Alerts

The Department of Agriculture, Fisheries and Forestry (the department) is making changes to permit validity periods for certain fully finished human therapeutics and medicines.

Permit validity periods will be increased from 2-years to 5-years for the following fully finished human therapeutics and medicines:
All standard permits:

• TGA AUST R human therapeutics and medicines
• ARTG registered Medical Devices included Class III
• Human therapeutics and medicines for use in a clinical trial (including accountability and disposal)

5-year validity periods for non-standard permits for fully finished human therapeutics and medicines will be considered based on certain criteria, including the following:

• If the goods are approved for use by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods, or an equivalent equivalent overseas authority, such as the US Food and Drug Administration or the European Medicines Agency.
• If the goods are being imported under the TGA Special Access Scheme or Clinical trials scheme.
• The likelihood that biosecurity-related conditions of manufacture will change over time and that these changes will have a bearing on the departments import conditions.
• Whether the overseas manufacturer has suitable controls to manage change. This is of particular significance where changes to the manufacturing process would lead to a change in the level of biosecurity risk associated with goods exported to Australia.

The changes will take effect immediately and will be applied to current and future applications.

Permits issued before today will not be affected and their validity periods remain unchanged.

Who does this notice affect:
Importers of fully finished human therapeutics and medicines, biosecurity staff and Pathway Operations Cargo – Assessment and Inspection.

Further information:
Please contact the Food Biosecurity Imports section on 1800 900 090 (prompt 1, then prompt 1) or email imports@agriculture.gov.au.