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

Added in September 2025

25 September

• NEW - Art. 46 PAR Havrix
• NEW - Art. 45 PAR Pheniramine maleate, naphazoline hydrochloride
• NEW - Overview referral timetables 2026
• UPDATE - Criteria for selection of products for SmPC Harmonisation
• UPDATE - RMS Validation Checklist for human medicinal products in DCP
• UPDATE - Common request form for RMS in DCP
• NEW - 22-23 July CMDh minutes
• NEW - Q1-Q2 2025 Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

24 September

• NEW - Report from the meeting held on 16-18 September 2025
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation

22 September

• UPDATE - Guidance on the application of the revised variations framework

15 September

• NEW - 16-18 September CMDh agenda

09 September

• UPDATE - Contact Points

Added in August 2025

27 August

• UPDATE - Contact Points

11 August

• Update - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

08 August

• NEW - HaRP assessment reports (Acetylcysteine, Adenosine, Ambroxol, Captopril, Combined Hormonal Contraceptives, Chlormadinone acetate/Ethinylestradiol, Flurbiprofen, Gabapentin, Gliclazide, Lactulose, Levosimendan, Linezolid, Loperamide, Olmesartan/Amlodipine/Hydrochlorthiazide, Piperacillin/Tazobactam, Warfarin)

01 August

• NEW - Art. 46 AR Repevax, Adacel-Polio, Triaxis-Polio
• UPDATE - Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCP
• UPDATE - Cover letter template for renewals
• UPDATE - Cover letter for Variation Applications in the Mutual Recognition Procedure
• UPDATE - Template cover letter for new applications submitted through MRP/DCP
• UPDATE - Overview AR Template (incl. instructions)
• UPDATE - D70 Overview AR Template (empty)
• NEW - Instructions for RMS when preparing the PAR based on the FAR
• NEW - PAR template (empty) - when prepared based on FAR

Added in July 2025

30 July

• NEW - Report from the meeting held on 22-23 July 2025
• UPDATE - CMDh statistics 2024

29 July

• NEW - European medicines regulatory network’s response to nitrosamine impurities in human medicines

25 July

• UPDATE - Contact Points

24 July

• NEW - Minutes of the 19 June 2025 meeting with Interested Parties
• NEW - 17-19 June CMDh minutes

21 July

• NEW - 22-23 July CMDh agenda

16 July

• UPDATE - List of documents published on CMDh website

08 July

• UPDATE - Contact Points

01 July

• UPDATE - SOP on the processing of PSUR single assessment for nationally authorised products
• UPDATE - Data requested for New Applications in the MRP/DCP
• UPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCP
• 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
• NEW - Agenda of the 19 June 2025 meeting with Interested Parties
• NEW - Presentations from the 19 June 2025 meeting with Interested Parties

Added in June 2025

30 June

• UPDATE - Guidance on the application of the revised variations framework

25 June

• NEW - Report from the meeting held on 17-19 June 2025

20 June

• NEW - 20-21 May CMDh minutes

16 June

• NEW - 17-19 June CMDh agenda

Added in May 2025

28 May

• UPDATE - National information on MAH transfers
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
• NEW - Art. 46 Public PdAR Bilastine (Bilaxten and associated names)
• NEW - Report from the meeting held on 20-21 May 2025
• UPDATE - Information on nitrosamines for marketing authorisation holders

27 May

• NEW - 23-24 April CMDh minutes

19 May

• NEW - 20-21 May CMDh agenda

02 May 

• UPDATE - MRP/RUP request form
• NEW - Report from the meeting held on 23-24 April 2025

Added in April 2025

28 April

• NEW - 25-26 March CMDh minutes

22 April

• NEW - 23-24 April CMDh agenda

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

• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation

Added in March 2025

31 March

• NEW - 25-26 February CMDh minutes

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 - 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