Chapter IV: Manufacturing and wholesale distribution.

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…