AERP request for 2010 annual summaries (Periodic Summary Updates)
31 August 2010
As per the APVMA Gazette notice on 31 August 2010, product registrants are reminded that, in accordance with the Guidelines for the Adverse Experience Reporting Program for veterinary medicines (AERP Vet) and agricultural chemicals (AERP Ag), they are requested to provide the APVMA with an annual summary of all suspected adverse experiences. This summary should be submitted by the close of business 30 September 2010.
To prepare an annual Periodic Summary Update (PSU), the following links and forms can be used:
Veterinary chemical products
Guidelines for registrants (PDF, 111kb)
Periodic Summary Update reporting form (DOC, 55kb)
Agricultural chemical products
Guidelines for Registrants (PDF, 116kb)
Periodic Summary Update reporting form (DOC, 47kb)
Registrants are requested to include the APVMA reference number (where available) if an adverse experience being included in the PSU was already reported to the APVMA during the year. This will help avoid redundancy and augment the accuracy of record keeping.
Along with a hard copy of the PSU, submission of editable electronic copy of the PSU is encouraged. This will help faster processing and migration of information into the AERP database.
Contact
For further information please contact:
Dr Taseer Bashir
Senior Reviewer – Adverse Experience Reporting Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Telephone: (02) 6210 4757
Facsimile: (02) 6210 4840
Email: AERPCoordinator@apvma.gov.au