French Public Health Code
In forceI.- A decision to refuse authorisation or, when the provisions of the fourth paragraph of article L. 6122-10 are applied, to refuse authorisation renewal may only be taken for one or more of the following reasons:
1° When the applicant is not one of the natural or legal persons mentioned in article L. 6122-3 ;
2° When the health needs defined by the care organisation plan have been met;
3° If the project is not compatible with the objectives of the healthcare organisation plan;
4° When the project does not comply with the conditions for setting up care activities and heavy equipment adopted in application of article L. 6123-1 and the technical operating conditions set in application of article L. 6124-1;
5° When the applicant does not agree to subscribe to the conditions or commitments mentioned in articles L. 6122-5 and L. 6122-7;
6° In the event of an application for renewal, where the applicant has not complied with either the undertakings mentioned in article L. 6122-5 or the special conditions or undertakings attached to the authorisation in question or to which it was subject by virtue of article L. 6122-7 or where the applicant has refused the consultation mentioned in article L. 6122-5;
7° If the applicant has not carried out the assessment provided for in article L. 6122-5 or has carried it out without using the indicators mentioned in the first two paragraphs of article R. 6122-24 and published no later than six months before the application for renewal is submitted;
8° When the assessment of the results of the evaluation shows that the quantified objectives or the conditions for implementing the care activity or the heavy equipment are not satisfactory, in particular by reference to the indicators provided for in article R. 6122-24 ;
9° Where it has been established that work has begun before the authorisation was granted, except where the application is for the renewal of an authorisation without modification or an authorisation to replace heavy equipment.
10° When the project presents a quality or safety defect.
II - For the application of I, account may be taken of any elements from the certification reports issued by the Haute Autorité de santé, relating to the project for which authorisation or its renewal is sought and relevant at the date of the decision.
