Section 10a: Parallel distribution

I.-When a company intends to ensure the parallel distribution in France of a proprietary medicinal product within the meaning of Article L. 5124-13-2, it shall inform the marketing authorisation holder of this intention and send the Director General of the Agence nationale de sécurité du médicament et des produits de santé the parallel distribution notification issued by the European Medicines Agency pursuant to Article 57 o of Regulation 726/2004 of…

At the time of each parallel distribution operation, the company responsible for the parallel distribution of the medicinal product notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch number of the medicinal product being distributed, stating the administrative identification number, the name, strength and pharmaceutical form of the medicinal product being distributed and the country of origin. At the…

When an adverse reaction to a proprietary medicinal product is reported to a company responsible for its parallel distribution, the latter will forward this report to the marketing authorisation holder for this proprietary medicinal product and, where applicable, to the company or organisation responsible for the operation of the proprietary medicinal product within the meaning of 3° of Article R. 5124-2. It invites the person responsible for the notification to…