Part Six: Health facilities and services

A decision to refuse authorisation may only be taken on one or more of the following grounds: 1° Where the project does not comply with the authorisation conditions laid down in articles R. 6322-14 to R. 6322-29 or with the technical operating conditions laid down pursuant to article L. 6322-3; 2° When it has been established that the facilities have been set up before the authorisation was granted.

A decision to refuse to renew an authorisation may only be taken on one or more of the following grounds: 1° Where the facilities and their use do not comply with the authorisation conditions set out in articles R. 6322-14 to R. 6322-29 or the technical operating conditions set out in article L. 6322-3 ; 2° When it is established that the obligations set out in article L. 6322-2 have…

Explicit authorisation or rejection decisions must be substantiated. They are notified to the applicant by registered letter with acknowledgement of receipt. All express authorisation, renewal or rejection decisions are published in the department’s registry of administrative acts. Any implicit decisions to renew the authorisation, as provided for in article R. 6322-6, and the date on which they take effect, will be mentioned in this journal. The Director General of the…

In the event of the transfer of the operation, including where this is the result of a merger or amalgamation, the transferee, before commencing operation on its own behalf, must send the Director General of the Regional Health Agency, in accordance with the procedures laid down in the first paragraph of Article R. 6322-3, an application for confirmation of the authorisation, accompanied by the file provided for in Article R….

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.