{"id":3358,"date":"2008-02-04T12:00:48","date_gmt":"2008-02-04T10:00:48","guid":{"rendered":"http:\/\/www.ced.org.tr\/?p=3358"},"modified":"2008-02-04T12:00:48","modified_gmt":"2008-02-04T10:00:48","slug":"beseri-tibbi-urunler-ambalaj-ve-etiketleme-yonetmenliginde-degisiklik","status":"publish","type":"post","link":"http:\/\/www.ced.org.tr\/?p=3358","title":{"rendered":"Be\u015feri T\u0131bbi \u00fcr\u00fcnler ambalaj ve etiketleme y\u00f6netmenli\u011finde de\u011fi\u015fiklik"},"content":{"rendered":"<p><strong><font size=\"2\"><strong><span style=\"font-size: 9pt\">Be\u015feri T\u0131bbi &uuml;r&uuml;nler ambalaj ve etiketleme y&ouml;netmenli\u011finde de\u011fi\u015fiklik yap\u0131lmas\u0131na dair y&ouml;netmelik Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan 02 \u015eubat 2008 tarih ve 26775 say\u0131l\u0131 resmi gazetede yay\u0131mland\u0131.<\/span><\/strong><\/font><\/strong><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><strong>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/strong> <span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 1 &ndash; <\/strong>12\/8\/2005 tarihli ve 25904 say\u0131l\u0131 Resm&icirc; Gazete&rsquo;de yay\u0131mlanan Be\u015feri T\u0131bbi &Uuml;r&uuml;nler Ambalaj ve Etiketleme Y&ouml;netmeli\u011finin 4 &uuml;nc&uuml; maddesine a\u015fa\u011f\u0131daki tan\u0131mlar eklenmi\u015ftir.<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;\u0130malat&ccedil;\u0131: &Uuml;r&uuml;n&uuml; pazara sunmak &uuml;zere serbest b\u0131rakan ger&ccedil;ek veya t&uuml;zel ki\u015fiyi,&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;Karekod: Datamatrix tipinde 2 boyutlu bir barkodu,&quot;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;G&ouml;zle okunabilir bilgiler: barkod veya karekoda ait i&ccedil;eriklerin kullan\u0131c\u0131lara g&ouml;sterilmesi amac\u0131yla, tan\u0131mlay\u0131c\u0131n\u0131n alt\u0131nda veya yak\u0131n\u0131nda bir b&ouml;lgede yaz\u0131lan tan\u0131mlay\u0131c\u0131 i&ccedil;erik bilgilerini,&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;<\/span><\/strong><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 2 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin 5 inci maddesinin birinci f\u0131kras\u0131n\u0131n (f), (i), (j), (m), (n), (&ouml;), (r) ve (s) bentleri a\u015fa\u011f\u0131daki \u015fekilde de\u011fi\u015ftirilmi\u015ftir.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;f) &Ccedil;ocuklar\u0131n g&ouml;remeyece\u011fi, eri\u015femeyece\u011fi yerlerde ve ambalaj\u0131nda saklay\u0131n\u0131z.&quot; &ouml;zel uyar\u0131s\u0131na yer verilir.<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;i) 24\/6\/2007 tarihli ve 26562 say\u0131l\u0131 Resm&icirc; Gazete&rsquo;de yay\u0131mlanan Ambalaj ve Ambalaj At\u0131klar\u0131n\u0131n Kontrol&uuml; Y&ouml;netmeli\u011fi gere\u011fince ambalajlar\u0131n &uuml;zerinde geri kazan\u0131labilir ambalaj sembol&uuml; ile ambalaj\u0131n cinsine ait numara ve k\u0131saltma bulundurulur. Bu y&ouml;netmelikte Radyofarmas&ouml;tikler ba\u015fl\u0131\u011f\u0131 alt\u0131nda zikredilen &uuml;r&uuml;nler hari&ccedil; olmak &uuml;zere, t\u0131bbi ve tehlikeli at\u0131k s\u0131n\u0131f\u0131nda olmayan, i&ccedil;, d\u0131\u015f ve nakliye ambalaj at\u0131klar\u0131n\u0131n y&ouml;netimi bahsi ge&ccedil;en y&ouml;netmelik kapsam\u0131nda yap\u0131l\u0131r.