Guidance: Completing an application for permission to import substances under Regulation 5G and 5H of the Customs (Prohibited Imports) Regulations 1956

Check one box to indicate whether the controlled substance you are proposing to import is a raw material (for example a bulk substance for further manufacturing) or a finished good (for example a pharmaceutical preparation).

Importer's name

State your full name.

Company name

State your company's name.

Company address

State the physical address to be displayed on the import permit.

Postal address

State the postal address to which you would like the import permit sent. Permits will be sent by standard mail unless a self-addressed, express post envelope accompanies the application.

Importer State/Territory Licence Number

Anabolic/androgenic and hormone substances are controlled under state/territory drugs and poisons legislation. When applying to import these substances you must demonstrate that you have the appropriate authorisation to possess and/or supply them. List the licence number of your licence issued under relevant state/territory drugs and poisons regulations.

Overseas exporter’s full name

State the full name of the overseas exporter.

Overseas exporter’s address

State the physical address of the overseas exporter to be displayed on the import permit.

Substance name

Provide the name of the drug (e.g. testosterone propionate)

Trade name

Trade name

Concentration/Strength

Indicate the concentration/strength of the controlled substance, e.g.

• Raw material: for assayable substances include the assay amount i.e. 98%
• Finished goods: show the amount of controlled substance in the preparation, for example mg/mL for liquids or mg per tablet for tablet products. The concentration should be in metric units.

Form of substance

Indicate the form of the finished goods, for example tablets, capsules, vials, ampoules etc.

Pack type and size

Provide details on the pack type and the size

• Raw material: for example, 25 kg drum
• Finished goods: for example; 24 tablet blister pack; 100 mL bottle; box of 100 tablets; box of 6 x 2mL ampoules.

Total number of packs in shipment

Specify the total number of packs (as defined above) that make up the proposed shipment. For example 25 packs of 24 tablets; 100 bottles of 100 mL; 1000 boxes of 100 tablets, 250 boxes of ampoules.

EUD for raw materials

For raw materials you should attach an End User Declaration (EUD) from yourself as the importer and from customers who you intend to supply the consignment to.

Importer EUD

The EUD from the importer must describe what the substance will be used for, including supply to nominated customers where relevant.

Customer EUD

Where you have nominated that you will supply imported materials to specific customers you should also attach signed EUD’s from those customers. All customer EUD’s must be signed by the proposed customer, state what the goods will be used for

ARTG / APVMA / Laboratory Use / SAS Sponsor / CTN

The ARTG No. (Australian Register of Therapeutic Goods) refers to the number allocated to all TGA-approved therapeutic goods. The ARTG number must be provided for all imported finished goods that have a therapeutic claim. This is not applicable to raw materials or non-therapeutic goods.

The APVMA Product No. (Australian Pesticides and Veterinary Medicines Authority) applies to all approved pesticides and veterinary products. If the APVMA number is not available a copy of the APVMA permission or permit must be provided. This is not applicable to raw materials.

Laboratory Use – Material that will be used for laboratory or research purposes only.

SAS Sponsor - A commercial quantity of an unregistered therapeutic good that is to be used in accordance with the Special Access Scheme – Sponsors Exemption.

The CTN refers to the clinical trial notification or CTX (clinical trial exemption).

Make sure you read and understand the declaration and consent. Sign the application form. Complete the contact details of the person signing the form.