{"id":4901,"date":"2024-09-06T11:41:12","date_gmt":"2024-09-06T16:41:12","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=4901"},"modified":"2026-01-27T11:12:14","modified_gmt":"2026-01-27T16:12:14","slug":"dietetic-products-sanitary-registration-peru-digemid","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/dietetic-products-sanitary-registration-peru-digemid\/","title":{"rendered":"Consideraciones Regulatorias en los Requisitos del RS de los Productos Diet\u00e9ticos en Per\u00fa."},"content":{"rendered":"

Autora: Q.F. Ana Susana Rojas Avalos<\/span><\/p>\n

El Producto Diet\u00e9tico es aquel producto cuyo prop\u00f3sito es complementar la dieta normal que consiste en\nfuentes concentradas de nutrientes o de otras sustancias que tengan un efecto nutricional o fisiol\u00f3gico, en\nforma simple o combinada y dosificada. Y que solo se emplean por v\u00eda oral, de acuerdo a la definici\u00f3n\ncitada en el Decreto Supremo 016-2011-SA y sus modificatorias: \u201cReglamento para el Registro, Control y\nVigilancia Sanitaria de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos Sanitarios\u201d, a trav\u00e9s\ndel Anexo N\u00b0 01 \u201cGlosario de T\u00e9rminos y definiciones\u201d.<\/span><\/p>\n

Es importante mencionar, que, si bien los productos diet\u00e9ticos no poseen una acci\u00f3n farmacol\u00f3gica, se\nencuentran clasificados como Productos Farmac\u00e9uticos; por tanto, la competencia de su registro sanitario\nes de la Direcci\u00f3n General de Medicamentos, Insumos y Drogas (DIGEMID), como entidad peruana\nreguladora de estos medicamentos.<\/span><\/p>\n

De acuerdo a la Ley N\u00b0 29459 \u201cLey de los Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y\nProductos Sanitarios\u201d, el registro sanitario de un producto faculta a su titular para la fabricaci\u00f3n,\nimportaci\u00f3n, almacenamiento, distribuci\u00f3n, comercializaci\u00f3n, promoci\u00f3n, dispensaci\u00f3n, expendio o\nuso de los mismos, en las condiciones que establece el presente Reglamento.<\/span><\/p>\n

El Decreto Supremo 016-2011-SAy sus modificatorias, mencionado ya anteriormente, establece que\nel registro sanitario de los productos diet\u00e9ticos se otorga por nombre, forma farmac\u00e9utica, cantidad\nde Ingrediente Activo (expresado en unidad de dosis o concentraci\u00f3n), fabricante y pa\u00eds. Siendo que\nla DIGEMID, otorga el registro sanitario con una vigencia de cinco a\u00f1os, contados desde la fecha de\nautorizaci\u00f3n del registro sanitario, el cual puede ser renovado por per\u00edodos iguales y sucesivos.<\/span><\/p>\n

Actualmente, la solicitud de registro se realiza en forma electr\u00f3nica, a trav\u00e9s de la Ventanilla \u00danica de\nComercio Exterior (VUCE), disponible en la p\u00e1gina web del Ministerio de Comercio Exterior\n\u2013MINCETUR, para tal fin, el solicitante debe contar obligatoriamente con la Autorizaci\u00f3n Sanitaria\nvigente como Establecimiento Farmac\u00e9utico (Laboratorio o Droguer\u00eda), otorgada por la misma\nDIGEMID.<\/span><\/p>\n

Acontinuaci\u00f3n, se mencionan los requisitos para la obtenci\u00f3n del Registro Sanitario de los productos\ndiet\u00e9ticos, los cuales est\u00e1n establecidos a trav\u00e9s del Decreto Supremo 016-2017-SA, que modific\u00f3 al\ninicial Art\u00edculo 93\u00b0 del \u201cReglamento para el Registro, Control y Vigilancia Sanitaria de Productos\nFarmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos Sanitarios\u201d, estos se presentan con un breve\ncomentario con recomendaciones para presentar algunos de los requisitos del registro de este tipo\nproductos:<\/span><\/p>\n

1. Solicitud con car\u00e1cter de declaraci\u00f3n jurada; dentro de la declaraci\u00f3n jurada para la solicitud del\nregistro sanitario, se solicitan datos t\u00e9cnicos que se deber\u00e1n requerir al fabricante del producto\ndiet\u00e9tico, o extraer del dossier t\u00e9cnico, sin considerar esta informaci\u00f3n como requisito documentario\npara adjuntar, entre estos datos t\u00e9cnicos se pueden mencionar a los siguientes:<\/span><\/p>\n