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;j) &Uuml;r&uuml;n&uuml;n ambalaj\u0131nda ruhsat\/izin sahibinin ad\u0131 ve adresi bulunur. \u0130steniliyorsa, ruhsat\/izin sahibinin kendisini temsile yetkili k\u0131ld\u0131\u011f\u0131 &uuml;r&uuml;n&uuml; pazarlayan firma ismi de bulunur.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;m) \u0130kincil tan\u0131mlay\u0131c\u0131 bilgileri ve karekodun g&ouml;zle okunabilir bilgileri i&ccedil;inde parti numaras\u0131 bulunur.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>n) Son kullanma tarihi kutunun &ouml;l&ccedil;&uuml;lerine g&ouml;re rakamla ya da yaz\u0131 ile ay olarak ve yaln\u0131zca rakamla y\u0131l olarak a&ccedil;\u0131k bir \u015fekilde yer al\u0131r.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;&ouml;) &quot;Kesilmi\u015f veya a&ccedil;\u0131lm\u0131\u015f ambalajlar\u0131 sat\u0131n almay\u0131n\u0131z&quot;; &quot;Kullanmadan &ouml;nce kullanma talimat\u0131n\u0131 okuyunuz&quot;; &quot;Beklenmeyen bir etki g&ouml;r&uuml;ld&uuml;\u011f&uuml;nde doktorunuza ba\u015fvurunuz&quot; uyar\u0131lar\u0131 ile Bakanl\u0131k&ccedil;a belirlenen di\u011fer uyar\u0131lar yer al\u0131r.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;r) &Uuml;r&uuml;nlerin takip edilebilirli\u011fini sa\u011flamak i&ccedil;in karekod \u015feklinde adland\u0131r\u0131lan ikincil bir tan\u0131mlay\u0131c\u0131 ve yan\u0131nda karekodun i&ccedil;eri\u011fine dair g&ouml;zle okunabilir bilgiler yer al\u0131r. Ruhsat\/izin sahipleri, &uuml;r&uuml;nlerinin d\u0131\u015f ambalajlar\u0131 &uuml;zerine, bu y&ouml;netmeli\u011fe ba\u011fl\u0131 olarak &ccedil;\u0131kar\u0131lacak barkod uygulama k\u0131lavuzunda belirlenen standartlar d&acirc;hilinde, karekod ve i&ccedil;eri\u011fine ait g&ouml;zle okunabilir bilgileri, piyasada yayg\u0131n \u015fekilde bulunan ve 2 boyutlu barkod okuyabilen okuyucularla okunabilecek \u015fekilde uygularlar. Karekod; tan\u0131t\u0131m numuneleri, hastane ambalajl\u0131 &uuml;r&uuml;nler, re&ccedil;eteli ya da re&ccedil;etesiz ila&ccedil;lar ile bedeli geri &ouml;demeye tabi olan ara &uuml;r&uuml;nler ve t\u0131bbi beslenme &uuml;r&uuml;nlerinin ambalajlar\u0131 &uuml;zerinde bulunur.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>s) &Uuml;r&uuml;n barkodu bulunur.&quot;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 3 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin 6 nc\u0131 maddesi a\u015fa\u011f\u0131daki \u015fekilde de\u011fi\u015ftirilmi\u015ftir.<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span>&nbsp;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;MADDE 6 &ndash;<\/strong> \u0130&ccedil; ambalajlar; bu maddenin ikinci f\u0131kras\u0131n\u0131n (a) ve (b) bentleri ile bu Y&ouml;netmeli\u011fin 5 inci maddesinin birinci f\u0131kras\u0131n\u0131n (o), (&ouml;), (p) ve (s) bentlerinde belirtilen hususlar\u0131n haricinde, Y&ouml;netmeli\u011fin 5 inci maddesinde belirlenen &ouml;zellik ve bilgileri ta\u015f\u0131mak zorundad\u0131r.