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Operational Information - Adverse Experience Reporting Program

Generic information

Document title Description Last updated
Adverse Experience Reporting (AER) Form (paper - download and print) (PDF, 55kb) Paper (download and print) form to report an adverse experience with agricultural chemicals or veterinary medicines 17 August 2009
Adverse Experience Reporting (AER) Form (interactive) (PDF, 374kb) Interactive form to report an adverse experience with agricultural chemicals or veterinary medicines 17 August 2009
The Causality Assessment Algorithm (121kb) Guide for registrants to conduct causality assessments of adverse experience reports. 17 August 2009
AER Key Process Flowchart - Overall (PDF, 20kb) Overall process of reporting an Adverse Experience 17 August 2009
AER Key Process Flowchart - in house (PDF, 18kb) Internal process for receiving an Adverse Experience 17 August 2009
How to process the Adverse Experience Report Instructions on how to process an Averse Experience Report Under review

Agricultural information

Document title Description Last updated
Guidelines for Registrants (PDF, 106kb) Guidelines for Registrants to report adverse experiences with agricultural chemicals to the APVMA 12 September 2007
Guidelines for Farmers, Chemical Users and Members of the Public (PDF, 130kb) Guidelines for Farmers, Chemical Users and Members of the Public to report adverse experiences with agricultural chemicals to the APVMA 12 September 2007
Periodic Summary Update (PSU) - For Crop And Environment - Registrant’s Reporting Form (DOC, 47kb) Form for Registrants to provide a Periodic Summary Update of adverse experiences for crops and the environment 17 August 2009
How to process Periodic Summary Updates (Ag) The processes used to evaluate registrant adverse experience report (rAER) annual summaries (Periodic Summary Updates - PSUs) submitted to the APVMA by registrants of agricultural chemicals Under review

Veterinary Medicines information

Document title Description Last updated
Guidelines for Registrants (PDF, 140kb) Guidelines for Registrants to report adverse experiences with veterinary medicines to the APVMA 12 September 2007
Guidelines for Veterinarians, Animal Owners and Chemical Users (PDF, 73kb) Guidelines for Veterinarians, Animal Owners and Chemical Users to report adverse experiences with veterinary medicines to the APVMA 12 September 2007
Periodic Summary Update (PSU) - For Veterinary Medicines - Registrant’s Reporting Form (DOC, 55kb) Form for Registrants to provide a Periodic Summary Update of adverse experiences for veterinary medicines 17 August 2009
Matrix For AERP Vet (RTF, 73kb) Matrix For AERP Vet 23 July 2004
How to process Periodic Summary Updates (Vet) The processes used to evaluate registrant adverse experience report (rAER) annual summaries (Periodic Summary Updates - PSUs) submitted to the APVMA by registrants of veterinary medicines Under review

 

Last updated on 3 May, 2011