a summary of impurities present in batches of the active substance(s) as well as those of the finished medicinal product (and where relevant decomposition products arising during storage) as proposed for use in the product to be marketed together with an evaluation of these impurities,
achoimre ar eisíontais atá i mbaisceanna den tsubstaint ghníomhach nó de na substaintí gníomhacha agus den táirge íocshláinte críochnaithe (agus, más ábhartha, torthaí an dianscaoilte a thagann chun cinn le linn a stórála) atá beartaithe lena n-úsáid sa táirge maille le measúnú ar na heisíontais sin,