{"id":36226,"date":"2021-06-29T09:26:56","date_gmt":"2021-06-29T07:26:56","guid":{"rendered":"https:\/\/www.tibagroup.com\/mra-suiza-ue-productos-sanitarios\/"},"modified":"2025-02-18T12:00:53","modified_gmt":"2025-02-18T11:00:53","slug":"fin-mra-suiza-ue","status":"publish","type":"post","link":"https:\/\/www.tibagroup.com\/es\/comercio-internacional\/acuerdos\/fin-mra-suiza-ue","title":{"rendered":"Fin del acuerdo de reconocimiento mutuo (MRA) entre Suiza en la UE para productos sanitarios"},"content":{"rendered":"<p>Suiza rompe con la Uni\u00f3n Europea su <a href=\"https:\/\/www.aemps.gob.es\/informa\/notasInformativas\/productosSanitarios\/2021\/NI-PS_20-2021_MRA.pdf?x60265\" target=\"_blank\" rel=\"noopener noreferrer\">acuerdo de mutuo reconocimiento de productos sanitarios<\/a> y todas las adquisiciones de<strong> productos sanitarios suizos<\/strong> ser\u00e1n sometidas a las mismas normas de <strong>importaci\u00f3n que cualquier tercer pa\u00eds<\/strong>, entre ellas la inspecci\u00f3n de farmacia en frontera.<\/p>\n<p>Hasta la fecha, gracias al acuerdo de reconocimiento mutuo, los productos sanitarios con origen y procedencia suiza no pasaban inspecci\u00f3n de farmacia en frontera, es decir una vez el producto llegaba a Espa\u00f1a, \u00fanicamente se despachaba. Sin embargo, a partir de ahora, roto el acuerdo, para poder importar productos sanitarios de Suiza ser\u00e1 necesario disponer de<strong> licencia de importaci\u00f3n de productos sanitarios<\/strong>.<\/p>\n<h2>Requisitos para importar productos sanitarios de Suiza sin acuerdo de reconocimiento mutuo (MRA)<\/h2>\n<p>Los requisitos para importar productos sanitarios con origen o procedencia suiza tras la ruptura del MRA UE-Suiza son:<\/p>\n<ul>\n<li><strong>Licencia de importaci\u00f3n<\/strong>: las empresas interesadas en adquirir productos con origen o procedencia suiza tendr\u00e1n que ser importadores. Esto significa que deber\u00e1n disponer\/gestionar una licencia previa de funcionamiento de instalaciones de productos sanitarios.<\/li>\n<li><strong>Controles para-aduaneros<\/strong> en la importaci\u00f3n de los productos.<\/li>\n<li>Actualizaci\u00f3n del <strong>etiquetado y de las instrucciones<\/strong> de uso.<\/li>\n<li><strong>Representante autorizado en Europa<\/strong>: los importadores tendr\u00e1n que verificar que los fabricantes suizos tengan su representante autorizado en Europa, as\u00ed como sus certificados CE emitidos por organismos notificados autorizados, si hubiese alg\u00fan certificado Emitido por un Organismo notificado Suizo perder\u00eda su vigencia.<\/li>\n<\/ul>\n<h2>Servicios para la importaci\u00f3n de productos sanitarios de Suiza tras el fin del acuerdo de reconocimiento mutuo (MRA) UE-Suiza<\/h2>\n<p>Para seguir garantizando tus importaciones de productos sanitarios de Suizo nuestro equipo especializado en log\u00edstica sanitaria te asistir\u00e1 en:<\/p>\n<ul>\n<li>La preparaci\u00f3n de la <strong>documentaci\u00f3n<\/strong> t\u00e9cnica necesaria para la importaci\u00f3n de los productos con todas las garant\u00edas.<\/li>\n<li>La gesti\u00f3n de tu propia <strong>licencia de importaci\u00f3n<\/strong> de productos sanitarios.<\/li>\n<li>La b\u00fasqueda de <strong>alternativas hasta la obtenci\u00f3n<\/strong> de la licencia de importaci\u00f3n.<\/li>\n<li>El proceso de importaci\u00f3n desde los <strong>fletes, inspecci\u00f3n de farmacia en frontera, aduanas<\/strong>.<\/li>\n<\/ul>\n<p>Trabajando con un equipo especializado como el nuestros, podr\u00e1s obtener los siguientes ahorros y <strong>beneficios<\/strong>:<\/p>\n<ul>\n<li>Garant\u00edas en cuanto a los <strong>documentos t\u00e9cnicos<\/strong> facilitados por los fabricantes.<\/li>\n<li>Evitar retrasos y demoras en los <strong>controles para-aduaneros y aduaneros<\/strong>.