26 July 2017

Introduction

The importation of antibiotics is prohibited unless the importer holds a permit issued by the Drug Control Section (DCS).

Antibiotics are subject to Regulation 5A of the Customs (Prohibited Imports) Regulations 1956.

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 antibiotics' 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
1. Importer information

Applicant's name

State your full name.

Company name

Provide the full business name of the company or organisation of the importer.

Company address

Provide the address of the company or organisation of the importer if different to postal address.

Email Address:

Provide your email address to receive your permit.

Importer State/Territory (S4) Licence No.

Antibiotics 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.

Also enter the expiry date of your licence issued under state/territory drugs and poisons legislation.

Date of expiry

Provide the date of expire of your State/Territory licence.

2. Declaration and Consent

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

Schedule 1: Antibiotic details

Antibiotic Name

Provide the common name of the antibiotic (e.g. penicillin).

ARTG/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 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 – Sponsor's Exemption should state SAS Sponsor.

End Use

Specify the purpose for which the antibiotic is to be used for example human, veterinary.

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 working 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 large numbers of substances, are incomplete or have incorrect information and require amendment, may also result in delays in processing.

Please limit your application to the substances that you reasonably expect to import within the financial year. Further additions of antibiotic substances can be made to your existing permits as need arises throughout the financial year at no expense.

It is the responsibility of the importer to ensure that the Notification of Antibiotics Imports form is completed and returned to this office within 5 days of the expiry of the permit. Failure to comply with this condition may result in cancellation of current import permits.


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