Medical practitioners applying to become Authorised Prescribers require endorsement from an ethics committee as follows:

• medical practitioners engaged in clinical practice in a hospital require endorsement by the ethics committee with jurisdiction at that hospital;
• medical practitioners treating patients outside a hospital setting require endorsement from an appropriate ethics committee.

It is important to note that under the Therapeutic Goods Act 1989, an ethics committee must be constituted and operating in accordance with NHMRC guidelines and have notified its existence to the Australian Health Ethics Committee. Thus, endorsement from ethics committees that do not satisfy these requirements will not be accepted by the TGA.

The legislation contains provisions for those doctors who do not have access to an ethics committee - see below.

For medical practitioners working outside of a hospital setting, an 'appropriate' ethics committee will be one which has jurisdiction either relating to the principal activities of the practitioner or within a geographic area in which the practitioner conducts his/her activities.

A specialist in private practice may obtain approval from an ethics committee at a hospital where he/she has admitting rights or the Area Health Service in which he/she practices. Alternatively, a specialist could be endorsed by the ethics committee of a college having expertise relevant to the treatment of the condition for which use of the product is being sought.

There may be circumstances in which a hospital ethics committee may not be prepared to cover treatment of patients outside the hospital. The legislation allows for this eventuality and requires:

• the practitioner to demonstrate that they do not have access to an ethics committee; and
• to obtain endorsement from a college having expertise relevant to the treatment of the condition for which use of the product is being sought.

The TGA may consult with independent expert advisory committees to determine the appropriateness of the endorsement.

It is recommended that the letter include:

• a clear statement that endorsement is being given for the purpose of the medical practitioner becoming an authorised prescriber;
• the name of the medical practitioner being endorsed;
• the drug and indication for which endorsement has been given;
• the site(s) at which use is covered by the endorsement;
• any conditions the ethics committee has imposed on the endorsement; and
• the signature of the chairman of the ethics committee over his/her official title.

When a medical practitioner becomes an Authorised Prescriber he/she can prescribe, without further approval from the TGA, the unapproved product named in the authorisation for the treatment of individual patients in his/her immediate care who have the condition (also known as the 'indication') identified in the authorisation. Use of the product under an authorisation must be at all times in line with the conditions specified in the authorisation.

The term 'immediate care' means the Authorised Prescriber plays an active and ongoing role in the treatment of that condition in that patient. Authorised Prescribers can only supply the product directly to specified patients and not to other practitioners to prescribe/administer the product to patients. There is no power under Section 19(5) of the Act to authorise a medical practitioner to supply product to parties other than the specified class of patient.

The basis for providing Section 19(5) approvals is that the authorised medical practitioner has training and expertise appropriate for the condition being treated and the proposed use of the product and that the Authorised Prescriber is able to best determine the needs of the patient and to monitor the outcome of therapy.

If the medicine or medical device is available from a supplier in Australia, the Authorised Prescriber should contact the supplier (sponsor) to organise supply. Within an institution, the pharmacy department can usually arrange supply of a medicine. Arrangements should be made for delivery to a doctor or pharmacy to allow for labelling and any additional instructions. A prescription is required for dispensing of the product.

The supplier will require authorisation to lawfully release the product. A copy of the letter of Authorisation must be forwarded to the supplier.

If the product is not available from an Australian sponsor, the requesting doctor will need to find an overseas source. The product will then need to be imported from that supplier. This can be done by the doctor, a pharmacist, hospital, by the patient or by a licensed importer. When seeking to arrange importation of an unapproved medicine, it is important to check whether it is controlled under Customs (Prohibited Import) Regulations, in which case it cannot be imported without an import permit. When approval is given for an Authorised Prescriber to supply of a controlled medicine, TGA will automatically issue an import permit.

A list of controlled substances can be found on the Australian Government Department of Health and Ageing website <http://www.health.gov.au/internet/main/publishing.nsf/Content/list-of-drug-substances-requiring-import-and-or-export-authorisations>.

No. The authorisation is a one-off approval from the TGA. No further notification is needed as long as the practitioner only treats patients suffering from the indication (medical condition) specified in the authorisation in accordance with any treatment directions and conditions imposed by the TGA.

The doctor is responsible for reporting the number of patients treated on a quarterly basis.

The sponsor of the product is also responsible for providing distribution data to the TGA on a six monthly basis.