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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, […]
Library Bulletin # 20 In this issue we report that Peru approved the Technical Document – Manual of Good Pharmacovigilance Practices; as well as the Emergency Decree that dictates extraordinary measures to facilitate and guarantee the acquisition, conservation and distribution of vaccines against COVID-19. In addition, the Technical Documents were approved: 1) Guidelines for the […]
Library Bulletin # 19 In this issue we inform Peru established the Emergency Decree that dictates extraordinary measures to facilitate and guarantee the acquisition, conservation and distribution of vaccines against COVID-19; the exceptional Authorization for the importation and use of Medications, Medical Devices or Health Products for prevention and individual treatment; register […]
Library Bulletin # 17 In this issue we inform that the Classification rules and the Essential Principles of Safety and Performance of Medical Devices, the Technical Specification for the Making of Textile Face Masks for Community Use. On the other hand, we carried out an analysis article on the Regulatory Scope in Relation to COVID – […]
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"; […]
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 # 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 […]