Q.F. Milagros Consuelo Arista Arévalo Quality and Regulatory Affairs Specialist SCR Consulting Peru With the purpose of establishing the technical and sanitary conditions for the operation of Pharmaceutical Establishments, on July 2011, the “Regulation of Pharmaceutical Establishments” was published in the Official Newspaper El Peruano, approved through Supreme Decree No. 014-2011-SA. In this document, for […]
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs and Pharmacovigilance Analyst SCR Consulting Peru As part of the development of the pharmacovigilance system in Peru, since the publication of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products (Supreme Decree No. 016-2011-SA), the preparation and presentation of the […]
Autora: Q.F. Ana Susana Rojas Avalos El Producto Dietético es aquel producto cuyo propósito es complementar la dieta normal, consistiendo en fuentes concentradas de nutrientes u otras sustancias que tienen un efecto nutricional o fisiológico, en forma simple o combinada y dosificada. Además, solo se utilizan para el consumo oral, según la definición [...]
Jeanette Cornelio Bello RESUMEN Los productos cosméticos en Perú están regulados por una normativa andina, conocida como Decisión. Este artículo expone de manera muy concisa los inicios de la regulación de productos cosméticos en la Subregión Andina para comprender la nueva decisión, la Decisión 883, que está en vigor desde [...]
Q.F. Walther Ricardo Vicente Mallma Associate Consultant and Medical Devices Regulatory Affairs Coordinator SCR Consulting Peru ABSTRACT The risk management report is one of the regulatory requirements for the registration of medical devices in Peru. According to Supreme Decree 016-2011-SA: Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health […]
Q.F. Ana Susana Rojas Avalos Regulatory Intelligence Consultant SCR Consulting Peru The Sanitary Registration is a legal instrument granted by the Ministry of Health, which, according to Law No. 29459 “Law of Pharmaceutical Products, Medical Devices and Health Products” and Supreme Decree N° 016-2011 “Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, […]
Q.F. Luz Marianee Castañeda Saavedra Quality and Regulatory Affairs Specialist SCR Consulting Peru BACKGROUND OF THE REGULATION OF THE SANITARY REGISTRATION OF PHARMACEUTICAL PRODUCTS In the late 1990s, with the enactment of General Health Law No. 26842 in Peru, it was established that the registration of medicines in the Sanitary Registry was automatic, requiring only […]
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs, Safety and Efficacy Analyst SCR Consulting Peru With the enactment of the Law No. 29459: “Law on Pharmaceutical Products, Medical Devices and Health Products” in 2009; and subsequently with the approval of the “Regulations for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health […]
En el complejo y riguroso mundo de las industrias farmacéutica, cosmética y de dispositivos médicos, la gestión de asuntos regulatorios desempeña un papel crucial para garantizar que las empresas no solo cumplan con las normativas vigentes, sino que también protejan el bienestar de la salud pública. En este contexto, los profesionales encargados de los asuntos regulatorios, con su profundo conocimiento y experiencia, [...]
By SCR Consulting Fiorella De la Cruz Huamán, Consultant & Comercial and Marketing Head of SCR Consulting The Commercial Intelligence Study: Annual Results 2023 and Projections 2025, conducted on February 27, marked a significant moment for the cosmetics and personal care sector in Peru. Organized by the “Gremio de Cosmética e Higiene Personal” (COPECOH) of […]