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

Added in March 2025

24 March

• NEW - 25-26 March CMDh agenda

13 March

• UPDATE - Q&A on QP declaration

11 March

• UPDATE - AR template Active Substance Master File (ASMF) Type IB Variation Assessment Report
• UPDATE - AR template Active Substance Master File (ASMF) Assessment Report (Applicant's Part)
• UPDATE - AR template Active Substance Master File (ASMF) Assessment Report (Restricted Part)

07 March

• UPDATE - AR template Lead Member State PSUR Follow-Up assessment report
• UPDATE - AR template Template - PSUR Assessment Report
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
• UPDATE - AR template Type II variation Preliminary Variation Assessment Report

06 March

• UPDATE - AR template Overview AR Template (incl. instructions)
• UPDATE - AR template Type II variation Final Variation Assessment Report
• UPDATE - AR template CMS comments in Mutual Recognition Procedure
• UPDATE - AR template Mutual Recognition Procedure
• UPDATE - AR template CMS Comments to be sent at Day 205 at the latest
• UPDATE - AR template CMS Day 120 Draft Assessment Report to be sent at Day 145 at the latest
• UPDATE - AR template CMS Comments Day 70 Preliminary Assessment Report to be sent at Day 100 at the latest
• UPDATE - AR template RMS Day 70 Preliminary Assessment Report
• UPDATE - AR template Preliminary Renewal Assessment Report
• UPDATE - AR template Member States comments on the Paediatric Work Sharing assessment reports for Article 45 and Article 46

05 March

• NEW - Art. 46 Public PdAR ActHib (Haemophilus type b conjugate vaccine (adsorbed))
• NEW - Art. 45 Public PdAR bromhexine & ephedrine
• NEW - CMDh statistics 2024
• NEW - Summary of CMDh activities 2024
• UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
• UPDATE - BPG for the Submission and Processing of Variations in the MRP, chapter 6
• UPDATE - BPG Article 45 and 46 EU Worksharing Procedure
• UPDATE - Cover letter for Submission of information about paediatric studies
• UPDATE - Questions and Answers on Paediatric Regulation
• UPDATE - End of procedure AR template
• NEW - Report from the meeting held on 25-26 February 2025

03 March

• NEW - 28-29 January CMDh minutes

Added In February 2025

24 February

• NEW - 25-26 February CMDh agenda

06 February

• UPDATE - Template for Request for RMS in DCP
• UPDATE - Procedural Advice on Repeat Use
• UPDATE - BPG 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/followed
• UPDATE - BPGs for the Submission and Processing of Variations in the MRP, chapters 3 and 6
• UPDATE - SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity
• NEW - Public Assessment Report Pamorelin LA 22.5 mg (triptorelin pamoate)

05 February

• NEW - Report from the meeting held on 28-29 January 2025

04 February

• NEW - 10-11 December CMDh minutes

Added In January 2025

31 January

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

27 January

• NEW - 28-30 January CMDh agenda

07 January

• UPDATE - Information on nitrosamines for marketing authorisation holders 

Added In December 2024

19 December 

• NEW - Report from the meeting held on 10-11 December 2024
• NEW - Minutes of the 20 November 2024 meeting with Interested Parties
• NEW - Presentations from the 20 November 2024 meeting with Interested Parties
• NEW - Minutes of the 14 November 2024 meeting of a subgroup of CMDh with Interested Parties
• NEW - Presentations from the 14 November 2024 meeting of a subgroup of CMDh with Interested Parties

16 December

• NEW - 12-14 November CMDh minutes

9 December

• NEW - 10-11 December CMDh agenda

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 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