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Library Bulletin # 9 In this issue we inform that the Modification of the Single Text of Administrative Procedures of the Ministry of Health was published, as well as information on the request for authorization for the formation of kits of health products or medical devices. Likewise, we made an analysis article on the Context and relevant technical requirements […]
Library Bulletin # 8 In this issue we inform that Amendments to the Regulations for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products, as well as the Regulations for Pharmaceutical Establishments, including Ireland as a High Sanitary Surveillance Country, were published. Likewise, we carry out an analysis article on the Law that regulates […]
Library Bulletin # 7 In this issue we report that the Law that repealed Legislative Decrees No. 1344 and No. 1345 was published; Therefore, the certificates of Good Manufacturing Practices (GMP) of the countries of the National Regulatory Authorities of Regional Reference for Medicines and Biological Products qualified by […]
Library Bulletin # 6 In this issue we inform that the List of quantities of retention samples of pharmaceutical products and medical devices was approved within the framework of the provisions of the Regulation of Pharmaceutical Establishments. Likewise, we inform that the Minimum Criteria to be considered for the presentation of the Active Pharmacovigilance Plan was published […]
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 […]
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 […]