Commonwealth legislation

Customs By-law No. 1800128

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Commonwealth

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legislative instrument

Plain English Summary

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Customs By-law No. 1800128 sets precise packaging, labelling and content rules for clinical trial "kits" so they meet the condition in subparagraph (a)(i) of item 56, Schedule 4 to the Customs Tariff Act. It requires kits not to reveal whether they contain medicaments or placebos, limits included items to medicines/placebos, safe‑transport packaging and necessary documentation, and treats encoded identifiers as non‑revealing. Importers and customs officers will use these rules to determine whether a kit qualifies under that tariff provision (see ss 3–5).

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Current sections

Direct links to the current provisions in Customs By-law No. 1800128.

Customs By-law No. 1800128

CUSTOMS ACT 1901

CUSTOMS TARIFF ACT 1995

SCHEDULE 4

BY-LAW No. 1800128

I, Alison Neil, delegate of the Comptroller-General of Customs, under section 271 of the Customs Act 1901 make the by-law set out in the Schedule below.

THE SCHEDULE

BY-LAW No. 1800128

Item 56

Schedule 4

This by‑law may be cited as Customs By-law No. 1800128.
This by‑law commences on 1 July 2018.
For the purposes of subparagraph (a)(i) of item 56 of Schedule 4 to the Customs Tariff Act 1995 (the Customs Tariff Act), the following requirements are prescribed:
1. the kits do not indicate whether their contents are medicaments or placebos; and
2. the kits do not contain goods other than:
  1. the medicaments and/or placebos, whether or not in syringes or other delivery mechanisms;
  2. any item or packaging which is necessary for the safe transport and/or storage of the goods;
  3. any associated and necessary documentation and forms.
For the purposes of subparagraph 3(i), 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 this 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 to other participants.
For the purpose of this by‑law, the “Customs Tariff Act 1995” means the Customs Tariff Act 1995, as amended or proposed to be altered.

Dated this 5th day of June 2018.

Alison Neil

Delegate of the

Comptroller-General of Customs

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Customs By-law No. 1800128

CUSTOMS ACT 1901

CUSTOMS TARIFF ACT 1995

SCHEDULE 4

BY-LAW No. 1800128

I, Alison Neil, delegate of the Comptroller-General of Customs, under section 271 of the Customs Act 1901 make the by-law set out in the Schedule below.

THE SCHEDULE

BY-LAW No. 1800128

Item 56

Schedule 4

This by‑law may be cited as Customs By-law No. 1800128.
This by‑law commences on 1 July 2018.
For the purposes of subparagraph (a)(i) of item 56 of Schedule 4 to the Customs Tariff Act 1995 (the Customs Tariff Act), the following requirements are prescribed:
1. the kits do not indicate whether their contents are medicaments or placebos; and
2. the kits do not contain goods other than:
  1. the medicaments and/or placebos, whether or not in syringes or other delivery mechanisms;
  2. any item or packaging which is necessary for the safe transport and/or storage of the goods;
  3. any associated and necessary documentation and forms.
For the purposes of subparagraph 3(i), 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 this 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 to other participants.
For the purpose of this by‑law, the “Customs Tariff Act 1995” means the Customs Tariff Act 1995, as amended or proposed to be altered.

Dated this 5th day of June 2018.

Alison Neil

Delegate of the

Comptroller-General of Customs