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Bu maddenin birinci f\u0131kras\u0131 h&uuml;km&uuml;ne uygun olmak \u015fart\u0131yla &ouml;zellikle;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>a) Blister \u015feklindeki i&ccedil; ambalajlarda;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>1) Y&ouml;netmeli\u011fin 5 inci maddesinin birinci f\u0131kras\u0131n\u0131n (a) bendinde belirtildi\u011fi \u015fekilde &uuml;r&uuml;n ad\u0131n\u0131n,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>2) Ruhsat\/izin sahibinin isminin veya ambleminin,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>3) \u0130&ccedil; ambalaj\u0131n &ouml;l&ccedil;&uuml;lerine ve &ouml;zelli\u011fine g&ouml;re rakamla ya da yaz\u0131 ile ay olarak ve yaln\u0131zca rakamla y\u0131l olarak a&ccedil;\u0131k bir \u015fekilde yaz\u0131lm\u0131\u015f son kullanma tarihinin,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>4) Parti numaras\u0131n\u0131n<span>&nbsp; <\/span>bulunmas\u0131 gerekir.<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>b) Y&ouml;netmeli\u011fin 5 inci maddesinde etiketleme y&ouml;n&uuml;nden belirlenen &ouml;zellik ve bilgilerin yer alamayaca\u011f\u0131 kadar k&uuml;&ccedil;&uuml;k i&ccedil; ambalajlarda;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>1) M&uuml;mk&uuml;nse, ruhsat\/izin sahibinin ismi veya amblemi,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>2) &Uuml;r&uuml;n<span>&nbsp; <\/span>ad\u0131, gerekti\u011finde dozu ve uygulama yolu,<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/span>3) Ay ve y\u0131l olarak a&ccedil;\u0131k bir \u015fekilde yaz\u0131lm\u0131\u015f son kullanma tarihi,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>4) Parti numaras\u0131,<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;<\/span>5) A\u011f\u0131rl\u0131k, hacim veya birim\/miktar olarak i&ccedil;eri\u011fi,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>6) Uygulama y&ouml;ntemi yer al\u0131r.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>D\u0131\u015f ambalaj\u0131 bulunmayan &uuml;r&uuml;nlerin mevcut ambalajlar\u0131, Y&ouml;netmeli\u011fin 5 inci maddesine uygun olmak zorundad\u0131r.&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>\u0130&ccedil; ambalajlarda parti numaras\u0131 bulundurulur.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;<\/span><\/strong><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 4 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin 11 inci maddesinin birinci f\u0131kras\u0131n\u0131n (a) bendi a\u015fa\u011f\u0131daki \u015fekilde de\u011fi\u015ftirilmi\u015ftir.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;a) Bu Y&ouml;netmelik ile belirlenen \u015fartlara uygun olmak zorundad\u0131r. Ancak bu &uuml;r&uuml;nlerin ambalajlar\u0131nda barkod bulunmaz, sadece karekod ve karekod i&ccedil;eri\u011fine ait g&ouml;zle okunabilir bilgileri a&ccedil;\u0131k olarak bulunur.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span><\/strong><\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong>MADDE 5 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin 14 &uuml;nc&uuml; maddesinin d&ouml;rd&uuml;nc&uuml; f\u0131kras\u0131 a\u015fa\u011f\u0131daki \u015fekilde de\u011fi\u015ftirilmi\u015ftir.