{"id":23664,"date":"2026-09-28T10:10:46","date_gmt":"2026-09-28T07:10:46","guid":{"rendered":"https:\/\/mirora.com\/?page_id=23664"},"modified":"2026-09-28T15:51:25","modified_gmt":"2026-09-28T12:51:25","slug":"ilac-ruhsatlandirma-cevirisi","status":"publish","type":"page","link":"https:\/\/mirora.com\/tr\/ilac-ruhsatlandirma-cevirisi\/","title":{"rendered":"\u0130la\u00e7 Ruhsatland\u0131rma ve Reg\u00fclasyon \u00c7evirisi"},"content":{"rendered":"\t\t
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Medikal \u00c7eviri Hizmetleri<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130la\u00e7 Ruhsatland\u0131rma ve Reg\u00fclasyon \u00c7evirisi<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130la\u00e7 ruhsatland\u0131rma ve reg\u00fclasyon \u00e7evirisi, bir ilac\u0131n bir \u00fclkede sat\u0131\u015fa sunulabilmesi i\u00e7in d\u00fczenleyici otoritelere verilen belgeleri kapsar. Bu belgeler T\u00fcrkiye’de T\u0130TCK, Avrupa’da EMA, ABD’de FDA gibi otoritelerin incelemesinden ge\u00e7er.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Bu nedenle \u00e7evirinin yaln\u0131zca terminolojik olarak do\u011fru olmas\u0131 yeterli de\u011fildir; hedef otoritenin bekledi\u011fi bi\u00e7im, terminoloji ve \u015fablonlara da uygun olmas\u0131 gerekir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tTeklif Al \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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T\u0130TCK<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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EMA<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Avrupa \u0130la\u00e7 Ajans\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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FDA<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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ABD G\u0131da ve \u0130la\u00e7 \u0130daresi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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01<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Reg\u00fclasyon Odakl\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Hedef otoritenin gerekliliklerine g\u00f6re \u00e7al\u0131\u015fma<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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02<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Terminoloji Tutarl\u0131l\u0131\u011f\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Onayl\u0131 s\u00f6zl\u00fckler ve \u00e7eviri belle\u011fi kullan\u0131m\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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03<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Uzman Ekip<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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T\u0131bbi, farmas\u00f6tik ve reg\u00fclasyon uzmanl\u0131\u011f\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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04<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kalite G\u00fcvencesi<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kontroll\u00fc \u00e7eviri ve redaksiyon s\u00fcreci<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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05<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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K\u00fcresel Kapsam<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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T\u00fcrkiye, Avrupa, ABD ve farkl\u0131 hedef pazarlar<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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S\u00fcre\u00e7<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsatland\u0131rma s\u00fcrecinde \u00e7evirinin yeri<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsat ba\u015fvurusu tek bir belge de\u011fil, birbirine ba\u011fl\u0131 bir dosya b\u00fct\u00fcn\u00fcd\u00fcr ve \u00fcr\u00fcn\u00fcn ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca g\u00fcncellenir.<\/p>

