Chapter IV: Manufacturing and wholesale distribution

The depositories defined in 4° of article R. 5124-2 carry out their activities under the conditions set out in a written contract which, in accordance with the good practices provided for in article L. 5121-5, applicable to these activities, sets out the respective obligations of the depository and the operator, manufacturer or importer on whose behalf it is acting. They may only distribute batches of medicinal products or other pharmaceutical…

The approval of a not-for-profit humanitarian organisation as provided for in article L. 5124-7 is granted by the Minister for Health, after obtaining the opinion of the Minister for Humanitarian Action and, depending on the location of the proposed pharmaceutical establishment, of the Central Council of Section C or E of the National Order of Pharmacists. If the Minister remains silent on the application for approval for more than four…

Humanitarian wholesale distributors as defined in 8° of article R. 5124-2 are subject to compliance with good practice in the donation of medicinal products, set by order of the Minister for Health and relating in particular to the quality, shelf life and storage of products.

Wholesalers of medicinal plants shall, with regard to the operations they carry out and prior to marketing, check the identification of the plants and release the batches defined during the operations carried out. They shall also ensure that the plants are properly preserved during the operations carried out and until they are delivered. Any operations carried out on these plants must not modify their botanical or organoleptic properties or affect…