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Modifican el “Listado de Documentos Considerados Equivalentes al Certificado de Buenas Prácticas de Manufactura”

RESOLUCIóN DIRECTORAL

N° 121-2026-DIGEMID-DG-MINSA

Lima, 5 de agosto de 2026

VISTO,

la Nota Informativa N° D000292-2026-DIGEMID-DICER-MINSA de la Dirección de Inspección y Certificación de la Dirección General de Medicamentos, Insumos y Drogas; y,

CONSIDERANDO,

Que, el artículo 5 de la Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, dispone que la Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM), es la entidad responsable de proponer políticas, y dentro de su ámbito, normar, regular, evaluar, ejecutar, controlar y supervisar, vigilar, auditar, certificar y acreditar en temas relacionados a lo establecido en dicha norma;

Que, el artículo 84 del Reglamento de Organización y Funciones del Ministerio de Salud, aprobado mediante Decreto Supremo N° 008-2017-SA, establece que la Dirección General de Medicamentos, Insumos y Drogas es el órgano de línea del Ministerio de Salud, dependiente del Viceministerio de Salud Pública, constituye la ANM a que hace referencia la Ley N° 29459 antes invocada, siendo la autoridad técnico normativa a nivel nacional y sectorial, responsable de proponer la regulación y normar dentro de su ámbito, así como evaluar, ejecutar, controlar, fiscalizar, supervisar, vigilar, auditar, certificar y acreditar en temas relacionados a lo establecido en la citada Ley N° 29459;

Que, de acuerdo con lo dispuesto en el artículo 5 del Decreto Supremo N° 012-2023-SA, por el que se dictan disposiciones referidas al Certificado de Buenas Prácticas de Manufactura para la inscripción y reinscripción en el registro sanitario y en la importación de productos farmacéuticos, la ANM aprueba por Resolución Directoral el listado de documentos considerados equivalentes al certificado de Buenas Prácticas de Manufactura;

Que, mediante Resolución Directoral N° 063-2026-
DIGEMID-DG-MINSA, se aprobó el “Listado de Documentos Considerados Equivalentes al Certificado de Buenas Prácticas de Manufactura”;

Que, con documento de visto, la Dirección de Inspección y Certificación en relación a la Nota Informativa N° 06-2026-DIGEMID-DG-CENADIM/MINSA que contiene el Informe N° 01-2026-DIGEMID-EA-CENADIM-FHC/MINSA del Centro Nacional de Documentación e Información de Medicamentos (CENADIM) de la Dirección General de Medicamentos, Insumos y Drogas, emite opinión técnica favorable para la reincorporación del Certificado de Producto Farmacéutico (CPP) emitido por la Agencia Europea de Medicamentos (EMA) como documento equivalente al Certificado de Buenas Prácticas de Manufactura (BPM), al no haberse identificado evidencia técnica, científica o normativa que justifique su exclusión ni que demuestre la existencia de un documento que lo sustituya para los mismos fines regulatorios;

Estando a lo antes expuesto, con la conformidad de la Dirección de Inspección y Certificación; y,

De conformidad con lo dispuesto en la Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, el Decreto Supremo N° 012-2023-SA por el que se dictan disposiciones referidas al Certificado de Buenas Prácticas de Manufactura para la inscripción y reinscripción en el registro sanitario y en la importación de productos farmacéuticos, y el Reglamento de Organización y Funciones del Ministerio de Salud aprobado por Decreto Supremo N° 008-2017-SA;

SE RESUELVE:

Artículo 1.- Modificar el “Listado de Documentos Considerados Equivalentes al Certificado de Buenas Prácticas de Manufactura” aprobado por la Resolución Directoral N° 063-2026-DIGEMID-DG-MINSA, cuyo Anexo forma parte integrante de la presente Resolución, conservando los demás extremos que contiene.

