French Public Health Code
In forceAuthorisation for activities or facilities covered by a regional plan is granted or renewed by the regional health agency after obtaining the opinion of the specialised commission of the regional conference on health and autonomy responsible for the health sector.
Authorisation for activities or facilities covered by a national or inter-regional plan is granted or renewed by the regional health agency for the region in which the applicant has its registered office or domicile, after obtaining the opinion of the specialised commission of the regional health and independence conference responsible for the health sector and the assent of each of the other agencies concerned by the project, given after consultation with the specialised commission of the regional health and independence conference responsible for the health sector concerned. The investigation period provided for in this article is interrupted between the day on which the competent agency refers the matter to the specialised committee of the regional health and independence conference responsible for the health sector set up under its auspices and the agencies of the other regions concerned for an opinion, and the day on which it receives the last of these opinions. However, opinions not received within four months are deemed to be in favour of the project.
In the case of an application for authorisation relating to organ transplants as referred to in article L. 1234-2 or haematopoietic cell allografts as referred to in article L. 1243-6, the decision of the Regional Health Agency is taken after receiving the assent of the Agence de la biomédecine (1).
Applications for authorisation or renewal of authorisation for similar care activities or facilities are received during periods determined by regulation. They are examined regardless of the order in which they are submitted.
In the month preceding the start of each period, the Director General of the Regional Health Agency publishes a quantitative assessment of the supply of healthcare, showing the areas referred to in a of 2° of Article L. 1434-9 in which this supply is insufficient with regard to the regional or inter-regional health plan. Requests for authorisation to create a healthcare activity or heavy equipment are only admissible, for the period in question, for projects involving these areas. However, in the interests of public health, applications may be received where they are intended to meet exceptional needs defined by order of the Director General of the Regional Health Agency.
The decision of the Regional Health Agency is notified to the applicant within a maximum of six months following the date of expiry of the period for receipt of applications. Reasons must be given for the decision. However, if no reply is received within this time limit, the application for authorisation will be rejected. In this case, and if the applicant so requests within a period of two months, the reasons justifying the rejection are notified to him within a period of one month. The time limit for appealing against the rejection decision then runs from this notification.
