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The Ionising Radiation (Medical Exposure) Regulations 2017

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Regulation 4

SCHEDULE 1Licensing

Licence applications: general

1.—(1) A person required by regulation 5 to hold a licence must make an application to the Licensing Authority in the form specified from time to time by the Licensing Authority.

(2) A person applying for a licence under sub-paragraph (1) must provide to the Licensing Authority—

(a)such of the information described in paragraph 2 as the Licensing Authority may from time to time specify necessary to determine the licence application;

(b)upon request in writing, any other information which the Licensing Authority requires for the purpose of considering the licence application; and

(c)the fee specified in paragraph 4.

(3) A person issued a licence under these Regulations (“the licensee”) must apply to the Licensing Authority if the licensee seeks a material change to the licence in respect of any matter dealt with by that licence.

Licence applications: indicative list of information

2.  The information referred to in paragraph 1(2) is information relating to—

(a)responsibilities and organisational arrangements for protection and safety;

(b)staff competences, including information and training;

(c)design features of the radiological installation and of radiation sources;

(d)anticipated occupational and public exposures in normal operation;

(e)safety assessment of the activities and the facility in order to—

(i)identify ways in which potential exposures or accidental and unintended medical exposures could occur;

(ii)estimate, to the extent practicable, the probabilities and magnitude of potential exposures;

(iii)assess the quality and extent of protection and safety provisions, including engineering features, as well as administrative procedures;

(iv)define the operational limits and conditions of operation;

(f)emergency procedures;

(g)maintenance, testing, inspection and servicing so as to ensure that the radiation source and the facility continue to meet the design requirements, operational limits and conditions of operation throughout their lifetime;

(h)management of radioactive waste and arrangements for the disposal of such waste, in accordance with applicable regulatory requirements;

(i)management of disused sources;

(j)quality assurance.

Licence applications: urgent cases

3.  The licensing authority may, on a case by case basis, relax any of the requirements relating to the making of an application for a licence in respect of a proposed urgent medical radiological exposure.

Licence applications: employer fees

4.—(1) The fee payable by a person described in column 1 of Table 1 in respect of an application type specified in column 2 of that table is the corresponding amount in column 3.

(2) No fee is payable where the amount specified in column 2 is “0”.

Table 1

Licence type (1)Application type (2)Fee (£) (3)
EmployerNew250
Amendment of an existing licence200
Renewal of an existing licence200
Notification0
PractitionerNew0
Amendment of an existing licence0
Renewal of an existing licence0
Particular patient request0

Review

5.—(1) A person who is aggrieved (“an aggrieved person”) by—

(a)a decision of the Licensing Authority—

(i)refusing to issue a licence;

(ii)imposing a limit of time upon a licence; or

(iii)revoking a licence; or

(b)the terms of any conditions attached to a licence by the Licensing Authority,

may ask the Licensing Authority for a review.

(2) Any aggrieved person seeking a review must—

(a)within 28 days of the date that the person was notified of the decision, or the terms, which caused them to become an aggrieved person request the Licensing Authority to undertake a review described in paragraph (1) ; and

(b)must particularise in writing the reasons for seeking the review.

(3) The Licensing Authority must undertake a review, and provide the results of that review in writing to the aggrieved person.

Destination of fees

6.  A fee payable under these Regulations is payable to the Secretary of State.

Regulation 6

SCHEDULE 2Employer’s Procedures

1.  The employer’s written procedures for exposures must include procedures—

(a)to identify correctly the individual to be exposed to ionising radiation;

(b)to identify individuals entitled to act as referrer or practitioner or operator within a specified scope of practice;

(c)for making enquiries of individuals of childbearing potential to establish whether the individual is or may be pregnant or breastfeeding;

(d)to ensure that quality assurance programmes in respect of written procedures, written protocols, and equipment are followed;

(e)for the assessment of patient dose and administered activity;

(f)for the use and review of such diagnostic reference levels as the employer may have established for radiodiagnostic examinations falling within regulation 3(a), (b), (e) and (f);

