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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 [...]
Library Bulletin # 12 In this issue we report that the Single National Petition for Essential Medications and a new version of the communication format in the health registry of pharmaceutical products were published. Download PDF Recent publications # 16 Bulletin # 15 Bulletin # 14 Bulletin # 13 Bulletin # 12 Bulletin # 11 Bulletin […]
Library Bulletin # 11 In this issue we inform that the Regulation that regulates the Interchangeability of Medications was published, the Regulation that regulates the issuance of the Certificate of Release of Batch of Biological Products: Vaccines or Derivatives of Human Plasma; and the Manual of Good Manufacturing Practices. Likewise, we made an analysis article on […]
Biblioteca Boletín # 1 En este número informamos que se publicaron los proyectos de directivas sanitarias que establecen la presentación y contenido para la reinscripción de productos biológicos – derivados de plasma, que establece los requisitos y procedimientos para la liberación de lotes de productos biológicos, y que establece la información mínima que debe contener […]