Legal basis of the Scheme

Therapeutic goods in Australia are regulated under the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations). Under the Act, only goods entered in the ARTG can be legally supplied in Australia.

Under section 19 of the Act, some medicines are exempt from inclusion in the ARTG. Similarly, some biologicals and medical devices are also exempt under subsection 32CM and chapter 4, parts 4–7 of the Act, respectively. These provisions allow for the Authorised Prescriber scheme.

On this page: Medicines | Biologicals | Medical devices | Prohibition of promoting 'unapproved' therapeutic goods | Information and privacy

Medicines

The following clauses relate to the Authorised Prescriber Scheme and access to 'unapproved' medicines:

• subsection 19(5) of the Act provides that a specific medical practitioner may be authorised to supply a medicine to a specified class or classes of patient
• regulation 12B of the Regulations relate to medicines and provide that:
  • you must be a medical practitioner and have approval from an appropriate ethics committee to become an Authorised Prescriber
  • if the medical practitioner does not have access to an appropriate ethics committee, they may seek endorsement from a specialist college with relevant expertise
  • if the medical practitioner wishes to apply for a medicine that is included in subregulation 12B(1B) of the Regulations, then ethics committee approval or specialist college endorsement is not required to be submitted to the TGA
  • the medical practitioner may prescribe an 'unapproved' therapeutic good only for patients with a life-threatening or serious illness
  • the medical practitioner must meet any conditions applied to their approval as an Authorised Prescriber.
• subsection 31B(3) of the Act provides that a medical practitioner who has been approved under subsection 19(5) may be notified in writing that they must provide information on matters including the:
  • supply of the goods
  • handling of the goods
  • monitoring of the supply of the goods
  • results of the supply of the goods.

Biologicals

The following clauses relate to the Authorised Prescriber Scheme and access to 'unapproved' biologicals:

• subsection 32CM(1) of the Act provides that a specific medical practitioner may be authorised to supply a biological to a specified class or classes of patients
• regulation 12C of the Regulations relate to biologicals and provides that:
  • you must be a medical practitioner and have approval from an appropriate ethics committee to become an Authorised Prescriber
  • if the medical practitioner does not have access to an appropriate ethics committee, they may seek endorsement from a specialist college with relevant expertise
  • the medical practitioner may prescribe an 'unapproved' therapeutic good only for patients with a life-threatening or serious illness
  • the medical practitioner must meet any conditions applied to their approval as an Authorised Prescriber
• subsection 32JG(3) of the Act provides that a medical practitioner who has been approved under subsection 32CM(1) may be notified in writing that they must provide information on matters including the:
  • supply of the biological
  • handling of the biological
  • monitoring and supply of the biological
  • results of the supply of the biological

Medical devices

The following clauses relate to access to 'unapproved' medical devices and the Authorised Prescriber Scheme:

• subsection 41HC of the Act states that, subject to the requirements of the Medical Devices Regulations, a specific medical practitioner may be authorised to supply specific kinds of medical devices to a specified class of patient. Conditions may be applied to this authority
• regulation 7.6 of the Medical Device Regulations states:
  • you must be a medical practitioner approved by an appropriate ethics committee to become an Authorised Prescriber
  • if the medical practitioner does not have access to an appropriate ethics committee, they may seek endorsement from a specialist college with relevant expertise
  • the class of patients for which the medical practitioner may prescribe an 'unapproved' therapeutic good must have a life-threatening or serious illness or condition
• regulation 7.7 of the Medical Device Regulations states the medical practitioner must meet any conditions applied to your approval as an Authorised Prescriber
• subsection 41JF(1) of the Act provides that a medical practitioner who has been approved under subsection 41HC may be notified in writing that they must provide information on matters including the:
  • supply of devices of those kinds
  • handling of devices of those kinds
  • monitoring of the supply of devices of those kinds
  • results of the supply of devices of those kinds

Prohibition of promoting 'unapproved' therapeutic goods

The Act provides (at Section 22(6) for medicines and biologicals and section 41MM for medical devices) that a person must not publicly claim they can supply 'unapproved' therapeutic goods.

Information and privacy

The TGA meets our privacy requirements under the Department of Health's Privacy Policy, the Privacy Act 1988 and the Freedom of Information Act 1982.