Title II: Medicinal products for human use

Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations, and in particular to collect and scientifically evaluate all the information relating to the adverse reactions mentioned in Article R. 5121-151, with a view to preventing and reducing risks and, if necessary, to take appropriate measures. Any company or organisation exploiting a…

As part of the pharmacovigilance system, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 : 1° Implements a risk management system for each medicinal product or each product for which the marketing authorisation was issued after 21 July 2012; 2° Monitors the results of the risk reduction measures described in the risk management plan or taken in application of Articles R. 5121-36-1,…

Any company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 has at its disposal on a permanent basis the services of a person responsible for pharmacovigilance residing and practising in a Member State of the European Union or a State party to the Agreement on the European Economic Area, and providing evidence of appropriate qualifications in pharmacovigilance. The identity, position and contact details…

The company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about this medicinal product or product without sending it, beforehand or, in an emergency, simultaneously, to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, to the European Medicines Agency and to the European Commission….

Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product or a product mentioned in Article R. 5121-150, occurring in a Member State of the European Union or a State party to the Agreement on the European Economic Area or a third country, of which it is aware,…