- F\u00f3rmula cualitativa y cuantitativa, la cual deber\u00e1 declararse expresada en unidades de peso o\nvolumen del sistema m\u00e9trico decimal o en unidades internacionales reconocidas, incluyendo todos\nlos excipientes y disolventes, aunque los disolventes desaparezcan en el proceso de fabricaci\u00f3n.
\n<\/span>Adem\u00e1s, la norma peruana menciona tambi\u00e9n que, para estos productos, si el ingrediente activo se\nencuentra bajo la forma de sal o hidrato, pero es activo como base, \u00e1cido o anhidro, debe\ndeclararse la cantidad de ambas presentaciones del ingrediente activo.
\n<\/span>- Las referencias t\u00e9cnicas, sean farmacopeicas o propias, tanto del o los ingredientes activos, as\u00ed\ncomo de los excipientes.
\n<\/span>- El tipo del envase mediato e inmediato.
\n<\/span>- El material del envase mediato e inmediato.
\n<\/span>- Las formas de presentaci\u00f3n del producto.
\n<\/span>- El sistema del c\u00f3digo de lote, con el que el producto diet\u00e9tico ser\u00e1 importado a Per\u00fa.<\/span><\/p>\n

2. Especificaciones t\u00e9cnicas del producto terminado; si el producto tiene como referencia \u201ct\u00e9cnica\npropia\u201d, la norma peruana para estos productos, no solicita que se adjunte la validaci\u00f3n de la t\u00e9cnica\nanal\u00edtica.<\/span><\/p>\n

3. Estudios de estabilidad o documento emitido por el fabricante que sustente la vida \u00fatil del producto;\nsiendo actualmente aceptable, incluir una carta de fabricante debidamente firmada, en donde se\ndetalle los datos del producto diet\u00e9tico, mencionando el tiempo de vida \u00fatil, as\u00ed como las condiciones\nde almacenamiento y detallando el sistema envase cierre del producto diet\u00e9tico.<\/span><\/p>\n

4. Proyecto de rotulado en idioma espa\u00f1ol del envase, mediato e inmediato; teniendo en cuenta que\npara este requisito se debe considerar primordialmente que \u00e9stos, no deben consignar propiedades\nde prevenci\u00f3n, tratamiento o cura de una enfermedad, as\u00ed como tampoco im\u00e1genes que induzcan a\nun uso inapropiado. La informaci\u00f3n general que debe considerarse en el rotulado mediato e\ninmediato de los productos diet\u00e9ticos, est\u00e1 contemplada en el Art\u00edculo 96\u00b0 del Decreto Supremo 016-\n2011-SAy sus modificatorias. Podemos equiparar la informaci\u00f3n demandada para las especialidades\nfarmac\u00e9uticas, considerando algunas diferencias espec\u00edficas para el rotulado mediato en este tipo de\nproductos:<\/span><\/p>\n

- La dosificaci\u00f3n del producto recomendada para consumo diario (para productos diet\u00e9ticos), para lo\ncual es importante la tabla de ingesta de referencia dietaria (Dietary Reference Intakes) o los limites\nconsiderados en pa\u00edses de alta vigilancia sanitaria para este tipo de productos. Se puede\nmencionar que, este dato se convierte en motivo de observaciones por parte de la DIGEMID,\nsiendo que la autoridad regulatoria resguarda apropiadamente que los componentes no sean\nusados por encima de los l\u00edmites permitidos, puesto que podr\u00edan generar un efecto no deseado.\n
\n- Recomendaciones para uso o aplicaci\u00f3n.\n
\n- Consignar \u201cComplemento o Suplemento diet\u00e9tico\u201d o \u201cSuplemento nutricional\u201d.\n
\n- Incluir la advertencia de no superar la dosis diaria expresamente recomendada para productos\ndiet\u00e9ticos.
\n- La afirmaci\u00f3n expresa de que los productos diet\u00e9ticos no deben utilizarse como sustituto de una\ndieta equilibrada.<\/p>\n

Si bien el proyecto de inserto no es un requisito obligatorio para los productos diet\u00e9ticos, la normativa\nperuana establece, que en caso no se pueda incluir toda la informaci\u00f3n que se demanda en el rotulado\nmediato, se debe contemplar incluirla en un inserto adjunto, exceptuando el nombre del producto,\nnombre y pa\u00eds del laboratorio fabricante, n\u00famero de lote, n\u00famero de registro sanitario y fecha de\nvencimiento.<\/span><\/p>\n

5. Certificado de libre comercializaci\u00f3n (CLV) emitido por la Autoridad competente del pa\u00eds de origen o\ndel exportador. Si bien la norma menciona que debe considerarse un CLV que preferiblemente siga el\nmodelo de la OMS, la autoridad reguladora peruana, no est\u00e1 discriminando otros modelos. Sin\nembargo, es importante, considerar que, si en el CLV no se consigna la f\u00f3rmula del producto o nombre\ndel producto a comercializar en el Per\u00fa, se debe presentar una carta del fabricante, que incluya el\nnombre del producto a comercializar en el pa\u00eds y\/o composici\u00f3n cualitativa y cuantitativa del producto.<\/span><\/p>\n

