26 July 2017

Introduction

The exportation of narcotic, psychotropic and precursor substances subject to regulation 10 and 10A of the Customs (Prohibited Exports) Regulations 1958 is prohibited unless the exporter holds a licence and permit issued by the Drug Control Section (DCS). A permit is required for each consignment that is exported whereas licenses are issued annually. Information on obtaining a licence is available separately from the Office of Drug Control website.

DCS has prepared a list of drug substances controlled under schedule 8 of the Customs (Prohibited Exports) Regulations 1958 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.

To apply for a permit to export controlled substances the application form titled 'Application for permission to export narcotic, psychotropic, precursor substances' must be submitted to DCS. 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 export is a raw material (for example a bulk substance for further manufacturing) or a finished good (for example a pharmaceutical preparation).

1. Exporter information

Licence holder's name

Permits to export controlled substances can only be issued to exporters who hold a licence to export substances covered by Regulation 10 and 10A of the Customs (Prohibited Exports) Regulations 1958. State the name of the licence holder.

Export establishment ID No.

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

Company name

State your company's name

Export licence number

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

Approximate date of export

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

Point of exit

The planned exit point for the export out of Australia. Specify port city and state.

Company address

State the physical address to be displayed on the export 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. Importer Information

Overseas importer's full name

State the full name of the overseas importer

Overseas importer's address

State the physical address of the overseas importer to be displayed on the export permit

Import establishment ID No.

State the import establishment ID number if known. Each overseas importer 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.

Point of entry

Indicate the port, city and state/region in the importing country where you propose that the shipment would be landed.

Import authorisation No.

Narcotic and psychotropic substances that are subject to control under the international drug treaties cannot be exported from a country without the prior approval of the competent authority in the receiving country.

State the import authorisation number listed on the authorisation issued by the competent authority in the destination country. The original copy of the import authorisation issued by the competent authority in the destination country must be provided with the export permit application to DCS. If required, this will be returned with the issued export permit.

Mode of transport

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

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, 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 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 export the same products on a regular basis should be able to include this code on their application.

ARTG/APVMA No

The ARTG No. (Australian Register of Therapeutic Goods) refers to the number allocated to all TGA-approved therapeutic goods (including export-only listings). The ARTG number must be provided for all exported 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.

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

Unfortunately due to international requirements, electronic submissions (email/fax) are not permitted.

You can submit your application in the following way:

Mail Drug Control Section
Office of Drug Control
GPO Box 9848 (MDP 95)
Canberra ACT 2601

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 this target timeframe, there will be times where high demand for permits may result in slightly longer processing times. Applications 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 exporter to ensure that the triplicate copy of the permit is correctly completed and contains the export declaration number associated with the shipment.

It is responsibility of the exporter to return the endorsed triplicate copy to DCS no later than 5 working days after the exportation has occurred. Failure to comply with this condition may result in cancellation of export 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