The application for authorisation referred to in Article L. 6323-4-3 shall be sent to the Director General of the Regional Health Agency by any means that provides a date of receipt. It is accompanied by an application file, the composition of which is set by order of the Minister for Health. Applications for renewal are submitted under the same conditions.
If the Director General of the Regional Health Agency does not respond to an initial application for authorisation within six months, or to an application for renewal within two months, this will be deemed to constitute acceptance of the application.