de respecter les principes et lignes directrices de bonnes pratiques de fabrication des médicaments et, dans ce contexte, de n'utiliser, comme substances actives, que des matières premières fabriquées conformément aux lignes directrices détaillées relatives aux bonnes pratiques de fabrication des matières premières.
to comply with the principles and guidelines of good manufacturing practice for medicinal products and, in so doing, to use only active substances employed as starting materials which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.