You need an employer licence under the Ionising Radiation (Medical Exposure) Regulations 2017 (2018 NI) (IR(ME)R) if you are the employer at a medical radiological installation (or site), responsible for the administrations of radioactive substances to humans. If an employer operates more than one site, a separate licence is required at each site.

Submit a new employer licence application to ARSAC

You should submit a new employer licence application if you have never held a licence at your site.

The application should be submitted by someone who can respond to any queries on behalf of the employer. You can add more people to the application on the ARSAC online portal so that they receive notifications, respond to queries, and access the licence. Further guidance on how to use the ARSAC online portal is available.

Follow these steps to submit your application:

1. Complete an employer licence application form.
2. Create a New employer application on the ARSAC online portal. You will need to create an account if you do not have one already.
3. Complete all required questions and attach the application form with any other relevant documents, such as an IR(ME)R governance statement.

Once ARSAC receives your application, details on how and when to pay the fee will be provided depending on your preferred payment method. The application fee for new employer applications for sites in England, Scotland and Wales is £298. The application fee for new employer applications for sites in Northern Ireland is £250.

All communication will be made through the online portal. You will also receive email notifications when your application status changes.

If approved, your licence will be added to the portal for you to download. Licences are usually issued for a 5-year term. If there are concerns noted during the processing of an application, then a shorter licence term may be issued. ARSAC will explain the reasons for a decision to issue a licence for less than 5 years.

Completing your application form

To complete an employer licence application form, you will need to provide:

• full legal name and address of the medical radiological installation as it will appear on the licence
• full legal name and address of the employer as it will appear on the licence
• name of the accountable representative of the employer under IR(ME)R – for an NHS hospital, this is often the Chief Executive Officer; for non-NHS organisations, an equivalent board level individual accountable under IR(ME)R should be listed
• name of the Medical Director
• procedures for which authorisation is sought and for which purpose – diagnostic procedures may be requested by checking the appropriate functional groups
• for procedures not listed in the ARSAC notes for guidance, local diagnostic reference levels (DRLs) where appropriate and effective dose to include references
• names and email addresses for the practitioners, Medical Physics Experts (MPEs) and relevant individuals responsible for radiopharmaceutical provision
• details of arrangements in place for remote support from practitioners and MPEs where relevant
• where appropriate, details of training of supporting staff
• equipment and facilities available to the employer including equipment based at a different site that is required for the procedures included within the application – for example, this would include sample counters for Glomerular Filtration Rate (GFR) studies and gamma probes for Sentinel Lymph Node Biopsy (SLNB) procedures where surgery is conducted elsewhere
• summary of governance and management arrangements for IR(ME)R, including information on how IR(ME)R is implemented on site; how the employer delegates the role of carrying out duties to others and how the employer is assured that IR(ME)R procedures are complied with
• information relating to the radiopharmaceutical service provision
• any other information as may be specified on the application form or may be reasonably required for the assessment of the application

There should be a multi-disciplinary team in place to support any service. This includes practitioners, MPEs and other healthcare professionals as appropriate (for example, radiographers, technologists, radiopharmacists, surgeons and nursing staff). You should provide details in the supporting information section of application form on how these individuals have appropriate training and experience for the procedures requested and how the service will be set up.

If you are making an application to include therapy procedures, then you will also need to include the following details in questions in the facilities and supporting information questions on the application form:

• start-up discussions for new procedures
• patient selection and onward management (for example, multidisciplinary team meetings)
• facilities and supporting staff appropriate to the administered activity of the radioactive substance to include diagnostic facilities where appropriate
• designated in-patient accommodation as appropriate
• number of procedures undertaken in the last 12 months and predicted numbers to be undertaken in the following 12 months

You should ensure that the application form is signed by the:

• lead MPE
• Chief Pharmacist (or equivalent individual in non-NHS organisations)
• responsible staff member for any radiopharmaceutical manufacturing facilities on site (if relevant)
• individual responsible for sealed sources (if applied for)
• Medical Director or Chief Executive Officer (or other equivalent individuals)

Amendment or renewal of existing licences

You should apply for an amendment or renewal to an employer licence when you want to make the following changes:

• addition of a procedure
• removal of a procedure
• change in purpose for a procedure (for example from research to diagnosis)
• renew your licence term
• request for authorisation for an administered activity above the DRL or for a significantly greater administered activity than previously authorised for any procedures not listed in the ARSAC notes for guidance

You can submit an amendment at any time once you have gained a licence.

The application should be submitted by someone who can respond to any queries on behalf of the employer. You can add more people to the application on the ARSAC online portal so that they receive notifications, respond to queries, and access the licence. Further guidance on how to use the ARSAC online portal is available.

Follow these steps to submit your application:

1. Complete an amendment application form.
2. Create an amendment or renewal application on the ARSAC online portal. You will need to create an account if you do not have one already.
3. Complete all required questions and attach the application form and any other relevant documents such as an IR(ME)R governance statement.

Once ARSAC receives your application, details on how and when to pay the fee will be provided depending on your preferred payment method. The application fee for an amendment or renewal licence application for a site in England, Scotland or Wales is £244. The application fee for an amendment or renewal licence application for a site in Northern Ireland is £200.

All communication will be made through the online portal. You will also receive email notifications when your application status changes.

If approved, your licence will be added to the portal for you to download. Amendments and renewals are usually issued for a 5-year term. If there are concerns noted during the processing of an application, then a shorter licence term may be issued. ARSAC will explain the reasons for a decision to issue a licence for less than 5 years.

Employer notifications

You should submit a notification to ARSAC through the ARSAC online portal prior to any material change in circumstances that may affect the validity of your licence.

Changes include, but are not limited to:

• change in chief executive officer or medical director
• change in admin details such as name of the hospital or employer
• replacement of equipment
• change of MPE or practitioner support
• suspension or closure of services

Follow these steps to submit a notification:

1. Create an Employer notification application on the ARSAC online portal. You will need to create an account if you do not have one already.
2. Complete all required questions and attach an extract of the new employer application form with the updated information.
3. Refer to the guidance on how to use the ARSAC online portal, if required.

Employer licence fees

Once ARSAC receives your application, details on how and when to pay the application fee will be provided through the portal depending on the type of application and your preferred payment method:

• new employer licence application (England, Scotland or Wales) – £298
• new employer licence application (Northern Ireland) – £250
• amendment or renewal of employer licence (England, Scotland or Wales) – £244
• amendment or renewal of employer licence (Northern Ireland) – £200

There is no fee for employer notification applications.

ARSAC support unit

Email: arsac@ukhsa.gov.uk

Telephone: 01235 825006