3A1 The Rules Governing Medicinal 805,155 Products in the European Union GUIDELINES Guidelines : medicinal products for human use : quality and biotechnology I European CommissionDirector ate General III-Industry Pharmaceuticals and cosmetics. - Luxembourg : Office for Official Publications of the European Communities, 1998. - [2], VI, 407, [5] s. ; 30 cm. - (The Rules Governing Medicinal Products in the European Union ; vol. 3A) ISBN 92-828-2437-3