Chapter II: Authorisations.

Renewal of the authorisation is subject to compliance with the conditions set out in articles L. 6122-2 and L. 6122-5. It may also be subject to the conditions mentioned in the second paragraph of article L. 6122-7. The holder of the authorisation sends the application for renewal of its authorisation to the Regional Health Agency no later than fourteen months before the authorisation expires. After examining the elements mentioned in…

The regional or inter-regional health plan and decisions to authorise activities or heavy equipment may be appealed to the Minister for Health, who will rule within a maximum of six months, after obtaining the opinion of the National Committee for Health and Social Organisation. This appeal is not a prerequisite for legal action.

All authorisations are deemed to have lapsed if the operation has not been started within three years. The authorisation is also deemed to have lapsed for any part of the activity, structure or equipment that has not been completed, implemented or installed within four years. Similarly, unless the Director of the Regional Health Agency gives his prior consent at the justified request of the holder of the authorisation, the receiver…

When the Director General of the Regional Health Agency establishes that the quantitative and qualitative targets mentioned in article L. 6122-8 are not being sufficiently met according to criteria defined by decree, he may revise the authorisation mentioned in article L. 6122-1. From the date of notification by the Regional Health Agency of the proposed revision of the authorisation, together with the reasons for the revision, the holder of the…

I.-When, during the performance of a healthcare activity or the installation of a piece of heavy equipment, it is established that the person holding the authorisation has failed to comply with the laws and regulations for the protection of public health or the continuity of care provided by medical staff, or has refused the consultation referred to in article L. 6122-5, the Director General of the Regional Health Agency will…

For the purposes of this Title, “heavy equipment” means movable equipment intended for the diagnosis, treatment or functional rehabilitation of the injured, the sick and pregnant women, or for information processing, which can only be used under particularly onerous installation and operating conditions or which may lead to an excess of medical procedures. The list of such equipment is established by regulation.

Authorisation for equipment to be used on a travelling basis in several health regions is granted or renewed by the regional health agency of the region in which the applicant has its registered office or domicile, after obtaining the opinion of the specialised commission of the regional conference on health and autonomy responsible for the health sector in this region, and after consulting the specialised commission of the regional conference…

In order to organise collaboration between medical professionals competent in imaging, the regional health agency may, at the request of the professionals concerned, authorise the creation of shared medical imaging platforms involving at least one health establishment and comprising several different types of heavy diagnostic imaging equipment, interventional imaging equipment or any other medical imaging equipment. To this end, authorisation holders draw up a cooperation project, which they send to…

The detailed rules for the application of the provisions of this chapter shall, unless otherwise provided and insofar as necessary, be the subject of decrees by the Conseil d’Etat.

The projects referred to in Article L. 6122-1 are subject to authorisation by the Prefect of the territorial collectivity of Saint-Pierre-et-Miquelon. Authorisations are granted in accordance with the objectives set by the territorial health plan.