Paragraph 4: Conditions specific to the modality: "systemic drug treatments for cancer".

The establishment authorised with grade A must have at least one team comprising: 1° At least one doctor specialising in medical oncology or radiation oncology. By way of derogation, this doctor may be a qualified specialist holding a complementary right to practise in a non-qualifying speciality in oncology with the option of medical cancer treatment, or a complementary non-qualifying group 1 specialised diploma in oncology with the option of “medical…

Without prejudice to the application of the provisions of article D. 6124-134-1, the establishment authorised with mention B also has a qualified team providing intensive chemotherapy leading to foreseeable aplasia of more than eight days and providing management of this aplasia. This team includes at least the following healthcare professionals: 1° At least one qualified doctor specialising in oncology-haematology or a doctor specialising in haematology who is competent and has…

I.-The establishment authorised with designation C has at least one qualified team comprising the following professions: 1° At least one doctor specialising in paediatrics, competent in cancerology and able to demonstrate experience in the practice of systemic medicinal treatments for cancer; 2° State-qualified nurses trained or able to demonstrate experience in the management of cancer in children. II.-Without prejudice to the application of the provisions of I, the establishment authorised…

At least one doctor with the titles or qualifications mentioned in articles D. 6124-134-1, D. 6124-134-2 or I of article D. 6124-134-3 and working in his field of expertise takes part, either physically or by videoconference, in the multidisciplinary consultation meeting or the inter-regional multidisciplinary paediatric oncology consultation meeting during which the file of a patient likely to receive chemotherapy is presented.

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….