Added in June 2023 19 June NEW – 20-21 June CMDh agenda UPDATE – Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding 6 June NEW – Agenda for the meeting with Interested Parties on 31 May 2023 NEW – Presentations from the meeting with Interested Parties on 31 May 2023 NEW – Presentations from the meeting with Interested Parties on variations on 16 May 2023 2 June UPDATE – Q&A on variations UPDATE – CMS validation checklist in MRP UPDATE – Hormone Replacement Therapy – Core Package Leaflet UPDATE – Hormone Replacement Therapy – Core SmPC UPDATE – CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System UPDATE – List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation NEW – Art. 45 assessment report for Prazosin NEW – Art. 46 assessment report for Fluarix Tetra 1 June NEW – Report from the meeting held on 23-25 May 2023 NEW – April 24-25 minutes
