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Son dakika: Sağlık Bakanı Fahrettin Koca sosyal medya hesabından açıkladı: Tüm aşılar için yapılmış bir düzenlemedir Sağlık Bakanı Fahrettin Koca, sosyal medya hesabından yaptığı paylaşımda "Bugün Resmi Gazete’de yayımlanan “Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik” hakkında asılsız bilgiler yayıldığı görülmüştür. Bu özellikle yerli aşı adaylarımız ve ülkemizde kullanılacak tüm aşılar için yapılmış bir düzenlemedir." ifadelerini kullandı. takvim.com.tr Giriş Tarihi : 18 Aralık 2020 , 22:01 Güncelleme Tarihi : 18 Aralık 2020 , 23:04
Sağlık Bakanı Fahrettin Koca, Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliğinde aşıların Acil Kullanım Onayı'na ilişkin düzenleme yapıldığını belirterek, "Acil Kullanım Onayı, 'ruhsat' anlamına gelmemektedir. Sadece, aşının ruhsatlandırılması için gerekli veriler sağlanıncaya kadar verilen, süresi belli olan geçici bir izindir." ifadelerini kullandı.
Bakan Koca, Twitter hesabından yaptığı paylaşımda, bugün Resmi Gazete'de yayımlanan ve Türkiye İlaç ve Tıbbi Cihaz Kurumunun Acil Kullanım Onayı verebilmesine imkan sağlayan "Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik" hakkında bilgi verdi.
Yönetmelikle ilgili asılsız bilgiler yayıldığının görüldüğünü aktaran Bakan Koca, düzenlemenin özellikle yerli aşı adayları ve Türkiye'de kullanılacak tüm aşılar için yapılmış bir düzenleme olduğunu vurguladı.
Acil Kullanım Onayı'nın, Kovid-19 gibi pandemilerde yayılımın önüne geçmek ve halk sağlığını korumak üzere geliştirildiğini ve güvenli aşılara vatandaşların mümkün olan en erken sürede erişimine olanak sağlayan bir uygulama niteliği taşıdığını belirten Koca, şunları kaydetti:
"Söz konusu değişiklikle bir eksiklik giderilmiş ve dünya genelinde uzun süredir kullanılan bu uygulamaya mevzuatımızda yer verilmiştir. Acil Kullanım Onayı, ABD ve Avrupa Birliği ülkeleri başta olmak üzere dünya genelinde uzun süredir kullanılmaktadır. Halihazırda dünyada öne çıkan Kovid-19 aşılarına verilen onay, bu kapsamdadır. Dünya Sağlık Örgütü de ihtiyaç duyulan durumlarda aşı dahil çeşitli ürün grupları için aynı prosedürü önermektedir. "
Türkiye genelinde 16 ayrı yerli aşı ile Ar-Ge çalışmalarının devam ettiğini bidiren Koca, halihazırda bir inaktif aşının Faz 1 klinik çalışmasında sona gelindiğini ve Faz 2 çalışmalarına hazırlanıldığını aktardı.
Eş zamanlı olarak farklı teknolojilerle geliştirilen 5 ayrı aşının da Faz 1 aşamasına geldiğini bildiren Koca, şu değerlendirmelerde bulundu:
"Mevzuat düzenlemesinin bir amacı da çalışmaları sonuçlanan yerli aşılarımızı güvenlik testlerinin ardından en erken şekilde vatandaşlarımızın kullanımına sunabilmektir. Acil Kullanım Onayı, 'ruhsat' anlamına gelmemektedir. Sadece, aşının ruhsatlandırılması için gerekli veriler sağlanıncaya kadar verilen, süresi belli olan geçici bir izindir. Toplumun sağlığını korumak ve gecikmelere meydan vermemek için yapılan bir işlemdir. Verilen süre sonunda da ürünün ruhsatlandırılması esastır. Acil Kullanım Onayı, yurt dışından getirilme veya yerli üretim olmasına bakılmaksızın bütün aşılar için aynı şartlara bağlı olarak verilecektir. Aşının güvenirliği ve etkililiği bilimsel çerçevede gösterildikten sonra, elde edilen verilerin yarar-risk dengesi gözetilerek uluslararası standartlara uygunluğu değerlendirilecektir. Gerekli teknik incelemeleri ve testler sonucunda uluslararası akredite bir kurum olan Türkiye Tıbbi Cihaz ve ilaç Kurumunca Acil Kullanım Onayı verilecektir."
Sağlık Bakanı Fahrettin Koca'nın o paylaşımı;