Article 2 Definitions
For the purposes of this Directive, the following definitions shall apply:
(1) ‘manufacturer’ means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC is required;
(2) ‘pharmaceutical quality system’ means the total sum of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use;
(3) ‘good manufacturing practice’ means the part of the quality assurance which ensures that medicinal products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use.