | (PDF, 27kb)Template letter for an Early Release of Reviewer Assessment17 August 2012
Second Notice of Requirements (Evaluation) (RTF, 135KB) | (PDF, 28kb)Template letter for a Second Notice of Requirements (Evaluation)17 August 2012
Notice to Suspend Consideration (RTF, 133KB) | (PDF, 27kb)Template letter for a Notice to Suspend Consideration17 August 2012
Notice confirming Provision of New Data (RTF, 133KB) | (PDF, 26kb)Template letter for a Notice confirming Provision of New Data17 August 2012
Record of Application Defects - Evaluation (RTF, 58KB) | (PDF, 26kb)Template for a Record of Application Defects (Evaluation) 03 March 2010
Notifying of Changes to Relevant Label Particulars (RLPs) (RTF, 128KB) | (PDF, 27kb)Letter template for Notifying of Changes to Relevant Label Particulars (RLPs)17 August 2012
Evaluation to Determination (RTF, 236KB) | (PDF, 26kb)Work instruction for Evaluation to Determination27 September 2010
Completing Finalisation Report (RTF, 234KB) | (PDF, 26kb)Work instruction for Completing Finalisation Report27 September 2010
Evaluating an Application (RTF, 101KB) | (PDF, 41kb)Work instruction for Evaluating an Application2 April 2012
Addressing Application Deficiency After Evaluation (RTF, 112KB) | (PDF, 35kb)Work Instruction for Addressing Application Deficiencies at Evaluation4 December 2012
Determining an Application (RTF, 202KB) | (PDF, 110kb)Work instruction for Determining an Application22 March 2013
Processing, assessing and approval of a label (RTF, 165KB) | (PDF, 23kb)Work instruction for processing, assessing and approval of a label27 September 2010
Ensuring Compliance with the Disclosure of Confidential Commercial Information (s.162) (RTF, 111KB) | (PDF, 23kb)Work instruction for Ensuring Compliance with CCI 4 December 2012
Conflict of Interest - Efficacy Reviewers (RTF, 204KB) | (PDF, 220kb)Work instruction for a Conflict of Interest - Efficacy Reviewers 13 March 2013
Registration of a New Product (RTF, 253KB) | (PDF, 134kb)Finalisation Report - New Registrations1 March 2011
Finalisation Report - Variation or Label Approval (RTF, 247KB) | (PDF, 97kb)Finalisation Report for a Variation or Label Approval1 March 2011
Is Public Consultation Required? (RTF, 88KB) | (PDF, 38kb)Work instruction to determine if a Public Consultation is required? 5 March 2003
Screening - Technical Screening Form (RTF, 464KB) | (PDF, 89kb)Form for Technical Screening 28 September 2012
Notice of Application Lodgement (RTF, 129KB) | (PDF, 25kb)Template letter for a Notice of Application Lodgement27 September 2010
Notice of Application Deficiencies (RTF, 148KB) | (PDF, 35kb)Template letter for a Notice of Application Deficiencies 17 August 2012
Screening - Advice Summary for Registration of Chemical Product (RTF, 197KB) | (PDF, 51kb)Template for an Advice Summary for Registration of Chemical Product (Screening)13 August 2007
Screening - Advice Summary for Variation to Registered Chemical Product (RTF, 193KB) | (PDF, 62kb)Template for an Advice Summary for Variation to Registered Chemical Product (Screening)14 August 2007
Application Data Lists for Agency Reports (RTF, 154KB) | (PDF, 19kb)Template for Application Data Lists for Agency Reports 13 August 2007
Additional Data Form (RTF, 194KB) | (PDF, 75kb)Additional Data Form (KP25S_F43)27 September 2010
Record of Application Defects - Admin Screening (RTF, 24KB) | (PDF, 19kb)Template for a Record of Application Defects - Admin Screening2 March 2010
Notice of Application Deficiencies (Category 7) (RTF, 131KB) | (PDF, 28kb)Template letter for a Notice of Application Deficiencies (Category 7)17 August 2012
Notice of Application Deficiencies (Category 7) (RTF, 131KB) | (PDF, 27kb)Template letter for a Notice of Application Deficiencies (Category 7)17 August 2012
Notice of Application Deficiencies (Chemistry) (RTF, 131KB) | (PDF, 30kb)Template letter for a Notice of Application Deficiencies (Chemistry) 27 September 2010
Notice of Provided Data (RTF, 135KB) | (PDF, 31kb)Template letter for a Notice of Provided Data27 September 2010
Notice of Proposal to Reject Application (RTF, 134KB) | (PDF, 28kb)Template letter for a Notice of Proposal to Reject Application17 August 2012
Final Extension Letter (Screening) (RTF, 125KB) | (PDF, 25kb)Template letter for Final Extension (Screening)15 October 2010

Agricultural information

Document title Description Last updated
Ag Checklist for Category 7 Applications (RTF, 79KB) | (PDF, 26kb)Checklist for Category 7 Applications (Ag)27 September 2010
Ag Product Label Checklist - Home Garden and Domestic Products (RTF, 51KB) | (PDF, 27kb)Checklist for an Ag Product Label (Home Garden and Domestic Products)27 September 2010
Ag Product Label Checklist - Commercial Label (RTF, 57KB) | (PDF, 29kb)Checklist for an Ag Product Label (Commercial)27 September 2010

Veterinary Medicines information

Document title Description Last updated
Application for Registration of a Veterinary Immunobiological Product (RTF, 413kb) Form to apply for registration of a veterinary immunobiological product 24 June 2010
Application for Registration of a Veterinary Chemical Product Containing a New Active Constituent (RTF, 432kb) Form to apply for registration of a veterinary chemical product containing a new active constituent 24 June 2010
Guideline for what Information the APVMA Considers CCI (RTF, 124KB)Guideline for what information the APVMA considers to be confidential commercial information (CCI) for the purposes of section 162 of the Agvet CodeJuly 2009
Confidential Commercial Information (CCI) vs Commercial In Confidence (CIC) (PDF, 160kb) | (RTF, 222kb) Information sheet on the differences between Confidential Commercial Information (CCI) and Commercial In Confidence (CIC) 31 May 2010
Guideline for what Information the APVMA Considers CCI (RTF, 124KB)Guideline for what information the APVMA considers to be confidential commercial information (CCI) for the purposes of section 162 of the Agvet CodeJuly 2009
Last updated on 9 August, 2013

Subscribe to our Newsletter

Get fortnightly, regular updates from the APVMA. Read more

Top