<\/li>\n<li><strong>Evitar rechazos<\/strong> de mercanc\u00eda por incumplimientos de la normativa aplicable.<\/li>\n<li>Trabajo de <strong>preparaci\u00f3n previo al embarque<\/strong> de la mercanc\u00eda.<\/li>\n<li><strong>Interlocuci\u00f3n especializada<\/strong> con la administraci\u00f3n en la gesti\u00f3n de sus env\u00edos.<\/li>\n<\/ul>\n<h2>A qui\u00e9n afecta el fin de acuerdo de reconocimiento mutuo (MRA) entre Suiza y la UE<\/h2>\n<p>Los principales afectados son importadores y distribuidores espa\u00f1oles de los productos con origen\/procedencia suiza recogidos en el <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/ES\/TXT\/PDF\/?uri=CELEX:32017R0745&amp;from=EL\" target=\"_blank\" rel=\"noopener noreferrer\">Reglamento (UE) 2017\/745<\/a> del Parlamento Europeo y del Consejo, de 5 de abril de 2017, sobre los productos sanitarios, por el que se modifican la Directiva 2001\/83\/CE, el Reglamento (CE) n.o 178\/2002 y el Reglamento (CE) n.o 1223\/2009 y por el que se derogan las Directivas 90\/385\/CEE y 93\/42\/CEE del Consejo.<\/p>\n<p>&nbsp;<\/p>\n<div style=\"background: #b1d1f1; padding: 20px; overflow: auto;\">\n<h2 style=\"text-align: center;\">Cuenta con nosotros<\/h2>\n<div  class='flex_column av-15dkt7d-81aa3fdb3cc33fa085b72ff9242d7a21 av_one_half  avia-builder-el-0  el_before_av_one_half  avia-builder-el-first  first flex_column_div  '     ><p><span class=\"bigtextblue\">Si eres distribuidor o importador de productos sanitarios y crees que la ruptura del acuerdo de mutuo reconocimiento entre Suiza y la UE para productos sanitarios puede afectarte contacta con nuestro equipo especializado en log\u00edstica sanitaria y ellos te ayudar\u00e1n a encontrar la mejor soluci\u00f3n para tus operaciones.<\/span><\/p>\n<p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1btw5g9-65c415a261b8de847a640f07d9a1222a\">\n.avia-image-container.av-1btw5g9-65c415a261b8de847a640f07d9a1222a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-1btw5g9-65c415a261b8de847a640f07d9a1222a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-1btw5g9-65c415a261b8de847a640f07d9a1222a av-styling- avia-align-center  avia-builder-el-1  el_before_av_image  avia-builder-el-first '  ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image- avia-img-lazy-loading-not- avia_image ' src=\"https:\/\/www.tibagroup.com\/wp-content\/uploads\/2023\/08\/IATA-CEIV-Pharma-Certification-80x80-1.webp\" alt='' title=''   \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mfkrqx-d8b96e732c061c7fe9ae99fe74c01e4a\">\n.avia-image-container.av-mfkrqx-d8b96e732c061c7fe9ae99fe74c01e4a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-mfkrqx-d8b96e732c061c7fe9ae99fe74c01e4a 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data-av_icon='\ue805' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title ' >Te respondemos con urgencia<\/h3><\/header><div class='iconbox_content_container ' ><script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof InitializeEditor,callIfLoaded:function(o){return!(!gform.domLoaded||!gform.scriptsLoaded||!gform.themeScriptsLoaded&&!gform.isFormEditor()||(gform.isFormEditor()&&console.warn(\"The use of gform.initializeOnLoaded() is deprecated in the form editor context and will be removed in Gravity Forms 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action='\/es\/wp-json\/wp\/v2\/posts\/36226#gf_8' data-formid='8' novalidate>\n                        <div class='gform-body gform_body'><ul id='gform_fields_8' class='gform_fields top_label form_sublabel_below description_below validation_below'><li id=\"field_8_14\" class=\"gfield gfield--type-html gfield--input-type-html gfield--width-full gfield_html gfield_html_formatted gfield_no_follows_desc field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><header class=\"entry-content-header\">\n<div class=\"iconbox_icon heading-color\" aria-hidden=\"true\" data-av_icon=\"\ue805\" data-av_iconfont=\"entypo-fontello\"><\/div><h2 class=\"iconbox_content_title \"><strong>\u00a1Cont\u00e1ctanos!