Artículo 2.- Los procedimientos administrativos que se encuentren en trámite a la entrada en vigencia de la Resolución Directoral N° 063-2026-DIGEMID-DG-MINSA se rigen por lo dispuesto en el artículo 1 de la presente resolución

Artículo 3.- Publicar la presente Resolución en el Diario Oficial “El Peruano” y en la sede digital del Ministerio de Salud (www.gob.pe/minsa).

Regístrese y publíquese.

LIDA ESTHER HILDEBRANDT PINEDO

Directora General

Dirección General de Medicamentos,

Insumos y Drogas

ANEXO

Listado de Documentos Considerados Equivalentes al Certificado de Buenas Prácticas de Manufactura

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

\n DOCUMENTO \n	\n AUTORIDAD O ENTIDAD COMPETENTE \n QUE EMITE EL DOCUMENTO \n	\n PAIS DE PROCEDENCIA EN LA AUTORIDAD O ENTIDAD QUE EMITE EL DOCUMENTO \n
\n Certificado de Producto Farmacéutico (indicando el cumplimiento de Buenas Prácticas de Manufactura y sólo avala al producto farmacéutico para el cual fue emitido). \n	\n 1) Autoridades de Países de Alta Vigilancia Sanitaria. \n 2) National Medical Products Administration (NMPA) o de los Departamentos regulatorios locales de la NMPA. \n 3) European Medicines Agency (EMA por sus siglas en inglés). \n	\n 1) Países de Alta Vigilancia Sanitaria. \n 2) República Popular China. \n 3) Países de la Unión Europea. \n
\n Certificado de Buenas Prácticas de Manufactura obtenido de la base de datos EudraGMDP (para productos Farmacéuticos, cuya autenticidad puedan ser verificados en la base de datos EudraGMDP). \n	\n Autoridades de Países de Alta Vigilancia Sanitaria. \n	\n Países de Alta Vigilancia Sanitaria. \n
\n Certificado de Buenas Prácticas de Manufactura obtenido de la base de datos MHRA-GMDP (para productos Farmacéuticos, cuya autenticidad puedan ser verificados en la base de datos MHRA-GMDP). \n	\n Medicines and Healthcare products Regulatory Agency (MHRA). \n	\n Reino Unido. \n
\n Oficio de Certificación (Para productos Farmacéuticos). \n	\n Comisión Federal para la Protección Contra Riesgos sanitarios - COFEPRIS \n	\n México. \n
\n Certificados ISO cuyo alcance esté referido a la fabricación de productos dietéticos y edulcorantes. \n	\n Entidades certificadoras acreditadas reconocidas por organismos de acreditación internacional. \n	\n Todos los países. \n
\n Certificados HACCP para productos dietéticos y edulcorantes. \n	\n Entidades certificadoras acreditadas reconocidas por organismos de acreditación internacional. \n	\n Todos los países. \n
\n Certificado o documento que acrediten el cumplimiento de Buenas Prácticas de Manufactura de productos dietéticos y edulcorantes. \n	\n Entidades certificadoras acreditadas reconocidas por organismos de acreditación internacional. \n	\n Todos los países. \n
\n Attestation pour L’exportation/Attestation for Exportation \n Atestado para Exportación, solo avala al producto/s dietético/s para el cual fue emitido; indicando que se vende libremente y que se cuenta con un Sistema de Aseguramiento de la Calidad. \n	\n División de Seguridad Sanitaria y Alimentaria. \n	\n Mónaco. \n
\n Attestation for Exportation \n Atestado para Exportación, solo avala al producto/s dietéticos para el cual fue emitido; indicando que se vende libremente y que cuenta con un Sistema de Aseguramiento de la Calidad. \n	\n Federal Food Safety and Veterinary Office - FSVO. \n	\n Suiza. \n
\n Certificate of Manufacture and Free Sale \n Certificado de Manufactura y Libre Venta, solo avala al producto/s dietéticos o edulcorantes para el cual fue emitido. \n	\n Departament for Environment, Food and Rural Affairs (DEFRA). \n	\n Reino Unido. \n

2541050-1

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