Book I: Pharmaceutical products

The import into the customs territory of medicinal products for human use and the import and export of gene therapy preparations or xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1 are subject to prior authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé. The marketing authorisation provided for in Article L. 5121-8 and Article L. 5121-9-1, the registrations provided…

In the case of research involving the human person relating to the gene therapy and xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1, the authorisation to conduct the research also constitutes authorisation for this research of the storage and preparation sites mentioned in Articles L. 4211-8 and L. 4211-9, and it constitutes the import and export authorisation mentioned in Article L. 5124-13.

A proprietary medicinal product subject to parallel distribution is a proprietary medicinal product : 1° Has a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ; 2° And imported from…

The limited company called “Laboratoire Français du fractionnement et des biotechnologies” carries out research, production and marketing activities for medicinal products for human use, in particular medicinal products derived from blood, medicinal products that can be substituted for medicinal products derived from blood and health products derived from biotechnologies. The majority of its capital is held by the State, its public establishments or other companies or bodies belonging to the…

Subject to the provisions ofOrder no. 2014-948 of 20 August 2014 relating to the governance and capital transactions of publicly held companies, “Laboratoire français du fractionnement et des biotechnologies” is governed by the provisions of the French Commercial Code applicable to public limited companies. If the articles of association provide that the general management of the company is the responsibility of a managing director within the meaning ofarticle L. 225-51-1…

Pharmaceutical companies and establishments may only be advertised in accordance with the conditions laid down by regulation.

An on-call system is organised to meet urgent requirements for medicinal products outside the opening days generally used by wholesaler-distributors in their territory of distribution. All the wholesaler-distributors mentioned in the first paragraph are required to participate in this system. The organisation of the on-call system is regulated by the organisations representing the profession. In the absence of an agreement, or if the organisation chosen does not meet public health…

Wholesaler-distributors are required to comply with the public service obligations determined by decree in the Conseil d’Etat within their distribution territory. They ensure continuous supply to the national market in order to cover the needs of patients in their area of distribution. They participate in the prevention and management of drug shortages, as part of the public service obligations mentioned in the first paragraph.

When the wholesaler-distributor has fulfilled its public service obligations as set out in article L. 5124-17-2, it may sell medicinal products outside the national territory or to wholesale distributors for export. It may not sell medicinal products of major therapeutic interest mentioned in article L. 5121-30 outside the national territory or to wholesale export distributors.

The following shall be determined by decree of the Conseil d’Etat: 1° The conditions under which any undertaking comprising at least one pharmaceutical establishment must be owned by a pharmacist or by a company in whose management or direction a pharmacist participates ; 2° The terms and conditions of the management lease provided for in the first paragraph of article L. 5124-2 ; 3° The duration and content of the…