Manufacturing and Batch Testing of Medicines

1 This entry concerns only industrially prepared medicinal products for human use, whether manufactured or imported into the European Union (‘EU’). These are either ‘prepared industrially’ or ‘manufactured by a method involving an industrial process’: a succession of operations which may in particular be mechanical or chemical in order to obtain a standardised product in significant quantities (Abcur AB v Apoteket Farmaci AB and Apoteket AB). 2 All the technical rules and standards relating to manufacturing and controls aim to guarantee the quality of the...