{ "id": "nexus-ext-1-0034-151174", "citation": "Res. 00405-2014 Sala Primera de la Corte", "section": "nexus_decisions", "doc_type": "court_decision", "title_es": "Ministerio de Salud puede exigir modificaciones y nueva información al renovar registros sanitarios", "title_en": "Ministry of Health can require modifications and new information when renewing health registries", "summary_es": "La Sala Primera de la Corte rechaza los recursos de casación interpuestos por una empresa farmacéutica contra la sentencia que validó las actuaciones del Ministerio de Salud (MS) al solicitar correcciones en los artes y usos terapéuticos de un producto para renovar su registro sanitario. La Sala confirma que no existe un derecho a la renovación automática de registros. El MS, como garante de la salud pública —derecho de raigambre constitucional—, posee amplias facultades para verificar, cuestionar y requerir modificaciones en productos de consumo humano, incluso cambiando de criterio sobre componentes previamente aceptados, siempre que exista base técnica. La carga de la prueba sobre la validez científica recae en el solicitante. La prevención administrativa no constituyó un acto arbitrario ni violó los principios de calificación única, seguridad jurídica o confianza legítima, pues las potestades del MS en materia de salud prevalecen sobre normas reglamentarias de mero trámite.", "summary_en": "The First Chamber of the Supreme Court dismisses the cassation appeals filed by a pharmaceutical company against the ruling that upheld the Ministry of Health's (MS) actions in requesting corrections to the labeling and therapeutic uses of a product as a condition for renewing its health registry. The Chamber confirms there is no right to automatic renewal. The MS, as guarantor of public health—a constitutionally rooted right—holds broad powers to verify, question, and require modifications in products for human consumption, and may even change its criteria on previously accepted components if technically justified. The applicant bears the burden of proving scientific validity. The administrative prevention was not arbitrary and did not violate the principles of single review, legal certainty, or legitimate expectations, as the MS's health-related powers prevail over purely procedural regulations.", "court_or_agency": "Sala Primera de la Corte", "date": "2014", "year": "2014", "topic_ids": [ "_off-topic" ], "primary_topic_id": "_off-topic", "es_concept_hints": [ "registro sanitario", "renovación automática", "calificación única", "Ley 8220 (Protección al ciudadano del exceso de requisitos y trámites administrativos)", "Ley General de Salud (LGS)", "Decreto Ejecutivo 29317-S (RICPRNICM)", "principio de confianza legítima", "intangibilidad de los actos propios" ], "concept_anchors": [ { "article": "Art. 21", "law": "Constitución Política" }, { "article": "Art. 1", "law": "Ley 5395" }, { "article": "Art. 2", "law": "Ley 5395" }, { "article": "Art. 112", "law": "Ley 5395" }, { "article": "Art. 119", "law": "Ley 5395" }, { "article": "Art. 4", "law": "Ley 8220" }, { "article": "Art. 6", "law": "Ley 8220" }, { "article": "Art. 15", "law": "Decreto 29317" } ], "keywords_es": [ "renovación de registro sanitario", "Ministerio de Salud", "derecho a la salud", "productos farmacéuticos", "potestades de control sanitario", "principio de calificación única", "seguridad jurídica", "confianza legítima", "Decreto Ejecutivo 29317-S", "Ley General de Salud", "Ley 8220", "Ley General de la Administración Pública", "recurso de casación" ], "keywords_en": [ "health registry renewal", "Ministry of Health", "right to health", "pharmaceutical products", "health control powers", "single review principle", "legal certainty", "legitimate expectations", "Executive Decree 29317-S", "General Health Law", "Law 8220", "General Public Administration Law", "cassation appeal" ], "excerpt_es": "No es factible situar el canon 15 del Decreto Ejecutivo 29317-S, por encima del derecho constitucional a la salud, ya que de conformidad con lo expuesto, el Ministerio del ramo, se encuentra en la obligación de corroborar que el producto sea apto para el fin propuesto. De tal manera, sostiene, la Administración está autorizada en este tipo de trámites, para requerir información u ordenar los cambios necesarios.\n\nLa competencia del MS no se puede limitar a la simple recepción de la solicitud de prórroga y a la comprobación del cumplimiento de los requisitos reglamentarios. Al contrario, el MS está obligado a verificar los usos de los componentes y de manera eventual, a formular aquellos requerimientos que desde su punto de vista técnico estime válidos, con la finalidad de autorizar los registros correspondientes.\n\nNo existe por supuesto violación al principio de confianza legítima, tampoco al denominado de intangibilidad de los actos propios, pues es evidente, se está ante una revisión, que más allá de resultar potestativa, es también obligatoria, sin dejar de lado, que la autorización del registro por primera vez, no puede ser considerada con la consolidación de un derecho subjetivo, que impida las posteriores revisiones de las condiciones terapéuticas de la mezcla a comercializar.", "excerpt_en": "It is not feasible to place Article 15 of Executive Decree 29317-S above the constitutional right to health, since, in accordance with the foregoing, the relevant Ministry is obliged to verify that the product is suitable for its intended purpose. Thus, the Administration is authorized in this type of procedure to request information or order the necessary changes.\n\nThe MS's competence cannot be limited to merely receiving the extension request and verifying compliance with regulatory requirements. On the contrary, the MS is obliged to verify the uses of the components and, if necessary, to formulate those requirements it deems technically valid in order to authorize the corresponding registries.\n\nThere is certainly no violation of the principle of legitimate expectations, nor of the so-called intangibility of one's own acts, since we are clearly dealing with a review that, far from being optional, is also mandatory, without overlooking the fact that the initial authorization of the registry cannot be considered the consolidation of a subjective right that prevents subsequent reviews of the therapeutic conditions of the mixture to be marketed.", "outcome": { "label_en": "Appeal denied", "label_es": "Recurso rechazado", "summary_en": "The cassation appeal is dismissed; it is confirmed that the Ministry of Health is empowered to require modifications and additional information when renewing a health registry, without violating the principles of single review, legal certainty, or legitimate expectations.", "summary_es": "Se declara sin lugar el recurso de casación; se confirma que el Ministerio de Salud está facultado para exigir modificaciones e información adicional al renovar un registro sanitario, sin violar los principios de calificación única, seguridad jurídica o confianza legítima." }, "pull_quotes": [ { "context": "Considerando IV", "quote_en": "It is not feasible to place Article 15 of Executive Decree 29317-S above the constitutional right to health, since, in accordance with the foregoing, the relevant Ministry is obliged to verify that the product is suitable for its intended purpose.", "quote_es": "No es factible situar el canon 15 del Decreto Ejecutivo 29317-S, por encima del derecho constitucional a la salud, ya que de conformidad con lo expuesto, el Ministerio del ramo, se encuentra en la obligación de corroborar que el producto sea apto para el fin propuesto." }, { "context": "Considerando VII", "quote_en": "The MS's competence cannot be limited to merely receiving the extension request and verifying compliance with regulatory requirements. On the contrary, the MS is obliged to verify the uses of the components and, if necessary, to formulate those requirements it deems technically valid.", "quote_es": "La competencia del MS no se puede limitar a la simple recepción de la solicitud de prórroga y a la comprobación del cumplimiento de los requisitos reglamentarios. Al contrario, el MS está obligado a verificar los usos de los componentes y de manera eventual, a formular aquellos requerimientos que desde su punto de vista técnico estime válidos." }, { "context": "Considerando