\u00c7eviri bu b\u00fct\u00fcn\u00fcn i\u00e7ine g\u00f6m\u00fcl\u00fcd\u00fcr: ilk ba\u015fvuruda, her varyasyonda ve g\u00fcvenlik g\u00fcncellemelerinde yeniden devreye girer. Bu nedenle ruhsatland\u0131rma \u00e7evirisi tek seferlik bir \u00e7al\u0131\u015fma de\u011fil, y\u0131llara yay\u0131lan ve y\u00fcksek terminoloji tutarl\u0131l\u0131\u011f\u0131 gerektiren bir s\u00fcre\u00e7tir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Kapsam\u0131m\u0131z<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ba\u015fl\u0131ca belge t\u00fcrleri<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsat dosyas\u0131nda bulunan belgelerin her birinin farkl\u0131 bir okuyucusu, amac\u0131 ve d\u00fczenleyici gereklili\u011fi vard\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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01 \/ eCTD<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsat ba\u015fvuru dosyas\u0131 ve eCTD<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Ba\u015fvuru dosyas\u0131 \u00e7o\u011fu pazarda ortak teknik dosya yap\u0131s\u0131na g\u00f6re d\u00fczenlenir. Dosyan\u0131n hangi b\u00f6l\u00fcmlerinin hangi dilde sunulaca\u011f\u0131 hedef otoriteye g\u00f6re de\u011fi\u015febilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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eCTD yap\u0131s\u0131n\u0131 inceleyin \u2192<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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02 \/ K\u00dcB \u2013 SmPC<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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K\u0131sa \u00fcr\u00fcn bilgisi (K\u00dcB \/ SmPC)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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K\u00dcB, \u00fcr\u00fcn\u00fcn sa\u011fl\u0131k profesyoneline y\u00f6nelik resm\u00ee bilgi belgesidir. Endikasyon, pozoloji, kontrendikasyonlar, uyar\u0131lar ve advers etkiler bu belgede yer al\u0131r.<\/p>

Avrupa’da EMA QRD, T\u00fcrkiye’de ise T\u0130TCK taraf\u0131ndan belirlenen yap\u0131ya uygunluk kritik \u00f6nem ta\u015f\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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03 \/ KT \u2013 PIL<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kullanma talimat\u0131 (KT \/ PIL)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Kullanma talimat\u0131 hastaya y\u00f6neliktir ve K\u00dcB’deki bilgilerin daha sade ve anla\u015f\u0131l\u0131r bi\u00e7imde aktar\u0131lmas\u0131n\u0131 gerektirir.<\/p>

\u00c7eviride K\u00dcB ile kullanma talimat\u0131 aras\u0131nda terminoloji ve bilgi a\u00e7\u0131s\u0131ndan tam tutarl\u0131l\u0131k korunmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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04 \/ PACKAGING<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Etiket ve ambalaj metinleri<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130\u00e7 ve d\u0131\u015f ambalaj metinleri s\u0131n\u0131rl\u0131 alana s\u0131\u011fmal\u0131 ve hedef pazar\u0131n gerektirdi\u011fi zorunlu ifadeleri i\u00e7ermelidir.<\/p>

K\u0131saltmalar, semboller ve \u00f6l\u00e7\u00fc birimleri ilgili pazar\u0131n d\u00fczenlemelerine uygun bi\u00e7imde haz\u0131rlanmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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05 \/ VARIATION<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Varyasyon ba\u015fvurular\u0131<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Yeni endikasyon, dozaj de\u011fi\u015fikli\u011fi veya g\u00fcvenlik g\u00fcncellemesi gibi ruhsat sonras\u0131 de\u011fi\u015fiklikler \u00f6nceki onayl\u0131 belgelerle uyumlu bi\u00e7imde y\u00f6netilmelidir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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06 \/ REGULATORY<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Reg\u00fclasyon yaz\u0131\u015fmalar\u0131<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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D\u00fczenleyici otoritelerle ger\u00e7ekle\u015ftirilen yaz\u0131\u015fmalar\u0131n terminolojik do\u011frulu\u011fu kadar, \u00f6nceki ba\u015fvuru ve a\u00e7\u0131klamalarla tutarl\u0131l\u0131\u011f\u0131 da \u00f6nemlidir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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eCTD'nin be\u015f mod\u00fcll\u00fc yap\u0131s\u0131<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Ortak teknik dosya, d\u00fczenleyici ba\u015fvurunun i\u00e7eri\u011fini belirli mod\u00fcller alt\u0131nda standartla\u015ft\u0131r\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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Mod\u00fcl 1<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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B\u00f6lgesel ve idari bilgiler<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Mod\u00fcl 2<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kalite, klinik ve klinik d\u0131\u015f\u0131 \u00f6zetler<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Mod\u00fcl 3<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kalite ve \u00fcretim bilgileri<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Mod\u00fcl 4<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik d\u0131\u015f\u0131 \u00e7al\u0131\u015fma raporlar\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Mod\u00fcl 5<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Klinik \u00e7al\u0131\u015fma raporlar\u0131<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\u00c7al\u0131\u015fma S\u00fcreci<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsatland\u0131rma \u00e7evirisinde izledi\u011fimiz yakla\u015f\u0131m<\/h2>\t\t\t\t<\/div>\n\t\t
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1<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u0130nceleme<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Hedef pazar, belge t\u00fcr\u00fc ve d\u00fczenleyici gerekliliklerin de\u011ferlendirilmesi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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2<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Terminoloji haz\u0131rl\u0131\u011f\u0131<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u00dcr\u00fcn bazl\u0131 s\u00f6zl\u00fck, referans belgeler ve \u00e7eviri belle\u011finin olu\u015fturulmas\u0131.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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3<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Uzman \u00e7eviri<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130\u00e7eri\u011fin t\u0131bbi ve farmas\u00f6tik terminolojiye h\u00e2kim uzmanlar taraf\u0131ndan \u00e7evrilmesi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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4<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Redaksiyon ve QA<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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\u00c7evirinin ba\u011f\u0131ms\u0131z edit\u00f6r kontrol\u00fc ve terminoloji tutarl\u0131l\u0131\u011f\u0131n\u0131n do\u011frulanmas\u0131.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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5<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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S\u00fcr\u00fcm takibi<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Varyasyon ve g\u00fcncellemelerde \u00f6nceki onayl\u0131 terminolojinin korunmas\u0131.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Otoriteler<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Hedef pazarlara g\u00f6re gereklilikler<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsatland\u0131rma gereklilikleri hedef pazara g\u00f6re de\u011fi\u015fir. T\u00fcrkiye’de T\u0130TCK, Avrupa’da EMA ve ilgili ulusal otoriteler, ABD’de FDA d\u00fczenleyici yap\u0131n\u0131n ba\u015fl\u0131ca \u00f6rnekleridir.<\/p>

K\u00dcB, kullanma talimat\u0131 ve etiket metinleri \u00e7o\u011fu pazarda standart \u015fablonlara ve onayl\u0131 terminolojiye ba\u011fl\u0131d\u0131r. Avrupa’da QRD \u015fablonlar\u0131 bunun en belirgin \u00f6rneklerinden biridir.<\/p>

Bu nedenle ruhsatland\u0131rma \u00e7evirisi serbest bir metin aktar\u0131m\u0131 de\u011fil; \u015fablona, terminolojiye, \u00fcr\u00fcn ge\u00e7mi\u015fine ve hedef otoritenin kurallar\u0131na ba\u011fl\u0131 disiplinli bir s\u00fcre\u00e7tir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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TR<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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T\u0130TCK<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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T\u00fcrkiye<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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EU<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EMA<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Avrupa Birli\u011fi<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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US<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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FDA<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Amerika Birle\u015fik Devletleri<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Kalite Y\u00f6netimi<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kalite ve terminoloji tutarl\u0131l\u0131\u011f\u0131<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsatland\u0131rma belgelerinde tutarl\u0131l\u0131k temel kalite kriterlerinden biridir. Ayn\u0131 terimin \u00fcr\u00fcn\u00fcn farkl\u0131 belgelerinde veya sonraki varyasyonlar\u0131nda farkl\u0131 kar\u015f\u0131l\u0131klarla kullan\u0131lmas\u0131 reg\u00fclasyon s\u00fcrecinde sorun yaratabilir.<\/p>

