Guidance: Completing applications for a licence and permit to import substances under the Special Access Scheme (SAS) and Authorised Prescriber (AP) only

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.

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. Permits will be sent by standard mail unless an express post envelope accompanies the application.

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 Medical Practitioner or Registered Pharmacist, not the patient.

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 NCS. State the licence holder’s name.

Please note - anabolic/androgenic and hormone substances, subject to Regulations 5G 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 standard service mail unless an express post envelope accompanies the application.

Import licence number (if applicable)

State your import licence number, which can be found on your licence issued by NCS, if applicable.

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

Patient's initials

Initials of the patient. Do not include the patient’s name.

Patient's date of birth

Date of birth of 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 an approval from the TGA that confirms a particular course of drug treatment has been approved.

NCS can only advise on aspects that relate to licensing and permitting functions under the Customs (Prohibited Imports) Regulations 1956.

Substance name

Provide the name of the drug (e.g. morphine sulphate).

Trade name

Provide the trade name of the goods.

Concentration/strength

Indicate the concentration/strength of the controlled substance.

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 expressed 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 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.

The total amount of drug proposed for import should be consistent with the treatment regime that has been determined by the prescriber (Category A and Category C notifications) OR approved by the TGA (Category B approvals).

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 Medical Practitioner or Registered Pharmacist, not the patient.