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Alt 02-20-2011, 20:27   #1
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Standart Ilaç ve eczacılık genel müdürlüğü 2011 yılı fiyat tarifesi

İLAÇ VE ECZACILIK GENEL MÜDÜRLÜĞÜ 2011 YILI FİYAT TARİFESİ
Fiyat Tarifesi (2011)

BELGE TÜRÜ2010 yılı ücreti(TL)2011 yılı ücreti(TL)Ruhsat /İzin 1)İlaç (Kan Ürünü, İmmünolojik Ürün) Ruhsatı 16.165,00 17.410,00 2)Devren Düzenlenen İlaç Ruhsatı 4.850,00 5.225,00 3)İhraç Amaçlı Ruhsat 1.635,00 1.765,00 4)Varyasyon İşlemlerine Bağlı Ruhsat Değişikliği 4.850,00 5.225,00 5)Ruhsat Yenileme 740,00 800,00 6) Ruhsat Başvurusu 1.470,00 1.585,00 7)Devren Düzenlenen Ruhsat Başvurusu 740,00 800,00 8) Zayi Ruhsat Belgesi 1.470,00 1.585,00 9) Devren Düzenlenen İhraç Amaçlı Ruhsat Başvurusu 345,00 375,00 10) Devren Düzenlenen İhraç Amaçlı Ruhsat 690,00 745,00 11)İlacın Piyasada Olduğuna Dair Belge 575,00 620,00 12) Ara Ürün İzni 170,00 185,00 13)Devren Düzenlenen Ara Ürün İzin Belgesi Başvurusu 85,00 95,00 14)Devren Düzenlenen Ara Ürün İzin Belgesi 170,00 185,00 15) Ara Ürün İzin Belgesi Başvurusu 170,00 185,00 16) Ara Ürün İzin Belgesi Yenileme 170,00 185,00 17) Zayi Ara Ürün İzin Belgesi 80,00 90,00 18)Geleneksel Bitkisel Tıbbı Ürün Ruhsatı 2.500,00 19-)Devren Düzenlenen Geleneksel Bitkisel Tıbbı Ürün Ruhsatı 1.000,00 20)Varyasyon işlemlerine bağlı Geleneksel Bitkisel Tıbbı Ürün Ruhsatı 1.000,00 21)Geleneksel Bitkisel Tıbbı ürün Ruhsatı yenileme 250,00 22)Geleneksel Bitkisel Tıbbı ürün Ruhsatı Başvurusu 500,00 23)Devren Düzenlenen Geleneksel Bitkisel Tıbbı ürün tuhsatı başvurusu 250,00 24)Zayi Geleneksel Bitkisel Tıbbı ürün Ruhsatı 250,00 25)Ecza Deposu Ruhsatı 1.635,00 1.765,00 26)Mümessil Ecza Deposu İzin Belgesi 4.850,00 5.225,00 27)Biyoyararlanım ve Biyoeşdeğerlik Sertifikası 80,00 90,00 28) Faz I, II, III- İlaç Araştırması İlk Başvurusu (Tez çalışmaları ve akademik çalışmalar hariç 1.720,00 1.855,00 29) Faz IV klinik İlaç Araştırması BY/BE çalışmaları ve Gözlemsel Çalışmaların İlk Başvurusu (Tez çalışmaları ve akademik çalışmalar hariç) 860,00 930,00 Ruhsatlı/Ruhsat başvurusu yapılmış ürünler için Varyasyon İşlemi Başvurularıa)Tip I A 155,00 170,00 b)Tip I B 375,00 405,00 c)Tip II 740,00 800,00 d)Yeni Başvuru Gerektiren Haller 1.470,00 1.585,00 e)Tip I, Tip II, Yeni Başvuru Gerektiren Haller (izinli / izin başvurusu yapılmış ürünler) 170,00 185,00 İzin Belgesia)İyi Üretim Uygulamaları (GMP) Kontrol Başvurusu (yurtdışı) 18.410,00 19.830,00 a-1)Herbir ürün başvurusu için ayrıca 2.500,00 2.695,00 a-2)Herbir ürün belgesi için ayrıca 2.500,00 2.695,00 b)BE/BY çalışmaları için İyi Klinik Uygulamaları (İKU) Klinik ve/veya biyoanalitik laboratuvar) Kontrol Başvurusu (yurtdışı) 18.410,00 19.830,00 c) Medikal Gaz Depolama ve Dağıtım Tesisi İzin Belgesi 3.075,00 3.315,00 d) İlaç Üretim Yeri İzin Belgesi (Geleneksel Bitkisel Tıbbı ürün yeri dahil) 16.165,00 17.410,00 e) Medikal Gaz Üretim/Dolum Tesisi İzin Belgesi 4.850,00 5.225,00 f)BY/BE Çalışmaları için iyi klinik uygulamaları (İKU)(Klinik ve/veya biyoanalitik labaratuvar ) kontrol başvurusu (yurt içi) 3.235,00 3.485,00 g)Sözleşmeli Farmakovijilans hizmet kuruluşu izin belgesi 5.725,00 6.170,00 h)Sözleşmeli araştırma kuruluşu kontrol başvurusu 5.725,00 6.170,00 ı-)Destekleyici kontrol başvurusu 10.000,00 10.770,00 Ürün/Satış İzinleria) Biyolojik Ürün İzni 330,00 360,00 b) Aşı İthal İzni 170,00 185,00 c)Allerji Aşıları ve Allergen Maddeler İzni 95,00 105,00 Mesul Müdürlük Belgesia)İlaç/Ara Ürün Üretim Yeri Mesul Müdürlük Belgesi 1.635,00 1.765,00 b)Mümessil Ecza Deposu Mesul Müdürlük Belgesi 1.225,00 1.320,00 c)Ecza Deposu Mesul Müdürlük Belgesi 820,00 885,00 d)Medikal Gaz Üretim/Dolum Tesisi Mesul Müdürlük Belgesi 820,00 885,00 e)Medikal Gaz Depolama ve Dağıtım Tesisi Sorumlu Personel İzin Belgesi 620,00 670,00 Permilera) Toluen permisi içinaa) 135 ton ve altındaki miktarlar 170,00 185,00 ab) 135 tonun üzerindeki miktarlar 1,30 TL/ton 1,40 TL/ton b) Diğer permiler için 170,00 185,00 Onaylanacak Her Türlü Sertifika/Tescil vb. Belgeler 155,00 170,00 Her Kalem Hammadde/Tıbbi Ürün Gaz Üretim İzni 330,00 360,00 Kontrol Belgeleria)Mamul Ürünler(Her Bir Ürün İçin) 95,00 105,00 b)Hammaddeler(Her Bir Hammadde İçin) 95,00 105,00 c)Mamul İlaç(Her Bir Hammadde İçin) 95,00 105,00 d)İlaç Hammaddeleri(Her Bir Hammadde İçin) 95,00 105,00 e)Ara Ürün/Geleneksel Bitkisel Tıbbı ürün 155,00 170,00 f) Fatura şerhleri 155,00 170,00 g)İthalat Kayıt Talep formu 105,00 Tıbbi Amaçlı Bebek Mamalarıa) İlk İthalat/ ilk imalat 740,00 800,00 b)Kontrol Belgesi Onayı 155,00 170,00 Enteral Beslenme Ürünleria) İlk İthalat/ilk imalat 375,00 405,00 b) Kontrol Belgesi Onayı 80,00 90,00 Biyomedikal Hizmetleria-(Serbest satış Sertifikası(Tıbbi Cihazlar, Vücut dışında kullanılan(İn Vitro) Tıbbi tanıo Cihazları ve Vücuda yerleştirilebilir Aktif Tıbbi cihazlar için 370,00 400,00 b-)Kontrol Belgesi(1-50 kalem arası, 50 kalem üzeri herbir kalem için 5 TL) 105,00 115,00 c-)CE işareti taşımayan Tıbbi Cihaz Araştırması İlk başvurusu (tez çalışmaları ve akademik çalışmalar hariç) 1.720,00 1.855,00 ç-)CE işaretli Tıbbi Cihaz Araştırması İlk başvurusu (tez çalışmaları ve akademik çalışmalar hariç) 860,00 930,00 d-)Onaylanmış Kuruluş İlk başvurusu 3.000,00 3.235,00 e-)Onaylanmış kuruluş ataması 13.000,00 14.005,00 f-)Onaylanmış Kuruluş olağan yıllık değerlendirilmesi 2.000,00 2.155,00 g-)Optisyenlik Müessesesi ruhsatnamesi 149,00 165,00 h-)Personel Çalışma Belgesi 76,00 85,00 ı-)Ortez Protez Yapım Uygulama Merkezi/İşitme cihazı satış uygulama Merkezi açılış izin belgesi 153,00 165,00 i-)Ortez Protez Yapım Uygulama Merkezi/İşitme cihazı satış ve uygulama Merkezi sorumlu müdür belgesi 83,00 90,00 Geçikmiş başvurularda yukarıda belirtilen ücretlerinin 2(iki) katı alınır213 Sayılı Vergi Usul kanunu gereğince %7.7 artışla belirlenmiştir.Vergi Usul Kanunu genel tebliği Sıra No:401 ( 12 Kasım 2010 tarihli Resmi Gazete)T.C. Ziraat Bankası Bulvar Şubesi
Iban Numarası
TR480001001235495313125001
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