S.L. 458.42 Art. 3Interpretation. S.L. 458.36. S.L. 458.36.

For the purposes of these regulations and unless the context otherwise requires:

"the Authority" means the Medicines Authority;

"good manufacturing practice" means the part of quality assurance which ensures that products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use and in line with the current detailed good manufacturing practice guidelines published by the European Union Commission;

"manufacturer" means any person engaged in the activities for which the licence referred to in the Manufacture and Importation of Medicinal Products for Human Use Regulations is required or has to register his activities in accordance with regulation 3A of the said regulations;

"medicinal product" means any product as defined in Article 1(2) of Directive 2001/83/EC;

"pharmaceutical quality system" means the total sum of the organised arrangements made with the object o f ensuring that medicinal products or active substances are of the quality required for their intended use;

"qualified person" means any person who is a qualified person as provided by regulation 9 of Manufacture and

Importation of Medicinal Products for Human Use Regulations.