Bu nedenle proje baz\u0131nda onayl\u0131 terminoloji s\u00f6zl\u00fckleri, referans belgeler ve \u00e7eviri belle\u011fi<\/a> kullan\u0131larak terminoloji s\u00fcreklili\u011fi sa\u011flan\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tOnayl\u0131 terminoloji\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\u00dcr\u00fcn ve m\u00fc\u015fteri bazl\u0131 terminoloji kaynaklar\u0131.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\u00c7eviri belle\u011fi\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\u00d6nceki onayl\u0131 i\u00e7eriklerin sistematik olarak korunmas\u0131.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tBa\u011f\u0131ms\u0131z redaksiyon\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\u00c7eviriden ba\u011f\u0131ms\u0131z ikinci dil uzman\u0131 kontrol\u00fc.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\n\t\t\t\t<\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tS\u00fcr\u00fcm kontrol\u00fc\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tVaryasyonlarda mevcut onayl\u0131 belgelerin esas al\u0131nmas\u0131.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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S\u0131k yap\u0131lan hatalar<\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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K\u00dcB ile kullanma talimat\u0131n\u0131n birbirinden ba\u011f\u0131ms\u0131z y\u00f6netilmesi, QRD veya T\u0130TCK \u015fablonlar\u0131n\u0131n ba\u015fl\u0131k yap\u0131s\u0131n\u0131n de\u011fi\u015ftirilmesi, onayl\u0131 terminoloji yerine serbest kar\u015f\u0131l\u0131klar\u0131n kullan\u0131lmas\u0131, varyasyon ba\u015fvurular\u0131nda \u00f6nceki s\u00fcr\u00fcm\u00fcn esas al\u0131nmamas\u0131 ve ambalaj metinlerindeki zorunlu ifadelerin hedef pazara g\u00f6re uyarlanmamas\u0131 ruhsatland\u0131rma s\u00fcrecinde gecikmeye neden olabilecek ba\u015fl\u0131ca sorunlard\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Terminoloji<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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K\u0131sa terim s\u00f6zl\u00fc\u011f\u00fc<\/h2>\t\t\t\t<\/div>\n\t\t
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K\u00dcB \/ SmPC<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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K\u0131sa \u00fcr\u00fcn bilgisi; sa\u011fl\u0131k profesyoneline y\u00f6nelik resm\u00ee \u00fcr\u00fcn bilgisi.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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KT \/ PIL<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Kullanma talimat\u0131; hastaya y\u00f6nelik \u00fcr\u00fcn bilgisi.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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eCTD<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsat ba\u015fvurusunun standart elektronik dosya yap\u0131s\u0131.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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QRD<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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EMA'n\u0131n \u00fcr\u00fcn bilgilerinde kullan\u0131lan standart \u015fablon yap\u0131s\u0131.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Varyasyon<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Ruhsat sonras\u0131nda ger\u00e7ekle\u015ftirilen de\u011fi\u015fiklik ba\u015fvurusu.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Ruhsat sahibi<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u00dcr\u00fcn\u00fcn pazardaki yasal sorumlulu\u011funu ta\u015f\u0131yan kurulu\u015f.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Farmakovijilans<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130la\u00e7lar\u0131n g\u00fcvenlili\u011finin izlenmesi ve de\u011ferlendirilmesi.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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SSS<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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S\u0131k Sorulan Sorular<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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\u0130la\u00e7 ruhsatland\u0131rma \u00e7evirisi neden \u00f6zel uzmanl\u0131k ister? