S.L. 458.35 Art. 2Interpretation. Cap. 458. Cap. 458.

For the purpose of these regulations:

"the Act" means the Medicines Act; "adverse reaction" means a response to a medicinal product which is noxious and unintended; "the Agency" means the European Medicines Agency established by Regulation (EC) No 2004/726; "the Authority" means the Medicines Authority established under article 4 of the Act; "the Commission" means the Commission in accordance with Council Decision 1999/468/EC of the 28th June, 1999; "the Community" means the European Union and the European Economic Area; "Member State" means a State which is a member of the Community; "serious adverse reaction" means an adverse reaction which results in death, or is life threatening, or requires in-patient hospitalisation or the prolongation of existing hospitalisation, or which results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect; "periodic safety update reports" means the periodical reports containing the records referred to in regulation 31; "pharmacovigilance system" means a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in these regulations and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance; "pharmacovigilance system master file" means a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products; "post-authorisation safety study" means any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures; "risk-benefit balance" means an evaluation of the positive therapeutic effects of the medicinal product in relation to any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health; "risk management system" means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions; "risk management plan” means a detailed description of the risk management system; "unexpected adverse reaction" means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.