<\/strong><\/h2><\/header><\/li><li id=\"field_8_1\" class=\"gfield gfield--type-text gfield--input-type-text gf_left_half gfield_contains_required field_sublabel_below gfield--no-description field_description_below hidden_label field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_8_1'>Nombre<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_1' id='input_8_1' type='text' value='' class='medium'    placeholder='Nombre' aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_8_2\" class=\"gfield gfield--type-email gfield--input-type-email gf_right_half gfield_contains_required field_sublabel_below gfield--no-description field_description_below hidden_label field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_8_2'>Email<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_email'>\n                            <input name='input_2' id='input_8_2' type='email' value='' class='medium'   placeholder='Email' aria-required=\"true\" aria-invalid=\"false\"  \/>\n                        <\/div><\/li><li id=\"field_8_3\" class=\"gfield gfield--type-text gfield--input-type-text gf_left_half gfield_contains_required field_sublabel_below gfield--no-description field_description_below hidden_label field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_8_3'>Tel\u00e9fono<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_text'><input name='input_3' id='input_8_3' type='text' value='' class='medium'    placeholder='Tel\u00e9fono' aria-required=\"true\" aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_8_4\" class=\"gfield gfield--type-text gfield--input-type-text gf_right_half field_sublabel_below gfield--no-description field_description_below hidden_label field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_8_4'>Empresa<\/label><div class='ginput_container ginput_container_text'><input name='input_4' id='input_8_4' type='text' value='' class='medium'    placeholder='Empresa'  aria-invalid=\"false\"   \/><\/div><\/li><li id=\"field_8_5\" class=\"gfield gfield--type-select gfield--input-type-select custom-opt gfield_contains_required field_sublabel_below gfield--no-description field_description_below hidden_label field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_8_5'>Oficina TIBA<span class=\"gfield_required\"><span class=\"gfield_required gfield_required_asterisk\">*<\/span><\/span><\/label><div class='ginput_container ginput_container_select'><select name='input_5' id='input_8_5' class='medium gfield_select'    aria-required=\"true\" aria-invalid=\"false\" ><option value='' selected='selected' class='gf_placeholder'>Oficina TIBA<\/option><optgroup label='Angola'><option value='lad' >Luanda<\/option><\/optgroup><optgroup label='Argentina'><option value='bue' >Buenos Aires<\/option><option value='mdz' >Mendoza<\/option><option value='sla' >Salta<\/option><\/optgroup><optgroup label='Brasil'><option value='vcp' >Campinas<\/option><option value='cxj' >Caxias do Sul<\/option><option value='cwb' >Curitiba<\/option><option value='itj' >Itaja\u00ed<\/option><option value='joi' >Joinville<\/option><option value='gru' >Sao Paulo<\/option><option value='vix' >Vit\u00f3ria<\/option><\/optgroup><optgroup label='Cabo Verde'><option value='rai' >Praia<\/option><\/optgroup><optgroup label='Chile'><option value='ccp' >Concepci\u00f3n<\/option><option value='scl' >Santiago de Chile<\/option><\/optgroup><optgroup label='China'><option value='ngb' >Ningbo<\/option><option value='tao' >Qingdao<\/option><option value='sha' >Shanghai<\/option><option