IX", "quote_en": "The initial authorization of the registry cannot be considered the consolidation of a subjective right that prevents subsequent reviews of the therapeutic conditions of the mixture to be marketed.", "quote_es": "La autorización del registro por primera vez, no puede ser considerada con la consolidación de un derecho subjetivo, que impida las posteriores revisiones de las condiciones terapéuticas de la mezcla a comercializar." } ], "cites": [], "cited_by": [], "references": { "internal": [ { "target_id": "norm-6581", "kind": "concept_anchor", "label": "Ley 5395 Art. 1" }, { "target_id": "norm-48116", "kind": "concept_anchor", "label": "Ley 8220 Art. 4" }, { "target_id": "norm-45912", "kind": "concept_anchor", "label": "Decreto 29317 Art. 15" } ], "external": [] }, "source_url": "https://nexuspj.poder-judicial.go.cr/document/ext-1-0034-151174", "tier": 2, "_editorial_citation_count": 0, "regulations_by_article": null, "amendments_by_article": null, "dictamen_by_article": null, "concordancias_by_article": null, "afectaciones_by_article": null, "resoluciones_by_article": null, "cited_by_votos": [], "cited_norms": [], "cited_norms_inverted": [ { "doc_id": "norm-45912", "norm_num": "29317", "norm_name": "Reglamento para la Inscripción, Importación, Comercialización y Publicidad de Recursos Naturales Industrializados y con Cualidades Medicinales", "tipo_norma": "Decreto Ejecutivo", "norm_fecha": "09/11/2000" }, { "doc_id": "norm-48116", "norm_num": "8220", "norm_name": "Protección al ciudadano del exceso de requisitos y trámites administrativos", "tipo_norma": "Ley", "norm_fecha": "04/03/2002" }, { "doc_id": "norm-6581", "norm_num": "5395", "norm_name": "Ley General de Salud", "tipo_norma": "Ley", "norm_fecha": "30/10/1973" } ], "sentencias_relacionadas": [], "temas_y_subtemas": [], "cascade_only": false, "amendment_count": 0, "body_es_text": "“IV. El Tribunal indicó, desde un punto de vista jurídico\r\nno es posible establecer la existencia de un derecho a la renovación automática\r\ndel registro de salud, ni que la Administración carezca de competencia al\r\ncuestionar aspectos relevantes para renovar o inscribir el producto. Considera,\r\nen materia de salud hay un evidente interés público, por ello el MS está en la\r\nobligación de calificar la gestión, valorar y proponer lo que sea necesario en\r\nbeneficio de la salud pública. Por esta razón, agrega, no encuentra invalidez\r\nalguna en sus actuaciones, al solicitar aclarar aspectos y ordenar cambios en\r\nel producto, pues son para el consumo humano. Apunta, dicha materia posee\r\nraigambre constitucional, pues esa Sala ha sostenido que el MS es el órgano público\r\nencargado de velar por la salud de los habitantes del país, y entre sus\r\nfacultades se incluyen la verificación de los requisitos de ley en cualquier\r\nactividad así como prevenir mejoras. De esa forma, no es factible situar el\r\ncanon 15 del Decreto Ejecutivo 29317-S, por encima del derecho constitucional a\r\nla salud, ya que de conformidad con lo expuesto, el Ministerio del ramo, se\r\nencuentra en la obligación de corroborar que el producto sea apto para el fin\r\npropuesto. De tal manera, sostiene, la Administración está autorizada en este\r\ntipo de trámites, para requerir información u ordenar los cambios necesarios. A\r\nesta Cámara le resulta inobjetable, los juzgadores fundamentaron su\r\nposición. Sin entrar aún al análisis de fondo, es indudable que el Tribunal\r\nbrinda un claro sustento a su fallo, cual es, su posición en cuanto a que, por\r\ntratarse de un un tema de salud, existe interés\r\npúblico incuestionable, que amplía las potestades de actuación del MS.\r\nAdicionalmente, los jueces refirieron en la sentencia, se trata de la\r\nautorización de un producto de consumo humano, con posible impacto sobre la\r\nsalud pública, aspecto de raigambre constitucional, que obliga a la\r\nAdministración a darle seguimiento y control, a fin de valorar el cumplimiento\r\nestricto de los requerimientos normativos. Por consiguiente, ante tal sustento,\r\nel Tribunal no incurre en la falta de motivación que como yerro procesal\r\napuntan las recurrentes, a la cual hace referencia el precepto 137 del CPCA, lo que obliga al rechazo del cargo de estudio. \n\r\n\r\n\nRecurso por motivos\r\nsustanciales […]\n\r\n\r\n\nVII. En la segunda censura, la casacionista\r\nendilga irrespeto al principio de calificación única, preceptos 4 y 6 de la ley\r\n8220, así como el quebranto de los numerales, 106 y 114 de la LGS, 15 del RICPRNICM, 11 de la LGAP y 11 Constitucional. El Tribunal indicó, no existe un\r\nderecho a la renovación automática de los registros, por el contrario, la\r\nAdministración posee competencia para cuestionar aspectos relevantes del\r\nproducto, pues el ámbito donde operan, está relacionado con el derecho a la salud. Sostiene,\r\nsi bien la norma 15 del RICPRNICM establece una serie\r\nde requisitos que deben cumplirse al momento de presentar la solicitud de\r\nrenovación, de su texto no se desprende que con su presentación, el MS esté\r\nobligado a renovarla “ipso facto”.\r\nIndica, por las responsabilidades que conlleva y tratándose de un asunto de\r\ninterés público, el MS se encuentra obligado a calificar la gestión y en su\r\ncaso, proponer lo que sea necesario en beneficio de la salud humana. Por esta\r\nrazón, apunta, no se encuentra invalidez alguna en la conducta administrativa\r\nque solicitó aclaraciones y ordenó cambios en la mezcla del producto para su\r\ninscripción, pues se trata de un jarabe para el consumo humano. Cita varias\r\ntesis de la Sala\r\n Constitucional en cuanto a la existencia de un derecho humano\r\na la salud, el cual, dice, deriva del precepto 21 de la Carta Magna, involucrando\r\nel bienestar físico, mental y social, y, que implica la obligación del Estado\r\nde proteger la vida humana. Menciona también varios fallos de esa Sala\r\nreferentes al rol del MS como órgano público encargado de velar por la salud de\r\nlos habitantes del país. Aduce, al Ministerio de cita se le ha dotado de\r\ndiversas facultades que incluyen la verificación de los requisitos de ley para\r\nla operación de cualquier actividad y la prevención de mejoras. Considera, no\r\npuede situarse al canon 15 del RICPRNICM por encima\r\ndel derecho a la salud, puesto que éste deriva de la propia Constitución\r\n Política. Ahora bien, explica, en el caso concreto, el 3 de\r\noctubre del 2008, la Dirección de Registros y Controles del MS, le remitió a la\r\nactora el oficio DRC-4046-08-R, mediante el cual le\r\nprevino presentar un juego de artes atinentes a la presentación externa del\r\nproducto, con algunas correcciones. Manifiesta, el 25 de noviembre del 2008, la\r\naccionante dirigió una nota a la Ministra de Salud,\r\nindicando su inconformidad con lo prevenido, específicamente, en cuanto a\r\nincluir dentro de los usos, el relativo a la “claudicación intermitente”.\r\nLuego, expresa, el 30 de julio del 2009, mediante oficio DAC-1970-09-RM, la Jefa de Unidad Plataforma de Servicios, del MS, le\r\ncomunicó a la demandante que no había cumplido con las correcciones\r\nsolicitadas. De lo anterior, aprecia el Tribunal, la accionante\r\nno cumplió con los requerimientos del MS, razón por la cual, en vista de que\r\ntampoco demostró que tales requisitos resultaran contrarios a las reglas\r\nunívocas de la ciencia o técnica (artículo 15 LGAP),\r\nsu cuestionamiento de las conductas administrativas resulta improcedente, pues\r\nse limita a pedir la “nulidad por la nulidad misma”. Para esta Sala, en lo\r\nmedular el alegato se sustenta en la violación del principio de calificación\r\núnica por parte del MS, mandatos 4 y 6 de la Ley 8220, así como de los\r\npreceptos 114 de la LGS y 15 del RICPRNICM,\r\nsin que en efecto se aluda en forma alguna a la sentencia combatida.