Regulatory approach to medicines offences
Medicines offences
The Medicines and Poisons Act 2019 (MPA) and Medicines and Poisons (Medicines) Regulation 2021 (MPMR) set out a range of offences and maximum penalties associated with unauthorised activities with medicines, as outlined below.
MPA offences – ‘authorised way’
Chapter 2 of the MPA contains a range of offence provisions which relate to persons not carrying out activities with medicines in the authorised way as per the table below.
MPA | "Authorised way" offence |
|---|---|
Offence to deal with prohibited substances | |
Offence to manufacture medicines or hazardous poisons | |
Offence to buy or possess S4 or S8 medicines or hazardous poisons | |
Offence to supply medicines or hazardous poisons | |
Offence to administer medicines | |
Offence to prescribe or make standing orders | |
Offence to dispose of waste from diversion-risk medicines |
MPA offences - other medicines offences
In addition to ‘authorised way’ offences, the MPA sets out a range of other medicines offences, as described below.
MPA | Other offences associated with dealings with medicines in the MPA |
|---|---|
Offence to supply or administer animal medicines to humans | |
Unlawfully buying diversion-risk medicines | |
Offences for self-prescribing or self-administering high-risk medicines | |
Requirement to check database for particular dealings with monitored medicines | |
Offence for giving or keeping false, misleading or incomplete information and records | |
Failure to comply with substance authority conditions | |
Requirements for substance management plan | |
Compliance with substance management plan | |
Giving information |
MPMR offences
Additional medicines offences are specified in the MPMR, as outlined below.
MPMR | Other offences associated with dealings with medicines in the MPMR |
|---|---|
Electronic prescription management systems | |
Secure storage systems | |
Containers | |
Recording and keeping information | |
Reporting particular matters | |
Advertising and vending machines |
Requirement to comply with departmental standards
The MPMR prescribes six (6) departmental standards which particular persons/entities must comply with. The table below lists the relevant provisions of the MPMR which specify the details of when compliance with each standard is required.
MPMR | Name of departmental standard |
|---|---|
Compounding | |
Monitored Medicines | |
Pseudoephedrine recording | |
Substance management plans for medicines | |
Requirements for an electronic prescription management system | |
Secure storage of S8 medicines |
All departmental standards are available on the Legislation, standards and extended practice authorities page.
General regulatory approach
Queensland Health is committed to a risk-based, education-first approach to monitoring and enforcement of medicines offences under the MPA and MPMR. A phased approach to monitoring and enforcement of medicines offences has been implemented with a focus on education and guidance.
- If non-compliance is identified, education and assistance for people to voluntarily comply with the legislation is typically the starting point. If this is not effective, Queensland Health may direct compliance by giving a person a compliance notice.
- If non-compliance continues, regulatory action may need to be escalated by, for example, taking administrative action such as cancelling the person’s substance authority, or an approved person’s authorisation. Prosecution of offences would only be considered as a final action where compliance is not being achieved and there is a continuing risk to the public.
The Compliance and enforcement pyramid for medicines offences (PDF 54 kB) illustrates how regulatory responses and enforcement interventions escalate to manage non-compliance based on the risks posed to public safety.
Queensland Health uses a combination of proactive and reactive strategies to monitor compliance with the MPA and MPMR. Compliance monitoring and enforcement activities for medicines offences are undertaken by entities both within the Department of Health and the Hospital and Health Services (e.g. Public Health Units).
View the Regulatory framework for medicines offences (PDF 542 kB) for more information about Queensland Health’s general approach to compliance monitoring and enforcement of medicines offences under the MPA and MPMR.
Promoting and supporting voluntary compliance
A fundamental premise of Queensland Health’s regulatory approach is that people who are authorised to deal with medicines must understand their legislative obligations and be empowered with the information and tools necessary to achieve compliance without intervention.
Therefore, a continuing focus on promoting and supporting voluntary compliance through advice, guidance, education, information, inspections and warning letters—to ensure authorised persons understand their obligations—is an important element in Queensland Health’s regulatory approach to administering the legislation.
Directing compliance
A compliance notice (Chapter 4, Part 4 of the MPA) may be given to a person requiring them to take specified steps to remedy substantiated non-compliance within a specified timeframe.
A compliance notice identifies the substantiated breaches of the MPA and/or MPMR in relation to a particular matter, how the person is believed to have contravened the provision, the evidence used to substantiate the breach, and the reasonable steps to be taken to rectify the non-compliance.
View the Regulatory framework for medicines offences (PDF 542 kB) for more information about compliance notices.
Enforcement action
The enforcement actions available to Queensland Health in relation to non-compliance with medicines offences under the MPA and MPMR are summarised below.
For more information about these actions, view the Regulatory framework for medicines offences (PDF 542 kB).
Prescribed infringement notices (PINs)
A PIN is an infringement notice issued in accordance with the requirements of the State Penalties Enforcement Act 1999 (Qld) which results in a financial impost on the offender. Five offences in the MPA have been identified as suitable for the serving of PINs under the State Penalties Enforcement Act 1999 as detailed in the table below.
MPA | PIN offence |
|---|---|
Failure to check the monitored medicines database (QScript) prior to prescribing or dispensing a monitored medicine as required by Section 41(2) of the MPA. The PIN fine for this offence is two (2) penalty units. | |
Failure to comply with substance authority conditions as required by Section 71 of the MPA. The PIN fine for this offence is five (5) penalty units. | |
Failure to comply with the requirements for a substance management plan as required by Section 93 of the MPA. The PIN fine for this offence is six (6) penalty units. | |
Failure to return inspector identity card as required by Section 137 of the MPA. The PIN fine for this offence is one (1) penalty unit. | |
Failure to provide prescribed information to the chief executive at the time, and in the way, prescribed by regulation as required by Section 226 of the MPA. The PIN fine for this offence is ten (10) penalty units. |
Show cause notices
Under Section 97 of the MPA, if the chief executive proposes to take administrative action in relation to an authority under Section 96, the chief executive must first give the holder of the authority a show cause notice stating:
- that the chief executive proposes to take the administrative action; and
- the proposed administrative action—including whether it applies to all regulated activities with regulated substances to which the authority relates; or a particular regulated activity or regulated substance; and
- the reasons for the proposed administrative action; and
- that the holder may, within a stated period of at least 21 days (the show cause period), give the chief executive a written response to the show cause notice.
See Chapter 4, Part 3, Division 2 of the MPA for more information about show cause notices.
If the chief executive considers it is reasonably necessary to take administrative action immediately because there is an urgent need to prevent a serious health risk to any person, the chief executive may decide to take administrative action without giving the holder of the authority a show cause notice Chapter 4, Part 3, Division 3 of the MPA.
Administrative action
Administrative action, in relation to an authority (a substance authority or an approved person’s authorisation), means:
- changing a condition of an authority; or
- suspending an authority for a stated period or indefinitely; or
- cancelling a substance authority (Section 95 of the MPA).
For more information about administrative action, view Chapter 4, Part 3 of the MPA or visit the Administrative action under the Medicines and Poisons Act 2019 page.
Prosecution
Prosecution is only used:
- for the most serious offences which have, or may have, resulted in a significant impact on human health
- where a PIN, compliance notice or administrative action would not be sufficient due to the severity of the non-compliance or the wilful and intentional nature of the non-compliance.