{"id":5094,"date":"2023-12-16T16:16:02","date_gmt":"2023-12-16T21:16:02","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=5094"},"modified":"2026-01-27T12:53:26","modified_gmt":"2026-01-27T17:53:26","slug":"pharmaceutical-labeling-bolivia-peru","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/pharmaceutical-labeling-bolivia-peru\/","title":{"rendered":"Aspectos regulatorios que deben tenerse en cuenta para la armonizaci\u00f3n del etiquetado de productos farmac\u00e9uticos en Bolivia y Per\u00fa."},"content":{"rendered":"

Q.F. Idaly Jazminy Morote Guzm\u00e1n<\/em><\/strong>
\n<\/i><\/b>QA Specialist & Biologics and Drug Regulatory Affairs Coordinator<\/em><\/strong>
\n<\/i><\/b>SCR Consultores Peru<\/i><\/b><\/p>\n

Q.F. Mary Carmen Chuquimia Socpaza<\/em><\/strong>
\n<\/i><\/b>Quality Specialist & Regulatory Affairs Coordinator<\/em><\/strong>
\n<\/i><\/b>SCR Consultores Bolivia<\/i><\/b><\/p>\n

La Red Panamericana para la Armonizaci\u00f3n de la Regulaci\u00f3n de Medicamentos (PANDRH), integrada por las Autoridades Reguladoras de Medicamentos de 35 Estados Miembros y representantes de la Federaci\u00f3n Latinoamericana de la Industria Farmac\u00e9utica (FIFARMA) y la Asociaci\u00f3n Latinoamericana de Industrias Farmac\u00e9uticas (ALIFAR), como asociaciones regionales de la Industria Farmac\u00e9utica de las Am\u00e9ricas, promueve la iniciativa de armonizaci\u00f3n regional desde noviembre de 1997, con la primera Conferencia Panamericana sobre Armonizaci\u00f3n de la Regulaci\u00f3n de Medicamentos<\/strong><\/em>, que se estableci\u00f3 oficialmente en noviembre de 1999, durante la Segunda Conferencia; su prop\u00f3sito es la b\u00fasqueda de bases comunes dentro del marco de las Normas Internacionales reconocidas, tomando en consideraci\u00f3n las diferencias en las realidades pol\u00edticas, sanitarias y legislativas de los pa\u00edses de las Am\u00e9ricas.<\/p>\n

Bolivia, a trav\u00e9s de la \u201cAgencia Estatal de Medicamentos y Tecnolog\u00edas en Salud\u201d (AGEMED), como miembro del PANDRH, reconoce el Documento T\u00e9cnico No. 10: Requisitos para el Registro de Medicamentos en las Am\u00e9ricas y, por lo tanto, adopta en parte la informaci\u00f3n sobre el etiquetado que contiene dicho documento.<\/p>\n

Per\u00fa, a trav\u00e9s de Decreto Legislativo N.\u00ba 016-2011-SA y sus modificaciones: Reglamento para el registro, control y vigilancia sanitaria de productos farmac\u00e9uticos, dispositivos m\u00e9dicos y productos sanitarios. <\/em>Establece los requisitos para el etiquetado primario y secundario de especialidades farmac\u00e9uticas (medicamentos sintetizados qu\u00edmicamente), que se consideran dentro de la clasificaci\u00f3n de Medicamentos y estos a su vez, de la clasificaci\u00f3n de Productos Farmac\u00e9uticos, mientras que el presente texto, cuando se refiere a Productos Farmac\u00e9uticos para Per\u00fa, se enmarcar\u00e1 en los requisitos de productos farmac\u00e9uticos.<\/p>\n

Este art\u00edculo ofrece una visi\u00f3n general de los requisitos relativos a la regulaci\u00f3n del etiquetado de productos farmac\u00e9uticos en Per\u00fa y Bolivia, para su registro y comercializaci\u00f3n, que permiten la armonizaci\u00f3n, de acuerdo con el Reglamento peruano. D.S. No. 016-2011-SA<\/em><\/strong> y sus modificaciones: Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos de Salud y el Reglamento Boliviano con Ley N\u00b0 1737: Ley de Medicamentos y Decreto N\u00b0 25235: Reglamento de la Ley de Medicamentos<\/em><\/strong>.<\/em><\/p>\n

A continuaci\u00f3n se presenta una tabla comparativa que muestra la informaci\u00f3n que debe incluirse en las etiquetas de los productos farmac\u00e9uticos en Per\u00fa y\/o Bolivia que se venden con receta m\u00e9dica, de acuerdo con la normativa vigente en cada pa\u00eds.<\/p>\n

