#1915903
An 31 Eanáir 2019, d’iarr an t-iarratasóir ar an gCoimisiún sonraí dílseánaigh le haghaidh roinnt staidéar a cuireadh isteach mar thaca leis an iarratas a chosaint, eadhon na tuarascála anailíseacha dílseánaigh ar an gcomparáid struchtúir trí athshondas maighnéadach núicléach (“AMN”) 6’-SL arna tháirgeadh trí choipeadh baictéarach 6’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéaracha agus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála; na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 6’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 6’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne; na tuarascálacha measúnachta ar iontógáil 6’-SL; tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6’-SL; tástáil micreanúicléis in vitro i gcealla mamach leis an gcomhdhúil ghaolta salann sóidiam 3’-siailiol-lachtóis (“3’-SL”); tástáil bhaictéarach ais-sócháin le salann sóidiam 6’-SL; tástáil bhaictéarach ais-sócháin le salann sóidiam 3’-SL; staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL; staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de; staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL; agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de.
On 31 January 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 6’-SL sodium salt batches; the analytical methods and validation reports; the 6’-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 6’-SL intake assessment reports; an in vitro mammalian cell micronucleus test with 6’-SL sodium salt; an in vitro mammalian cell micronucleus test with the related compound 3’-sialyllactose (‘3’-SL’) sodium salt; a bacterial reverse mutation test with 6’-SL sodium salt; a bacterial reverse mutation test with 3’-SL sodium salt; a 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt; a 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations; a 14-day oral toxicity study in the neonatal rat with 3’-SL sodium salt; and a 90-day oral toxicity study in the neonatal rat with 3’-SL sodium salt, including the summary table of the statistically significant observations.