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Application forms and guidelines

Guidance for completing import permit applications for antibiotics

The importation of antibiotics is prohibited unless the importer holds a permit issued by the Office of Chemical Safety (OCS).

PDF printable version of Guidance for completing import permit applications for antibiotics (PDF 43 KB)

Application for a permit to import antibiotics (PDF 337 KB)

Application for a permit to import antibiotics (Word 390 KB)

Introduction

The importation of antibiotics is prohibited unless the importer holds a permit issued by the Office of Chemical Safety (OCS).

These substances are subject to Regulation 5A of the Customs (Prohibited Imports) Regulations 1956. The OCS has prepared a list of controlled substances which is available from the Department of Health and Ageing's website to assist 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.

To apply for a permit to import controlled substances the application form titled "Application for a permit to import antibiotics" must be submitted to the OCS. 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.

1. Importer information
Importer’s name	State your full name
Postal address	Provide the address where you would like the permit to be posted. Permits will be sent by normal mail unless an express post envelope accompanies the application
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
Importer State/Territory 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
2. Permit details
Type of permit required	Check one box to indicate the type of permit required Limited authority: refers to a permit that is valid for a single consignment. The permit must be used within 3 months from the date of issue. Please check this box for all applications to import unregistered medicines. Continuing authority: refers to a permit that can be used for multiple consignments. The permit is valid for up to 12 months of the financial year it is issued. Please check this box for all applications to import antibiotic raw material or medicines currently listed on the Australian Register of Therapeutic Goods (ARTG) or registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA)
3. 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 (eg penicillin)
Trade Name	Provide the tradename of the antibiotic product to be imported (eg Pentax)
ARTG/APVMA No. or SAS Sponsor	The ARTG No. (Australian Register of Therapeutical 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 – Sponsors Exemption should state SAS Sponsor
Manufacturer	Provide the name of the antibiotic manufacturer
Country of Origin	Indicate the country where the antibiotic was manufactured
End Use	Specify the purpose for which the antibiotic is to be used for example human, veterinary.
Form	Indicate the form of the finished goods, for example tablets, capsules, vials, ampoules etc.
Quantity	(Limited authority only): Specify the total number of packs 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.
Pack size	Provide details on the pack type for example; 24 tablet blister pack; box of 6 x 2 mL ampoules.
Unit Size	Specify the unit size, eg 50 mL vial, 25 mg tablet etc
Strength	Specify the strength (concentration) of the antibiotic in metric weight units eg 2 mg/mL. If the concentration of the antibiotic is in IU or similar, you must convert to standard weights and volumes (mg, ml etc)

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Submitting an application

You can submit your application in the following ways:

Mail
Drug Import Export Licensing Compliance
Office of Chemical Safety
GPO Box 9848 (MDP 88)
Canberra ACT 2601

Fax
02 6289 2500

Email
tmu (to request/submit a digital format of the application)

The OCS endeavours to process applications for permits within 30 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 Form F (available from the Department of Health and Ageing's website) is returned within 5 days of import for a Limited authority permit, or within 5 days of the expiry of a Continuing authority permit to the Office of Chemical Safety. Failure to comply with this condition may result in cancellation of current import permits.

IMP_GUID_4 v2.1 Revised June 2012