In particular, when trials are conducted with authorised medicinal products and on patients with the same characteristics as those covered by the authorised indication, requirements already fulfilled by these authorised medicinal products, as far as manufacturing or importation are concerned, should be taken into consideration.
Eelkõige kui need uuringud viiakse läbi lubatud ravimitega ja patsientidega, kellel on lubatud näidustustega samad sümptomid, tuleks arvestada vastavate lubatud ravimite importi ja tootmist puudutavaid juba täidetud nõudeid.