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;&Uuml;r&uuml;n&uuml;n piyasaya arz edilmesi i&ccedil;in d\u0131\u015f, i&ccedil; ambalaj ve kullanma talimat\u0131na ait bilgiler T&uuml;rk&ccedil;e olmal\u0131d\u0131r. Ancak gerekli hallerde ve istenilen durumlarda d\u0131\u015f ambalaj, i&ccedil; ambalaj ve kullanma talimat\u0131nda T&uuml;rk&ccedil;e yan\u0131nda, AB &uuml;ye &uuml;lkelerinin resmi dillerinden birisi ile di\u011fer &uuml;lkelerin resmi dillerinden birisi de kullan\u0131labilir.&quot;<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 6 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin 16 nc\u0131 maddesine a\u015fa\u011f\u0131daki f\u0131kralar eklenmi\u015ftir.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;Ruhsat\/izin sahipleri; birden fazla &uuml;r&uuml;n&uuml; sevk ederken, &uuml;r&uuml;n g&uuml;venilirli\u011fini sa\u011flamak &uuml;zere,ta\u015f\u0131ma ambalajlar\u0131 kullanmal\u0131d\u0131rlar. Ta\u015f\u0131ma ambalajlar\u0131 paket, koli, kutu veya ba\u011f olarak ve i&ccedil; i&ccedil;e konulacak \u015fekilde olabilir. Ta\u015f\u0131ma ambalajlar\u0131n\u0131n i&ccedil;erdi\u011fi miktarlar sat\u0131\u015f esnas\u0131nda a&ccedil;\u0131lmadan son noktaya kadar ta\u015f\u0131yacak makul seviyelerde belirlenmelidir.&quot;<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;Ta\u015f\u0131ma ambalajlar\u0131n\u0131n &uuml;st&uuml;nde, ta\u015f\u0131ma ambalaj\u0131n\u0131 tan\u0131mlayan bilgileri i&ccedil;eren bir tan\u0131mlay\u0131c\u0131 veya ta\u015f\u0131ma ambalaj\u0131n\u0131n i&ccedil;indeki &uuml;r&uuml;nlerin karekod bilgilerinin t&uuml;m&uuml;n&uuml; i&ccedil;eren bir tan\u0131mlay\u0131c\u0131 mutlaka bulunmal\u0131d\u0131r. Ta\u015f\u0131ma ambalaj\u0131 &uuml;zerine konulacak tan\u0131mlay\u0131c\u0131lar bu y&ouml;netmeli\u011fe ba\u011fl\u0131 olarak &ccedil;\u0131kar\u0131lacak barkod uygulama k\u0131lavuzunda belirlenen \u015fekilde uygulan\u0131r.&quot;<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 7 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin 19 uncu maddesi a\u015fa\u011f\u0131daki \u015fekilde de\u011fi\u015ftirilmi\u015ftir:<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;MADDE 19 &ndash; <\/strong>Bakanl\u0131k gerekli oldu\u011fu durumlarda ve &ouml;zellikle;<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>a) Baz\u0131 &uuml;r&uuml;n kategorileri i&ccedil;in uyar\u0131lar olu\u015fturulmas\u0131nda,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>b) Kendi kendine tedavi amac\u0131 ile kullan\u0131lacak &uuml;r&uuml;nlerde kullan\u0131c\u0131ya ait &ouml;zel bilgiler d&uuml;zenlenmesinde,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>c) Ambalaj ve Etiket bilgilerinin anla\u015f\u0131labilirli\u011fi i&ccedil;in,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><span style=\"font-size: 9pt\"><span>&nbsp;<\/span><\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>d) &Uuml;r&uuml;n&uuml;n tan\u0131mlama y&ouml;ntemleri, d\u0131\u015f ambalajlar ve ta\u015f\u0131ma ambalajlar\u0131n\u0131n &uuml;st&uuml;nde bulunmas\u0131 gereken tan\u0131mlay\u0131c\u0131 i&ccedil;erikleri ve g&uuml;venilirli\u011fi i&ccedil;in,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>e) &Uuml;r&uuml;n&uuml;n etiketinde yer almas\u0131 gereken yard\u0131mc\u0131 maddelerin listesi ve belirtilme \u015fekilleri i&ccedil;in, uyulacak genel ilkeleri k\u0131lavuz halinde yay\u0131mlar.