Section 4: Authorisations

Applications for authorisation, including those submitted with a view to the grouping or conversion of care activities defined in Article L. 6122-6, and applications for renewal of authorisation submitted in application of the fourth paragraph of Article L. 6122-10 may, after transmission from the Director General of the Regional Health Agency, only be examined if they are accompanied by a complete supporting file. This file includes: 1° Information verifying compliance…

The application for renewal that the holder of an authorisation submits, in accordance with the conditions laid down in article R. 6122-28, includes: 1° The applicant’s undertaking to implement and maintain the conditions for the location of care activities and heavy equipment, as well as the technical operating conditions laid down in application of articles L. 6123-1 and L. 6124-1; 2° The number and qualifications of the medical and paramedical…

When, in application of the fourth paragraph of Article L. 6122-10, the Regional Health Agency issues an injunction under the conditions provided for in the second paragraph of Article R. 6122-27, the holder of the authorisation submits, during the submission period provided for in Article R. 6122-29, the supporting documents provided for in Article R. 6122-32. The applicant attaches to this file a full report, covering the period provided for…

I.- 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°…

In the event of a transfer of authorisation, including when this transfer is the result of a merger, the transferee must send the General Director of the Regional Health Agency a request for confirmation of the authorisation. This request may be submitted outside the periods mentioned in article R. 6122-29. This request for confirmation is accompanied by a dossier, the composition of which is set by order of the Minister…

The periods mentioned in the first and second paragraphs of article L. 6122-11 run from the date of notification of the express decision granting authorisation.

I.-The period of validity of the authorisations referred to inarticle L. 6122-8 is set at seven years. II -When the holder of the authorisation begins the healthcare activity or puts the heavy equipment into service, he must immediately notify the Director General of the Regional Health Agency that issued the authorisation. III – The period of validity of an authorisation is counted from the date of receipt of this declaration….

I.-The declaration provided for in article R. 6122-37 is sent to the Director General of the Regional Health Agency by registered letter with acknowledgement of receipt, or by any means providing equivalent guarantees of receipt on a date certain. The holder of the authorisation undertakes to ensure that the healthcare activity or the installation of the heavy equipment complies with the conditions of the authorisation. All documents attesting to the…

The replacement of authorised heavy equipment mentioned in 4° or 5° of article R. 6122-26 before the authorisation expires is subject to the modification of the initial authorisation. If the nature and clinical use of the new heavy equipment is identical to that of the previously authorised equipment, the request for modification may be made in accordance with the provisions of II of article D. 6122-38.

In the event of the installation of new heavy equipment mentioned in 2° of article R. 6122-26 which does not lead to the threshold mentioned in the first paragraph of II of article R. 6123-161 being exceeded, as well as, regardless of the number of authorised units held by the holder, in the event of the replacement of one of these units by a unit of the same type, the…