(g)for determining whether the practitioner or operator is required to effect one or more of the matters set out in regulation 12(4) including criteria on how to effect those matters and in particular procedures for the use of dose constraints established by the employer for biomedical and medical research programmes falling within regulation 3(c) where no direct medical benefit for the individual is expected from the exposure;

(h)for the giving of information and written instructions as referred to in regulation 12(6);

(i)providing that wherever practicable, and prior to an exposure taking place, the individual to be exposed or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the exposure;

(j)for the carrying out and recording of an evaluation for each exposure including, where appropriate, factors relevant to patient dose;

(k)to ensure that the probability and magnitude of accidental or unintended exposure to individuals from radiological practices are reduced so far as reasonably practicable;

(l)to ensure that the referrer, the practitioner, and the individual exposed or their representative are informed of the occurrence of any relevant clinically significant unintended or accidental exposure, and of the outcome of the analysis of this exposure;

(m)to be observed in the case of non-medical imaging exposures;

(n)to establish appropriate dose constraints and guidance for the exposure of carers and comforters.

Regulation 17

SCHEDULE 3Adequate Training

1.  Practitioners and operators must have successfully completed training, including theoretical knowledge and practical experience, in—

(a)such of the subjects detailed in Table 1 as are relevant to their functions as practitioner or operator; and

(b)such of the subjects detailed in Table 2 as are relevant to their specific area of practice.

Table 1

Radiation production, radiation protection and statutory obligations relating to ionising radiations

Fundamental Physics of Radiation
Properties of RadiationExcitation and ionisation
Attenuation of ionising radiation
Scattering and absorption
Radiation Hazards and DosimetryBiological effects of radiation – stochastic and deterministic
Risks and benefits of radiation
Absorbed dose, equivalent dose, effective dose, other dose indicators and their units
Management and Radiation Protection of the individual being exposed
Special Attention AreasPregnancy and potential pregnancy
Asymptomatic individuals
Breastfeeding
Infants and children
Medical and biomedical research
Health screening
Non-medical imaging
Carers and comforters
High dose techniques
JustificationJustification of the individual exposure
Use of existing appropriate radiological information
Alternative techniques
Radiation ProtectionDiagnostic reference levels
Dose Constraints
Dose Optimisation
Dose reduction devices and techniques
Dose recording and dose audit
General radiation protection
Quality Assurance and Quality Control including routine inspection and testing of equipment
Risk communication
Use of radiation protection devices
Statutory Requirements and Non-Statutory Regulations
Regulations
Non-statutory guidance
Local procedures and protocols
Individual responsibilities relating to exposures
Responsibility for radiation safety
Clinical audit

Table 2

Diagnostic radiology, radiotherapy and nuclear medicine

All Modalities
GeneralFundamentals of radiological anatomy
Factors affecting radiation dose
Dosimetry
Fundamentals of clinical evaluation
Identification of the individual being exposed
Diagnostic radiology
GeneralPrinciples of radiological techniques
Production of X-rays
Equipment selection and use
Specialised TechniquesComputed Tomography: advanced applications
Interventional procedures
Cone Beam Computed Tomography
Hybrid imaging
Fundamentals of Image Acquisition etc.Optimisation of image quality and radiation dose
Image formats, acquisition, processing, display and storage
Contrast MediaUse and preparation
Contraindications
Use of contrast injection systems
Radiotherapy
GeneralProduction of ionising radiation
Treatment of malignant disease
Treatment of benign disease
Principles of external beam radiotherapy
Principles of brachytherapy
Specialised techniques

Intra-operative radiotherapy

Stereotactic radiotherapy and radiosurgery

Stereotactic ablative radiotherapy

Proton therapy

MR Linac therapy

Radiobiological Aspects for Radiotherapy

Fractionation

Dose rate

Radiosensitisation
Target volumes
Practical Aspects for Radiotherapy

Localisation equipment selection

Therapy equipment selection

Verification techniques including on-treatment imaging

Treatment planning systems
Radiation Protection Specific to Radiotherapy

Side effects—early and late

Toxicity

Assessment of efficacy
Nuclear Medicine
GeneralAtomic structure and radioactivity
Radioactive decay
Principles of molecular imaging and non-imaging exposures
Principles of molecular radiotherapy
Molecular Radiotherapy

