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 […]
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 […]
Jeanette Cornelio Bello ABSTRACT Cosmetic products in Peru are regulated by an Andean Regulation, which is called Decision. This article makes known in a very concise way the beginnings of the regulation of cosmetic products in the Andean Subregion in order to understand about the new decision, Decision 883, which has been in force since […]
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 […]
In the complex and rigorous world of the pharmaceutical, cosmetic and medical device industries, regulatory affairs management plays a crucial role in ensuring that companies not only comply with current regulations, but also protect the welfare of public health. In this context, the professionals in charge of regulatory affairs, with their deep knowledge and experience, […]
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 […]
By SCR Consulting Fiorella De la Cruz Huamán, Consultant & Comercial and Marketing Head of SCR Consulting At the end of August, SCR Consulting had the privilege of attending, as an associate, the presentation of the Commercial Intelligence Study conducted by the “Gremio de Cosmética e Higiene Personal” (COPECOH) of the Lima Chamber of Commerce […]