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Article R6123-91-9 of the French Public Health Code

The authorisation holder has an organisation that ensures that each patient receives treatment that complies with the recommendations or guidelines for good clinical practice defined by the National Cancer Institute, the Haute Autorité de Santé, the Agence Nationale de Sécurité du Médicament et des Produits de Santé, the Agence de la Biomédecine and, failing this, with recommendations that are the subject of a consensus by learned societies.

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Article R6123-91-10 of the French Public Health Code

I.-The authorisation may only be granted if the applicant has an organisation, set up where appropriate jointly with other cancer treatment authorisation holders, which ensures that each patient is treated throughout the course of the disease and in accordance with the best practice guidelines defined by the Institut national du cancer in application of 2° of article L. 1415-2 : 1° Assessment of patients’ needs and access to the necessary…

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Article R6123-91-11 of the French Public Health Code

I.-The holder of the authorisation organises the continuity of care and, where appropriate, the coordination of care for the patients it treats, within the establishment and by means of agreements with other establishments or persons holding the authorisation referred to in article R. 6123-86-1. II.-It has an organisation for the treatment of complications and emergency situations, under the same conditions as those mentioned in I. This organisation is set up,…

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Article R6123-91-12 of the French Public Health Code

I.-The holder of the authorisation collects and sends to the Regional Health Agency and the National Cancer Institute, on an annual basis, anonymised indicators for monitoring the quality of its healthcare activity, set by order of the Minister for Health on a proposal from the National Cancer Institute. II – For each authorised cancer treatment modality, a self-assessment of care activity practices is carried out annually in the establishment as…

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Article R6123-91-13 of the French Public Health Code

I.-The provisions of the present sub-section also apply to holders of neurosurgery authorisations, when they perform therapeutic procedures aimed at curing cancerous tumours and associated with this authorisation, with the exception of the provisions of 2° of article R. 6123-91-1 and articles R. 6123-91-4 and R. 6123-91-12.

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Article R6123-92 of the French Public Health Code

The authorisation including the surgical oncology modality may only be granted to an applicant who simultaneously holds or receives the authorisation to carry out the surgical care activity provided for in 2° of article R. 6122-25, and, if applicable, the authorisation to carry out the neurosurgical care activity provided for in 12° of the same article.

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Article R6123-92-1 of the French Public Health Code

Authorisation for surgical oncology in children and adolescents under the age of eighteen with a C rating may only be granted if the applicant or holder is also authorised for the systemic drug treatment of cancer in children and adolescents under the age of eighteen. However, by way of derogation from the provisions of the first paragraph, in the event of a shortfall identified in the regional health plan, authorisation…

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Article R6123-92-2 of the French Public Health Code

Authorisation for cancer treatment by surgical oncology may only be granted if the applicant has an organisation, either on site or by means of an agreement, enabling it to guarantee: 1° The performance of anatomopathology examinations, if necessary extemporaneously; 2° Post-operative scheduled or unscheduled medical imaging examinations enabling any early complications of the treatment to be anticipated and managed; 3° Management of any complications arising from surgical treatment, including emergency…

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Article R6123-92-3 of the French Public Health Code

Authorisation for cancer treatment by complex oncology surgery with grade B as referred to in II of Article R. 6123-87-1 may only be granted if the applicant has an organisation enabling it to: 1° Organise the multidisciplinary consultation meetings for complex oncology surgery referred to in I of Article R. 6123-91-2; 2° Organise and protocolise multidisciplinary cooperation around complex surgical oncology care pathways, on site or territorialised by means of…

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Article R6123-92-4 of the French Public Health Code

Authorisation may only be granted if the holder has access, on site or by agreement, to digestive endoscopy and an interventional radiology unit for the purposes of managing any post-operative complications associated with the risks of organ obstruction or haemorrhage, for the following procedures and indications: 1° Visceral and digestive oncology surgery with A1 or B1 indication; 2° Thoracic oncology surgery with A2 or B2 indication; 3° Urological oncology surgery…

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