Administrative action under the Medicines and Poisons Act 2019
Section 95 of the Medicines and Poisons Act 2019 (MPA) defines administrative action, in relation to an authority (a substance authority or an approved person’s authorisation), as:
- changing a condition of an authority; or
- suspending an authority for a stated period or indefinitely; or
- cancelling a substance authority.
Under Section 96 of the MPA, the chief executive may take administrative action in relation to an authority if they believe:
- a relevant person for the authority has contravened a requirement under the MPA or a corresponding law; or
- the administrative action is reasonably necessary to prevent or minimise a health risk; or
- a relevant person for the authority is not a fit and proper person; or
- a relevant person for the authority has made a materially false or misleading representation to obtain the authority.
Administrative action may be:
- immediate administrative action—taken because there is an urgent need to prevent a serious health risk to any person, including to the authority holder (see Section 102 of the MPA); or
- agreed administrative action—taken if a relevant person to whom the action applies agrees to the action being taken (see Section 103 of the MPA).
Requesting a review of an administrative action
The holder of an authority in relation to which administrative action has been taken (other than administrative action that is the cancellation of a substance authority) may:
- ask the chief executive, in writing, to review the administrative action, and
- give the chief executive information supporting the holder’s request.
The holder may make such a request only on or after the ‘review day’ for the administrative action – view the Regulatory framework for medicines offences (PDF 542 kB) for more information.
To request a review of an administrative action under Section 105 of the MPA, complete and submit the appropriate form on or after the review day:
- Request by holder of a substance authority to review administrative action relating to medicines (PDF 267 kB)
- Request by holder of an authority as an approved person for medicines to review administrative action (PDF 271 kB)
Applying for an internal review of an original decision
Chapter 6, Part 1, Division 2 of the MPA covers applications for internal reviews of original decisions made under the MPA.
An application for internal review of an original decision must be in the appropriate approved form:
- Application for internal review of an original decision relating to a substance authority for medicines (PDF 287 kB)
- Application for internal review of an original decision relating to an authorisation as an approved person for medicines (PDF 261 kB)
Applying to QCAT for a review of an original decision
Chapter 6, Part 1 of the MPA covers Queensland Civil and Administrative Tribunal (QCAT) reviews of decisions.
Under Section 197 of the MPA, an affected person for an original decision (other than decisions about compensation made under Section 128 of the MPA) may apply to QCAT for a review of the decision only if a decision on an application for internal review of the decision has been made, or is taken to have been made, under Chapter 6, Part 1, Division 2 of the MPA.
Requesting information from the administrative action register
Under Section 228(a) of the MPA, the chief executive must keep a register about administrative action taken under Chapter 4, Part 3 of the MPA. This is called the administrative action register.
Individuals can use this form to request information from the administrative action register (PDF 267 kB).
Further information
For further information about administrative actions for medicines offences under the MPA:
- view Chapter 4, Part 3 of the MPA
- view the Regulatory framework for medicines offences (PDF 542 kB); or
- email MedicinesCompliance@health.qld.gov.au.