Regulatory approach to medicines

Regulatory approach cycle

Queensland Health implements five major activities to administer the regulatory framework for medicines under the Medicines and Poisons Act 2019 (MPA) and the Medicines and Poisons (Medicines) Regulation 2021 (MPMR):

• authorisations to deal with medicines
• assessing substance authority applications and granting/refusing authorisations
• education through promoting and supporting voluntary compliance
• monitoring compliance
• directing compliance and enforcement intervention.

Download the Regulatory approach cycle diagram (PDF 694 kB).

Managing authorisations to deal with medicines

The Medicines and Poisons Act 2019 (MPA) details how people are authorised to deal with medicines and poisons. Queensland Health manages changes to authorisations such as new Extended Practice Authorities or changed Schedules relating to approved persons.

Assessing substance authority applications and granting authorisations

Queensland Health assesses substance authority applications and make decisions on granting or refusing authorisations.

Education - promoting and supporting voluntary compliance

Our regulatory approach requires 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.

We encourage promoting compliance through education to ensure authorised people understand their obligations.

Monitoring compliance

Compliance with the MPA and Medicines and Poisons (Medicines) Regulation 2021 (MPMR) is monitored using a combination of proactive and reactive strategies.

The Monitored Medicines Monitoring Strategy outlines how Queensland Health monitors QScript (the monitored medicines database) and the Monitored Medicines Standard.

Directing compliance and enforcement interventions

If people do not comply with the MPA and MPMR, we can issue warning letters and compliance notices.

Non-compliance can be addressed using enforcement options, including:

• serving a Penalty Infringement Notice (PIN)
• giving a Show Cause Notice
• taking administrative action
• commencing legal proceedings (prosecutions).

Compliance and enforcement pyramid

Download the Compliance and enforcement pyramid (PDF 778 kB).

The Compliance and enforcement pyramid shows how regulatory responses and enforcement interventions escalate so we can manage non-compliance based on the risk it poses to public safety.

Verbal advice and education

The initial implementation of the MPA and MPMR will focus on advice and education regarding the new legislation. Verbal advice and education should be used:

• for first time non-compliance
• when there is a low risk to human health
• when advice and education will likely be sufficient to ensure compliance.

All verbal advice and education must be documented as this evidence may be required if future non-compliance is identified and the enforcement intervention is to be escalated.

Warning letter

Written warnings may be given when there is evidence that non-compliances have occurred. The total number of offences will be considered in deciding the appropriate course of action. For example, written warnings will:

• detail the nature of the alleged offence
• cite relevant clauses of the legislation
• specify the maximum penalty for the offence
• state the intention to enforce the legislation.

Where significant non-compliance is evident, escalated enforcement action may be appropriate.

Compliance notice

Compliance notices are addressed in Chapter 4, Part 4 of the MPA.

A compliance notice is given to a person and requires them to take specified steps to fix proven non-compliance within a specified timeframe. The chief executive and those appointed under the MPA can give compliance notices in circumstances where:

• a person has contravened a provision of the MPA and/or MPMR and the chief executive or inspector believes that it is likely to continue or be repeated
• the situation is reasonably capable of being rectified
• it is appropriate to give the person an opportunity to rectify the matter.

A compliance notice must state:

• that the chief executive or inspector believes the person has contravened a provision of the MPA and/or MPA in circumstances that make it likely the contravention will continue or be repeated
• the provision of the MPA and/or MPMR that the chief executive or inspector believes has been contravened
• how it is believed the provision has been contravened
• the matter related to the contravention that the chief executive or inspector believes is reasonably capable of being rectified
• the reasonable steps the person must take to rectify the matter
• that the person must take the steps within a reasonable period
• that it is an offence to fail to comply with the compliance notice unless the person has a reasonable excuse.

The notice must specify the timeframe in which the person is:

• expected to rectify the non-compliance by undertaking the steps identified
• advise Queensland Health that the requirements of the notice have been fulfilled. Evidence may be required to be submitted as part of this notification.

Failure to comply with a compliance notice is an offence unless the person has a reasonable excuse.

Queensland Health has discretion when determining whether an excuse presented by a person is reasonable in the circumstances.

Penalty Infringement Notice (PIN)

Five offences in the MPA have been identified as suitable for serving PINs under the State Penalties Enforcement Act 1999.

Administrative action

Chapter 4, Part 3 of the MPA covers administrative action.

Prosecution will only be used:

• for the most serious offences which may have, or has, 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.

Both the MPA and the MPMR set out the offences and maximum penalties that are associated with unauthorised activities with medicines.

Authorised way offences in MPA

Other offences associated with dealings with medicines in MPA

Other offences associated with dealings with medicines in the MPMR

Requirement to comply with Departmental Standards

Penalty infringement notice (PIN) offences

• 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.