In the case of fixed combination products, the investigator shall also draw conclusions concerning the safety and the efficacy of the product when compared with the separate administration of the active substances involved.
I gcás comhtháirgí, bainfidh an t-imscrúdaitheoir amach freisin conclúidí maidir le sábháilteacht agus éifeachtúlacht an táirge i gcomparáid le córas tabhartha ar leithligh de na substaintí gníomhacha atá i gceist.