Particular attention must be paid to any missing information and justification must be given as to why demonstration of an acceptable level of safety and/or efficacy can be supported although some studies are lacking.
Caithfear aird faoi leith a thabhairt ar aon fhaisnéis atá in easnamh agus caithfear míniú a thabhairt cén fáth gur féidir tacú le léiriú leibhéal sábhailteachta agus/nó éifeachtúlachta inghlactha cé go bhfuil roinnt staidéar in easnamh.