This is the 'Recently Published' page for the Human Medicines section
Recently Published (last 6 Months)
Added in May 2026
27 May
- NEW - 21-22 April CMDh Minutes
- NEW - Art. 46 PAR Rapibloc, Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)
- NEW - Art. 46 PAR Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)
- NEW - Art. 46 PAR Vaccin rabique Pasteur, Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))
- UPDATE - Non Clinical / Clinical AR for Generics - MRP & DCP
- NEW - Report from the meeting held on 19-20 May 2026
21 May
18 May
07 May
Added in April 2026
30 April
29 April
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure
- UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure)
- NEW - Report from the meeting held on 21-22 April 2026
28 April
20 April
07 April
03 April
- UPDATE - Position paper common grounds seen for invalidation/delaying day 0 for variations
- UPDATE - Questions and Answers on Variations
- UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
- UPDATE - Type II variation Preliminary Variation Assessment Report
- UPDATE - Chapter 1 - CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing
- UPDATE - Chapter 6 - CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure
- UPDATE - Questions and answers on the Paediatric Regulation
- UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure
- UPDATE - D70 Overview AR Template (empty)
- UPDATE - Overview AR Template (incl. instructions)
- UPDATE - PAR template (empty) - when prepared based on FAR
- UPDATE - Instructions for RMS when preparing the PAR based on the FAR
- UPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal product
- UPDATE - Annex 2 - Applicant's declaration template
- NEW - CMDh Multi-annual Workplan to 2028
- NEW - CMDh Summary of activities 2025
01 April
Added in March 2026
31 March
23 March
04 March
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- NEW - Art. 45 PAR Benzocaine / Tyrothricin
- NEW - 2025 Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
- UPDATE - Q&A on Biologicals
- NEW - CMDh Multi-Annual Workplan to 2025 - Summary Report
- NEW - Report from the meeting held on 24-25 February 2026
- NEW - Overview of biological active substances of non-recombinant origin
- NEW - 27-28 January CMDh Minutes
03 March
- CORRECTION - 09-11 December CMDh minutes
- CORRECTION - Report from the meeting held on 9-11 December 2025
Added in February 2026
24 February
13 February
10 February
- NEW - Art. 46 PAR Elvanse (lisdexamfetamine dimesylate)
- NEW - Art. 46 PAR Pneumovax and associated names (pneumococcal polysaccharide vaccine)
04 February
03 February
Added in January 2026
27 January
19 January
08 January
07 January
Added in December 2025
18 December
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only
- CORRECTION - Q&A Submission of variations for human medicinal products
- UPDATE - Hormone Replacement Therapy - Core SmPC
- UPDATE - Hormone Replacement Therapy - Core Package Leaflet
17 December
- NEW - PSUFU Levonorgestrel intra-uterine devices (LNG-IUDs)
- NEW - PSUR WS summary AR nebivolol hydrochloride/amlodipine besilate
- NEW - Art. 45 PAR Mycobutin (rifabutin)
- NEW - Art. 45 PAR Prothyrid 100 microgram/10 microgram (levothyroxine sodium/liothyronine hydrochloride)
- NEW - Art. 45 PAR Cynomel 0,025 mg, Thyrotardin inject (liothyronine sodium) / Thybon 20 Henning. Thybon 100 Henning (liothyronine hydrochloride)
- UPDATE - National recommendations for requests to act as RMS
- UPDATE - CMDh Best Practice Guide on Variation Worksharing, Chapter 7
- NEW - Report from the meeting held on 9-11 December 2025
- NEW - 11-13 November CMDh minutes
- NEW - Minutes of the 19 November 2025 meeting with Interested Parties
8 December