This is the 'Recently Published' page for the Human Medicines section
Recently Published (last 6 Months)
Added in May 2025
19 May
02 May
Added in April 2025
28 April
22 April
09 April
- UPDATE - Report from the meeting held on 25-26 March 2025
- UPDATE - AR template for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006
- UPDATE - AR template for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006
- UPDATE - AR template CMS Comments on LMS’s Preliminary Assessment Report
02 April
- UPDATE - BPG on fast track procedure for the annual strain update of human influenza vaccines, chapter 9
- NEW - Report from the meeting held on 25-26 March 2025
01 April
Added in March 2025
31 March
24 March
13 March
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 - 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
Added In February 2025
24 February
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
04 February
Added In January 2025
31 January
27 January
07 January
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
9 December
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