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Application forms and guidelines

Guidance for completing Licence and Import Permit applications (Special Access Scheme)

This page provides guidance for completing Licence and Import Permit applications (Special Access Scheme).

Printable version of Guidance for completing Licence and Import Permit applications (Special Access Scheme) (PDF 62 KB)

Application for a licence to import narcotic, psychotropic and precursor substances (Special Access Scheme only) (PDF 351 KB)

Application for a licence to import narcotic, psychotropic and precursor substances (Special Access Scheme only) (Word 360 KB)

Introduction

This guidance will assist a medical practitioner or registered pharmacist complete an application for a licence (if required) and permit to import an unapproved medicine containing a drug substance controlled under Regulation 5, 5A and 5H of the Customs (Prohibited Imports) Regulations 1956 in accordance with the provisions of the Special Access Scheme (SAS).

Under Australian therapeutic goods legislation, medical practitioners can request access to unapproved medicines in certain circumstances. Such use may require approval by the Therapeutic Goods Administration (TGA) under what is referred to as the SAS. To obtain more information on the SAS please visit the TGA website or contact the TGA at:

Therapeutics Goods Administration (TGA)
PO Box 100
Woden ACT 2606

Phone: 1800 020 653
Fax: 02 6232 8605
Email: infotga

The importation of narcotic, psychotropic and precursor 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 OCS. Antibiotic and anabolic/androgenic substances, subject to Regulations 5A and 5H respectively, require a permit only.

The substances subject to these import controls are listed in Schedule 4 and Schedule 8 (Item 3C) of the Customs (Prohibited Imports) Regulations 1956. The OCS has also prepared lists of controlled substances which are 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.

To apply for an annual licence to import an unapproved medicine containing a narcotic, psychotropic and/or precursor substance the application form titled "Application for a licence to import narcotic, psychotropic and precursor substances (Special Access Scheme only)" must be submitted to the OCS. To apply for a permit to import an unapproved medicine containing a controlled drug substance the application form titled "Application for a permit to import drug substances (Special Access Scheme only)" must be submitted to the OCS. Importers must apply for a permit to import for each consignment of goods.

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All applications for a licence/permit to import an unapproved medicine containing a controlled drug substance under the SAS must include either:

Category A – a completed notification on the form prescribed by the TGA; or
Category B – a letter from the TGA confirming that a particular course of drug treatment has been approved

Licenses and permits are not granted to individuals for the purpose of obtaining unapproved medications for personal use. If you are an individual wanting to access unapproved medications containing a controlled drug substance you should consult your doctor.

The guidance provided here will assist you in completing and submitting the application forms.

Completing the licence application form

If you already have a valid licence to import then you do not need to complete this form. If the drug substance is an antibiotic or an anabolic/androgenic agent then you do not need to complete a licence application.

Part of application form	Explanation of required information
1. Applicant Details
Name of Medical Practitioner or Registered Pharmacist	Under the Special Access Scheme the application for a licence may only be made by a Medical Practitioner or Registered Pharmacist.
Profession	Select your profession
Medicare Provider No. or Pharmacy Registration No.	Provide your Medicare provider number or pharmacist registration number.
2. Business Information
Company name (if applicable)	State the name of your company/practice, if applicable
Street address	Provide the street address at which activities associated with your profession are carried out.
Postal address	Provide the address where you would like your licence to be posted. Licences will be sent by normal mail unless an express post envelope accompanies the application
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.

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Completing the permit application form

A permit is required for each proposed importation of the controlled drug.

Part of application form	Explanation of required information
1. Importer information
Licence holder’s name (if applicable)	The importation of narcotic, psychotropic and precursor substances subject to Regulation 5 of the Customs (Prohibited Imports) Regulations 1956 is prohibited unless the importer holds a licence issued by the OCS. State the licence holder’s name. Please note - antibiotic and anabolic/androgenic substances, subject to Regulations 5A and 5H respectively, require a permit only.
Company name	State your company’s name
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 normal mail unless an express post envelope accompanies the application.
Import establishment ID number	Each establishment is given a unique identifier by the OCS, for example RN123 or CV987. State your import establishment ID number if known.
Import licence number (if applicable)	State your import licence number which can be found on your licence issued by the OCS, if applicable.
Point of entry	The planned entry point for the import into Australia. Specify port city and state.
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.
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
Export establishment ID number	Each overseas exporter is given a unique identifier by the OCS, for example O12345. State the export establishment ID number if known.
Mode of transport	Specify whether the shipment will be transported to Australia by sea or air.
3. Patient Details
Patient’s initials	Provide the initials of the patient only.
Patient’s date of birth	Provide the date of birth of the patient
Type of application	The Special Access Scheme (SAS) is administered by the Therapeutic Goods Administration and allows access to unapproved therapeutic goods. There are two categories under the scheme: Category A: For patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in absence of early treatment. Where you are proposing that the use of the drug you intend to import would be in accordance with Category A of the SAS you must attach a completed Category A notification on the form prescribed by the Therapeutic Goods Administration (TGA). If you are proposing to use a therapeutic good in accordance with Category A of the SAS then you are required to notify the TGA. Matters relating to: getting approvals under the SAS; notification of category A use; interpretation of the Therapeutic Goods Act 1989 or Therapeutic Goods Regulations 1990 should be referred to the TGA. Category B: For patients who do not fit the definition of Category A. Where you are proposing that the use of the drug you intend to import would be in accordance with Category B of the SAS you must attach a letter from the TGA that confirms a particular course of drug treatment has been approved. The OCS can only advise on aspects that relate to licensing and permitting functions under the Customs (Prohibited Imports) Regulations 1956.
4. Substance Details
Description of goods	The description should include the controlled substance name of the goods being imported. For example “Pseudoephedrine Hydrochloride Cold and Flu tablets”.
Concentration/strength	Indicate the concentration/strength of the controlled substance. 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. For example; 24 tablet blister pack; 100 mL bottle; box of 100 tablets; box of 6 x 2 mL 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. The total amount of drug proposed for import should be consistent with the treatment regime that has been: determined by the prescriber (Category A notifications) OR approved by the TGA (Category B approvals).
Drug code	This is an identifier assigned to specific substances and preparations by the OCS. State the drug code if you know it.
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.

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Submitting an application

You can submit your application in the following ways:

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

Fax
02 6289 2500

Email
tmu

The OCS endeavours to process import applications that are linked to the proposed use of medicines under the Special Access Scheme within 1 working day (Category A) or 7 working days (Category B) 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 importer to ensure that the triplicate copy of the permit is endorsed by the Australian Customs and Border Protection Service and the importer at the time of importation.

It is responsibility of the importer to return the endorsed triplicate copy to the OCS no later than 5 working days after the importation has occurred. Failure to comply with this condition may result in cancellation of import licenses.

IMP_GUID_3 v2.2 Revised June 2012