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Guidance: Completing an import permit application for narcotic and psychotropic substances

Guidance for completing an import permit application for narcotic and psychotropic substances.

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Guidance

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 Narcotics Control Section (NCS). A permit is required for each consignment that is imported whereas licenses are issued annually. Information on importing is available separately from the Office of Drug Control (ODC) website.

NCS 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 Narcotics 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.

Company name

State your company's name

Import licence number

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

Overseas exporter's address

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

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 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.

ARTG / APVMA No. / 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).

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 Narcotics Control Section
Office of Drug Control
PO Box 9848
Canberra ACT 2601
By email NCS@health.gov.au

NCS endeavours to process applications for permits within 20 business days from the date of receipt of a correctly completed application and requisite supporting documentation. 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 completed at the time of importation and the hardcopy returned to NCS.

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

Unused or expired permits must be returned within 14 days.

Page history

Version 1.3, Updated information, approved by ODC

Version 1.2, Updated information, approved by ODC

Version 1.1, Updated contact information, approved by ODC

Version 1.0, Original publication, approved by ODC

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