Title II: Sanitary equipment

I.-The consultation for a first prescription of a systemic drug treatment for cancer mentioned in 2° of I of article R. 6123-94, is carried out on the authorised site, during a one-to-one interview with the patient, by a prescribing doctor from the team of the holder of the authorisation for systemic drug treatments for cancer practising in accordance with the qualifications mentioned in articles D. 6124-134-1 and D. 6124-134-2 when…

I.-All the information relating to the administration schedule for anti-cancer medicinal products, their international non-proprietary name, the dose administered, the carrier solute used, the route of administration, the duration of administration, the storage conditions and duration are made available to the healthcare teams for each patient. II – Authorised establishments using advanced therapy medicinal products must meet the regulatory requirements defined in application of article L. 1151-1.

The authorised establishment must : 1° Comply with the medication circuit and take into account the criteria in the certification manual for healthcare establishments; 2° Formalise the steps involved in prescribing, preparing, reconstituting, dispensing, transporting and administering injectable systemic cancer treatments, including in emergencies; 3° Ensuring that a record is kept in the patient’s file of all the various stages in the medication circuit, including prescribing, preparation or reconstitution, dispensing,…

For intensive chemotherapy leading to a foreseeable aplasia of more than eight days, the health establishment must have, in application of 3° of article R. 6123-94-2, during the treatment period, a permanent on-site medical presence: 1° For the holder of mention B, a specialised qualified doctor able to intervene twenty-four hours a day. A qualified doctor specialising in oncology-haematology or haematology with experience in the management of long-term aplasias is…

I.-The holder of the systemic cancer drug treatment authorisation is organised in such a way that, in order to guarantee continuity of care for the patient, the following information can be communicated: 1° To the patient and to the patient’s treating doctor, information on how to deal with the most frequent foreseeable situations relating to the patient’s treatment requiring urgent medical advice; 2° To the patient or to the doctor…

The authorisation holder has an organisation enabling it to record in writing, in order to ensure traceability, referrals of patients for the continuation of systemic cancer drug treatments close to their home within the framework of an association mentioned in Article R. 6123-90-1 and any initial prescriptions for significant changes in treatment made within this framework by advanced consultations or teleconsultations in application of the last paragraph of Article R….

I.-Health establishments authorised for interventional medicine, surgery or radiology and holders of authorisations for medical care and rehabilitation or home hospitalisation, applying systemic cancer drug treatments under the conditions set out in 1° of II of article R. 6123-90-1, have at least one practitioner with a university degree in continuing medical education or certified training in oncology, or who can demonstrate experience in administering specific cancer drug treatments. For hospital…