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Belgeler d\u00fczenleyici otoritelerin de\u011ferlendirmesine sunulur ve standart \u015fablonlarla onayl\u0131 terminolojiye uygun haz\u0131rlanmal\u0131d\u0131r. Bu nedenle hem t\u0131bbi ve farmas\u00f6tik terminoloji hem de reg\u00fclasyon s\u00fcre\u00e7leri konusunda uzmanl\u0131k gerekir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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K\u00dcB ve kullanma talimat\u0131 \u00e7evirisinde nelere dikkat edilir? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Resm\u00ee \u015fablonlara, hedef pazar terminolojisine ve onayl\u0131 \u00fcr\u00fcn bilgilerine uygunluk sa\u011flanmal\u0131; K\u00dcB ile kullanma talimat\u0131 aras\u0131nda tam terminoloji ve bilgi tutarl\u0131l\u0131\u011f\u0131 korunmal\u0131d\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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eCTD nedir, \u00e7eviriyi nas\u0131l etkiler? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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eCTD, ruhsat ba\u015fvurusunun be\u015f mod\u00fcll\u00fc standart elektronik yap\u0131s\u0131d\u0131r. Hangi b\u00f6l\u00fcm\u00fcn yerel dilde sunulaca\u011f\u0131 hedef otoritenin gerekliliklerine g\u00f6re de\u011fi\u015febilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Hangi otoriteler i\u00e7in \u00e7eviri yap\u0131l\u0131r? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
\n\t\t\t\t
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Hedef pazara g\u00f6re T\u00fcrkiye’de T\u0130TCK, Avrupa’da EMA ve ulusal d\u00fczenleyici otoriteler, ABD’de FDA gibi kurumlar\u0131n gereklilikleri do\u011frultusunda i\u00e7erikler haz\u0131rlanabilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

\n\t\t\t\t\n\t\t\t\t\t
Varyasyon ba\u015fvurular\u0131 neden dikkat gerektirir? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
\n\t\t\t\t
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Yeni belgelerin \u00f6nceki onayl\u0131 dok\u00fcmanlarla tutarl\u0131 olmas\u0131 gerekir. Terminoloji veya \u00fcr\u00fcn bilgisindeki kontrols\u00fcz farkl\u0131l\u0131klar reg\u00fclasyon s\u00fcrecinde ek de\u011ferlendirmelere yol a\u00e7abilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Terminoloji tutarl\u0131l\u0131\u011f\u0131 nas\u0131l sa\u011flan\u0131r? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
\n\t\t\t\t
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Onayl\u0131 s\u00f6zl\u00fckler, referans dok\u00fcmanlar ve \u00e7eviri belleklerinden yararlan\u0131l\u0131r. \u0130\u00e7erik ayr\u0131ca ba\u011f\u0131ms\u0131z redaksiyon ve kalite kontrol s\u00fcre\u00e7lerinden ge\u00e7irilir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Mirora<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Medikal \u00e7eviride deneyim ve kontroll\u00fc s\u00fcre\u00e7<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Otuz y\u0131l\u0131 a\u015fk\u0131n s\u00fcredir medikal \u00e7eviri alan\u0131nda hizmet veren Mirora, ISO 9001 belgeli ve ISO 17100 ile uyumlu i\u015f ak\u0131\u015f\u0131yla ila\u00e7 ve ya\u015fam bilimleri sekt\u00f6r\u00fcndeki projelerde terminoloji, kalite kontrol ve s\u00fcrd\u00fcr\u00fclebilir proje y\u00f6netimine odaklan\u0131r.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Medikal \u00c7eviri Hizmetleri \u0130la\u00e7 Ruhsatland\u0131rma ve Reg\u00fclasyon \u00c7evirisi \u0130la\u00e7 ruhsatland\u0131rma ve reg\u00fclasyon \u00e7evirisi, bir ilac\u0131n bir \u00fclkede sat\u0131\u015fa sunulabilmesi i\u00e7in…<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-23664","page","type-page","status-publish","hentry"],"yoast_head":"\n\u0130la\u00e7 Ruhsatland\u0131rma ve Reg\u00fclasyon \u00c7evirisi | Mirora<\/title>\n<meta name=\"description\" content=\"\u0130la\u00e7 ruhsatland\u0131rma \u00e7evirisi: eCTD dosyas\u0131, K\u00dcB\/SmPC, kullanma talimat\u0131, etiket ve varyasyon ba\u015fvurular\u0131; otoriteler (Titck, EMA, FDA) ve s\u0131k yap\u0131lan hatalar.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mirora.com\/tr\/ilac-ruhsatlandirma-cevirisi\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u0130la\u00e7 Ruhsatland\u0131rma ve Reg\u00fclasyon \u00c7evirisi | Mirora\" \/>\n<meta property=\"og:description\" content=\"\u0130la\u00e7 ruhsatland\u0131rma \u00e7evirisi: eCTD dosyas\u0131, K\u00dcB\/SmPC, kullanma talimat\u0131, etiket ve varyasyon ba\u015fvurular\u0131; 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