This is the 'Recently Published' page for the Human Medicines section
Recently Published (last 6 Months)
Added In November 2024
25 November
- UPDATE - Hormone Replacement Therapy - Core SmPC
- UPDATE - Hormone Replacement Therapy - Core Package Leaflet
- UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure)
- UPDATE - EMA/CMDh Explanatory notes on variation application form (Human medicinal products only)
- NEW - Art 46 PAR on Panzyga and associated names (human normal immunoglobin (IVIg))
20 November
19 November
11 November
4 November
Added in October 2024
31 October
25 October
- NEW - Recommendations on submission dates in 2025 for Applications of the DCP
- NEW - Recommendations on submission dates in 2025 for Applications of the MRP
24 October
22 October
14 October
4 October
3 October
1 October
Added in September 2024
25 September
- NEW - Report from the meeting held on 17-18 September 2024
- UPDATE - Request for MRP/RUP / Update assessment report
- UPDATE - Pharmacovigilance Legislation
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- NEW - Art 45 PAR on Loperamide, loperamide/simethicone
- NEW - Art 46 PAR on Vaxigrip Tetra
- NEW - Overview of timetables 2025
23 September
16 September
Added in July 2024
31 July
- NEW - Report from the meeting held on 23-24 July 2024
- NEW - Minutes of the CMDh meeting with Interested Parties on 27 June 2024
- NEW - 2024 - January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
- UPDATE - EU ASMF number request form
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National procedures
- UPDATE - Requirements on Submissions for Variations and Renewals within MRP and National procedures
26 July
22 July
11 July
- NEW - 27 June 2024 Agenda of CMDh meeting with Interested Parties
- NEW - Presentations from the 27 June 2024 meeting with Interested Parties
- UPDATE - CMDh Best Practice Guidae on Multilingual Packaging
- UPDATE - Cover letter for new applications submitted thourgh MRP/DCP
- UPDATE - Template for Art. 61.3 notifications
- UPDATE - Request for MRP/RUP / Update assessment report
- UPDATE - 'Blue-box' requirements
5 July
2 July
Added in June 2024
24 June
20 June
7 June
5 June
- NEW - 23-25 April 2024 CMDh minutes
- NEW - Report from the meeting held on 28-29 May 2024
- UPDATE - The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF)
- UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers
Added in May 2024
27 May
2 May
- NEW - Report from the meeting held on 23-25 April 2024
- UPDATE - Request for MRP/RUP / Update assessment report
- NEW - Art 45 PAR on Alphanate (human von Willebrand factor, human coagulation factor VIII)
- NEW - Art 46 PAR on Riamet (artemether / lumefantrine)
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation