Chapter III: Conditions for setting up certain healthcare activities and heavy equipment

I-Treatment of cancer by systemic medicinal treatments for cancer consists, within the authorised site : 1° The development of a therapeutic proposal in a multidisciplinary consultation meeting, following the initial diagnosis but also on the occasion of reassessment assessments; 2° The therapeutic decision on systemic cancer drug treatment, regardless of the method of administration, taken during a one-to-one interview by a prescribing doctor, as well as any decision, taken under…

When providing systemic cancer treatment by immunotherapy or innovative therapeutic medicinal products, the holder of the authorisation for systemic cancer treatment has a patient care organisation which must guarantee a multidisciplinary territorial approach to continuity of care. This organisation includes, either on its own or in conjunction with other health establishments, direct access to a network of specialised doctors and to specialised medical technical platforms capable of dealing with foreseeable…

The establishment authorised to provide systemic medicinal treatments for cancer with a C rating complies with the obligations imposed on holders of authorisations for medicine caring for children and adolescents mentioned in articles R. 6123-151 and R. 6123-158.

I. – Establishments authorised for systemic medicinal treatments for cancer with designation B or C must have on site : 1° The organisation of a medical permanence at least by means of operational on-call duty; 2° A continuous surveillance unit; 3° An organisation allowing specialised and reinforced care for patients whose treatment of malignant haemopathy or malignant solid tumour by intensive chemotherapy results in foreseeable aplasia of more than eight…