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Substance management plans (SMPs)

A substance management plan (SMP) is a document setting out how known and foreseeable risks associated with any dealing with a regulated substance are to be managed at, or in connection with, a regulated place. Where an SMP applies, a person must comply with the SMP to carry out a regulated activity in the authorised way. Read about substance management plans (SMPs) (PDF 238 kB).

An SMP for medicines is required for any place specified as a ‘regulated place’ under the Medicines and Poisons (Medicines) Regulation 2021 (MPMR). These places include:

  • public and private hospitals
  • aged care facilities
  • ambulance stations
  • schools and child care facilities
  • pharmacies
  • other licenced private health facilities
  • prisons and detention centres.

The person responsible for making the SMP at a place is specified in the Schedule 17 of the MPMR. Typically this is a senior person such as an executive director, a school principal or a pharmacy owner or owners.

SMPs are outcome-focused and are required to contain minimum risk management, accountability benchmarks and governance criteria. SMPs must comply with the departmental standard Substance management plans for medicines (PDF 412 kB).

For most entities, the information to be included in an SMP will already exist. To support regulated places to meet this new requirement, a transitional period of one year has been created to allow entities time to develop and implement a compliant SMP. Some supporting materials are available and will be added to throughout the year.

Regulated places and responsible persons

Schedule 17 of the MPMR states

In this table—

  • manager, of a regulated place, means the person who is responsible for the day-to-day management of the place.
  • senior officer, of a regulated place, means a person who holds an office that is sufficiently senior to supervise compliance with a substance management plan made for the place.
  • specified pharmacy means—
    • a community pharmacy operated by a friendly society or the Mater Misericordiae Health Services Brisbane Limited
    • a pharmacy supplying medicines only to inpatients of a hospital.

Regulated place

Responsible person

a place where a medicine is manufactured under a manufacturing licence

if the holder of the licence is an individual—the individual

if the holder of the licence is a body corporate—each executive officer of the body corporate

otherwise—the manager of the place where the medicine is manufactured

a place where a medicine is stored for supply by wholesale, other than—

  • a community pharmacy
  • a specified pharmacy
  • a place at which a wholesale representative works   independently

if the wholesaler of the medicine is an individual—

the individual if the wholesaler of the medicine is a body corporate—each executive officer of the body corporate

otherwise—the manager of the place where the medicine is stored

a place required to have a substance management plan under a condition of a substance authority

if the holder of the authority is an individual—the individual

if the holder of the authority is a body corporate—each executive officer of the body corporate

otherwise—the manager of the place

an isolated site stated in a general approval (acute health conditions at isolated sites)

the holder of the general approval

a site stated in a general approval (emergency first aid) or at which an event notified to the chief executive under section 35 takes place

the holder of the general approval

a location stated in a general approval (emergency management of animals)

the holder of the general approval

an aged care facility

the nurse manager of the aged care facility

an ambulance station

the ambulance officer in charge of the ambulance station

a child care facility

the senior officer of the child care facility employed by the approved provider of the facility

a community pharmacy other than a specified pharmacy

each pharmacist who owns the community pharmacy

a specified pharmacy

the pharmacist who is the manager of the pharmacy

a detention centre

the executive director of the detention centre

a non-State school

the principal of the non-State school or, if a person has not been appointed to be the principal, the manager of the non-State school

a prison

the manager of the prison and the senior officer of the prison responsible for health services at the prison

a private health facility

if the holder of the licence for the private health facility is an individual—the individual

if the holder of the licence for the private health facility is a body corporate—each executive officer of the body corporate

a public sector hospital

each senior officer of the hospital appointed by the board of a Hospital and Health Service for the hospital

a State school

the principal of the State school

Related information

Last updated: 24 September 2021