\r\nSimplemente refiere aspectos que desde su perspectiva implicarían la\r\nnulidad de una serie de actos administrativos, sin que se señalen argumentos\r\nque permitan establecer el quebranto en que incurren los juzgadores en su\r\nsentencia. Por consiguiente, ante la expresión de simples disconformidades\r\ngenerales las cuales no han sido contrastadas con el fallo, el cargo no es\r\nadmisible, circunstancia que obliga a su rechazo. Sin perjuicio de lo anterior\r\ny a mayor abundamiento de razones, la casacionista\r\nbásicamente aduce, que el MS incurrió en contradicciones al aceptar en\r\nprincipio la utilización del Panax ginseng en la mezcla, lo que luego objetó. Cita también en\r\nesa línea, la emisión de una serie de oficios, los cuales dice, junto con el\r\ncambio de criterio que ha señalado, acreditan la vulneración al principio de\r\ncalificación única en que incurre el Ministerio. En cuanto a este punto\r\nespecífico, el numeral 4 de la Ley 8220, refiere el sometimiento de toda\r\ngestión administrativa, a los principios de publicidad y legalidad. De igual\r\nforma, el ordinal 6 de ese cuerpo normativo, obliga a resolver el trámite,\r\nverificando la información aportada y previniendo la presentación de los\r\nrequisitos, por una única vez. No obstante, a lo anterior, debe aunarse, que se\r\nestá frente a conductas relacionadas con la renovación y/o autorización de un\r\nproducto para consumo humano, con indicaciones terapéuticas, cuya incidencia en\r\nel ámbito de la salud pública es evidente. Por esta razón, la competencia del\r\nMS no se puede limitar a la simple recepción de la solicitud de prórroga y a la\r\ncomprobación del cumplimiento de los requisitos reglamentarios. Al contrario,\r\nel MS está obligado a verificar los usos de los componentes y de manera\r\neventual, a formular aquellos requerimientos que desde su punto de vista\r\ntécnico estime válidos, con la finalidad de autorizar los registros\r\ncorrespondientes (canon 2 LGS). Ello como parte de la\r\nfunción que le ha sido atribuida constitucional y legalmente al Estado, a fin\r\nde velar por la salud de la población, con apego al principio que enarbola a la\r\nsalud, como un derecho humano fundamental. En ese sentido, de acuerdo al\r\nnumeral 1° de la LGS, no existe duda en cuanto a que\r\nla salud es un bien de interés público tutelado por el Estado. Adicionalmente,\r\ndebe partirse del hecho irrefutable, de que tanto la Ley como el Reglamento de\r\namplia cita, conceden al MS una facultad anterior y de mayor grado, que la\r\nsimple revisión del cumplimiento de requisitos a efecto de prorrogar los\r\nregistros, cual es, la de autorizar la solicitud de inscripción. Acorde al\r\nprecepto 8 del RICPRNICM, las solicitudes de\r\ninscripción de productos industrializados con base en elementos naturales,\r\ndeben cumplir con una amplia gama de requisitos y aspectos informativos, que\r\nobviamente, permiten una interacción entre la comisión técnica nombrada al\r\nefecto y el solicitante. Llama la atención, que con esa finalidad y de acuerdo\r\nal mandato reglamentario de referencia, la responsabilidad de aportar\r\ndocumentación científica que acredite la validez de la solicitud, recae en el\r\nsolicitante. Asimismo, los continuos avances en el conocimiento científico,\r\nimponen además al MS, la obligación de mantenerse al día en cuanto a las\r\nconsecuencias que puedan provocar los productos cuyo registro se solicita, lo\r\ncual implica revisar las formulaciones, sea que se trate de solicitudes\r\noriginales, o renovaciones. Desde esa arista, en modo alguno podría estimarse,\r\nque por el solo acto que conceda el registro original, las formulaciones o\r\nmezclas puedan mantenerse inalteradas, pues es indudable, éstas pueden ser\r\neventualmente objetadas o modificadas de cara a la generación de conocimientos\r\nnovedosos sobre su campo de acción. De ahí que no se observe que la conducta\r\nadministrativa del MS sea contraria a derecho al cambiar de criterio en cuando\r\na la utilización de ciertos componentes en la fórmula del producto cuya\r\nrenovación del registro se solicitó, salvo que se pruebe mediante probanzas\r\ntécnicas lo contrario. En efecto, nótese que el numeral 112 de la LGS, establece la obligación del solicitante en cuanto a\r\nsatisfacer los requerimientos técnicos al indicar que: “Toda persona física\r\no jurídica sólo podrá importar, fabricar, manipular, comerciar o usar\r\nmedicamentos registrados en el Ministerio y cuyo registro haya satisfecha las\r\nexigencias reglamentarias, en especial las relativas a: la naturaleza y\r\ncantidad de la información requerida sobre el medicamento o producto sometido a\r\nregistro; la entrega de muestras necesarias para practicar los análisis \r\nque haya menester, a las pertinentes al nombre con que se identificará el\r\nproducto; al contenido de la rotulación; al tipo de envases o envolturas que se\r\nusarán y al pago de las tasas que indique el arancel pertinente”. \r\nIgualmente, acorde al canon 119 de la LGS: “La\r\nimportación, venta, expendio, manipulación y almacenamiento de todo medicamento\r\nqueda sujeto a las exigencias generales legales y reglamentarias y a las\r\nrestricciones que el Ministerio decrete para cada medicamento en particular…” \r\nEn el caso concreto, el Tribunal tuvo por demostrado, que el 3 de octubre de\r\n2008, la Dirección de Registros y Controles del Ministerio de Salud, le remitió\r\na la demandante el oficio DRC-4046-08-R, mediante el\r\ncual le previno enviar dos juegos de artes con las siguientes correcciones:\"1.\r\nIndicación aceptada: \"Coadyuvante en el tratamiento sintomático de la\r\ninsuficiencia cerebro vascular leve o moderada; alivio sintomático de la\r\nclaudicación intermitente. Debe existir una valoración médica previa. 2.\r\nEliminar la frase que aparece encima del nombre PROMITON,\r\nque menciona CIRCULACIÓN CEREBRAL Y VASCULAR. 3. Corregir la forma de\r\nalmacenamiento \"MANTÉNGASE EN UN LUGAR FRESCO, SECO, ALEJADO DE LA LUZ SOLAR, CIERRE BIEN\r\nEL FRASCO LUEGO DE SU USO, UNA VEZ ABIERTO ÉSTE DEBE REFRIGERARSE, Y DESECHARSE\r\nDESPUÉS DE 10 DÍAS DE ABIERTO 4. Corregir la leyenda: \"Agitar el frasco\r\nantes de usar\". 5. Corregir la leyenda: \"El Ministerio de Salud no\r\navala otros usos que los aceptados en esta etiqueta\". 6. La leyenda\r\n\"Manténgase fuera del alcance de los niños\", colocarla en\r\nAdvertencias. No omito manifestarles que de acuerdo a la ley 8220 el trámite\r\nquedará pendiente de respuesta a este oficio y que cuenta con un máximo de 10\r\ndías para tal efecto.\" (hecho tenido\r\npor probado no. 11). Aunque la actora, mediante nota del 25 de noviembre\r\nde 2008 se opuso a la prevención, no cumplió con lo requerido, situación que le\r\nfue notificada el 30 de julio del 2009, mediante oficio DAC-1970-09-RM (hecho tenido por probado 17). Dicha resolución,\r\nsegún se ha hecho ver, consistía en una serie de correcciones informativas en\r\nlos artes del producto a comercializar. De tal manera, no se observa que el\r\noficio DRC-4046-08-R (requerimiento que no fue\r\ncumplido), haya excedido las potestades conferidas por ley al Ministerio en\r\ncuestión. Tampoco, se quebrantó el precepto 114 de la LGS,\r\npuesto que dicho numeral solo establece el plazo de vigencia del registro, tema\r\nrespecto del cual el MS no emitió opinión alguna, circunstancia que por demás,\r\nno ha sido objeto de examen en este proceso. Adicionalmente, el mandato de cita\r\nmenciona: “El registro de todo medicamento durará cinco años, salvo que las\r\ninfracciones en la elaboración, comercio o uso en que haya incurrido su\r\ntitular, o experiencias demostrativas de que el producto es inseguro o ineficaz\r\nen los términos en que fue autorizado y registrado, hagan procedente su\r\ncancelación o la modificación que corresponda”. Como se observa, la\r\nnorma limita el plazo de vigencia a cinco años, el cual podría ser aún menor de\r\nllegar a presentarse los supuestos de excepción ahí dispuestos. En la especie,\r\nes claro, el MS no ha emitido acto alguno que limite el plazo de vigencia del\r\nregistro del producto, por el contrario, se encontraba frente a una solicitud\r\nde prórroga ante el vencimiento, de ahí que no se observe quebranto de la norma\r\nen cuestión. Por su parte, el mandato 15 del RICPRNICM\r\nmenciona los requisitos que deben acompañarse a la renovación solicitada, entre\r\nellos, la solicitud respectiva, declaración jurada del representante legal en\r\ncuanto a que las condiciones de inscripción no han variado, etiqueta del\r\nproducto tal y como se está comercializando, recibo de pago por concepto del\r\nregistro y permiso de funcionamiento vigente. La casacionista\r\nconsidera que al solicitarse modificaciones en la mezcla, el MS violentó dicha\r\nnorma, toda vez que formuló exigencias mas allá de las potestades que le han\r\nsido conferidas por ley. Tal posición no es compartida por este órgano decisor, pues, se reitera, el derecho a la salud de la\r\npoblación, tiene su origen en la Carta Fundamental.