This is the 'Recently Published' page for the Human Medicines section
Recently Published (last 6 Months)
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
Added in November 2025
27 November
- NEW - Presentations from the 19 November 2025 meeting with Interested Parties
- NEW - Art. 46 PAR Cleviprex (clevidipine)
- NEW - Art. 46 PAR Botox (botulinum toxin type A)
- NEW - Art. 46 PAR Pentavac (Corynebacterium diphtheriae toxoid, Clostridium tetani toxoid, Haemophilus influenzae type B polysaccharide, Bordetella pertussis, filamentous hemagglutinin, Bordetella pertussis toxoid, poliovirus type 1, strain Mahoney, inactivated, poliovirus type 3, strain Saukett, inactivated, poliovirus type 2, strain MEF-1, inactivated)
- UPDATE - Instructions for RMS when preparing the PAR based on the FAR
- UPDATE - PAR template (empty) - when prepared based on FAR
- UPDATE - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures
- UPDATE - D70 Overview AR Template (empty)
19 November
17 November
10 November
07 November
04 November
Added in October 2025
23 October
- MOVED - National information on MAH transfers
- NEW - Q&A Post-Brexit
- NEW - D70 Overview AR Template (incl. instructions)
- NEW - Art. 46 PAR Riamet (artemether / lumefantrine)
- NEW - Art. 46 PAR Panzyga and associated names (human normal immunoglobin (IVIg))
- NEW - Art. 46 PAR Xalatan / Latanoprost Viatris (latanoprost)
- NEW - Art. 46 PAR Hiberix (haemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid (TT))
- NEW - Recommendations on submission dates in 2026 for Applications of the MRP
- NEW - Recommendations on submission dates in 2026 for Applications of the DCP
22 October
21 October
17 October
13 October
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
15 September
09 September
Added in August 2025
27 August
11 August
08 August
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
29 July
25 July
24 July
21 July
16 July
08 July
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