value='szx' >Shenzhen<\/option><option value='tsn' >Tianjin<\/option><option value='xmn' >Xiamen<\/option><\/optgroup><optgroup label='Colombia'><option value='baq' >Barranquilla<\/option><option value='bog' >Bogot\u00e1<\/option><option value='Zona Franca de Bogot\u00e1' >Zona Franca de Bogot\u00e1<\/option><option value='bun' >Buenaventura<\/option><option value='clo' >Cali<\/option><option value='ctg' >Cartagena<\/option><option value='mde' >Medell\u00edn<\/option><option value='pei' >Pereira<\/option><\/optgroup><optgroup label='Ecuador'><option value='gye' >Guayaquil<\/option><option value='uio' >Quito<\/option><\/optgroup><optgroup label='El Salvador'><option value='sal' >El Salvador city<\/option><\/optgroup><optgroup label='Espa\u00f1a'><option value='alg' >Algeciras<\/option><option value='alc' >Alicante<\/option><option value='bcn' >Barcelona<\/option><option value='bio' >Bilbao<\/option><option value='lpa' >Las Palmas<\/option><option value='mad' >Madrid<\/option><option value='tci' >Tenerife<\/option><option value='vlc' >Valencia<\/option><option value='vgo' >Vigo<\/option><\/optgroup><optgroup label='Guatemala'><option value='gua' >Guatemala City<\/option><\/optgroup><optgroup label='Hong Kong'><option value='hkg' >Tsim Sha Tsui<\/option><\/optgroup><optgroup label='Marruecos'><option value='casablanca' >Casablanca<\/option><option value='tng' >Tanger<\/option><\/optgroup><optgroup label='M\u00e9xico'><option value='mex' >CDMX<\/option><option value='gdl' >Guadalajara<\/option><option value='leo' >Le\u00f3n<\/option><option value='mid' >M\u00e9rida<\/option><option value='mty' >Monterrey<\/option><option value='qro' >Quer\u00e9taro<\/option><\/optgroup><optgroup label='Mozambique'><option value='mpm' >Maputo<\/option><\/optgroup><optgroup label='Panam\u00e1'><option value='pty' >Panam\u00e1 City<\/option><option value='onx' >Zona Libre de Col\u00f3n<\/option><\/optgroup><optgroup label='Per\u00fa'><option value='lim' >Lima<\/option><\/optgroup><optgroup label='Portugal'><option value='cbp' >Coimbra<\/option><option value='lis' >Lisboa<\/option><option value='opo' >Oporto<\/option><option value='sie' >Sines<\/option><\/optgroup><optgroup label='Rep\u00fablica Dominicana'><option value='sdq' >Santo Domingo<\/option><\/optgroup><optgroup label='Tunez'><option value='tunis' >Rades<\/option><option value='sfax' >Sfax<\/option><option value='sousse' >Sousse<\/option><\/optgroup><optgroup label='Turqu\u00eda'><option value='ist' >Estambul<\/option><option value='izm' >Izmir<\/option><\/optgroup><optgroup label='Uruguay'><option value='mvd' >Montevideo<\/option><\/optgroup><\/select><\/div><\/li><li id=\"field_8_6\" class=\"gfield gfield--type-textarea gfield--input-type-textarea gfield_contains_required field_sublabel_below gfield--no-description field_description_below hidden_label field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_8_6'>\u00bfEn qu\u00e9 podemos ayudarle?<span 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sobre el fin del acuerdo de mutuo reconocimiento de Suiza y la UE y de los requisitos para importar productos sanitarios de Suiza.<\/p>\n","protected":false},"author":2,"featured_media":36227,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[852,628],"tags":[805,832],"class_list":["post-36226","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-acuerdos","category-industria-sanitaria","tag-espana","tag-portugal"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ruptura del MRA entre Suiza y la UE | TIBA<\/title>\n<meta name=\"description\" content=\"Inf\u00f3rmate sobre el fin del acuerdo de mutuo reconocimiento de Suiza y la UE y de los requisitos para importar productos sanitarios de Suiza\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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