Title II: Medicinal products for human use

In order to carry out the activities listed in the first paragraph of article L. 5124-1, within the limits defined by the present section, public health establishments which meet the condition set out in article L. 5124-9, create one or more pharmaceutical establishments within their walls, by decision of their board of directors. They must obtain the authorisation referred to in article L. 5124-3 for these establishments. Subject to the…

The activities of pharmaceutical establishments managed by public health establishments may only concern medicinal products that meet public health needs that are not already satisfied by medicinal products available in France and benefiting from the marketing authorisation provided for in article L. 5121-8 or the early access authorisation or compassionate access authorisation referred to in article L. 5121-12 and II of article L. 5121-12-1. The content of the annual report…

In support of the application for authorisation provided for in article L. 5124-3, public health establishments must prove that they were manufacturing medicinal products industrially on 31 December 1991 and specify the nature and quantities of medicinal products manufactured annually.

In each of the public health establishments mentioned in article R. 5124-68, the pharmaceutical establishment or establishments are placed under the responsibility of a pharmacist in charge within the meaning of the second paragraph of article L. 5124-2. To this end, the pharmaceutical establishment(s) is/are organised into business units or internal structures of such a unit, other than functional units.

Decisions to appoint or assign staff covered by the provisions of article L. 6152-1 to a pharmaceutical establishment are taken after consulting the pharmacist in charge.

Where a public health care institution sets up several pharmaceutical establishments, each of these establishments is placed under the control of a delegated pharmacist who ensures compliance with the provisions of this section under the authority of the pharmacist in charge. Where the pharmacist in charge performs his duties in one of the pharmaceutical establishments, the appointment of a delegated pharmacist is not compulsory in that establishment. The delegate pharmacist…