DateContentStatus
17/05/2024 Document: Minimum inhibitory concentration (MIC) breakpointsUpdated
17/05/2024 Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data servicesUpdated
17/05/2024 Document: European Medicines Agency’s data protection notice for the EMA Help DeskUpdated
17/05/2024 Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1Updated
17/05/2024 Document: Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan AfricaNew
16/05/2024 Document: Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/202304 New
16/05/2024 Document: PDCO minutes of the 19-22 March 2024 meetingNew
16/05/2024 Document: Meeting Summary of the Medicine Shortages (SPOC) Working Party - 14 March 2024New
16/05/2024 Document: Agenda - Medicine Shortages (SPOC) Working Party 14 March 2024New
16/05/2024 Document: Records of data processing activity for study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period”New
16/05/2024 Document: EudraVigilance registration documentsUpdated
16/05/2024 Document: EudraVigilance Form AUpdated
16/05/2024 Document: New Organization First User QPPV/RP or Change of EU QPPV/RPUpdated
16/05/2024 Document: European Medicines Agency's data protection notice on the study of the “Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV- during the Omicron period”New
16/05/2024 Document: Organisation chart: Information ManagementUpdated
15/05/2024 Document: Policy 78: EMA environmental policyUpdated
14/05/2024 Document: Agenda of the PRAC meeting 13-16 May 2024Updated
14/05/2024 Document: Guidebook for tenderersUpdated
14/05/2024 Document: Article 57 product dataUpdated
14/05/2024 Document: Minutes of the PRAC meeting 4-7 March 2024New
14/05/2024 Document: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation GuideUpdated
08/05/2024 Document: Timetable: Post-authorisation safety study (PASS) protocols and final resultsUpdated
08/05/2024 Document: Timetable: Initial (Full) marketing authorisation application - ATMPUpdated
07/05/2024 Document: Organisation chart: Advisory functionsUpdated
07/05/2024 Document: List of medicines currently in PRIME schemeUpdated
06/05/2024 Document: Record of data processing activity relating to Security Access Control SystemUpdated
06/05/2024 Document: Records of data processing activity for audiovisual tool for checking presence in meeting roomsNew
06/05/2024 Document: European Medicines Agency’s privacy statement for the operation of the Security Access Control SystemUpdated
06/05/2024 Document: European Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting roomsNew
06/05/2024 Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma WorkshopNew
06/05/2024 Document: Minutes of the COMP meeting 12-14 March 2024New
06/05/2024 Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modificationUpdated
06/05/2024 Document: List of signals discussed at PRAC since September 2012Updated
06/05/2024 Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meetingNew
03/05/2024 Document: Agenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methodsUpdated
03/05/2024 Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesUpdated
03/05/2024 Document: Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23Updated
03/05/2024 Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidenceNew
02/05/2024 Document: Template for scientific document (part B-F)Updated
02/05/2024 Document: Scientific recommendations on classification of advanced therapy medicinal productsUpdated
02/05/2024 Document: Appendix 1: Acceptable intakes established for N-nitrosaminesUpdated
02/05/2024 Document: Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS ProcedureNew
02/05/2024 Document: CAT quarterly highlights and approved ATMPs - February - April 2024New
02/05/2024 Document: Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productsNew
02/05/2024 Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to LabellingNew
02/05/2024 Document: List of eligible industry stakeholder organisationsUpdated