Section 1: Authorisation

Applications for authorisation or renewal of authorisation may only be examined by the Director General of the Regional Health Agency if they are accompanied by a complete file.

The application must include the following

1° An administrative file including :

a) The identity and legal status of the applicant ;

b) A presentation of the proposed installation for the practice of cosmetic surgery or the proposed practice of cosmetic surgery within the health establishment and, in the case of an application for renewal, any changes envisaged;

c) An undertaking by the applicant to maintain the characteristics of the installation after authorisation or renewal;

d) The agreements concluded with one or more health establishments authorised to carry out the emergency medicine and intensive care activities referred to in article R. 6122-25, with a view to organising, where applicable, the emergency transfer of people cared for by the applicant, when the applicant is not a health establishment authorised to carry out these activities;

e) Where applicable, the agreement referred to in Article R. 5126-107 ;

f) A document attesting to the implementation of the quality management system for the sterile medical device circuit referred to in Article R. 6111-10, the adoption of the system for ensuring the quality of sterilisation of medical devices referred to in Article L. 6111-2 and, where applicable, one of the contracts referred to in Article R. 6111-20;

g) An attestation from the applicant and its insurer that they are aware of the information obligations of the health insurance funds, pursuant toarticle L. 376-1 of the Social Security Code, in the event of an accident or injury caused to a member of the social security system;

2° A file relating to staff, showing the applicant's commitments regarding the number and qualifications of the staff, particularly medical, pharmaceutical and non-medical staff, required to implement the project and carry out cosmetic surgery;

3° A technical and financial file including :

a) A presentation, accompanied by dimensioned and oriented plans, of the installations used for the activity of cosmetic surgery, as well as the hospitalisation resources and technical resources, in particular the operating area, which have been set up or which the applicant undertakes to set up in order to satisfy the conditions for authorisation and the technical operating conditions laid down in application of article L. 6322-1 ;

b) A presentation of how the project will be financed and the projected operating account or budget;

4° An assessment file containing :

a) A statement of the objectives set by the applicant, relating in particular to the quality, safety and continuity of care given to people undergoing cosmetic surgery;

b) A description of the indicators and methods planned to assess the achievement of these objectives;

c) A description of the system for collecting and processing the medical, technical and administrative data needed to carry out the assessment, including :

-the characteristics of the procedures carried out, in particular the condition of the person concerned before and after the procedure;

-the volume of procedures by type and degree of complexity;

-data relating to the monitoring of the risks of the occurrence of serious adverse events or infections associated with healthcare, in particular nosocomial infections, medical accidents, iatrogenic disorders or adverse events linked to a healthcare product, as well as the reporting of such events;

d) A description of the arrangements for informing and involving medical and non-medical staff involved in the assessment procedure;

e) A description of the procedures or methods for evaluating the satisfaction of persons undergoing cosmetic surgery.

In the case of an application for renewal, the applicant must attach to the file the assessment reports drawn up during the previous authorisation period and a summary of the measures taken or which he undertakes to take to correct any discrepancies observed. The objectives and means of assessment mentioned above take account of the results of the assessment corresponding to this period.

The applicant must also attach to the application a copy of the report on certification by the Haute Autorité de santé, or failing this, a copy of the acknowledgement of receipt by this authority of its application to initiate the certification procedure.