Title II: Medicinal products for human use

The provisions of this chapter apply to the companies, bodies and public establishments mentioned in articles L. 1413-1, L. 5124-2, L. 5124-7, L. 5124-8, L. 5124-9-1 as well as to their pharmaceutical establishments.

The 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…

Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, wholesale distributors of gases for medical use, wholesale distributors for the armed forces health service and humanitarian wholesale distributors may only distribute the medicinal products or products they stock to other companies or organisations authorised to distribute them wholesale or to natural or legal persons authorised to dispense them. To this…

By way of derogation from the provisions of Article R. 5124-3, manufacturers and importers of medicinal products may only distribute investigational medicinal products and, where applicable, ancillary medicinal products used for the purposes of a clinical trial within the meaning of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC,…

Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, distributors of gases for medical use, wholesale distributors of products necessary for the protection of the population against serious health threats and wholesale distributors of the armed forces health service may export outside the national territory the medicinal products or products that they sell, transfer free of charge or distribute, with…