French Public Health Code
In forceThe following definitions apply
1° Manufacturer means the company or organisation engaged in the manufacture of medicinal products, products or articles referred to in article L. 4211-1 , with a view to their wholesale sale, free transfer or testing on humans.
Manufacturing includes operations concerning the purchase of raw materials and packaging items, production operations, quality control, batch release, as well as the corresponding storage operations, as defined by the good practices provided for in article L. 5121-5 applicable to this activity.
For dressing items and articles presented as complying with the pharmacopoeia mentioned in 2° of article L. 4211-1, wholesale, free-of-charge transfer as well as batch monitoring and, if applicable, withdrawal and, where applicable, pharmacovigilance operations are carried out by the manufacturer. In the case of investigational medicinal products, the monitoring of these medicinal products and, where applicable, their withdrawal are carried out by the manufacturer, under the responsibility of the sponsor mentioned in article L. 1121-1 ;
2° Importer, the company or organisation engaged, with a view to their wholesale, free transfer or experimentation on humans, in the import, storage, quality control and release of batches of medicinal products, products or objects mentioned in article L. 4211-1 from :
a) States which are not members of the European Community or parties to the Agreement on the European Economic Area ;
b) Or from other Member States of the European Community or parties to the Agreement on the European Economic Area when the medicinal products, products or articles have been manufactured by an establishment not authorised under Article 40 of Directive 2001/83 of 6 November 2001 on the Community code relating to medicinal products for human use.
For dressing objects and articles presented as complying with the pharmacopoeia mentioned in 2° of article L. 4211-1, wholesale, free-of-charge transfer as well as batch monitoring and, if applicable, their withdrawal and, where applicable, pharmacovigilance operations are carried out by the importer. For investigational medicinal products, the monitoring of these medicinal products and, where applicable, their withdrawal are carried out by the importer, under the responsibility of the sponsor mentioned in Article L. 1121-1 ;
3° Operator, the company or organisation engaged in the operation of medicinal products other than investigational medicinal products, generators, kits and precursors mentioned in 3° of article L. 4211-1.
Exploitation includes wholesale or free-of-charge sales, advertising, information, pharmacovigilance, batch monitoring and, where applicable, withdrawal, as well as any corresponding storage operations.
Operation is carried out either by the holder of the marketing authorisation referred to in Article L. 5121-8, of the early access authorisation referred to in Article L. 5121-12 or of one of the registrations referred to in Articles L. 5121-13 and L. 5121-14-1, or, on behalf of this holder, by another company or organisation, or by both, each carrying out one or more categories of operations constituting the operation of the medicinal product or product;
4° Custodian: the company acting on behalf of and for :
-one or more operators of medicinal products, generators, kits or precursors mentioned in 3° of article L. 4211-1 ;
-or of one or more manufacturers or importers of dressing products or articles presented as complying with the Pharmacopoeia mentioned in 2° of article L. 4211-1, to the storage of these medicines, products, objects or articles of which it is not the owner, with a view to their wholesale distribution in the state in which they are sold;
5° Wholesaler-distributor, a company engaged in the purchase and storage of medicinal products other than investigational medicinal products, with a view to their wholesale distribution as is;
This company may also purchase and store medicinal products other than investigational medicinal products, with the exception of medicinal products reimbursable by compulsory health insurance schemes, on behalf of pharmacists or the structures mentioned in article D. 5125-24-1, with a view to distributing them wholesale and as is;
6° Wholesale distributor of pharmaceutical products other than medicinal products, the company engaged in the purchase and storage of intermediate products intended for further processing by an authorised manufacturer or of products, objects, articles, generators, kits or precursors mentioned in 2° and 3° of article L. 4211-1, with a view to their wholesale distribution as is;
7° Wholesale distributor for export, the company engaged in the purchase and storage of medicinal products other than experimental medicinal products, products, objects, articles, generators, kits or precursors mentioned in 2° and 3° of article L. 4211-1, medicinal plants mentioned in 5° of article L. 4211-1, with a view to their export as such;
8° Humanitarian wholesale distributor, the non-profit organisation mentioned in article L. 5124-7 engaged in the acquisition free of charge or against payment and the storage of medicinal products other than investigational medicinal products, with a view to their wholesale distribution or export under the conditions set out in the same article;
9° (repealed) ;
10° Distributors of investigational medicinal products, any company engaged, where applicable by order and on behalf of one or more promoters defined in article L. 1121-1, in the storage of investigational medicinal products manufactured or imported by companies or organisations defined in 1° or 2° of this article, with a view to their distribution as such;
11° Wholesale distributor of medicinal plants, the company engaged in storage and the controls and operations necessary for the wholesale and bulk distribution, in sachet-doses, in fragments or in a fresh or dried state of medicinal plants mentioned in 5° of article L. 4211-1 ;
12° Wholesale distributor of gas for medical use, the company engaged in the purchase and storage of packaged gas for medical use, with a view to distributing it wholesale and as is;
13° Distributeur en gros du service de santé des armées, l'établissement de ravitailment sanitaire du service de santé des armées comportant un ou plusieurs établissements pharmaceutiques se livrer, dans le cadre du décret n° 91-685 du 14 juillet 1991 fixant les attributions du service de santé des armées, à la distribution en gros et en l'état des médicaments, produits ou objets mentionnés à l'article L. 5124-8 ;
14° Etablissement pharmaceutique pour la protection de la population face aux menaces sanitaires graves (Pharmaceutical establishment for the protection of the population in the face of serious health threats), the pharmaceutical establishment opened by the Agence nationale de santé publique (National Public Health Agency), engaged in the purchase, manufacture, import and export of products necessary for the protection of the population in the face of serious health threats, with a view to their distribution.
Where appropriate, this pharmaceutical establishment carries out operations including information, pharmacovigilance, batch monitoring and, if necessary, withdrawal, as well as the corresponding storage operations. All or part of these operations may be entrusted to a third party under a written contract setting out their respective obligations.
15° Pharmaceutical purchasing centre, the company which, either in its own name and on its own behalf, or on behalf of pharmacists or the structures mentioned in article D. 5125-24-16, purchases and stores medicinal products other than experimental medicinal products, with the exception of medicinal products reimbursable by compulsory health insurance schemes, with a view to their wholesale distribution to pharmacists.