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>Bakanl\u0131k bu Y&ouml;netmelikte say\u0131lmayan haller i&ccedil;in ve gerekli g&ouml;rd&uuml;\u011f&uuml; durumlarda Y&ouml;netmeli\u011fin uygulanmas\u0131na y&ouml;nelik ek k\u0131lavuz veya tebli\u011fler yay\u0131mlar.&quot;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 8 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fin ge&ccedil;ici 1 inci maddesinin y&uuml;r&uuml;rl&uuml;\u011f&uuml;, orijinal &uuml;r&uuml;nler i&ccedil;in 1\/7\/2009 tarihine, jenerik &uuml;r&uuml;nler i&ccedil;in 31\/12\/2009 tarihine kadar uzat\u0131lm\u0131\u015ft\u0131r.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 9 &ndash; <\/strong>Ayn\u0131 Y&ouml;netmeli\u011fe a\u015fa\u011f\u0131daki ge&ccedil;ici maddeler eklenmi\u015ftir.<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;GE&Ccedil;\u0130C\u0130 MADDE 2 &ndash; <\/strong>Bu Y&ouml;netmeli\u011fin yay\u0131mland\u0131\u011f\u0131 tarihten itibaren 1\/1\/2009 tarihine kadar ila&ccedil; ambalajlar\u0131na karekod eklenecektir. Bu tarihten sonra t&uuml;m &uuml;r&uuml;nlerde karekod bulunmas\u0131 mecburi olup, bu tarihten &ouml;nce karekodsuz &uuml;retilmi\u015f ve piyasada mevcut olan &uuml;r&uuml;nlerin 31\/12\/2009 tarihine kadar sat\u0131\u015f\u0131na izin verilecektir.&quot;<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>&quot;GE&Ccedil;\u0130C\u0130 MADDE 3 &ndash; <\/strong>Bu Y&ouml;netmelik y&uuml;r&uuml;rl&uuml;\u011fe girdikten sonra ruhsatl\u0131 &uuml;r&uuml;nlerin yenilenmesi gereken d\u0131\u015f ambalajlar\u0131 hakk\u0131nda ruhsat\/izin sahipleri taraf\u0131ndan yap\u0131lacak ba\u015fvuruda, sadece fiyat kup&uuml;rlerinin kald\u0131r\u0131l\u0131p, karekod ve g&ouml;zle okunabilir bilgilerinin konuldu\u011funun<span>&nbsp; <\/span>Bakanl\u0131\u011fa bildirilmesi 1\/1\/2009 tarihine kadar yeterli say\u0131lacak olup uygulama i&ccedil;in ayr\u0131ca onay beklenmeyecek ve bu kapsamdaki ambalaj g&uuml;ncellemeleri 1\/1\/2009 tarihine kadar varyasyon kapsam\u0131nda de\u011ferlendirilmeyecektir. Ancak bu tarihten sonra yap\u0131lacak g&uuml;ncellemeler i&ccedil;in varyasyon ba\u015fvurusu yap\u0131lmas\u0131 zorunludur. Ambalaj g&uuml;ncellemeleri fiyat kup&uuml;r&uuml;n&uuml;n kald\u0131r\u0131lmas\u0131 ve karekod uygulanmas\u0131 d\u0131\u015f\u0131nda bir de\u011fi\u015fiklik i&ccedil;erdi\u011fi takdirde varyasyon kapsam\u0131nda ba\u015fvuru yap\u0131lacakt\u0131r.&quot;<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 10 &ndash; <\/strong>Bu Y&ouml;netmeli\u011fin;<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>a) 8 inci maddesi 31\/12\/2007 tarihinden ge&ccedil;erli olmak &uuml;zere yay\u0131m\u0131 tarihinde,<\/span><span style=\"font-size: 9pt\">&nbsp;<\/span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><\/span><\/span><\/font><\/font>&nbsp;<font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\"><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>b) Di\u011fer maddeleri yay\u0131m\u0131 tarihinde y&uuml;r&uuml;rl&uuml;\u011fe girer.