Part five: Health products

The application for authorisation to create or transfer an in-house pharmacy, as provided for in article L. 5126-4, is submitted by the natural person holding the authorisation to operate the establishment or by the legal representative of the legal entity concerned. It is accompanied by a file containing the following information: 1° The number of patients to be cared for daily by the pharmacy, broken down by activity or discipline…

I.-For the establishments, services or organisations mentioned in 1°, 2°, 3° or 4° of article R. 5126-1, with the exception of army hospitals and the Institution nationale des invalides, the application provided for in article R. 5126-27 is sent, by any means that provides a date certain upon receipt of the application, to the director general of the regional health agency with territorial jurisdiction. The authorisation is issued by the…

I.-The application for authorisation provided for in article L. 5126-4 is sent by the head of the organisation concerned to the Minister for Defence in the case of army hospitals and to the Minister for Veterans’ Affairs in the case of the National Invalids Institution. II.-The authorisation is issued after informing the Director General of the regional health agency concerned, by the Minister for Defence in the case of army…

I. Silence on the part of the Director General of the Regional Health Agency on the expiry of a period of four months from the date of receipt of the application for authorisation accompanied by a complete file, will be deemed to constitute tacit authorisation. In the event of an incomplete file, the Director General of the Regional Health Agency may ask the applicant for the additional information required to…