\r\n Asimismo, la\r\n propia LGS confiere facultades al\r\nórgano rector del sector salud, a fin de que, entre otras cosas, solicite\r\namplia información al gestionante, todo ello con el\r\nfin de tutelar el derecho a la\r\n salud. Así las cosas, no es dable interpretar que en el caso\r\nconcreto, el MS estuviese limitado a la simple recepción de los documentos\r\ndispuestos por el precepto 15 del RICPRNICM. Por el\r\ncontrario, ante información novedosa sobre los usos del producto; y aún en caso\r\nde duda sobre las cualidades de la mezcla propuesta, podía perfectamente\r\nsolicitar nueva información o las modificaciones que en esa línea estimara\r\npertinentes, todo ello en aplicación de principios superiores dispuestos\r\nconstitucionalmente y facultades concedidas legalmente, a fin de garantizar el\r\nderecho fundamental a la\r\n salud. Por las razones expuestas el cargo debe ser rechazado.\n\r\n\r\n\nVIII. En el tercer reparo, reclama, los oficios DRC-2640-08-R, DRC-4046-08-R,\r\nDAC-0068-09-RM y DAC-1301-09-RM,\r\nson absolutamente nulos, toda vez que carecen de elementos esenciales de validez.\r\nLa actora destaca a su vez, que dichos documentos carecen de motivación.\r\nRefiere, el acto DRC-2640-08-R indica que el Ginseng no cumplía ningún papel en la mezcla, sin\r\njustificar la razón para ello. Por su parte, arguye, el oficio DRC-4046-08-R, invoca como motivo los cánones 157 de la LGAP y 114 de la LGS, sin que se\r\nhubiese presentado un error material ni se estuviera ante una cancelación y/o\r\nmodificación de un registro. Afirma, el oficio DAC-0068-09-RM,\r\nevalúa la solicitud de prórroga como si se tratara de una inscripción, sin\r\nhacer constar la razón para ello. El documento DAC-1301-09-RM,\r\nargumenta, hace referencia a 25 citas bibliográficas del Lexi\r\nDrugs, que no están en la bibliografía recomendada\r\npor el MS ni fueron presentadas al expediente. Al respecto, observa esta Sala,\r\nsi bien la casacionista considera, que los actos de\r\nreferencia carecen de elementos de validez, señalando algunas de las posibles\r\nfalencias que la llevan a esa conclusión, es incuestionable, el cargo omite\r\natacar los fundamentos del fallo que se recurre. Aunque refiere aspectos\r\nque desde esa óptica justifican su tesis en cuanto a las limitaciones y\r\nnulidad de una serie de actos administrativos, no se señalan en realidad las\r\nrazones que permitan establecer el quebranto en que incurren los jueces en su\r\nresolución. En efecto, no se hace referencia alguna a la sentencia o a los\r\nyerros en que los juzgadores pudieran haber incurrido. Por consiguiente, aunque\r\nexpresa una serie de disconformidades generales y meramente argumentativas, se omite\r\nel contraste de lo decidido con las infracciones que, en su criterio, tuvieron\r\nlugar, razón por la cual, el cargo no es admisible, circunstancia que obliga a\r\nsu rechazo. \n\r\n\r\n\nIX. En el cuarto motivo, la recurrente alega infracción\r\nde los principios constitucionales de seguridad jurídica y legalidad. No\r\nobstante, en criterio de esta Cámara, conforme se indicara en el considerando VII de esta resolución, la tesis que esgrime el Tribunal en\r\ncuanto a la existencia de un derecho fundamental a la salud, resulta\r\nincontestable. No se trata, como lo expone la casacionista,\r\nde una simple argumentación a fin de justificar que a la parte se le pida “lo\r\nque se le ocurra”, sino del ejercicio de un poder/deber, dispuesto entre\r\notras por las normas 1, 2, 112 y 119, de la LGS, que\r\nen acatamiento de ese principio básico del Estado social de derecho, así como\r\nde los de legalidad, seguridad pública, razonabilidad\r\ny buena fe, obligan a requerir modificaciones y a solicitar toda aquella\r\ninformación que a ese fin se estime conveniente. No existe por supuesto\r\nviolación al principio de confianza legítima, tampoco al denominado de\r\nintangibilidad de los actos propios, pues es evidente, se está ante una\r\nrevisión, que más allá de resultar potestativa, es también obligatoria, sin\r\ndejar de lado, que la autorización del registro por primera vez, no puede ser\r\nconsiderada con la consolidación de un derecho subjetivo, que impida las\r\nposteriores revisiones de las condiciones terapéuticas de la mezcla a\r\ncomercializar. Aunque la casacionista endilga,\r\nque el Tribunal funda su fallo en el supuesto incumplimiento de lo requerido en\r\nel oficio CRC-4046-08-R, sin reparar en que dicho acto fue impugnado; en los\r\ntérminos dispuestos en el considerando VII, no se\r\nobserva la violación a los principios constitucionales de seguridad jurídica y\r\nlegalidad, puesto que lo solicitado en el acto CRC-4046-08-R, no era mas que\r\nuna prevención a fin de que fueran realizadas algunas modificaciones en los\r\nartes, requerimiento que acorde al fundamento brindado en el considerando VII de este fallo, dista mucho de un acto arbitrario. De\r\nesa suerte, el cargo debe ser desestimado.”", "body_en_text": "“**IV.** The Trial Court indicated that, from a legal standpoint, it is not possible to establish the existence of a right to automatic renewal of the health registration (registro de salud), nor that the Administration lacks competence when questioning relevant aspects for renewing or registering the product. It considers that, in health matters, there is an evident public interest, and therefore the Ministry of Health (Ministerio de Salud, MS) is obligated to evaluate the application, assess, and propose whatever is necessary for the benefit of public health. For this reason, it adds, it finds no invalidity whatsoever in its actions, in requesting clarification of aspects and ordering changes to the product, since they are for human consumption. It points out that this matter has constitutional roots, as this Chamber has held that the MS is the public body charged with safeguarding the health of the country's inhabitants, and its powers include verifying legal requirements in any activity as well as preventing improvements. Thus, it is not feasible to place canon 15 of Decreto Ejecutivo 29317-S above the constitutional right to health, given that, in accordance with the foregoing, the relevant Ministry is obligated to corroborate that the product is suitable for its intended purpose. Therefore, it maintains, the Administration is authorized in this type of procedure to request information or order the necessary changes. To this Chamber, it is unobjectionable that the judges substantiated their position. Without yet entering into the analysis of the merits, it is undeniable that the Trial Court provides clear support for its ruling, which is its position that, because it concerns a health matter, there is an unquestionable public interest that expands the MS's powers of action. Additionally, the judges referred to in the judgment, it concerns the authorization of a product for human consumption, with a possible impact on public health, an aspect of constitutional roots that obligates the Administration to follow up and control it, in order to assess strict compliance with regulatory requirements. Consequently, given such support, the Trial Court does not incur the lack of reasoning (motivación) that the appellants point out as a procedural error, to which precept 137 of the CPCA refers, which requires that the charge under study be dismissed.\n\n**Appeal on substantive grounds […]**\n\n**VII.