Guidance: Completing import permit applications for precursor substances

Check one box to indicate whether the precursor 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).

Licence holder's name

Permits to import controlled substances can only be issued to importers who hold a licence to import substances covered by regulation 5 of the Customs (Prohibited Imports) Regulations 1956. State the name of the licence holder.

Company name

State your company's name

Import licence number

State your import licence number, which can be found on your licence issued by the NCS.

Approximate date of import

Indicate the expected import date for the consignment if the import permit is issued. If the exact date is not known, provide the approximate time period (e.g. Oct 2022).

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 export permit sent. Permits will be sent by standard mail unless an express post envelope accompanies the application.

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 precursor chemical (e.g. ephedrine HCl)

Trade name

If a finished good, provide trade name of the goods

Concentration/Strength

Indicate the concentration/strength of the controlled substance:

• Raw material: for assayable substances include the assay amount i.e. 98%
• Finished goods: how 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 2 mL 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.

End user declaration

For precursor substances that are 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 and that the goods will not be used for the production of illicit drug substances.

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. The form must be signed by the licence holder or a person that the licence holder has authorised in writing to make applications under the licence.