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The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018

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Regulation 4

SCHEDULE 1Licensing

This schedule has no associated Explanatory Memorandum

Licence applications: general

1.—(1) A person required by these Regulations 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;

(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 3 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 and including 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 for Health.

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