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Library Bulletin # 18 In this number we report the Provisions for the registration, re-registration and changes in the Sanitary Registry and the importation of pharmaceutical products; and for the operation of pharmaceutical establishments in Peru, the approval by DIGEMID of the "List of documents considered equivalent to the certificate of Good Manufacturing Practices"; […]
El día 17 de agosto de 2018, los Químicos Farmacéuticos Rosa Campos y Walther Vicente, miembros del equipo de Asuntos Regulatorios y Farmacovigilancia de SCR Consultores, asistieron a la reunión de revisión del «Proyecto de Norma Técnica de Salud que regula la Elaboración del Plan de Gestión de Riesgo de los Productos Farmacéuticos”. Dicho evento […]
Library Bulletin # 15 In this issue we inform that the Single National Request for Essential Medical Devices, the Regulation for the Sanitary Registry of Sanitary Products: Articles for Babies, the Technical Standard that regulates the preparation of the Risk Management Plan for Pharmaceutical Products was published and the Good Practices Inspection Guide […]
Library Bulletin # 16 In this issue we inform you that by means of an Emergency Decree, the approval of declaring medicines, biological products and medical devices as an essential part of the right to health was published. Likewise, to provide public opinion with the draft of the Regulation that regulates the most important changes of the products […]
Library Bulletin # 5 In this issue we inform you that the Sanitary Directive that regulates the conditions for the presentation of the quality control results of the first batch and subsequent batches of pharmaceutical products and medical devices was pre-published. Likewise, we inform that the List of Competent Authorities for the Issuance of the […]
Library Bulletin # 4 In this issue we inform that Provisions referring to the Peruvian System of Pharmacovigilance and Technovigilance, the Schedule for submitting applications for certification in Good Storage Practices, as well as the Draft Sanitary Directive that regulates the presentation and content of the documents required in the registration and re-registration [...]
Library Bulletin # 3 In this issue we inform you that the List of Excipients for the sanitary registration of pharmaceutical products in DIGEMID was published. Download PDF Recent publications # 16 Bulletin # 15 Bulletin # 14 Bulletin # 13 Bulletin # 12 Bulletin # 11 Bulletin # 10 Bulletin # 9 Bulletin # 8 Bulletin […]
Library Bulletin # 2 In this issue we report that a Draft Amendment to the Regulation for the Registration, Control and Health Surveillance of Pharmaceutical Products, Medical Devices and Health Products was published; as well as a Draft Directive that regulates the conditions for the presentation of the quality control results of the first batch […]
Library Bulletin # 14 In this issue we report that an Amendment to the Pharmaceutical Establishment Regulations and the List of reference products that will be used as comparators in carrying out Therapeutic Equivalence Studies have been published. Likewise, we inform that the DIGEMID approved the notification formats of suspected adverse incidents to […]
Library Bulletin # 13 In this issue we inform that the Regulation that regulates the Medicinal and Therapeutic Use of Cannabis and its derivatives was published, the Technical Health Standard that regulates the minimum information that the validation document of own analytical techniques must contain. Likewise, we inform that the Certificate format was approved [...]