Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

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 of this person are communicated to the Director General of the Agence nationale de sécurité du médicament et des produits de santé and to the European Medicines Agency as soon as they are appointed.

In addition, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 has the services of a pharmacovigilance reference person attached to the qualified person responsible for pharmacovigilance activities. This reference person, a doctor or pharmacist, resides and practises in France and must have experience in pharmacovigilance. The identity, position and contact details of this person are communicated to the Director General of the Agence nationale de sécurité du médicament et des produits de santé as soon as they are appointed.

These persons work together to :

1° Gathering, processing and making accessible to any authorised person information brought to the attention of the company or organisation exploiting the medicinal product or product, as well as to the persons mentioned in article L. 5122-11 who provide information by canvassing or canvassing for medicinal products and products, and relating to adverse reactions suspected of being due to medicinal products or products exploited by the company or organisation;

2° Setting up and managing the pharmacovigilance system provided for in Article R. 5121-162 and the risk management system provided for in Article R. 5121-163 ;

3° Prepare and submit the declarations and reports mentioned in Articles R. 5121-166, R. 5121-168 and R. 5121-170;

4° Ensuring the implementation and monitoring of post-authorisation safety studies as well as the specific monitoring of the risk, its complications and its medico-social management mentioned in Articles R. 5121-36-1 and R. 5121-37-3;

5° Ensure that the procedures and information mentioned in the first paragraph of Article R. 5121-167 are put in place and send any new information to the European "Eudravigilance" database;

6° Ensure that requests from the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioned in the third paragraph of I of Article R. 5121-155 and requests from the regional pharmacovigilance centres mentioned in Article R. 5121-158 and the drug dependence and addictovigilance assessment and information centres mentioned in Article R. 5132-112 are responded to fully and promptly;

7° Provide the Director General of the Agence nationale de sécurité du médicament et des produits de santé with any other information relevant to the assessment of the risks and benefits associated with a medicinal product or product, in particular the positive and negative results of biomedical research and safety and efficacy studies for all indications and populations, whether or not they are mentioned in the marketing authorisation, as well as data concerning any use of the medicinal product that does not comply with the terms of the marketing authorisation and any information relating to the volume of sales and prescriptions for the medicinal product or product concerned.