** In the second censure, the appellant (casacionista) alleges disrespect for the principle of single qualification (principio de calificación única), precepts 4 and 6 of Law 8220, as well as the violation of numerals 106 and 114 of the LGS, 15 of the RICPRNICM, 11 of the LGAP, and Article 11 of the Constitution. The Trial Court indicated that there is no right to the automatic renewal of registrations; on the contrary, the Administration has the competence to question relevant aspects of the product, since the sphere in which they operate is related to the right to health. It maintains that, although norm 15 of the RICPRNICM establishes a series of requirements that must be met when submitting the renewal application, it does not follow from its text that, upon its submission, the MS is obligated to renew it “ipso facto.” It indicates that, due to the responsibilities involved and since this is a matter of public interest, the MS is obligated to evaluate the application and, where appropriate, propose whatever is necessary for the benefit of human health. For this reason, it points out, no invalidity whatsoever is found in the administrative conduct that requested clarifications and ordered changes to the product mixture for its registration, since it involves a syrup for human consumption. It cites several opinions of the Constitutional Chamber (Sala Constitucional) regarding the existence of a human right to health, which, it says, derives from precept 21 of the Magna Carta, involving physical, mental, and social well-being, and which implies the State's obligation to protect human life. It also mentions several rulings of that Chamber concerning the role of the MS as the public body charged with safeguarding the health of the country's inhabitants.\n\nIt argues that the cited Ministry has been granted various powers that include verifying the legal requirements for the operation of any activity and the prevention of improvements. It considers that canon 15 of the RICPRNICM cannot be placed above the right to health, since the latter derives from the Political Constitution itself. Now, it explains, in the specific case, on October 3, 2008, the Directorate of Registries and Controls of the MS sent the plaintiff official letter DRC-4046-08-R, by which it warned her to submit a set of artwork related to the external presentation of the product, with some corrections. It states that on November 25, 2008, the plaintiff addressed a note to the Minister of Health, indicating her disagreement with the warning, specifically, regarding the inclusion among the uses of that relating to \"intermittent claudication.\" Later, it expresses, on July 30, 2009, by official letter DAC-1970-09-RM, the Head of the Service Platform Unit of the MS notified the plaintiff that she had not complied with the requested corrections. From the foregoing, the Court appreciates that the plaintiff did not comply with the MS's requirements, and therefore, given that she also did not demonstrate that such requirements were contrary to the unequivocal rules of science or technique (article 15 LGAP), her challenge to the administrative conduct is unfounded, as it is limited to requesting \"nullity for nullity's sake.\" For this Chamber, the core of the argument rests on the alleged violation of the principle of single qualification (principio de calificación única) by the MS, mandates 4 and 6 of Law 8220, as well as precepts 114 of the LGS and 15 of the RICPRNICM, without in fact alluding in any way to the contested judgment. It simply refers to aspects that from its perspective would imply the nullity of a series of administrative acts, without pointing out arguments that would allow establishing the breach incurred by the judges in their judgment. Consequently, given the expression of simple general disagreements which have not been contrasted with the ruling, the charge is inadmissible, a circumstance that compels its rejection. Notwithstanding the foregoing and for greater abundance of reasons, the appellant basically argues that the MS incurred in contradictions by initially accepting the use of Panax ginseng in the mixture, which it later objected to. In that line, it also cites the issuance of a series of official letters, which, it claims, together with the change of criteria it has pointed out, prove the violation of the principle of single qualification (principio de calificación única) incurred by the Ministry. Regarding this specific point, numeral 4 of Law 8220 refers to the submission of all administrative proceedings to the principles of publicity and legality. Likewise, ordinal 6 of that normative body obliges the procedure to be resolved by verifying the information provided and warning for the presentation of requirements, on a single occasion. However, to the foregoing must be added that we are dealing with conduct related to the renewal and/or authorization of a product for human consumption, with therapeutic indications, whose impact on the sphere of public health is evident. For this reason, the competence of the MS cannot be limited to the simple receipt of the extension request and the verification of compliance with regulatory requirements. On the contrary, the MS is obliged to verify the uses of the components and, eventually, to formulate those requirements that, from its technical point of view, it deems valid, for the purpose of authorizing the corresponding registrations (canon 2 LGS). This is part of the function constitutionally and legally attributed to the State, in order to safeguard the health of the population, in adherence to the principle that champions health as a fundamental human right. In that sense, according to numeral 1 of the LGS, there is no doubt that health is a public interest asset protected by the State. Additionally, one must start from the irrefutable fact that both the Law and the Regulation widely cited grant the MS a prior and higher-ranking power than the simple review of compliance with requirements for the purpose of extending registrations, which is the power to authorize the registration application. According to precept 8 of the RICPRNICM, applications for registration of industrialized products based on natural elements must comply with a wide range of requirements and informational aspects, which obviously allow for interaction between the technical commission appointed for that purpose and the applicant. It is noteworthy that for this purpose and in accordance with the referenced regulatory mandate, the responsibility for providing scientific documentation attesting to the validity of the application falls on the applicant. Likewise, continuous advances in scientific knowledge also impose on the MS the obligation to stay up to date regarding the consequences that the products whose registration is requested may cause, which implies reviewing the formulations, whether for original applications or renewals. From that perspective, in no way could it be considered that the formulations or mixtures may remain unchanged by the sole act of granting the original registration, since it is undeniable that they may eventually be objected to or modified in light of the generation of new knowledge about their field of action. Hence, it is not observed that the administrative conduct of the MS is contrary to law by changing its criteria regarding the use of certain components in the formula of the product whose registration renewal was requested, unless the contrary is proven through technical evidence. Indeed, note that numeral 112 of the LGS establishes the obligation of the applicant to satisfy technical requirements by indicating that: \"*Any natural or legal person may only import, manufacture, handle, trade, or use medications registered with the Ministry and whose registration has satisfied the regulatory requirements, especially those relating to: the nature and quantity of the information required about the medication or product submitted for registration; the delivery of samples necessary to carry out the required analyses; those pertaining to the name under which the product will be identified; the content of the labeling; the type of containers or packaging to be used; and the payment of the fees indicated in the relevant tariff*\". Equally, according to canon 119 of the LGS: \"*The importation, sale, dispensing, handling, and storage of all medications is subject to general legal and regulatory requirements and to the restrictions that the Ministry decrees for each medication in particular*…\" In the specific case, the Court considered it proven that on October 3, 2008, the Directorate of Registries and Controls of the Ministry of Health sent the plaintiff official letter DRC-4046-08-R, by which it warned her to send two sets of artwork with the following corrections: \"*1. Accepted indication: 'Adjunct in the symptomatic treatment of mild or moderate cerebrovascular insufficiency; symptomatic relief of intermittent claudication. A prior medical evaluation must exist.' 2. Eliminate the phrase appearing above the name PROMITON, which mentions CEREBRAL AND VASCULAR CIRCULATION. 