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Authorised Prescriber Scheme
Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors
About this guidance
This guidance is for medical practitioners, Human Research Ethics Committees (HRECs), specialist colleges and sponsors of 'unapproved' therapeutic goods and provides information about the:
- Authorised Prescriber scheme
- roles and responsibilities of HRECs, specialist colleges, Authorised Prescribers, sponsors and TGA in relation to the Authorised Prescriber scheme
- legal basis for supply of 'unapproved' therapeutic goods
This guidance also provides details about relevant amendments to the Therapeutic Goods Regulations 1990 to streamline the application process for medicines considered to have an established history of use.
This document replaces previous guidance on this topic.
This information is provided for guidance only and should not be relied on to address every aspect of the relevant legislation.
You should seek your own independent legal advice to ensure that all of the legislative requirements are met.
Authorised Prescriber Scheme
Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported into, supplied in, and exported from Australia. Therapeutic goods that are not included in the ARTG (described by us as 'unapproved' goods) cannot be lawfully supplied in Australia unless exempt, approved or authorised under the therapeutic goods legislation.
The therapeutic goods legislation provides a number of avenues that allow access to therapeutic goods that are not included in the ARTG. The Authorised Prescriber scheme allows authorised medical practitioners to access and legally supply a specified 'unapproved' therapeutic good (or class of 'unapproved' therapeutic goods) to a class of patients with a particular medical condition.
An Authorised Prescriber is allowed to supply the product directly to patients in their immediate care without requiring separate approval for individual patients. The product must not be supplied to other practitioners who prescribe or administer the product.
Changes to the Authorised Prescriber Scheme
On 24 July 2020, the Therapeutic Goods Administration (TGA) implemented a change to the Authorised Prescriber scheme to streamline the application process for medicines considered to have an established history of use in Australia.
This change removes the TGA requirement for Human Research Ethics Committee (HREC) approval or specialist college endorsement in circumstances where the medical practitioner is applying to become an Authorised Prescriber of medicines specified in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990, that are considered to have an established history of use. The new arrangement will only apply where the medicine to be prescribed, concentration (if any), dosage form, route of administration and indication match an entry in subregulation 12B(1B).
A printable list of medicines with an established history of use is available on our website. HREC or institutional approval may still be required to use certain 'unapproved' therapeutic goods within an institution such as a hospital. Medical practitioners need to liaise with the relevant institution to confirm the institution's requirements.
The standard duration of authorisation for medicines is up to 2 years. For medicines accessed under subregulation 12B(1B), with an established history of use, the Delegate may authorise supply for up to a five year period. However, the individual delegate assessing the application has full discretion to apply any duration they assess is appropriate for the application.
No changes have been made to the application process for medical devices and biologicals. The duration of authorisation may be extended for medical devices (from one year to two years) and biologicals (from two years to five years) that are listed in the Special Access Scheme rules.
Who can become an Authorised Prescriber
Only medical practitioners can apply to become Authorised Prescribers under the Therapeutic Goods Act 1989. The therapeutic goods legislation defines a medical practitioner as 'a person who is registered, in a state or internal territory, as a medical practitioner'. In addition, the HREC (if applicable) and TGA Delegate must be assured that the medical practitioner has the qualifications and experience necessary to appropriately manage the medical condition and use the product.
To become an Authorised Prescriber, applicants must:
- be a medical practitioner with specialist registration or general registration with the Medical Board of Australia
- generally, applications from medical practitioners with non-practising, limited, student, provisional registration (requiring supervised practice), or conditions placed on their registration will not be considered for the Authorised Prescriber scheme
- have the training and expertise appropriate for the condition being treated and the proposed use of the product
- be able to best determine the needs of the patient
- be able to monitor the outcome of therapy.
The application should specify the medical practitioner's registration number in the national Register of practitioners on the Australian Health Practitioner Regulation Agency (AHPRA) website. 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
The TGA administers the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations), and various Orders and Determinations, and regulates the quality, safety and efficacy of therapeutic goods as well as access to therapeutic goods that have not been approved for general use ('unapproved' therapeutic goods).
- encourages the use of products included in the ARTG
- 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
Medical practitioners who wish to apply to become Authorised Prescribers must:
- determine whether any suitable alternative therapeutic goods are included in the ARTG
- apply for approval from an HREC or endorsement from a specialist college (if applicable)
- submit an application to the TGA.
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 of the 'unapproved' for 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 six monthly report for the periods 1 January to 30 June and 1 July to 31 December. These reports must be supplied to TGA within one calendar month after the reporting period ends
- 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 (where applicable) 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
Sponsors of 'unapproved' therapeutic goods
- 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
- inform us of emerging safety concerns associated with the use of unapproved goods that they supply
|||As per the requirements of Section 47(B)(1)(c)(iii) of the Therapeutic Goods Regulations 1990|