{"id":9740,"date":"2026-04-01T09:57:58","date_gmt":"2026-04-01T01:57:58","guid":{"rendered":"https:\/\/regask.com\/?p=9740"},"modified":"2026-04-01T09:57:58","modified_gmt":"2026-04-01T01:57:58","slug":"turquia-actualiza-las-normas-sobre-el-embalaje-y-los-prospectos-para-pacientes-de-los-medicamentos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/turkiye-updates-packaging-and-patient-leaflet-rules-for-medicinal-products\/","title":{"rendered":"Turqu\u00eda actualiza las normas sobre envases y prospectos para pacientes\u2026"},"content":{"rendered":"<p>La Agencia Turca de Medicamentos y Dispositivos M\u00e9dicos public\u00f3 <strong>revisiones sustanciales<\/strong> a su directriz sobre <strong>Informaci\u00f3n del envase y folletos informativos para el paciente (PIL)<\/strong> para productos medicinales humanos en <strong>19 de marzo de 2026,<\/strong> con aplicabilidad a partir del 18 de marzo de 2026. La actualizaci\u00f3n afecta <strong>todos los titulares de autorizaci\u00f3n de comercializaci\u00f3n de productos farmac\u00e9uticos en Turqu\u00eda,<\/strong> cubriendo ambos <strong>medicamentos con receta (Rx) y medicamentos de venta libre (OTC), <\/strong>y presenta <strong>Requisitos de cumplimiento graduales hasta 2027.<\/strong><\/p>\n<div class=\"row\"  id=\"row-1989832784\">\n\n\t<div id=\"col-735459591\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1417941912\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1417941912 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-1336893238\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1336893238 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La gu\u00eda revisada introduce\u00a0<\/span><b><span data-contrast=\"auto\">cambios significativos en el dise\u00f1o del empaque y los folletos informativos para el paciente.<\/span><\/b><span data-contrast=\"auto\">, incluyendo actualizaciones de\u00a0<\/span><b><span data-contrast=\"auto\">est\u00e1ndares de legibilidad, requisitos de Braille, jerarqu\u00eda de contenido y divulgaci\u00f3n de sustancias auxiliares<\/span><\/b><span data-contrast=\"auto\">. Estos cambios requieren que las empresas\u00a0<\/span><b><span data-contrast=\"auto\">Revisar y actualizar el dise\u00f1o del producto y los prospectos.<\/span><\/b><span data-contrast=\"auto\">\u00a0para garantizar el cumplimiento de las nuevas expectativas de formato y contenido.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Los nuevos requisitos tambi\u00e9n exigen el uso de\u00a0<\/span><b><span data-contrast=\"auto\">s\u00edmbolos de diferenciaci\u00f3n y advertencia<\/span><\/b><span data-contrast=\"auto\">\u00a0para categor\u00edas de productos espec\u00edficas, incluyendo\u00a0<\/span><b><span data-contrast=\"auto\">psicotr\u00f3picos, narc\u00f3ticos y medicamentos de alto riesgo<\/span><\/b><span data-contrast=\"auto\">. Estos s\u00edmbolos deben seguir\u00a0<\/span><b><span data-contrast=\"auto\">est\u00e1ndares iconogr\u00e1ficos definidos<\/span><\/b><span data-contrast=\"auto\">, con\u00a0<\/span><b><span data-contrast=\"auto\">Plazos de aplicaci\u00f3n graduales seg\u00fan el tipo de producto y la clasificaci\u00f3n de riesgo.<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Adem\u00e1s, la gu\u00eda introduce\u00a0<\/span><b><span data-contrast=\"auto\">componentes digitales obligatorios<\/span><\/b><span data-contrast=\"auto\">, incluido\u00a0<\/span><b><span data-contrast=\"auto\">folletos electr\u00f3nicos (e-KT)<\/span><\/b><span data-contrast=\"auto\">\u00a0y\u00a0<\/span><b><span data-contrast=\"auto\">C\u00f3digos QR multimedia<\/span><\/b><span data-contrast=\"auto\">\u00a0para la mayor\u00eda de los productos. Estos requisitos aumentan la necesidad de\u00a0<\/span><b><span data-contrast=\"auto\">sistemas robustos de gesti\u00f3n de contenido digital<\/span><\/b><span data-contrast=\"auto\">\u00a0y actualizaciones continuas para garantizar el cumplimiento a lo largo de todo el ciclo de vida del producto.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-735459591 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1006566355\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Fecha l\u00edmite<\/h2>\n\t<div id=\"gap-1513119951\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1513119951 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los plazos clave incluyen:<strong> 1 de julio de 2026,<\/strong> por el cual e<strong>Requisitos ampliados, como pictogramas de riesgo y caracter\u00edsticas antimanipulaci\u00f3n.<\/strong> debe implementarse, y el 1 de enero de 2027, cuando <strong>Los folletos electr\u00f3nicos (e-KT) y los c\u00f3digos QR multimedia se vuelven obligatorios.<\/strong> para la mayor\u00eda de los medicamentos de uso humano.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1006566355 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-330374852\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-1888366342\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1888366342 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">Esta actualizaci\u00f3n introduce<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">mayor claridad regulatoria<\/span><\/span><\/strong><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">\u00a0en torno al embalaje y la comunicaci\u00f3n con el paciente, al tiempo que se alinea con\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">iniciativas de transformaci\u00f3n digital<\/span><\/span><\/strong><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">\u00a0en el sector farmac\u00e9utico. La inclusi\u00f3n de<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">Iconograf\u00eda estandarizada y folletos electr\u00f3nicos<\/span><\/span><\/strong><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">\u00a0apoya\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">Mejor comprensi\u00f3n y accesibilidad para el paciente.