Definitions
Article 2
For the purposes of this Regulation, the following definitions shall apply: (1) ‘manufacturer’ means any person engaged in activities for which an authorisation is required in accordance with Article 61(1) of Regulation (EU) No 536/2014; (2) ‘third country manufacturer’ means any person established in a third country and engaged in manufacturing operations in that third country; (3) ‘product specification file’ means a reference file containing, or referring to files containing, all the information necessary to draft detailed written instructions on processing, packaging, quality control, testing and batch release of an investigational medicinal product and to perform batch certification; (4) ‘validation’ means action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results.