Department of Health

Key messages

  • It is compulsory to hold a radiation management licence prior to taking possession of a medical radiation source (i.e. prior to conducting a radiation practice).
  • You must provide supporting documentation when applying for a new radiation management licence or applying to vary an existing radiation management licence.
  • From 6 September 2021 a Radiation Management Plan must be provided with all radiation management licence applications including new applications, variations and transfers.

Overview

A wide range of radiation sources including X-ray apparatus, sealed radiation sources and unsealed radiation sources are used in the medical sector for both diagnostic and therapeutic applications.

A radiation management licence is a mandatory requirement for any company seeking to possess a medical radiation source. Multiple sources can be authorised on a single management licence and a separate authorisation on the licence is required for each source. In addition to authorising possession of the radiation source, the radiation management licence may also authorise other practices such as disposal or storage.

Applicants seeking a management licence for a medical practice must meet certain prerequisites prior to being issued with a management licence.

Prerequisites: what information do I include with my application?

The following documentation must be included with your application (electronic files can be attached with your application).

1. Establishment of identity and authorisation

A radiation Management Licence can only be issued to a legal entity. In most cases the legal entity will be a registered company or a person.

If you are applying for a management licence under a company name you must provide:

  • A current Company Extract issued by the Australian Securities and Investments Commission (ASIC). The extract must display the ACN number and the name of the director(s) of the company. A registration of a business or ABN is not accepted as evidence of a legal entity.
  • If you are not a director of the company, then you must provide a Letter of Authority signed by a director of the company. The director must be listed on the ASIC company extract. A template for the Letter of Authority can be found at sample Letter of Authorisation page. The Letter of Authority will authorise you to do the following on behalf of the company:
    • Apply for a new management licence.
    • Apply to vary an existing management licence.
    • Submit a notification of acquisition and/or disposal.
    • Discuss matters relating to the radiation management licence with the department.

If you are applying for a management licence under a person’s name:

  • Proof of Identity (Drivers licence or passport showing current physical address) of the person applying to be the licence holder.
  • If you are applying on behalf of another person, then you must provide a Letter of Authority from that person. A template for the Letter of Authority can be found at sample Letter of Authorisation page. The letter must be signed by the person that is proposed to be the licence holder. The Letter of Authority will authorise you to do the following on behalf of the proposed licence holder:
    • Apply for a new management licence.
    • Apply to vary an existing management licence
    • Submit a notification of acquisition and/or disposal.
    • discuss matters relating to the radiation management licence with the department

2. A Radiation Management Plan

From 6 September 2021 a Radiation Management Plan (RMP) must be submitted when undergoing any of the following activities:

  • Applying for a new Radiation Management Licence
  • Applying for a variation to an existing Radiation Management Licence
  • Applying to transfer an existing Radiation Management Licence to another legal entity

The Radiation Management Plan page provides details on the minimum requirements that must be included in your RMP.

In addition to the minimum RMP requirements, you need to include the following information in your RMP:

  1. The name of the dosimetry service provider (DSP) that you will use.
  2. The centre number assigned to you by the DSP.
  3. Address all applicable requirements detailed in required by the Code of Practice for Radiation Protection in the Medical Applications of Ionizing RadiationExternal Link .

3. Shielding assessment

If you are applying for a licence involving medical radiation apparatus you must submit a shielding assessment report with your application. A shielding assessment determines the minimum amount of shielding that is required in the walls, doors, floor and ceiling of the room in which the radiation source is will be installed to ensure that no person receives a radiation dose in excess of the relevant radiation protection limits specified in the Radiation Regulations 2017. The assessment report must include the following:

  • Floor plan showing the room in which the radiation source will be installed and surrounding rooms.
  • Occupancy factors and purpose of surrounding rooms.
  • Methodology/references used in the assessment.
  • Shielding required for the operator
  • Radiation apparatus workloads used in the assessment
  • The location of any related equipment e.g. X-ray equipment, tables, buckys, controls, protective screens, warning lights.
  • The shielding assessment must take into consideration exposures arising from all aspects of the proposed radiation practice (e.g. a Nuclear Medicine assessment must consider exposure from patients administered with radioactive material as well as radioactive material that is in storage.
  • Details (including thicknesses) of construction/shielding materials used in the walls, doors, floor, ceiling and windows of the room in which the radiation source is or will be installed. Where a shielding material is used that is different to the material specified in the shielding report, evidence must be provided of the material used having equivalent shielding properties.

4. Practice specific documentary requirements

This section describes the specific documents which need to be supplied with an application.

Radiography practices

Fluoroscopy (fixed apparatus used for image guided interventional procedures)
  1. Provide details on the equipment that will be used to minimize radiation exposure to the eyes of staff in close proximity to the fluoroscopic apparatus (e.g. shields, lead glasses); and
  2. Provide details of the dosimeters that will be used to monitor radiation exposure to the eyes of staff in close proximity to the fluoroscopic apparatus.

or

A dose assessment showing that doses to the lens of the eye are not likely to exceed an equivalent dose of 2 mSv in any one year.