<\/span><\/span><\/strong><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\"><strong>,<\/strong> mientras que los plazos escalonados ayudan a equilibrar\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">eficiencia de cumplimiento con viabilidad de implementaci\u00f3n<\/span><\/span><\/strong><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">. Sin embargo, el alcance ampliado tambi\u00e9n aumenta<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">complejidad operativa y riesgo de cumplimiento<\/span><\/span><\/strong><span class=\"TextRun SCXW43652904 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43652904 BCX0\">\u00a0si no se aborda\u00a0<\/span><span class=\"NormalTextRun SCXW43652904 BCX0\">de manera oportuna<\/span><span class=\"NormalTextRun SCXW43652904 BCX0\">.<\/span><\/span><span class=\"EOP SCXW43652904 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-330374852 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-155248480\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>A qui\u00e9n afecta esto<\/h2>\n\t<div id=\"gap-556173290\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-556173290 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\">Esta actualizaci\u00f3n es relevante para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\">Equipos de Asuntos Regulatorios, Control de Calidad, Empaquetado, TI y Cumplimiento de Productos<\/span><\/span><\/strong><span class=\"TextRun SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\"><strong>\u00a0<\/strong>dentro del marketing de las compa\u00f1\u00edas farmac\u00e9uticas\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\">Productos con receta y de venta libre en Turqu\u00eda<\/span><\/span><\/strong><span class=\"TextRun SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\"><strong>,<\/strong> particularmente aquellos responsables de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\">Sistemas de etiquetado, gesti\u00f3n de ilustraciones y contenido digital<\/span><\/span><span class=\"TextRun SCXW44410009 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW44410009 BCX0\">.<\/span><\/span><span class=\"EOP SCXW44410009 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-155248480 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1655067979\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-2013670017\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2013670017 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deber\u00edan iniciar\u00a0<\/span><b><span data-contrast=\"auto\">revisiones interfuncionales del embalaje existente, los prospectos y los flujos de trabajo digitales.<\/span><\/b><span data-contrast=\"auto\">\u00a0para identificar las brechas con respecto a los requisitos revisados. Los equipos deber\u00edan\u00a0<\/span><b><span data-contrast=\"auto\">Priorizar las actualizaciones en funci\u00f3n de plazos escalonados.<\/span><\/b><span data-contrast=\"auto\">, asegurando la implementaci\u00f3n oportuna de\u00a0<\/span><b><span data-contrast=\"auto\">Pictogramas de riesgo, caracter\u00edsticas antimanipulaci\u00f3n y sistemas de folletos electr\u00f3nicos<\/span><\/b><span data-contrast=\"auto\">\u00a0evitar\u00a0<\/span><b><span data-contrast=\"auto\">retrasos regulatorios o medidas coercitivas<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A medida que los requisitos normativos se vuelven m\u00e1s complejos y est\u00e1n impulsados por la tecnolog\u00eda digital, las soluciones que permiten un cumplimiento proactivo y la orquestaci\u00f3n de flujos de trabajo son cada vez m\u00e1s importantes.\u00a0<\/span><b><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de agencia.<\/span><\/b><span data-contrast=\"auto\">\u00a0que capacita a las organizaciones globales en sectores altamente regulados, incluidas las ciencias de la vida, para navegar por requisitos cambiantes como los introducidos por TITCK. Al combinar IA avanzada con validaci\u00f3n de expertos,\u00a0<a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a>\u00a0entrega\u00a0<\/span><b><span data-contrast=\"auto\">Informaci\u00f3n oportuna, predictiva y pr\u00e1ctica.<\/span><\/b><span data-contrast=\"auto\">, ayudando a los equipos a optimizar las actualizaciones de los procesos de etiquetado, embalaje y cumplimiento digital en m\u00e1s de 160 pa\u00edses.<strong> <a href=\"http:\/\/regask.com\/es\/\">M\u00e1s informaci\u00f3n <\/a><\/strong>o<strong> <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reserve una demostraci\u00f3n ahora.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1655067979 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1353578576\">\n\n\t<div id=\"col-1430308233\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1544778730\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1544778730 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW139044237 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW139044237 BCX0\">\u00bfQu\u00e9 actualiz\u00f3 TICK en marzo de 2026?