Authorised Prescriber Scheme

Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors

3 July 2017

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Authorised Prescriber Scheme

Therapeutic goods not included on the Australian Register of Therapeutic Goods (ARTG) cannot legally be supplied unless TGA grants an exemption. The Authorised Prescriber Scheme allows medical practitioners who become Authorised Prescribers to access and legally supply an unapproved therapeutic good or class of goods to appropriate patients.

On 1 July 2017, Therapeutic Goods Administration (TGA) implemented a change to the application process of Authorised Prescriber Scheme to streamline access to unapproved therapeutic goods. This change removed the requirement for a medical practitioner to resubmit their clinical justification to the TGA as this is required to be submitted to and be evaluated by a Human Research Ethics Committee (HREC) or specialist college. The duration of approval may now also be extended for therapeutic goods which are deemed to have an established history of use - from one year to two years for medical devices and from two years to five years for medicines and biologicals, at the discretion of the Delegate who makes the decision.

Goods and their indications/uses listed on in the following legislative instruments are deemed to have an established history of use:

Goods other than those listed in the instruments above or the same goods used for different indications/uses will be considered on an individual basis at the discretion of the Delegate.

This guidance:

  • provides an overview of the Authorised Prescriber Scheme
  • describes the roles and responsibilities of HRECs, specialist colleges, Authorised Prescribers, sponsors and TGA
  • outlines the legal basis for supply

This document replaces previous guidance on this topic.

Who can become an Authorised Prescriber

Medical practitioners can become Authorised Prescribers under the Therapeutic Goods Act 1989 and its associated regulations.

Other health practitioners, including dentists, are not eligible to become Authorised Prescribers. These practitioners may be able to access unapproved therapeutic goods for individual patients under the Special Access Scheme.

Roles and responsibilities

Medical practitioners

Medical practitioners who wish to become Authorised Prescribers must:

  • determine whether any suitable alternative marketed goods are available on the ARTG
  • apply to an HREC for approval
  • provide the HREC with complete and accurate information in support of the application
  • In circumstances where the medical practitioner seeking to become an Authorised Prescriber of unapproved medicines or biologicals does not have access to an ethics committee, the medical practitioner may obtain endorsement from a specialist college that has expertise relevant to the treatment of the medical condition for which authority is sought.
  • In circumstances where the medical practitioner seeking to become an Authorised Prescriber of unapproved medical devices does not have access to an ethics committee that:
    • has the expertise relating to the use of the unapproved good; or
    • conducts its activities in the geographical area where the approval is sought
    the medical practitioner may seek endorsement from a specialist college that has expertise relevant to the treatment of the medical condition.

Medical practitioners who become Authorised Prescribers must:

  • remain informed about changes to the benefits and risks of the good as they arise
  • consider the potential benefits and risks the unapproved good may offer each patient it is prescribed for
  • obtain written informed consent from each patient before prescribing
  • arrange supply of the goods directly through a sponsor or pharmacy
  • monitor the patient during and after use of the unapproved good
  • provide TGA with a supply report every six months for the periods ending 30 June and 31 December. These reports must be supplied to TGA within one calendar month after the reporting period
  • inform us of adverse events associated with use of the good
  • meet any conditions the TGA, HREC or specialist college applies to the approval or endorsement
  • comply with relevant State or Territory legislation governing the supply of therapeutic goods. Approval as an Authorised Prescriber does not override State or Territory legislation

HRECs and specialist colleges

HRECs and specialist colleges:

  • evaluate a medical practitioner's submission and, if appropriate, approve or endorse it
  • if the application is approved or endorsed, provide the medical practitioner with a letter declaring they have reviewed all necessary documentation and clearly stating this approval or endorsement
  • monitor the medical practitioner's use of the unapproved goods to ensure continued endorsement is appropriate. Examples of monitoring that have been undertaken by HRECs and specialist college have included the requirement for medical practitioner to submit to them:
    • reports outlining the number of patients who have been treated
    • adverse event or product defect reports.
  • consider any new information available to determine whether it would be appropriate to continue the endorsement or approval

TGA

TGA:

  • encourages the use of approved, fully evaluated products
  • determines whether there are emerging safety concerns that would make approval or endorsement inappropriate
  • determines whether the requirements for authorisation as an Authorised Prescriber have been met

Sponsors of unapproved therapeutic goods

Sponsors:

  • must obtain a copy of the TGA approval letter from the medical practitioner before supplying the unapproved good to the medical practitioner
  • supply the unapproved good, at their discretion
  • monitor the use of the goods, report adverse events and product defects and record the balance of benefits and risks
  • provide TGA with six-monthly reports on the supply of unapproved goods[1]
  • inform us of emerging safety concerns associated with the use of unapproved goods that they supply

Footnote

  1. As per the requirements of Section 47(B)(1)(c)(iii) of the Therapeutic Goods Regulations 1990

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