Regulation 8

overseeing the conduct of examinations and in vivo assay procedures, and the provision of treatment, by the licensee;

ensuring that the examinations and in vivo assay procedures are conducted, and the treatment is provided, in accordance with the correct methods and procedures for the examination, in vivo assay procedure or treatment concerned;

implementing and overseeing a radiation safety programme to ensure the safety of personnel and patients and other individuals within or in the vicinity of the approved permanent premises of the licensee, including the proper handling, use and disposal of radioactive substances;

evaluating new processes the licensee intends to implement for the provision of the nuclear medicine service, including processes relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals;

where the licensee intends to use any radiopharmaceutical (X) for the first time in the provision of the nuclear medicine service for a therapy purpose, evaluating X for all of the following:

the safety and efficacy of X;

the necessity, advantages and disadvantages of using X, including —

whether the licensee is using any other radiopharmaceutical for the same indication as the indication for which X is proposed to be used; and

the comparative advantages and disadvantages of using X and the other radiopharmaceutical;

where the licensee intends to provide any specified service for the nuclear medicine service, evaluating that specified service before the specified service is provided; and

where the licensee is approved to provide nuclear medicine imaging and intends to provide any imaging modality, evaluating that imaging modality before the imaging modality is provided.

overseeing the conduct of examinations by the licensee in relation to the provision of nuclear medicine imaging;

ensuring that the examinations mentioned in sub‑paragraph (a) are conducted in accordance with the correct methods and procedures for the examinations;

implementing and overseeing a radiation safety programme to ensure the safety of personnel and patients and other individuals within or in the vicinity of any part of the approved permanent premises that is used for the provision of nuclear medicine imaging, including the proper handling, use and disposal of radioactive substances;

evaluating new processes the licensee intends to implement for the provision of nuclear medicine imaging, including processes relating to the preparation, dispensing, radiolabelling, compounding and quality control of radiopharmaceuticals; and

where the licensee is approved to provide nuclear medicine imaging and intends to provide any imaging modality, evaluating that imaging modality before the imaging modality is provided.