Nuclear medicine practices

Unsealed radioactive materials

Provide details regarding surface finishes, ventilation, drains in areas where radioactive material is to be used, and proposed arrangements for storage and disposal of radioactive material.

As a guide to good practice it is recommended that the principles contained in the following Standards be adopted for all laboratories in which radioactive substances are used or stored:

  • AS 2243.4-1998 Safety in laboratories Part 4: Ionizing radiations
  • AS/NZS 2982:2010 Laboratory design and construction
  • Australasian Health Facility Guidelines HPU B.0500 – Nuclear Medicine / PET Unit
Sealed sources Provide a plan outlining how the radioactive source will be disposed of when it is no longer required. For example, there may be documentation from the manufacture or supplier of the radiation source indicating a disposal option at the end of the working life of the radiation source. The proposed disposal pathway must comply with the Disposal of radioactive material document.

Radiotherapy practices

Linear accelerators

Linear accelerators intended to be used for radiotherapy must undergo a two-stage licensing process.

Stage 1

Submit an application for authorisation to possess a linear accelerator for the purpose of commissioning and testing. This authorisation allows the licence holder to acquire the linear accelerator and perform commissioning and testing on the apparatus.

Stage 2

After completion of the commissioning and testing in Stage 1 submit an application for authorisation to possess the linear accelerator for the purpose of radiotherapy (i.e. clinical use).

Stage 1 supporting documents:

  1. A shielding assessment as specified above under the heading General supporting documents required for medical practices. The shielding assessment must be verified by a physicist who is independent of the person who produced the shielding assessment.

Stage 2 supporting documents:

  1. A radiation survey that demonstrates that the radiation shielding is sufficient to ensure that no person receives a radiation dose in excess of the relevant radiation protection limits specified in the Radiation Regulations 2017.
  2. Evidence of the facility having undergone dosimetric audits as required by the document titled Requirements for independent dosimetric auditing of linear accelerators (i.e. evidence of the commissioned linear accelerator having passed a level Ib audit and evidence of at least one linear accelerator at the site having passed a level III audit in the last 4 years).
High dose rate brachytherapy

Additional source security requirements apply to high dose rate brachytherapy apparatus. A facility construction licence may need to be obtained before commencing the construction of a new facility or renovation of an existing facility to accommodate the practice.

Supporting documents:

The following documents must be submitted with application:

  • acopy of an approved security plan and security compliance certificate
  • if the applicant is a ‘natural person’, evidence of the person’s identity
  • if the applicant is a body corporate, evidence of the identity of the person who is to be responsible for the security of the unit.

Conditions of licence

General and practice specific conditions of licence are mandatory requirements that apply to radiation management licence holders. It is important as a management licence holder that you understand and comply with all the conditions of licence that apply to your licence. Failure to comply with a condition of licence is an indictable offence under the Radiation Act 2005.

General conditions of licence

Two general conditions apply to all radiation management licence. The general conditions relate to the reporting of incidents and the acquisition and disposal of radiation sources. Further information on the general conditions can be found at Disposal of radioactive material and X-ray equipment page.

Practice specific conditions of licence relating to medical radiation sources

Compliance with the following documents is a practice specific condition applied to all radiation management licences authorising medical practice:

Compliance with Requirements for independent dosimetric auditing of linear accelerators is a practice specific condition that applies to all radiation management licences authorising linear accelerators

Compliance with Supplementary quality control requirements for radionuclide generators is a practice specific condition that applies to all radiation management licences authorising radionuclide generators

Compliance with both the Security Standards for security plans and transport security plans and Additional matters to be addressed in security and transport security plans is a practice specific condition that applies to all radiation management licences authorising medical radiation sources classified as high consequence sealed sources.

We strongly recommend that applicants become familiar with the Code as well as the following Safety Guide(s) relevant to their practice before lodging an application:

Safety Guide: Radiation Protection in Diagnostic and Interventional RadiologyExternal Link

Safety Guide: Radiation Protection in Nuclear MedicineExternal Link

Safety Guide: Radiation Protection in RadiotherapyExternal Link

Licence durations, licence fees, assessment process and timeframes

See the General information about management licences in Victoria page.

Is a use licence required for medical radiation sources?

Any individual wishing to use a medical radiation source must hold a valid use licence.

The use of a radiation source without the required use licence is an offence under the Radiation Act 2005.

To apply for a use licence please visit the use licence section.

Apply for a management licence or apply to vary an existing licence

All of the department's forms for applications are on-line forms. The form is completed online and automatically emailed to the department upon submission. Please remember to check what mandatory documents must be included with your application.

Complete the online form: Application for a new management licenceExternal Link

Complete the online form: Application to vary a management licenceExternal Link

Reviewed 17 August 2021

Health.vic

Contact details

Our phone service is available Monday to Friday, from 9.00am to 1.00pm or we can be contacted via email. 

Radiation Safety Department of Health GPO Box 4057, Melbourne, VIC 3000

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