SUMMARY OF ALTERATIONS

CUSTOMS TARIFF PROPOSAL (No. 2) 2018

Reasons for changes: To insert a concessional item into Schedule 4

Date of effect: 1 July 2018

Alterations to the Customs Tariff Act 1995

The Australian Government has committed to reducing the regulatory burden on companies conducting clinical trials in Australia and to provide a ‘Free’ rate of customs duty for clinical trial kits and placebos used in clinical trials.

These commitments will be implemented through a new item, in Schedule 4 of the Customs Tariff Act 1995 which provides for concessional rates of customs duty for eligible goods.

The new concessional item, Item 56, will provide a ‘Free’ rate of customs duty for goods that are either:

i. kits containing either or both medicaments and placebos, that do not indicate whether their contents are medicaments or placebos, that are imported for use in a clinical trial in Australia and which satisfy the requirements prescribed by by‑law; or

ii. placebos imported for use in a clinical trial in Australia;

The requirements prescribed by by-law will include what items can be included in the kit, the packaging of the kit and the documentation that can be included in the kit.

For the purposes of Item 56 and the associated by-law, identifiers, regardless of their form, that cannot be deciphered without additional information or equipment, do not indicate whether the contents of the kit are medicaments or placebos.

For the purpose of Item 56 and the associated by-law, ‘Placebo’ means a good not containing an active agent under study, administered to some participants to compare the effects of the active agent on other participants.

The rate of ‘Free’ will apply from 1 July 2018.