Dose rate

Fractionation

Radiobiology aspects

Radiosensitisation

Specialised techniques

Quantitative imaging – advanced applications

Hybrid imaging – advanced applications

Selective Internal Radiation Therapy

Principles of Radiation Detection, Instrumentation and Equipment

Types of detection systems

Optimisation of image quality and radiation dose

Image acquisition, artefacts, processing, display and storage

RadiopharmaceuticalsCalibration
Working practices in the radiopharmacy
Preparation of individual doses
Radiation Protection Specific to Nuclear Medicine

Conception, pregnancy and breastfeeding

Arrangements for radioactive individuals

Regulation 21

SCHEDULE 4Consequential amendments

Amendment of the Justification of Practices Involving Ionising Radiation Regulations 2004

1.—(1) The Justification of Practices Involving Ionising Radiation Regulations 2004(1) are amended as follows.

(2) For regulation 21 (saving for medical practices) substitute—

21.  Nothing in regulation 4(5) of 5(3) shall prevent anything permitted under regulation 11 of the Ionising Radiation (Medical Exposure) Regulations 2017..

Amendment of the Human Medicines Regulations 2012

2.—(1) The Human Medicines Regulations 2012(2) are amended as follows.

(2) In regulation 173 (exemption for certain radiopharmaceuticals)—

(a)in paragraph (d), at the beginning insert “in Northern Ireland”;

(b)after paragraph (d) insert—

(e)in England and Wales and Scotland, for administration in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017.

(3) In regulation 240 (radioactive medicinal products)—

(a)for paragraph (1)(a) substitute—

(a)either—

(i)in Northern Ireland, a radioactive medicinal product, administration of which results in a medical exposure; or

(ii)in England and Wales and Scotland, a radioactive substance, administration of which results in a medical exposure; or;

(b)in paragraph (2), after “Condition A” insert “in Northern Ireland”;

(c)after paragraph (2) insert—

(2A) Condition A in England and Wales and Scotland is that the prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017.;

(d)in paragraph (4), after “condition C” insert “in Northern Ireland”;

(e)after paragraph (4A) inert—

(4) Condition C in England and Wales and Scotland is that the IRME practitioner mentioned in paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017.;

(f)in paragraph (6) after “Condition C” insert “in Northern Ireland;

(g)after paragraph (6) insert—

(6A) Condition D in England and Wales and Scotland is that the prescription only medicine is not a radioactive substance..

(h)for paragraph (7) substitute—

(7) In this regulation—

“IRME practitioner” means—

(a)

in Northern Ireland, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000;

(b)

in England and Wales and Scotland, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;

“medical exposure”—

(a)

in Northern Ireland has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000; and

(b)

in England and Wales and Scotland has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2017; and

“radioactive medicinal product” means a medicinal product which consists of, contains or generates a radioactive substance so that, when the product is administered, the radiation it emits may be used..

Amendment of the Ionising Radiations Regulations 2017

3.—(1) The Ionising Radiations Regulations 2017(3) are amended as follows.

(2) In regulation 2(1) (interpretation)—

(a)omit the definition of “carers and comforters”;

(b)insert after the definition of “calendar year”—

“carers and comforters” means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone a medical exposure (other than as a carer and comforter);;

(c)in the definition of “medical exposure”, after paragraph (d), insert—

(e)carers and comforters;.

(3) In regulation 3 (application)—

(a)in paragraph (2), omit “33”;

(b)omit paragraph (4).

(4) Omit regulation 33 (equipment used for medical exposure).

(5) In regulation 35(6) (duties of employees)—

(a)in sub-paragraph (a), after “overexposure;” insert “or”;

(b)in sub-paragraph (b), omit “or” the second time it appears;

(c)omit sub-paragraph (c).

(6) In regulation 38(2)(d) (exemption certificates)—

(a)before “25(2)” insert “and”;

(b)omit “and 33(1)”.

(1)

S.I. 2004/1769; there are amending instruments but none is relevant.

(2)

S.I. 2012/1916 as amended by S.I. 2014/490; there are other amending instruments but none is relevant.

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