French Public Health Code
In forceThe company carrying out the activity of wholesaler-distributor declares to the Director General of the Agence nationale de sécurité du médicament et des produits de santé the territory in which each of its establishments carries out its distribution activity. The declaration of the intended distribution territory is attached to the file accompanying the application for authorisation to open a wholesaler-distributor as referred to in Article L. 5124-3.
The territory declared is compatible with the obligations set out in 1° and 2° below. The request for modification of the declared distribution territory referred to in 9° of Article R. 5124-10 is accompanied by any information justifying compliance with the obligations set out in 1° and 2° below for the entire distribution territory. The Director General of the Agency may request any evidence of compliance with these obligations. He may refuse, by means of a reasoned decision and within the period specified in article R. 5124-10, all or part of the requested change to the declared distribution territory.
A municipality in which the establishment usually serves at least one pharmacy or pharmacy for internal use is part of this territory.
With a view to its distribution, the company has an assortment of medicinal products comprising at least nine-tenths of the presentations of proprietary medicinal products actually marketed in France, as defined in 1° below, which is effective and sufficient to cover the needs of the declared distribution territory.
The medicinal products purchased by the wholesaler-distributor or sold to the wholesaler-distributor are distributed in such a way as to cover the needs of patients in France, in the declared distribution territory.
Within its distribution territory, the establishment is bound by the following public service obligations:
1° It must be able, outside Saturdays after 2 p.m., Sundays and public holidays :
a) Satisfy the needs of its regular customers at all times for at least two weeks ;
b) To deliver within twenty-four hours any order placed before Saturday 2 p.m., of any presentation of specialities actually marketed, with the exception of medicines reserved for hospital use, medicinal plants and homeopathic medicines; nevertheless, for pharmaceutical specialities belonging to generic groups, it must be able to deliver the reference speciality and at least one generic speciality and, in the case of a generic group without a reference speciality, at least two specialities;
c) to supply any medicinal product and, when it distributes them under the conditions provided for in Article R. 5124-8, any other product, object or article mentioned in Article L. 4211-1 and any divided officinal product mentioned in 4° of Article L. 5121-1 operated in France to any pharmacy that requests it;
2° On Saturdays, from 2 p.m. onwards, as well as on Sundays and public holidays, it is obliged to participate in an inter-company on-call system, enabling medicines to be delivered on time and within eight hours at most, in order to respond :
a) At the request of the Prefect, after consultation with the Director General of the Regional Health Agency, in the event of a health emergency, in particular in application of article L. 3131-1 ;
b) At the request of the dispensing pharmacist providing the on-call service provided for in article L. 5125-22, to meet urgent requirements for prescription medicines in one of the categories provided for in article R. 5121-36 and vaccines, under the conditions defined by a charter agreed between the organisations representing wholesaler-distributors and dispensing pharmacists; in the absence of an agreement between them or if the organisation chosen does not allow urgent requirements for medicines to be met, an order by the Minister for Health defines these conditions.
The on-call schedule is sent every six months for the following six months by the representative organisations to the regional health agency with territorial jurisdiction and to the Agence nationale de sécurité du médicament et des produits de santé (National Agency for the Safety of Medicines and Health Products).
These provisions do not prevent an establishment from exceptionally supplying, in the event of an emergency, a pharmacy or a pharmacy for internal use of a healthcare establishment located outside its distribution territory.
Exceptionally and in the absence of any other source of supply, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, on his own initiative, or at the request of the Prefect after obtaining the opinion of the Director General of the Regional Health Agency, require an establishment to supply a pharmacy or a pharmacy for internal use in a health care establishment located outside its area of distribution.