6. Certificado de Buenas Pr\u00e1cticas de Manufactura (BPM) del fabricante. Para el caso de productos\nfabricados en el Per\u00fa, que cuenten con BPM vigente emitido por la DIGEMID, bastar\u00e1 con consignar el\nn\u00famero de certificado de BPM del fabricante emitido por la DIGEMID.<\/span><\/p>\n

Dentro de los documentos equivalentes al Certificado de BPM, para el caso en que el solicitante desee\nregistrar un producto diet\u00e9tico, de un fabricante, cuyo pa\u00eds no emite certificado de BPM, se deben\nconsiderar a los siguientes:<\/span><\/p>\n

- CPPcomo equivalente de Certificado de BPM, no de CLV.
\n- Oficio de Certificaci\u00f3n.
\n- Certificados ISO.
\n- Certificados HACCP.
\n- Attestation for exportation.
\n- Certificado de Manufactura y Libre Venta.<\/p>\n

Adicionalmente, para el registro sanitario de los productos diet\u00e9ticos en Per\u00fa, es importante tener\npresente que en su fabricaci\u00f3n puede emplearse vitaminas, minerales y otros nutrientes aprobados\npor la DIGEMID, a trav\u00e9s del listado que se publica y actualiza peri\u00f3dicamente, el cual de acuerdo a lo\nque se\u00f1ala la normativa se basa en listados aprobados por los pa\u00edses de alta vigilancia sanitaria. Para\nreferencia, se menciona que el \u00faltimo documento actualizado y publicado en Per\u00fa para este punto, es\nel aprobado a trav\u00e9s de la Resoluci\u00f3n Directoral N\u00b0 025-2022-DIGEMID-DG-MINSA \u201cListado de\nVitaminas, Minerales y Otros Nutrientes Permitidos en la Fabricaci\u00f3n de Productos Diet\u00e9ticos.<\/span><\/p>\n

Para el caso de productos diet\u00e9ticos que contengan vitaminas, minerales y\/u otros nutrientes que no\nse encuentren en la lista establecida por la DIGEMID, el Decreto Supremo 016-2011-SA y sus\nmodificatorias, establece que el solicitante deber\u00e1 presentan adicionalmente informaci\u00f3n cient\u00edfica\nque justifique el empleo de tales materias primas, sustentando debidamente su seguridad y eficacia.<\/span><\/p>\n

Adem\u00e1s, la normativa peruana para productos diet\u00e9ticos tambi\u00e9n recoge que estos productos se\npueden combinar con recursos naturales de origen vegetal, animal y\/o mineral que tengan\npropiedades nutricionales.<\/span><\/p>\n

Por \u00faltimo, es importante mencionar que la evaluaci\u00f3n de los productos diet\u00e9ticos se da en un tiempo\nmenor, comparando su evaluaci\u00f3n con el de las especialidades farmac\u00e9uticas; as\u00ed el Decreto\nSupremo 016-2017-SA, se\u00f1ala que debe darse en 30 d\u00edas, aunque en la pr\u00e1ctica puede convertirse\nen un mayor tiempo, dependiendo de si la solicitud de registro sanitario presenta observaciones.<\/span><\/p>\n

En resumen, la gesti\u00f3n regulatoria de productos diet\u00e9ticos debe tener en cuenta que en Per\u00fa, la\naplicaci\u00f3n de los requisitos de registro tiene consideraciones particulares que buscan responder a la\nmisma definici\u00f3n de productos diet\u00e9ticos seg\u00fan la normativa peruana as\u00ed como a su adaptaci\u00f3n al\ncontexto regulatorio internacional de este tipo de productos, los cuales no son siempre clasificados\ncomo productos farmac\u00e9uticos en todos los pa\u00edses, sino que tambi\u00e9n est\u00e1n incluidos en otras\ncategor\u00edas de productos regulados por las autoridades de salud.<\/span><\/p>\n



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Author: Q.F. Ana Susana Rojas Avalos The Dietetic Product is that product whose purpose is to supplement the normal diet consisting of concentrated sources of nutrients or other substances that have a nutritional or physiological effect, in simple or combined and dosed form. And that are only used for oral use, according to the definition […]<\/p>\n","protected":false},"author":4,"featured_media":4922,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46],"tags":[],"class_list":["post-4901","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"\nDietetic Products in Peru: DIGEMID Sanitary Registration Requirements and Timelines<\/title>\n<meta name=\"description\" content=\"Learn how to obtain sanitary registration for dietetic products in Peru with DIGEMID: VUCE submission, key documents (FSC, GMP, stability, artworks) and 5-year validity.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/scrconsultings.com.dream.website\/dietetic-products-sanitary-registration-peru-digemid\/\" \/>\n<meta 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