Radiological Protection Act 1991 (Authorisation Application and Fees) Regulations 2019
Jurisdiction: Republic of Ireland
Commencement: 8th February 2019
Revokes: Radiological Protection Act, 1991 (Licensing Application and Fees) Regulations, 2007 (SI 654/2007)
These Regulations outline the application process for the authorisation to carry out a practice involving the use of radiological sources and defines the applicable application fees.
These Regulations outline the application process for the authorisation to carry out a practice involving the use of radiological sources and also defines the applicable fees for making an application.
An authorisation will be given as either a certificate of registration or a licence. See Regulation the use of radiation sources for more information.
These Regulations do not apply to licences granted immediately before 8th February 2019; however, they will apply upon renewal of those licences.
An application for a new, amended, or renewed licence must be made electronically via the online application portal (Environmental Data Exchange Network, maintained by the Environmental Protection Agency (EPA) at www.epa.ie).
Applications must be made no later than one month before commencement of the practice (radiological activity) or for existing practices, not later than one month before the licence expires.
A practice cannot continue beyond the expiry of a licence previously in force unless it has been renewed, or a registration in respect of the practice has been approved.
An application for an amendment to a registration or a licence must be made to the EPA before the implementation of the practice concerned. The practice may not be implemented until the registration or licence has been amended by the EPA in accordance with Regulation 12(2) of the Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019 (€œIonising Radiation Regulations 2019€)
Information to be provided
The application for a new, or amendment of an authorisation, or the renewal of a licence must include the information specified in Schedule 1, Part 1.
The EPA may require additional information:
- Information in Schedule 1, Part 2.
- Radiation safety procedures and the risk assessment referred to in regulation 32(1) and 31(2) respectively of the Ionising Radiation Regulations 2019.
- For relevant workplaces, the information referred to in regulation 51(3) of the Ionising Radiation Regulations 2019.
- For practices involving non-medical imaging exposure using medical radiological equipment, the plan referred to in regulation 16(4)(b) of the Ionising Radiation Regulations 2019.
- For practices involving radioactive waste management, a safety assessment referred to in regulation 17(3) of the Ionising Radiation Regulations 2019.
- For an amendment of a licence or registration, the grounds for the amendment, plus a revised risk assessment as referred to in regulation 31(2) of the Ionising Radiation Regulations 2019.
- The agreed arrangements under regulation 33(3) of the Ionising Radiation Regulations 2019 with the named radiation protection advisor/s that have been appointed.
- Any other information that the EPA may request.
In the case of an application for a new, or amendment of, an authorisation, or renewal of a licence to carry out a practice of a class or type carried out immediately before the commencement of the Ionising Radiation Regulations 2019, the EPA may require that supporting information justifying the grounds for the practice continuing to be supplied.
The EPA may require supporting information related to the justification and implementation of the requirement in regulation 5(1)(b)* of the Ionising Radiation Regulations 2019, to be supplied.
*the justification requirement means a practice that falls within a class or type of practice which is justified by the EPA in regards to its social, health, environmental, or other benefits in relation to the detriment it may cause.
Applications for a practice or a class or type involving medical exposure may be required to submit evidence that it has been justified by the Health Information and Quality Authority in accordance with regulation 7 of the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018.
Issue of licence or certificate of registration
The EPA will issue a certificate or licence by electronic means to the applicant. It will include defined particulars.
Expiry of an authorisation
Unless revoked, a licence shall normally expire 10 years after the date it was granted.
Registrations do not require renewal unless revoked.
(Differentiation between a licence or a registration is explained here: Graded Authorisation.)
Authorisation fee charging
A fee is charged by the EPA for making an application for authorisation or renewal of a licence, as indicated in Schedule 2.
The fee category is determined by the following:
- the number of radiation sources;
- the purpose of the practice;
- the quantity of the radioactive substance; and
- the profession or work activity to which the practice relates.
Fees paid are not refundable by the EPA.
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