Tabla N\u00b0 01:<\/strong><\/p>\n

Informaci\u00f3n que debe incluirse en el etiquetado secundario de los productos farmac\u00e9uticos vendidos con receta m\u00e9dica:<\/strong><\/span><\/p>\n

\"\"<\/p>\n

La informaci\u00f3n para el etiquetado primario de los productos farmac\u00e9uticos vendidos con receta m\u00e9dica debe ser la siguiente, de acuerdo con la normativa vigente en cada pa\u00eds:<\/p>\n

Tabla N\u00b0 02:<\/strong><\/p>\n

Informaci\u00f3n que debe incluirse en el etiquetado primario de los productos farmac\u00e9uticos que se venden con receta m\u00e9dica:<\/strong><\/p>\n

\"\"<\/p>\n

La siguiente informaci\u00f3n debe incluirse en el etiquetado de los envases vendidos sin receta m\u00e9dica, de conformidad con la normativa vigente en cada pa\u00eds:<\/p>\n

Tabla n\u00ba 03:<\/strong><\/p>\n

Informaci\u00f3n que debe incluirse en el etiquetado de los productos farmac\u00e9uticos que se venden sin receta m\u00e9dica:<\/strong><\/p>\n

\"\"<\/p>\n

A continuaci\u00f3n se presentan algunas consideraciones comparativas que deben tenerse en cuenta para el etiquetado en cada uno de estos pa\u00edses, seg\u00fan R.M. No. 909: Manual para el Registro Sanitario en Bolivia y D.S. No. 016-2011-SA y sus modificaciones: Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos de Salud<\/em>, en Peru:<\/p>\n

En general, AGEMED aceptar\u00e1 etiquetas o dise\u00f1os, con leyendas en varios idiomas siempre que uno de ellos sea espa\u00f1ol seg\u00fan la secci\u00f3n 2.7.1. Punto C del Manual para Registro Sanitario. Mientras que la \u201cDirecci\u00f3n de Medicamentos, Insumos y Drogas\u201d (DIGEMID) acepta etiquetas en espa\u00f1ol y adem\u00e1s se pueden agregar otros idiomas siempre que correspondan a la informaci\u00f3n presentada en el registro sanitario del producto, de acuerdo con las disposiciones de Art\u00edculo n.\u00ba 17 del Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmac\u00e9uticos, Dispositivos M\u00e9dicos y Productos Sanitarios.<\/em><\/p>\n

In the case of imported products that due to the volume destined to Bolivia cannot include the Sanitary Registration number from the origin, it is accepted under the company’s responsibility, the use of a sticker or printed seal that includes the Number and year of the Sanitary Registration in Bolivia according to secci\u00f3n 2.7.1. Punto E del Manual para el Registro Sanitario<\/em>. While the DIGEMID in Peru indicates that labels (stickers) may not be attached to correct or add information, except for importer’s data or any express indication by the authority, information may be added on the labeling whose printing (printed seal) must be clear, legible and indelible.<\/p>\n

En Bolivia, para los productos importados, se aceptar\u00e1n las leyendas autorizadas por la Autoridad Reguladora de Medicamentos del pa\u00eds de origen, siempre que la diferencia con el est\u00e1ndar nacional no constituya un riesgo para la salud seg\u00fan Secci\u00f3n 2.7.1. Punto H del Manual de Registro Sanitario<\/em>. Si bien el DIGEMID en Per\u00fa no acepta la inclusi\u00f3n de informaci\u00f3n adicional que no haya sido previamente aprobada o comunicada.<\/p>\n

De la evaluaci\u00f3n antes mencionada, se puede concluir que, si bien existen puntos divergentes entre las autoridades de Bolivia y Per\u00fa, hay puntos en com\u00fan que las empresas pueden utilizar para gestionar el mismo etiquetado para ambos pa\u00edses y armonizarlo de acuerdo con las regulaciones, lo que apoyar\u00eda una mejor log\u00edstica en la distribuci\u00f3n de productos farmac\u00e9uticos.<\/p>","protected":false},"excerpt":{"rendered":"

Q.F. Idaly Jazminy Morote Guzm\u00e1n QA Specialist & Biologics and Drug Regulatory Affairs Coordinator SCR Consulting Peru Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consultores Bolivia The Pan American Network for Drug Regulatory Harmonization (PANDRH), made up of the Drug Regulatory Authorities of 35 Member States and representatives of the […]<\/p>\n","protected":false},"author":4,"featured_media":5082,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,87],"tags":[],"class_list":["post-5094","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-regulatory-affairs"],"yoast_head":"\nPharmaceutical Labeling in Bolivia vs Peru: Key Requirements<\/title>\n<meta name=\"description\" content=\"Compare AGEMED and DIGEMID labeling requirements for pharmaceutical products in Bolivia and Peru, including Spanish language rules, stickers and mandatory label content.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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