This is the 'Recently Published' page for the Human Medicines section

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

• NEW - Report from the meeting held on 12-14 November 2024

19 November

• NEW - 15-16 October CMDh minutes

11 November

• NEW - 12-14 November CMDh agenda

4 November 

• NEW - PSUFU SmAR Fluoroquinolones (for systemic and inhalation use)

Added in October 2024

31 October

• NEW - Amended Variation Regulation

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

• NEW - Report from the meeting held on 15-16 October 2024

22 October

• NEW - 17-18 September CMDh minutes

14 October 

• NEW - 15-16 October CMDh agenda

4 October

• UPDATE - Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh

3 October

• UPDATE - Article 30 Tracking table 

1 October

• UPDATE - Contact Points

Added in August 2024

2 August

• 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 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

• NEW - 25-26 June 2024 CMDh minutes 

22 July

• NEW - 23-24 July CMDh agenda

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

• NEW - Report from the meeting held on 25-26 June 2024

2 July

• NEW - 28-29 May 2024 CMDh minutes

Added in May 2024

27 May

• NEW - 28-29 May CMDh agenda

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

Added in May 2024

2 May

• NEW - Report from the meeting held on 23-25 April 2024