3. Correct the storage form: 'KEEP IN A COOL, DRY PLACE, AWAY FROM SUNLIGHT, CLOSE THE BOTTLE WELL AFTER USE, ONCE OPENED IT MUST BE REFRIGERATED, AND DISCARD AFTER 10 DAYS OF BEING OPENED.' 4. Correct the legend: 'Shake the bottle before using.' 5. Correct the legend: 'The Ministry of Health does not endorse uses other than those accepted on this label.' 6. Place the legend 'Keep out of reach of children' in Warnings. I do not omit to inform you that in accordance with Law 8220 the procedure will remain pending a response to this official letter and that you have a maximum of 10 days for that effect.*\" (fact deemed proven no. 11). Although the plaintiff, by note of November 25, 2008, opposed the warning, she did not comply with what was required, a situation that was notified to her on July 30, 2009, by official letter DAC-1970-09-RM (fact deemed proven 17). This resolution, as has been shown, consisted of a series of informational corrections in the artwork of the product to be marketed. In this way, it is not observed that official letter DRC-4046-08-R (requirement that was not fulfilled) exceeded the powers conferred by law to the Ministry in question. Likewise, precept 114 of the LGS was not violated, since said numeral only establishes the validity period of the registration, a topic on which the MS did not issue any opinion, a circumstance which, moreover, has not been the subject of examination in this proceeding. Additionally, the cited mandate mentions: \"*The registration of any medication shall last five years, unless infractions in its manufacture, trade, or use incurred by its holder, or experiences demonstrating that the product is unsafe or ineffective under the terms in which it was authorized and registered, make its cancellation or corresponding modification appropriate*\". As can be observed, the rule limits the validity period to five years, which could be even shorter should the exception scenarios provided therein arise. In the species, it is clear that the MS has not issued any act limiting the validity period of the product's registration; on the contrary, it was facing an extension request upon expiration, hence no breach of the rule in question is observed. For its part, mandate 15 of the RICPRNICM mentions the requirements that must accompany the requested renewal, among them, the respective application, an affidavit from the legal representative stating that the registration conditions have not changed, the product label as it is being marketed, proof of payment for the registration concept, and the current operating permit. The appellant considers that by requesting modifications to the mixture, the MS violated said rule, since it formulated demands beyond the powers conferred upon it by law. Such a position is not shared by this deciding body, as it is reiterated that the right to health of the population has its origin in the Fundamental Charter. Likewise, the LGS itself confers powers on the governing body of the health sector so that, among other things, it may request extensive information from the applicant, all for the purpose of safeguarding the right to health. Thus, it is not possible to interpret that in the specific case, the MS was limited to the simple receipt of the documents provided for in precept 15 of the RICPRNICM. On the contrary, in the face of novel information regarding the uses of the product, and even in case of doubt about the qualities of the proposed mixture, it could perfectly well request new information or the modifications it deemed pertinent in that line, all in application of superior principles constitutionally provided and powers legally granted, in order to guarantee the fundamental right to health. For the reasons stated, the charge must be rejected.\n\n**VIII.** In the third objection, it claims that official letters DRC-2640-08-R, DRC-4046-08-R, DAC-0068-09-RM, and DAC-1301-09-RM are absolutely null, since they lack essential elements of validity. The plaintiff highlights in turn that said documents lack reasoning. It refers that act DRC-2640-08-R indicates that Ginseng played no role in the mixture, without justifying the reason for this. For its part, it argues that official letter DRC-4046-08-R invokes canons 157 of the LGAP and 114 of the LGS as its grounds, without a material error having occurred nor being in the presence of a cancellation and/or modification of a registration. It affirms that official letter DAC-0068-09-RM evaluates the extension request as if it were a new registration, without stating the reason for this. Document DAC-1301-09-RM, it argues, refers to 25 bibliographic citations from Lexi Drugs, which are not in the bibliography recommended by the MS nor were they presented to the case file. In this regard, this Chamber observes that although the appellant considers that the referenced acts lack elements of validity, pointing out some of the possible flaws that lead her to that conclusion, it is unquestionable that the charge fails to attack the grounds of the ruling being appealed. Although it refers to aspects that from that perspective justify its thesis regarding the limitations and nullity of a series of administrative acts, the reasons that would allow establishing the breach incurred by the judges in their resolution are not actually pointed out. Indeed, no reference is made to the judgment or to the errors the judges may have incurred. Consequently, although it expresses a series of general and merely argumentative disagreements, the contrast of what was decided with the infractions that, in its view, took place is omitted, which is why the charge is inadmissible, a circumstance that compels its rejection.\n\n**IX.** In the fourth ground, the appellant alleges violation of the constitutional principles of legal certainty and legality. However, in the opinion of this Chamber, as indicated in recital VII of this resolution, the thesis put forward by the Court regarding the existence of a fundamental right to health is incontestable. It is not, as the appellant states, a simple argument to justify asking the party for \"*whatever it may think of*\", but rather the exercise of a power/duty, provided for among others by rules 1, 2, 112, and 119 of the LGS, which, in compliance with that basic principle of the social rule of law, as well as those of legality, public safety, reasonableness, and good faith, oblige the request for modifications and the request for all information deemed convenient for that purpose. There is, of course, no violation of the principle of legitimate expectation, nor of the so-called principle of intangibility of one's own acts, as it is evident that this is a review which, beyond being discretionary, is also mandatory, without disregarding that the authorization of the registration for the first time cannot be considered as the consolidation of a subjective right that would prevent subsequent reviews of the therapeutic conditions of the mixture to be marketed. Although the appellant blames the Court for basing its ruling on the alleged non-compliance with what was required in official letter CRC-4046-08-R, without noting that said act was challenged, in the terms set forth in recital VII, no violation of the constitutional principles of legal certainty and legality is observed, since what was requested in act CRC-4046-08-R was nothing more than a warning so that some modifications to the artwork could be made, a requirement that, according to the reasoning provided in recital VII of this ruling, is far from an arbitrary act.\n\nThus, the claim must be dismissed.”\n\n**Appeal on substantive grounds […]**\n\n**VII.