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The DIGEMID through RD No. 5557-2021-DIGEMID/DPF/MINSA published on June 9, 2021, provided the following: The holders of the health registrations of the current pharmaceutical specialties that contain IBUPROFEN OR KETOPROFEN AND ASSOCIATIONS, must modify in the technical sheet and insert the information corresponding to the sections indicated in the articles [...]
The Ministry of Health, through Ministerial Resolution No. 808-2021/MINSA, published on July 2, 2021 in the Official Gazette "El Peruano", provides for the publication of the project "Technical Document: Manual of Good Practices of the Pharmaceutical Office and its approving Ministerial Resolution”, in the Institutional Portal of the Ministry of Health, during the […]
On December 03, 2020, Idaly Jazminy Morote Guzmán, our Quality Assurance Specialist and Coordinator of Regulatory Affairs for Medicines and Biological Products, participated on behalf of SCR Consultores – Peru Headquarters, in the Technical Meeting: Proposal for Changes in the Regulation of Dietetic Products and Sweeteners – DIGEMID, which […]
The DIGEMID through RD No. 4521-2021-DIGEMID/DPF/MINSA published on May 20, 2021, provided the following: The holders of the health registrations of the current pharmaceutical specialties that contain BENZOCAINE SOLD BY PRESCRIPTION, must modify in the technical sheet and insert the information corresponding to the sections indicated in the […]
Library Bulletin # 21 In this issue we report that Peru approved the Regulation for the Conditional Sanitary Registration of Medicines and Biological Products; as well as the incorporation to the Administrative Procedures in the Single Text of Administrative Procedures (TUPA) of the Ministry of Health. In addition, the Technical Documents were approved: 1) Modification of the Regulation of Pharmaceutical Establishments, […]
Ronald Erik Quiñonez Dextre, Regulatory Affairs and Pharmacovigilance Analyst de nuestra sede SCR Consultores Perú, ha realizado un Análisis Regulatorio sobre «Principales consideraciones para la elaboración de informes periódicos de seguridad de Productos Farmacéuticos en el Perú», el cual les invitamos a revisar en el siguiente enlace: Descargue PDF en Español Download PDf in English
The Ministry of Health, through Ministerial Resolution No. 680-2021/MINSA, published on May 30, 2021 in the Official Gazette "El Peruano", modified the following: Article 2 of Ministerial Resolution No. 1053-2020 / MINSA, in order to ensure the progressive implementation and compliance with Good Pharmacovigilance Practices; being that the […]
The DIGEMID through RD No. 5556-2021-DIGEMID/DPF/MINSA published on June 09, 2021, provided the following: The holders of the health registrations of the current pharmaceutical specialties that contain HYDROCHLOROTHIAZIDE AND ASSOCIATIONS, must modify in the technical sheet and insert the information corresponding to the sections indicated in articles 1 and […]
Noticias Ley que Regula, Autoriza, Asegura y Garantiza el uso de Oxígeno Medicinal en los Establecimientos de Salud Públicos y Privados a nivel nacional El Gobierno Peruano a través del D.S. Nº 009-2021-SA, publicada el 19 de febrero del 2021 en el Diario Oficial “El Peruano”, prorrogó a partir del 7 de marzo de 2021 […]
On January 21, 2021, Walther Vicente Mallma, Specialist in Quality Assurance and Coordinator of Regulatory Affairs for Health Products and Medical Devices, and Ronald Quiñonez Dextre, Analyst for Regulatory Affairs and Pharmacovigilance, participated on behalf of SCR Consultores based in Peru. the Technical Meeting “Pharmacovigilance of Vaccines against COVID-19 […]