Section 14: Nuclear medicine activities

The activity of nuclear medicine consists of the use, for diagnostic or therapeutic purposes, of a radiopharmaceutical or an active implantable medical device, in unsealed sources, emitting ionising radiation, administered to the patient, including the use of a single-photon emission tomography or positron emission tomography camera and incorporating, where appropriate, other imaging systems.

The nuclear medicine authorisation includes one of the following entries: 1° “A” entry, when the activity includes diagnostic or therapeutic procedures, excluding cancer therapy, performed by administering a radiopharmaceutical ready for use or prepared in accordance with the summary of product characteristics, using an aseptic process in a closed system; 2° “B” entry, when the activity includes, in addition to the procedures mentioned in 1°, the following procedures: a) Diagnostic…

I.- Nuclear medicine authorisations are granted for each geographical site. It may only be granted if the holder has at least one single-photon emission tomography camera or one positron emission tomography camera, possibly coupled with other imaging systems. If the holder of the authorisation has only one of these pieces of equipment, it must draw up an agreement with a holder who has the missing piece of equipment, in order…

I.-An “A” nuclear medicine authorisation may only be granted if the holder has a formalised emergency procedure enabling patients to be cared for if necessary, within a timeframe compatible with health protection requirements. II.-An “B” nuclear medicine authorisation may only be granted if the holder has: 1° A hospitalisation sector, on site or by agreement, enabling patients requiring full hospitalisation to be cared for; 2° An intensive care unit or…

The provisions of sub-section 2 of section 7 relating to cancer treatment of this chapter also apply to holders of a nuclear medicine authorisation with mention B, with the exception of 2° of article R. 6123-91-1, I and III of article R. 6123-91-3 and article R. 6123-91-12.

The granting of a nuclear medicine activity authorisation is subject to compliance with the applicable provisions of Chapter III of Title III of Book III of Part One of this Code.