Directive 2009/53/EC of the European Parliament and of the Council has further harmonised the system for examination of applications for variations to cover also many medicinal products authorised under purely national procedures.
Le Treoir 2009/53/CE ó Pharlaimint na hEorpa agus ón gComhairle, déantar tuilleadh comhchuibhithe ar an gcóras chun iarratais ar athruithe a scrúdú sa mhéid go gclúdódh sé freisin go leor táirgí íocshláinte a údaraítear faoi nósanna imeachta náisiúnta amháin.