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Bulletin # 21

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, […]

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Bulletin # 20

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 […]

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Bulletin # 15

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 […]

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Bulletin # 14

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 […]