| Document title |
Description |
Last updated |
| Application for Registration of a Repack Agricultural or Veterinary Chemical Product |
Form to apply for the
repack of an agricultural or veterinary chemical product |
24 June 2010 |
| Application for Variation of an Agricultural or Veterinary Chemical Product |
Form to apply for the variation of an agricultural or veterinary chemical product (change product details / additional pack size / minor formulation change / copy uses of image or repack reference product) |
24 June 2010 |
| Application for Variation to the Label of an Agricultural or Veterinary Chemical Product |
Form to apply for the variation to the label of an agricultural or veterinary chemical product |
24 June 2010 |
| Application for Variation of an Agricultural or Veterinary Chemical Product |
Form to apply for the variation of an agricultural or veterinary chemical product (other variations) |
24 June 2010 |
| Application for Registration of a Chemical Product and/or Approval of an Active Constituent (not in any other Category) |
Form to apply for registration of a chemical product and/or approval of an active constituent that doesn't fit in any other category. |
24 June 2010 |
| Application for Assessment of a Trial Protocol |
Form to apply for the assessment of a trial protocol |
24 June 2010 |
| Application for Variation of an Agricultural or Veterinary Chemical Product or Active Constituent (not in any other category) |
Form to apply for the variation of an agricultural or veterinary chemical product or active constituent that doesn't fit in any other category. |
24 June 2010 |
| Application for Pre-registration or Pre-approval Assessment of Data |
Form to apply for
pre-registration or pre-approval assessment of data |
24 June 2010 |
| Application for Listed Registration of an Agricultural or Veterinary Chemical Product |
Form to apply for a
listed registration of an agricultural or veterinary chemical product |
24 June 2010 |
| Application for Registration of an Agricultural or Veterinary Chemical Product |
Form to apply for the registration of an agricultural or veterinary chemical product |
24 June 2010 |
| 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 Administration | 29 August 2008 |
| Efficacy Technical Report Template (RTF, 122KB) | (PDF, 35kb) | Template for an Efficacy Technical Report | 20 April 2006 |
| Efficacy Covering Letter Template (RTF, 118KB) | (PDF, 32kb) | Template for an Efficacy Covering Letter | 20 April 2006 |
| Efficacy Reveiwer External Declaration (RTF, 140KB) | (PDF, 26kb) | Template for an Efficacy Reveiwer External Declaration | 28 September 2012 |
| Efficacy Reviewer State Declaration (RTF, 151KB) | (PDF, 29kb) | Template for an Efficacy Reviewer State Declaration | 28 September 2012 |
| Efficacy Data Distribution Form (RTF, 126KB) | (PDF, 55kb) | Form for Efficacy Data Distribution | 3 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 Details | 27 September 2010 |
| Notice Not to Suspend Consideration (RTF, 134KB) | (PDF, 27kb) | Template letter for a Notice Not to Suspend Consideration | 17 August 2012 |
| Notice of Application Treated as Withdrawn (RTF, 134KB) | (PDF, 27kb) | Template letter for a Notice of Application Treated as Withdrawn | 17 August 2012 |
| Early Release of Reviewer Assessment (RTF, 133KB) | (PDF, 27kb) | Template letter for an Early Release of Reviewer Assessment | 17 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 Consideration | 17 August 2012 |
| Notice confirming Provision of New Data (RTF, 133KB) | (PDF, 26kb) | Template letter for a Notice confirming Provision of New Data | 17 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 |
| Completing Technical Screening Form (RTF, 431KB) | (PDF, 122kb) | Work instruction for Completing Technical Screening Form | 27 September 2010 |
| Evaluation to Determination (RTF, 236KB) | (PDF, 26kb) | Work instruction for Evaluation to Determination | 27 September 2010 |
| Completing Finalisation Report (RTF, 234KB) | (PDF, 26kb) | Work instruction for Completing Finalisation Report | 27 September 2010 |
| Evaluating an Application (RTF, 101KB) | (PDF, 41kb) | Work instruction for Evaluating an Application | 2 April 2012 |
| Addressing Application Deficiency After Evaluation (RTF, 112KB) | (PDF, 35kb) | Work Instruction for Addressing Application Deficiencies at Evaluation | 4 December 2012 |
| Determining an Application (RTF, 202KB) | (PDF, 110kb) | Work instruction for Determining an Application | 22 March 2013 |
| Processing, assessing and approval of a label (RTF, 165KB) | (PDF, 23kb) | Work instruction for processing, assessing and approval of a label | 27 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 Registrations | 1 March 2011 |
| Finalisation Report - Variation or Label Approval (RTF, 247KB) | (PDF, 97kb) | Finalisation Report for a Variation or Label Approval | 1 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 Lodgement | 27 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 Screening | 2 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 Data | 27 September 2010 |
| Notice of Proposal to Reject Application (RTF, 134KB) | (PDF, 28kb) | Template letter for a Notice of Proposal to Reject Application | 17 August 2012 |
| Final Extension Letter (Screening) (RTF, 125KB) | (PDF, 25kb) | Template letter for Final Extension (Screening) | 15 October 2010 |
| Document title |
Description |
Last updated |
| Application for Registration of an Agricultural Chemical Product (Category 1 or 2) |
Form to apply for the tegistration of an agricultural chemical product (Category 1 or 2) |
24 June 2010 |
| Application for Registration of an Agricultural Chemical Product (Category 3 or 4) |
Form to apply for the registration of an agricultural chemical product (Category 3 or 4) |
24 June 2010 |
| 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 |
| 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 |
| Application for Registration of a Veterinary Chemical Product which is ‘similar’ or ‘closely similar’ to a registered reference product |
Form to apply for the registration of a veterinary chemical product which is ‘similar’ or ‘closely similar’ to a registered reference product |
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 Code | July 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 |
| APVMA Standard Conditions for Approvals and Registrations | List of the standard conditions commonly applied to notices of active constituent approval, product registration, label approval or variation of registration. | 13 September 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 Code | July 2009 |
Last updated on
5 June, 2013
