Chapter VI

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…

The duration of the authorisation referred to in I of Article L. 5126-8 for supply and retail sales may not exceed one year.

I.-The provisions of the first paragraph of article R. 5126-27 and those of articles R. 5126-28 and R. 5126-30 relating to requests for the creation and transfer of a pharmacy are applicable to requests for the closure of an in-house pharmacy. These requests must include all evidence to show that the existence of an in-house pharmacy is no longer justified and must specify the means envisaged to meet the pharmaceutical…

For the application of II of article L. 5126-4, the authorisation may only be suspended, except in the event of an immediate danger to public health, or withdrawn once the administrative authority competent to issue the authorisation has informed, as appropriate, the natural person holding the authorisation to operate the establishment or the legal representative of the legal entity concerned of the nature of the infringements observed and has given…