Section 13: Pharmacovigilance

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,…

Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluation of suspected adverse reaction reports, collects follow-up information concerning these reports and sends new elements to the European “Eudravigilance” database. Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 participates in the detection of duplicates…

I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety update report containing : 1° All information relating to the benefits and risks associated with this medicinal product or product, including the results of studies which may have an impact on the marketing authorisation; 2° A scientific evaluation of the risk-benefit…

The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or to the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and of the Council in order to request the setting of European Union reference…

By way of derogation from the provisions of Article R. 5121-168, any company or organisation exploiting an authorised or registered medicinal product or product, in accordance with the procedure laid down in 1° of Articles R. 5121-26 and R. 5121-28 and in Article R. 5121-97 is required to submit a periodic safety update report: 1° Under the conditions determined by the marketing authorisation or registration; 2° At the request of…

If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament and of the Council, that the marketing authorisation should be varied, the marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé an application to vary his authorisation…

For the medicinal products mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are carried out in accordance with the procedures set out in the therapeutic use protocol.