Responsibilities of AA where imported biologicals are used in vivo
There are two main groups registered under this system: research laboratories and vaccine or therapeutics manufacturers. Both categories pose a potential biosecurity risk, as conditions restricting the product to a particular facility cannot be applied.
- Research or production must not commence until:
- The facility has received in-vivo approvals permitting all imported biological material required for the project to be used in non-laboratory animals. A completed application form, with the required lodgement fee, must be forwarded to the Animal and Biological Import assessments Branch (ABIAB) for assessment and processing.
- The facility must be inspected and become an Approved Arrangement (AA).
- The facility must ensure that in vivo approval is obtained prior to any non-laboratory animal being directly or indirectly exposed to an imported biological. An in vivo approval granted by the department will be valid for two years.
- The facility must ensure compliance with all conditions of the in vivo approval throughout the life of the research project or manufacturing process. Any facility not adhering to all conditions risks losing their approved arrangement status and/or prosecution in a court of law.
- The facility shall have laboratory procedures in place which meet the Australian Standard AS2243.3, Safety in Laboratories - Part 3 Microbiology.
- The facility shall have an approved method of disposal for all imported biological waste categorised as high risk. Approved methods include autoclaving, incineration, waste disposal service.
- It is the facility’s responsibility to ensure continual adherence with all of the requirements of Approved Arrangement for the use of imported biologicals in non-laboratory animals.