Subsection 1: General provisions.

For the purposes of this chapter, the following definitions shall apply

1° "Adverse reaction": a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150 ;

2° "Serious adverse reaction": an adverse reaction which is lethal or life-threatening, or which results in persistent or significant disability or incapacity, or which results in, or prolongs, hospitalisation, or which manifests itself as a congenital anomaly or malformation;

3° "Unexpected adverse reaction": an adverse reaction whose nature, severity or course do not correspond to the information contained in the summary of product characteristics mentioned in Article R. 5121-21;

4° "Misuse": intentional and inappropriate use of a medicinal product or a product which does not comply with the marketing authorisation or registration or with the recommendations of good practice;

5° "Abuse": intentional, persistent or sporadic excessive use of medicines or products mentioned in Article R. 5121-150, accompanied by harmful physical or psychological reactions;

6° "Overdose": administration of a quantity of medicinal product or product, either per dose or cumulatively, in excess of the maximum dose recommended by the summary of product characteristics mentioned in Article R. 5121-1;

7° "Post-authorisation safety studies": any study relating to an authorised medicinal product or product and intended to identify, characterise or quantify a safety risk, to confirm the safety profile of the medicinal product or to measure the effectiveness of risk management measures;

8° "Post-authorisation efficacy studies": any biomedical research or observational study on the efficacy of a medicinal product or product in current medical practice;

9° "Risk management system": a set of pharmacovigilance activities aimed at identifying and describing the risks associated with a medicinal product or a product mentioned in Article R. 5121-150 and a set of measures aimed at preventing or minimising these risks, including the evaluation of the effectiveness of said activities and measures. This set of activities and measures shall be proportionate to the proven risks and potential risks of the medicinal product or product, and to the need for safety information after marketing authorisation;

10° "Risk management plan": a detailed description of the risk management system defined in 9°;

11° "Pharmacovigilance system": a system set up and used by any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 and by the Agence nationale de sécurité du médicament et des produits de santé in order to fulfil their pharmacovigilance obligations and aimed at monitoring the safety of medicinal products or products mentioned in Article R. 5121-150 and identifying any change in the benefit/risk balance;

12° "Pharmacovigilance system permanent file": a detailed description of the pharmacovigilance system set up and used by any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 concerning one or more of these medicinal products or products;

13° "Medication error": an unintentional error by a healthcare professional, a patient or a third party, as the case may be, occurring during the healthcare process involving a medicinal product or a healthcare product mentioned in article R. 5121-150, in particular during prescription, dispensing or administration;

14° "Occupational exposure": exposure to a medicinal product or a product mentioned in article R. 5121-150 in the context of professional activity.