S.L. 458.57 Art. 2Interpretation. Cap. 458.

For the purpose of these regulations:

"the Authority" means the Medicines Authority set up in terms of article 4 of the Medicines Act; "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.