26 July 2017

Introduction

The importation of narcotic and psychotropic substances subject to regulation 5 of the Customs (Prohibited Imports) Regulations 1956 is prohibited unless the importer holds a licence and permit issued by the Drug Control Section (DCS). A permit is required for each consignment that is imported whereas licenses are issued annually. Information on obtaining a licence is available separately from the Office of Drug Control (ODC) website.

DCS has prepared a list of drug substances controlled under schedule 4 of the Customs (Prohibited Imports) Regulations 1956 on the ODC website. The list is intended to assist importers in identifying drug substances that are prohibited imports and subject to licensing/permitting requirements.

Permits are not granted to individuals for the purpose of obtaining medications for personal use. If you are an individual wanting to access medications that are prohibited imports you should consult your doctor and refer to the Special Access Scheme on the TGA website.

To apply for a permit to import controlled substances the application form titled 'Application for permission to import narcotic and psychotropic substances' must be submitted to the Drug Control Section. The guidance provided here will assist you in completing and submitting the application form.

Completing the form

The table below will assist you in identifying the required information for completing the permit application form.

Part of application form Explanation of required information
Check box for 'Raw Material' or 'Finished Goods'

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).

1. Importer information

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.

Import establishment ID No:

Each establishment that has a licence to import is given a unique identifier by DCS, for example RN123 or CV987. State your import establishment ID number if known.

Company name

State your company's name

Import licence number

State your import licence number which can be found on your licence issued by DCS.

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.

Point of entry

The planned entry point for the import into Australia. Specify port city and state.

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.

2. Exporter Information

Overseas exporter's full name

State the full name of the overseas exporter

Export establishment ID number

State the export establishment ID number if known. Each overseas exporter is given a unique identifier by DCS, for example O12345. There is an expectation that companies which conduct their business with the same overseas entity on a regular basis should be able to include this code on their application.

Overseas exporter's address

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

Mode of transport

Specify whether the shipment will be transported to Australia by sea or air.

Approximate date of export

Indicate the expected export date for the consignment if the import permit is issued. If the exact date is not known, provide the approximate time period.

3. Substance Details

Substance name

Provide the name of the drug (e.g. morphine sulphate)

Trade name

If a finished good, provide the 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: show the amount of controlled substance in the preparation, for example X mg/mL for liquids or Y mg/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.

Drug code

This is an identifier assigned to specific substances and preparations by DCS. State the drug code if you know it. There is an expectation that companies which import the same products on a regular basis should be able to include this code on their application.

ARTG/CTN/ APVMA No. or SAS Sponsor

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

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.

Companies wishing to import a commercial quantity of an unregistered therapeutic good in accordance with the Special Access Scheme - Sponsors Exemption should state SAS Sponsor.

4. Declaration and Consent

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.

Submitting an application

You can submit your application in the following ways:

Mail Drug Control Section
Office of Drug Control
(MDP 95) GPO Box 9848
Canberra ACT 2601
Fax 02 6203 1740
Email dcs@health.gov.au

DCS endeavours to process applications for permits within 20 business days from the date of receipt. While a very high proportion of applications are processed within 10 days, there will be times where high demand for permits may result in slightly longer processing times. Application forms that contain incomplete or incorrect information will be returned to you for amendment, resulting in delays in processing.

It is the responsibility of the importer to ensure that the triplicate copy of the permit is endorsed by the Australian Border Force and the importer at the time of importation.

It is responsibility of the importer to return the endorsed triplicate copy to DCS no later than 14 working days after the importation has occurred. Failure to comply with this condition may result in cancellation of import licenses.


Version history
Date Version Amendments Approved by
8 December 2016 1.0 Original publication ODC
26 July 2017 1.1 Updated contact information ODC