<\/span><\/span><\/span><\/font><\/font> <\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><\/span><\/font><\/font><\/p>\n<p><font color=\"#000000\"><font face=\"Times New Roman\"><span style=\"font-size: 9pt; line-height: 150%\"><span><span style=\"font-size: 9pt\">&nbsp;<\/span><span><strong><span>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/span>MADDE 11 &ndash;<\/strong> Bu Y&ouml;netmelik h&uuml;k&uuml;mlerini Sa\u011fl\u0131k Bakan\u0131 y&uuml;r&uuml;t&uuml;r.<\/span><font size=\"3\">&nbsp;<\/font><\/span><\/span><\/font><\/font><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Be\u015feri T\u0131bbi &uuml;r&uuml;nler ambalaj ve etiketleme y&ouml;netmenli\u011finde de\u011fi\u015fiklik yap\u0131lmas\u0131na dair y&ouml;netmelik Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan 02 \u015eubat 2008 tarih ve 26775&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_monsterinsights_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-3358","post","type-post","status-publish","format-standard","hentry","category-ced"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.3 - aioseo.com -->\n\t<meta name=\"description\" content=\"Be\u015feri T\u0131bbi \u00fcr\u00fcnler ambalaj ve etiketleme y\u00f6netmenli\u011finde de\u011fi\u015fiklik yap\u0131lmas\u0131na dair y\u00f6netmelik Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan 02 \u015eubat 2008 tarih ve 26775 say\u0131l\u0131 resmi gazetede yay\u0131mland\u0131. MADDE 1 \u2013 12\/8\/2005 tarihli ve 25904 say\u0131l\u0131 Resm\u00ee Gazete\u2019de yay\u0131mlanan Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ambalaj ve Etiketleme Y\u00f6netmeli\u011finin 4 \u00fcnc\u00fc maddesine a\u015fa\u011f\u0131daki tan\u0131mlar eklenmi\u015ftir. &quot;\u0130malat\u00e7\u0131: \u00dcr\u00fcn\u00fc pazara sunmak \u00fczere serbest\" \/>\n\t<meta name=\"robots\" content=\"max-image-preview:large\" \/>\n\t<meta name=\"author\" content=\"CED \u0130STANBUL\"\/>\n\t<meta name=\"google-site-verification\" content=\"4\/PADeybIVXNi1FWDn2PVVeqiyUv8gGZqu7DNmOEZBNDKJiHEdIk47RKA\" \/>\n\t<meta name=\"msvalidate.01\" content=\"4\/PADeybIVXNi1FWDn2PVVeqiyUv8gGZqu7DNmOEZBNDKJiHEdIk47RKA\" \/>\n\t<meta name=\"p:domain_verify\" content=\"-01Tt29FgD8frNEEpRik8kzbF8-9TRCVGsm93a0wCBA\" \/>\n\t<meta name=\"keywords\" content=\"\u00e7ed\" \/>\n\t<link rel=\"canonical\" href=\"http:\/\/www.ced.org.tr\/?p=3358\" \/>\n\t\t<meta name=\"generator\" content=\"All in One SEO (AIOSEO) 5.0.3\" \/>\n\n\t\t<meta name=\"google-site-verification\" content=\"-01Tt29FgD8frNEEpRik8kzbF8-9TRCVGsm93a0wCBA\" \/>\n\t\t<meta property=\"og:locale\" content=\"tr_TR\" \/>\n\t\t<meta property=\"og:site_name\" content=\"\u00c7a\u011fda\u015f Eczac\u0131lar Derne\u011fi\" \/>\n\t\t<meta property=\"og:type\" content=\"article\" \/>\n\t\t<meta property=\"og:title\" content=\"Be\u015feri T\u0131bbi \u00fcr\u00fcnler ambalaj ve etiketleme y\u00f6netmenli\u011finde de\u011fi\u015fiklik | \u00c7a\u011fda\u015f Eczac\u0131lar Derne\u011fi\" \/>\n\t\t<meta property=\"og:description\" content=\"Be\u015feri T\u0131bbi \u00fcr\u00fcnler ambalaj ve etiketleme y\u00f6netmenli\u011finde de\u011fi\u015fiklik yap\u0131lmas\u0131na dair y\u00f6netmelik Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan 02 \u015eubat 2008 tarih ve 26775 say\u0131l\u0131 resmi gazetede yay\u0131mland\u0131. 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