Chapter IV: Manufacturing and wholesale distribution

The pharmaceutical establishment of a company or organisation mentioned in Article R. 5124-2 engaged in wholesale, free transfer or wholesale distribution must keep, for each incoming and outgoing transaction, including when it uses a broker, at least the following information: 1° the date of the transaction 2° The name of the medicinal product or other pharmaceutical product; 3° The number and expiry date of the various batches with the quantities…

The 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…

The company operating as a wholesaler-distributor informs the operator of any shortage of supply of a medicinal product for which it is responsible for purchasing and storage, and of which it has not already been informed by the operator or by the Agence nationale de sécurité du médicament et des produits de santé.

The pharmaceutical establishment of a company or organisation mentioned in article R. 5124-2 engaged in the wholesale, free transfer or wholesale distribution of medicinal products mentioned in 1° of article L. 4211-1, generators, kits or precursors mentioned in 3° of the same article must have an emergency plan which guarantees the effective implementation of any withdrawal of batches of these medicinal products or products organised by the operator. This obligation…

The pharmaceutical establishment of a company or organisation mentioned in Article R. 5124-2 engaged in wholesale, free transfer or wholesale distribution shall verify that the medicinal products received have not been falsified by checking the safety features mentioned in Article R. 5121-138-2, in accordance with the procedures set out in Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council…

I.-The pharmaceutical establishment of a company or organisation mentioned in 1° to 5° and 8° of article R. 5124-2 engaged in wholesale, free transfer or wholesale distribution checks the safety devices mentioned in article R. 5121-138-2 and deactivates the unique identifier mentioned in this same article before dispensing the medicinal products mentioned in article R. 5121-138-1: 1° To the practitioners mentioned in article R. 5124-43 ; 2° Veterinarians and organisations…

Without prejudice to the powers conferred on the Agence nationale de sécurité du médicament et des produits de santé by Article L. 5124-3, the wholesale distribution of medicinal products to a natural or legal person authorised to dispense such medicinal products in France, by a wholesale distributor located in another Member State of the European Union or party to the Agreement on the European Economic Area, is subject to the…