<\/span><\/span><span class=\"EOP SCXW139044237 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-412974537\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-412974537 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW268401594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268401594 BCX0\">TITCK actualiz\u00f3 su gu\u00eda sobre\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW268401594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268401594 BCX0\">Informaci\u00f3n del envase y folletos informativos para el paciente (PIL)<\/span><\/span><\/strong><span class=\"TextRun SCXW268401594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268401594 BCX0\">, presentando nuevos\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW268401594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268401594 BCX0\"><strong>requisitos t\u00e9cnicos, de contenido y digitales<\/strong><\/span><\/span><span class=\"TextRun SCXW268401594 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW268401594 BCX0\"><strong>\u00a0<\/strong>para productos medicinales de uso humano.<\/span><\/span><span class=\"EOP SCXW268401594 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1430308233 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-154259974\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW97429215 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97429215 BCX0\">\u00bfCu\u00e1les son los plazos clave para el cumplimiento de las normas?<\/span><\/span><span class=\"EOP SCXW97429215 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1802806515\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1802806515 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">Los plazos principales son<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">1 de julio,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW125734321 BCX0\">2026 <\/span><\/span><\/strong><span class=\"TextRun SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">para <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">Pictogramas de riesgo y caracter\u00edsticas antimanipulaci\u00f3n<\/span><\/span><span class=\"TextRun SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">, y\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">1 de enero,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW125734321 BCX0\">2027 <\/span><\/span><\/strong><span class=\"TextRun SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">para <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">Folletos electr\u00f3nicos obligatorios (e-KT) y c\u00f3digos QR<\/span><\/span><span class=\"TextRun SCXW125734321 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW125734321 BCX0\">.<\/span><\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-154259974 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-534081076\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW34578999 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW34578999 BCX0\">\u00bfA qui\u00e9n afecta la directriz actualizada?<\/span><\/span><span class=\"EOP SCXW34578999 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1256898044\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1256898044 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Todo <strong>Compa\u00f1\u00edas farmac\u00e9uticas que comercializan medicamentos con receta y de venta libre en Turqu\u00eda, incluidos los titulares de la autorizaci\u00f3n de comercializaci\u00f3n,<\/strong> debe cumplir.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-534081076 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-856693893\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW204239453 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW204239453 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW204239453 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW204239453 BCX0\">\u00a0\u00bfNecesita ayuda con las actualizaciones de cumplimiento de TITCK?<\/span><\/span><span class=\"EOP SCXW204239453 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-445889192\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-445889192 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">RegASK ayuda a las organizaciones\u00a0<\/span><b><span data-contrast=\"auto\">Realizar un seguimiento de los cambios regulatorios, evaluar su impacto y coordinar las actualizaciones interfuncionales.<\/span><\/b><span data-contrast=\"auto\">, lo que permite un cumplimiento eficiente de los requisitos en constante evoluci\u00f3n, como por ejemplo:\u00a0<\/span><b><span data-contrast=\"auto\">Actualizaciones del empaquetado, revisiones del prospecto informativo e implementaci\u00f3n del folleto digital.<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-856693893 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The Turkish Medicines and Medical Devices Agency published substantial revisions to its guideline on package information and patient information leaflets (PILs) for human medicinal products on March 19, 2026, with applicability starting March 18, 2026. The update affects all pharmaceutical market authorization holders in T\u00fcrkiye, covering both prescription (Rx) and over-the-counter (OTC) medicines, and introduces&#8230;<\/p>","protected":false},"author":41,"featured_media":9741,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[525,33,35],"tags":[],"class_list":["post-9740","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-turkey-regulations","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>T\u00fcrkiye Updates Packaging and Patient Leaflet Guidelines<\/title>\n<meta name=\"description\" content=\"Explore the new T\u00fcrkiye updates on packaging and patient leaflet rules for medicinal 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