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.
- Departmental standard - Substance management plans for medicines (PDF 412 kB)
- Guideline to developing a substance management plan for medicines (PDF 462 kB)
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—
| 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
- Departmental standard - Substance management plans for medicines (PDF 412 kB)
- Guideline for substance management plans for medicines (PDF 462 kB)
- Departmental standard - Substance management plans for regulated poisons
(PDF 283 kB) - Substance management plan (SMP) - checklist PDF (PDF 237 kB) | WORD (DOCX 85 kB)