Title II: Other health services

The Director General of the Regional Health Agency shall declare that the authorisation has lapsed. The three-year period referred to in the third paragraph of Article L. 6322-1 runs from the date of notification of the express decision granting the authorisation. Authorisations are valid for five years. For the first authorisation, this period is counted from the day on which the positive result of the compliance visit provided for in…

The suspension and withdrawal decisions provided for in the fifth paragraph of Article L. 6322-1 are taken by the Director General of the Regional Health Agency on the grounds and under the conditions defined by Article L. 6122-13 . They shall state the reasons on which they are based. They are notified and published in accordance with the procedures laid down in article R. 6322-9. Suspension does not extend the…

When, during the examination of an application for renewal or an application for confirmation of an authorisation, the findings made during the inspection mentioned in the last paragraph of Article R. 6322-6 lead to the suspension of the authorisation, the time limits provided for in Article R. 6322-6, as well as the periods mentioned in the second paragraph of Article R. 6322-11, are interrupted until the final decision is taken….

Authorisation may only be granted for facilities that meet the conditions set out in articles R. 6322-15 to R. 6322-29.

When they are not served by the in-house pharmacy of a health establishment by virtue of article R. 5126-13 , cosmetic surgery facilities may have an in-house pharmacy under the conditions provided for in article L. 5126-1 and articles R. 5126-8 to R. 5126-55. Failing this, they must comply with the provisions of articles R. 5126-105 to R. 5126-112 for the supply, holding and dispensing of pharmaceutical products and medicines.

The person holding the authorisation for the cosmetic surgery facilities ensures the implementation of quality management for the sterile medical device circuit mentioned in article R. 6111-10 and ensures the quality of the sterilisation of these devices under the conditions set out in articles R. 6111-18 to R. 6111-21.

Waste from cosmetic surgery activities is considered to be waste from healthcare activities, within the meaning and for the application of the provisions of article R. 1335-1. The provisions of articles R. 1335-2 to R. 1335-8 and articles R. 1335-13 and R. 1335-14 relating to the elimination of waste from healthcare activities involving infectious and similar risks are applicable to cosmetic surgery facilities.

The provisions of articles R. 1113-1 to R. 1113-9 relating to the responsibility of establishments for the property of patients are applicable to cosmetic surgery facilities.

The provisions of articles R. 1112-79 to R. 1112-94 relating to the users’ commission are applied to persons cared for in cosmetic surgery facilities where the holder of the authorisation is a health establishment. In this case, the Director General of the Regional Health Agency receives the report provided for in 3° of II of article R. 1112-80, or communication of the information relating to the cosmetic surgery activity included…

Where the holder of the authorisation is not a health care establishment, it shall set up a user relations and quality of care committee composed of : 1° The authorisation holder, or his representative, as chairman ; 2° Two medical mediators and their alternates; 3° Two non-physician mediators and their alternates; 4° A user representative and his/her alternate. The non-physician mediators and their alternates are appointed by the authorisation holder…