{"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":"<p><span style=\"font-weight: 400;\">Autora: Q.F. Ana Susana Rojas Avalos<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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 cited in Supreme Decree 016-2011-SA and its amendments: \u201cRegulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products\u201d, through Annex N\u00b0 01 \u201cGlossary of Terms and definitions\u201d.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">According to Law N\u00b0 29459 \u201cLaw of Pharmaceutical Products, Medical Devices and Health Products\u201d, the sanitary registration of a product entitles its holder to manufacture, import, store, distribute, commercialize, promote, dispense, sell or use them, in the conditions established in this Regulation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">Currently, the application of registration is made electronically, through the Single Window for Foreign Trade (VUCE), available on the website of the Ministry of Foreign Trade \u2013 MINCETUR, for this purpose, the applicant must have the Sanitary Authorization in force as a Pharmaceutical Establishment (Laboratory or Drugstore), granted by the same DIGEMID.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Then, the requirements for obtaining the Sanitary Registration of dietetic products are mentioned, which are established through Supreme Decree 016-2017-SA, which modified the initial Article 93\u00b0 of the \u201cRegulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products\u201d, these are presented with a brief commentary with recommendations to present some of the requirements for the registration of this type of products:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">\u2013 Qualitative and quantitative formula, which must be declared in units of weight or volume of the metric system or in recognized international units, including all excipients and solvents, even if the solvents disappear in the manufacturing process.<br \/>\n<\/span><span style=\"font-weight: 400;\">\u2013 In addition, the Peruvian standard also mentions that, for these products, if the active ingredient is found in the form of salt or hydrate, but is active as a base, acid or anhydrous, the amount of both presentations of the active ingredient must be declared.<br \/>\n<\/span><span style=\"font-weight: 400;\">\u2013 Technical references, whether pharmacopoeia or in-house, both of the active ingredient(s) as well as of the excipients.<br \/>\n<\/span><span style=\"font-weight: 400;\">\u2013 The type of primary and secondary packaging.<br \/>\n<\/span><span style=\"font-weight: 400;\">\u2013 The primary and secondary packaging material.<br \/>\n<\/span><span style=\"font-weight: 400;\">\u2013 Forms of product presentation.<br \/>\n<\/span><span style=\"font-weight: 400;\">\u2013 The lot code system, with which the dietetic product will be imported into Peru.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">2. Technical specifications of the finished product; if the product has as reference \u201cin-house\u201d, the Peruvian standard for these products does not request the validation of the analytical technique to be attached.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">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<p class=\"translation-block\">- 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<br>\n- Recomendaciones para uso o aplicaci\u00f3n.\n<br>\n- Consignar \u201cComplemento o Suplemento diet\u00e9tico\u201d o \u201cSuplemento nutricional\u201d.\n<br>\n- Incluir la advertencia de no superar la dosis diaria expresamente recomendada para productos\ndiet\u00e9ticos.<br>\n- La afirmaci\u00f3n expresa de que los productos diet\u00e9ticos no deben utilizarse como sustituto de una\ndieta equilibrada.<\/p>\n<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">6. Certificate of Good Manufacturing Practices (GMP) of the manufacturer. In the case of products manufactured in Peru, which have an in force GMP issued by DIGEMID, it will be sufficient to consign the number of the manufacturer\u2019s GMP certificate issued by DIGEMID.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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<p class=\"translation-block\">- CPPcomo equivalente de Certificado de BPM, no de CLV.<br>\n- Oficio de Certificaci\u00f3n.<br>\n- Certificados ISO.<br>\n- Certificados HACCP.<br>\n- Attestation for exportation.<br>\n- Certificado de Manufactura y Libre Venta.<\/p>\n<p><span style=\"font-weight: 400;\">Additionally, for the sanitary registration of dietetic products in Peru, it is important to keep in mind that vitamins, minerals and other nutrients approved by the DIGEMID can be used in their manufacture, through the list that is published and updated periodically, which according to the regulations is based on lists approved by High Sanitary Surveillance Countries. For reference, it is mentioned that the last updated and published document in Peru for this point is the one approved through Directorial Resolution N\u00b0 025-2022-DIGEMID-DG-MINSA \u201cList of Vitamins, Minerals and Other Nutrients Permitted in the Manufacture of Dietetic Products\u201d.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">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<p><span style=\"font-weight: 400;\">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<p><br style=\"font-weight: 400;\" \/><br style=\"font-weight: 400;\" \/><\/p>","protected":false},"excerpt":{"rendered":"<p>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 [&hellip;]<\/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":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dietetic 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\" 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