Title II: Medicinal products for human use

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…

The pharmacy for internal use must be set up or transferred within one year of the date on which the authorisation is deemed to have been obtained or has been notified by any means that provides a definite date of receipt. At the end of this period, any authorisation that has remained without effect lapses. However, if justification is provided before the expiry of this period, it may be extended…

I.- Pursuant to the second paragraph of I of Article L. 5126-4, any changes to the information contained in the authorisation referred to in Article R. 5126-28 that do not fall within the scope of II must be declared in advance to the Director General of the Regional Health Agency with territorial jurisdiction by the natural or legal person holding the authorisation referred to in Article R. 5126-28. This declaration…

The following are activities involving particular risks, mentioned in the third paragraph of the I of Article L. 5126-4, for which authorisation is granted for a period of seven years by the competent authority: 1° sterile preparations covered by 2° of the I of Article R. 5126-9; 2° preparations covered by 2° of the I of Article R. 5126-9 produced from raw materials or pharmaceutical specialities containing substances that are…

I.-The draft contract by which a pharmacy for internal use in a healthcare establishment or an army hospital entrusts the production of the preparations mentioned in Article R. 5126-22 to a pharmaceutical establishment is submitted for the opinion of the Director General of the Regional Health Agency for the location of the establishment or army hospital, by any means which ensures that it is received with a date certain. The…