** In the second challenge, the appellant alleges disrespect for the principle of single review (principio de calificación única), precepts 4 and 6 of Law 8220, as well as the violation of numerals 106 and 114 of the LGS, 15 of the RICPRNICM, 11 of the LGAP, and 11 of the Constitution. The Court indicated that there is no right to the automatic renewal of registrations; on the contrary, the Administration possesses the competence to question relevant aspects of the product, because the scope in which they operate is related to the right to health. It maintains that while norm 15 of the RICPRNICM establishes a series of requirements that must be met when submitting the renewal application, it does not follow from its text that upon submission, the MS is obligated to renew it “ipso facto.” It indicates that, due to the responsibilities it entails and as it is a matter of public interest, the MS is obligated to assess the application and, where appropriate, propose whatever is necessary for the benefit of human health. For this reason, it notes, no invalidity is found in the administrative conduct that requested clarifications and ordered changes in the product mixture for its registration, as it is a syrup for human consumption. It cites several theses of the Constitutional Chamber regarding the existence of a human right to health, which, it says, derives from precept 21 of the Magna Carta, involving physical, mental, and social well-being, and implying the State's obligation to protect human life. It also mentions several rulings of that Chamber referring to the role of the MS as the public body responsible for safeguarding the health of the country's inhabitants. It argues that the cited Ministry has been endowed with various powers that include the verification of legal requirements for the operation of any activity and the prevention of improvements. It considers that canon 15 of the RICPRNICM cannot be placed above the right to health, since this right derives from the Political Constitution itself. Now then, it explains, in the specific case, on October 3, 2008, the Directorate of Registries and Controls of the MS sent the plaintiff official letter DRC-4046-08-R, by which it formally required her to submit a set of artwork pertaining to the external presentation of the product, with some corrections. It states that on November 25, 2008, the plaintiff addressed a note to the Minister of Health, indicating her disagreement with the requirement, specifically regarding the inclusion among the uses of that relating to “intermittent claudication.” Subsequently, it expresses, on July 30, 2009, by means of official letter DAC-1970-09-RM, the Head of the Service Platform Unit of the MS notified the plaintiff that she had not complied with the requested corrections. From the foregoing, the Court appreciates that the plaintiff did not comply with the MS's requirements, and for this reason, given that she also did not demonstrate that such requirements were contrary to the unequivocal rules of science or technique (article 15 LGAP), her challenge of the administrative conduct is improper, as it is limited to requesting “nullity for nullity’s sake.” For this Chamber, the allegation is essentially based on the violation of the principle of single review by the MS, mandates 4 and 6 of Law 8220, as well as precepts 114 of the LGS and 15 of the RICPRNICM, without in fact referring in any way to the contested judgment. It simply mentions aspects that, from her perspective, would imply the nullity of a series of administrative acts, without providing arguments that allow establishing the violation incurred by the judges in their judgment. Consequently, given the expression of simple general disagreements which have not been contrasted with the ruling, the claim is not admissible, a circumstance that mandates its rejection. Notwithstanding the foregoing and for further abundance of reasons, the appellant basically argues that the MS incurred contradictions by initially accepting the use of Panax ginseng in the mixture, which it later objected to. She also cites along those lines, the issuance of a series of official letters, which she says, together with the change of criteria she has pointed out, prove the violation of the principle of single review incurred by the Ministry. Regarding this specific point, numeral 4 of Law 8220 refers to the submission of all administrative procedures to the principles of publicity and legality. Likewise, ordinal 6 of that regulatory body obligates the resolution of the procedure, verifying the information provided and formally requiring the presentation of requirements only once. However, to the foregoing, it must be added that we are dealing with conduct related to the renewal and/or authorization of a product for human consumption, with therapeutic indications, whose incidence in the sphere of public health is evident. For this reason, the competence of the MS cannot be limited to the simple receipt of the renewal application and the verification of compliance with regulatory requirements. On the contrary, the MS is obligated to verify the uses of the components and, eventually, to formulate those requirements that from its technical point of view it deems valid, with the purpose of authorizing the corresponding registrations (canon 2 LGS). This is part of the function constitutionally and legally attributed to the State, in order to safeguard the health of the population, in accordance with the principle that champions health as a fundamental human right. In that sense, according to numeral 1 of the LGS, there is no doubt that health is a public interest good protected by the State. Additionally, one must start from the irrefutable fact that both the Law and the widely cited Regulation grant the MS a power prior to and of a higher degree than the simple review of compliance with requirements for the purpose of extending registrations, which is that of authorizing the registration application. In accordance with precept 8 of the RICPRNICM, applications for the registration of industrialized products based on natural elements must comply with a wide range of requirements and informational aspects, which obviously allow an interaction between the technical commission appointed for that purpose and the applicant. It is noteworthy that for this purpose and according to the referenced regulatory mandate, the responsibility for providing scientific documentation that proves the validity of the application falls on the applicant. Likewise, continuous advances in scientific knowledge also impose on the MS the obligation to stay up-to-date regarding the consequences that the products whose registration is requested may cause, which implies reviewing the formulations, whether they are original applications or renewals. From this perspective, it could in no way be considered that by the mere act granting the original registration, the formulations or mixtures can remain unchanged, as it is unquestionable that these can eventually be objected to or modified in light of the generation of new knowledge about their field of action. Hence, it is not observed that the administrative conduct of the MS is contrary to law when changing criteria regarding the use of certain components in the formula of the product for which registration renewal was requested, unless proven otherwise through technical evidence. Indeed, note that numeral 112 of the LGS establishes the applicant's obligation to satisfy the technical requirements by stating: “Every natural or legal person may only import, manufacture, handle, trade, or use medications registered with the Ministry and whose registration has satisfied the regulatory requirements, especially those relating to: the nature and quantity of the information required about the medication or product submitted for registration; the delivery of samples necessary to carry out the analyses that may be needed; those pertinent to the name with which the product will be identified; the content of the labeling; the type of containers or wrappers to be used; and the payment of the fees indicated by the relevant tariff.” Equally, according to canon 119 of the LGS: “The importation, sale, dispensing, handling, and storage of any medication is subject to the general legal and regulatory requirements and to the restrictions that the Ministry decrees for each medication in particular…” In the specific case, the Court deemed it proven that on October 3, 2008, the Directorate of Registries and Controls of the Ministry of Health sent the plaintiff official letter DRC-4046-08-R, by which it formally required her to send two sets of artwork with the following corrections: “1. Accepted indication: ‘Adjunctive in the symptomatic treatment of mild to moderate cerebrovascular insufficiency; symptomatic relief of intermittent claudication. A prior medical evaluation must exist.’ 2. Eliminate the phrase that appears above the name PROMITON, which mentions CEREBRAL AND VASCULAR CIRCULATION. 