Book I: Pharmaceutical products

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…

The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in Articles R. 5124-6, R. 5124-7, R. 5124-10, R. 5124-10-1, R. 5124-10-2, R. 5124-13 and R. 5124-14 , as well as the content of the file attached to the application, are laid down by decision of the Director General of the Agence nationale de…

The authorisation to open, provided for in the first paragraph of Article L. 5124-3, a pharmaceutical establishment, a company or a body mentioned in Article R. 5124-2 is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the competent Central Council of the Ordre national des pharmaciens and after an administrative enquiry by one of the…

I.- The premises of a pharmaceutical establishment are located on the same site, the continuity of which is not interrupted by the presence of other premises occupied by third parties. Pharmaceutical establishments authorised under 1° and 4° of article R. 5124-2 may include, without separate authorisation, a storage room located close to the establishment. This room, placed under the responsibility of the pharmacist in charge or the delegated pharmacist of…

Unless expressly stated otherwise in the authorisation to open provided for in Article R. 5124-6, a pharmaceutical establishment benefiting from an authorisation granted under 5° of Article R. 5124-2 also benefits from authorisations granted under 6° of the same article, with the exception of intermediate products.

I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé issues the authorisation to open provided for in the first paragraph of Article L. 5124-3 in accordance with the procedure set out in Article R. 5124-6 and within the time limits set out in this Article. II.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé verifies that…

For an authorised establishment, the addition of a new activity within the meaning of Article R. 5124-2 is subject to an application for authorisation examined under the conditions set out in Article R. 5124-9.