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Article L5124-14 of the French Public Health Code

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…

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Article L5124-16 of the French Public Health Code

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…

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Article L5124-17-1 of the French Public Health Code

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…

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Article L5124-17-2 of the French Public Health Code

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.

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Article L5124-17-3 of the French Public Health Code

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.

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Article L5124-18 of the French Public Health Code

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…

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Article L5124-20 of the French Public Health Code

Any drug brokering activity carried out by a person located in France must be declared to the Agence nationale de sécurité du médicament et des produits de santé. Persons involved in the brokering of medicinal products must ensure that the medicinal products brokered are covered by a marketing authorisation or registration under articles L. 5121-13 or L. 5121-14-1. When the brokering activity is carried out on behalf of the State,…

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Article L5125-1 of the French Public Health Code

A dispensary is defined as an establishment dedicated, on the one hand, to the retail dispensing of the medicinal products, products and articles mentioned in articles L. 4211-1 and L. 5125-24 and, under the conditions defined by decree, of experimental or ancillary medicinal products, and to the dispensing of magistral or officinal preparations and, on the other hand, to providing pharmaceutical advice and carrying out the tasks set out in…

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