This content is current only at the time of printing. This document was printed on 7 September 2020. A current copy is located at http://www.gitygostar.com/node/311
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How do I report an adverse experience?
Product registration holders should record, investigate and assess all adverse experiences involving veterinary medicines or agricultural chemicals and report them to us using the APVMA’s adverse experience reporting forms. Veterinarians and the general public are also encouraged to use these reporting methods.
- online—adverse experience reporting tool
- directly contacting the registration holder.
We request a line listing of adverse experience reports classified as ‘probable’ or ‘possible’, with an indication of whether there was off-label use involved or not (see classification).
Registration holders should ensure:
- any adverse experience reports sent directly to any and all manufacturers of their products are recorded, investigated and assessed by an appropriately qualified representative
- all the information mentioned in the reporting forms is submitted to the APVMA within the suggested timeframes
- the report is
- signed by the registration holder or their legally responsible person or representative
- submitted with a covering letter containing a brief overview of all the adverse experience reports included in the summary (for example, the number of products involved, the number of reports for each product, the types of reports—lack of efficacy, human safety, animal safety, crop safety, and environmental damage) and comments on any reports that should be highlighted
- accompanied by a copy of the actual label text of the veterinary medicine or agricultural chemical product involved.
When should I report an adverse experience?
Registration holders of veterinary medicines
Registration holders should report all adverse experiences of a serious nature involving veterinary medicines to the APVMA in writing as soon as the registration holder becomes aware of the information. All serious and non-urgent adverse experiences should be investigated and evaluated as soon as possible and the findings should be reported to us as soon as practically possible.
Registration holders of agricultural chemicals
Registration holders should report all adverse experiences of a serious nature involving agricultural chemicals to the APVMA in writing as soon as the registration holder becomes aware of the information. A final investigation report, including conclusions, should be submitted as soon as practically possible.
Veterinarians and the general public
Veterinarians and the general public may submit voluntary adverse experience reports directly to the APVMA at any time. These reports are copied and forwarded to the relevant product registration holder(s) for investigation and assessment. The registration holder should review the submission and send us an initial investigation report, containing as much information as possible, within 28 working days of receipt of the original AER. The registration holder should then provide us with a concluding investigation report within three months of receipt of the original adverse experience report.
Ongoing expectations of registration holders
Registration holders of currently registered products (including all veterinary medicines or agricultural chemical products that were registered at some time during the reporting period) are requested to provide the APVMA with an annual summary of all suspected adverse experiences, unless we request an interim report or more frequent reporting. The annual summary should be submitted using the forms below at the end of each financial year and no later than close of business on 30 September each year. A reminder notice is published in the APVMA Gazette each year.