3. Correct the storage form ‘KEEP IN A COOL, DRY PLACE, AWAY FROM DIRECT SUNLIGHT, CLOSE THE BOTTLE TIGHTLY AFTER USE, ONCE OPENED IT MUST BE REFRIGERATED, AND DISCARD AFTER 10 DAYS OF BEING OPENED.’ 4. Correct the legend: ‘Shake the bottle before using.’ 5. Correct the legend: ‘The Ministry of Health does not endorse uses other than those accepted on this label.’ 6. Place the legend ‘Keep out of the reach of children’ under Warnings. I must not omit to inform you that according to Law 8220, the procedure will remain pending a response to this official letter and that you have a maximum of 10 days for this purpose.” (fact deemed proven no. 11). Although the plaintiff, by note of November 25, 2008, opposed the requirement, she did not comply with what was requested, a situation that was notified to her on July 30, 2009, by official letter DAC-1970-09-RM (fact deemed proven 17). Said resolution, as has been noted, consisted of a series of informational corrections to the artwork of the product to be marketed. Thus, it is not observed that official letter DRC-4046-08-R (a requirement that was not fulfilled) exceeded the powers conferred by law on the Ministry in question. Nor was precept 114 of the LGS violated, since said numeral only establishes the term of validity of the registration, a topic on which the MS did not issue any opinion, a circumstance which, moreover, has not been the subject of examination in this proceeding. Additionally, the cited mandate mentions: “The registration of any medication shall last five years, unless the infractions in its manufacture, commerce, or use incurred by its holder, or demonstrative experiences that the product is unsafe or ineffective under the terms in which it was authorized and registered, make its cancellation or the corresponding modification appropriate.” As can be observed, the norm limits the validity period to five years, which could be even shorter if the exception scenarios provided therein were to occur. In the case at hand, it is clear the MS has not issued any act that limits the validity period of the product's registration; on the contrary, it was facing a renewal application upon expiration, hence no violation of the norm in question is observed. For its part, mandate 15 of the RICPRNICM mentions the requirements that must accompany the requested renewal, among them, the respective application, a sworn declaration from the legal representative that the registration conditions have not changed, the product label as it is being marketed, proof of payment for the registration fee, and a valid operating permit. The appellant considers that by requesting modifications to the mixture, the MS violated said norm, given that it formulated demands beyond the powers conferred upon it by law.\n\nThis position is not shared by this decision-making body (órgano decisor), for, it is reiterated, the right to health of the population has its origin in the Fundamental Charter (Carta Fundamental). Likewise, the General Health Law (Ley General de Salud, LGS) itself confers powers upon the governing body of the health sector so that, among other things, it may request extensive information from the applicant (gestionante), all with the aim of protecting the right to health. Thus, it is not possible to interpret that in the specific case, the Ministry of Health (Ministerio de Salud, MS) was limited to the simple receipt of the documents required by precept 15 of the RICPRNICM. On the contrary, in the face of new information about the uses of the product; and even in case of doubt about the qualities of the proposed mixture, it could perfectly well request new information or the modifications that it deemed pertinent along those lines, all in application of higher principles constitutionally established and powers legally granted, in order to guarantee the fundamental right to health. For the reasons stated, the objection must be rejected.\n\n**VIII.** In the third objection, it claims that official letters (oficios) DRC-2640-08-R, DRC-4046-08-R, DAC-0068-09-RM, and DAC-1301-09-RM are absolutely null, since they lack essential elements of validity. The plaintiff (actora) highlights, in turn, that those documents lack motivation. It states that the act (acto) DRC-2640-08-R indicates that Ginseng (Ginseng) played no role in the mixture, without justifying the reason for it. For its part, it argues, official letter (oficio) DRC-4046-08-R invokes as grounds canons 157 of the General Law of Public Administration (Ley General de la Administración Pública, LGAP) and 114 of the General Health Law (LGS), even though no material error had been presented nor was it a situation involving a cancellation and/or modification of a registration. It asserts that official letter (oficio) DAC-0068-09-RM evaluates the request for an extension as if it were an initial registration, without stating the reason for it. The document DAC-1301-09-RM, it argues, makes reference to 25 bibliographic citations from Lexi Drugs (Lexi Drugs), which are not in the bibliography recommended by the Ministry of Health (MS) nor were they presented to the case file. In this regard, this Chamber (Sala) observes that, although the appellant (casacionista) considers that the referenced acts lack elements of validity, pointing out some of the possible flaws that lead her to that conclusion, it is unquestionable that the objection omits to attack the grounds of the ruling under appeal. Although it mentions aspects that from that viewpoint justify its thesis regarding the limitations and nullity of a series of administrative acts, the reasons that would make it possible to establish the violation incurred by the judges in their resolution are not actually indicated. Indeed, no reference is made to the judgment or to the errors into which the adjudicators might have fallen. Consequently, although it expresses a series of general and merely argumentative disagreements, the contrast between what was decided and the infractions that, in its opinion, took place is omitted, which is why the objection is not admissible, a circumstance that requires its rejection.\n\n**IX.** In the fourth ground, the appellant (recurrente) alleges an infringement of the constitutional principles of legal certainty and legality. However, in the opinion of this Chamber (Cámara), as indicated in recital (considerando) VII of this resolution, the thesis argued by the Trial Court (Tribunal) regarding the existence of a fundamental right to health is incontestable. It is not, as the appellant (casacionista) presents it, a simple argumentation in order to justify that the party be asked for \"whatever occurs to them,\" but rather the exercise of a power/duty, established among others by norms 1, 2, 112, and 119 of the General Health Law (LGS), which, in compliance with that basic principle of the social state of law, as well as those of legality, public safety, reasonableness (razonabilidad), and good faith, obligate the requiring of modifications and the requesting of all information that is deemed convenient for that purpose. There is, of course, no violation of the principle of legitimate expectations, nor of the so-called principle of the intangibility of one's own acts, since it is evident that we are dealing with a review, which, beyond being discretionary (potestativa), is also mandatory, without setting aside the fact that the authorization of the registration for the first time cannot be considered the consolidation of a subjective right that prevents subsequent reviews of the therapeutic conditions of the mixture to be marketed. Although the appellant (casacionista) attributes that the Trial Court bases its ruling on the alleged non-compliance with what was required in official letter (oficio) CRC-4046-08-R, without noticing that said act was challenged; in the terms set forth in recital (considerando) VII, no violation of the constitutional principles of legal certainty and legality is observed, since what was requested in act (acto) CRC-4046-08-R was nothing more than a warning (prevención) so that some modifications be made to the labels (artes), a requirement that, according to the basis provided in recital (considerando) VII of this judgment, is far from an arbitrary act. Thus, the objection must be dismissed." }