Chapter II: Authorisations.

The authorisation referred to in Article L. 6122-1 is subject to compliance with commitments relating, on the one hand, to the expenditure to be borne by the health insurance scheme or to the volume of activity and, on the other hand, to the completion of an evaluation under conditions laid down by decree. This evaluation takes into account compliance with the benchmarks mentioned in the first paragraph of article L. 162-30-3 of the Social Security Code and, where applicable, the results of the programme mentioned in the third paragraph of the same article L. 162-30-3.

When the application for authorisation concerns a change in the location of an existing establishment, which does not result in a grouping of establishments, the applicant must attach to his application a document setting out his commitments relating to the expenditure to be borne by the health insurance scheme and the volume of activity, set by reference to the expenditure and activity recorded in the establishment. The authority responsible for receiving the application may, within two months of receiving it, ask the applicant to amend its commitments. The application is then deemed complete only if the applicant complies with this request within one month.

When vigilance indicators relating to the quality and safety of care, defined by order of the Minister of Health on a proposal from the Haute Autorité de santé, reveal an alert level that needs to be analysed, the maintenance or renewal of the authorisation may be made subject to the applicant's participation in a consultation with the relevant regional health agency, concerning the possible implementation of corrective measures. The Director General of the Regional Health Agency will notify the applicant of the start of this consultation by any means that provides a definite date of receipt. The applicant will be invited to take part in the consultation within a period of at least two months.

If the undertakings mentioned in the second paragraph are not complied with, or if the authorisation holder refuses to take part in the consultation mentioned in the previous paragraph, the authorisation may be suspended or withdrawn under the conditions laid down in article L. 6122-13.