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Search results (723)
List of centrally authorised products requiring a notification of a change for update of annexes
English (EN) (334.49 KB - PDF)
IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
English (EN) (3.93 MB - PDF)
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
Chapter 7 : XEVMPD - PMS Migration guide
English (EN) (740.01 KB - PDF)
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
English (EN) (412.32 KB - PDF)
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes
English (EN) (438.76 KB - PDF)
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1
English (EN) (503.94 KB - PDF)
EudraVigilance registration documents
English (EN) (173.15 KB - PDF)
Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide
Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction – EU Implementation Guide
English (EN) (238.66 KB - PDF)
Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
English (EN) (435.87 KB - PDF)
Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
English (EN) (83.47 KB - PDF)