Added in July 2025 01 July UPDATE – SOP on the processing of PSUR single assessment for nationally authorised productsUPDATE – Data requested for New Applications in the MRP/DCPUPDATE – Data requested for Variations and/or Renewal Applications in the MRP/DCPUPDATE – Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National ProceduresUPDATE – Requirements on submissions for Variations and Renewals within MRP and National ProceduresNEW – Agenda of the 19 June 2025 meeting with Interested PartiesNEW – 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 transfersUPDATE – List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric RegulationNEW – Art. 46 Public PdAR Bilastine (Bilaxten and associated names)NEW – Report from the meeting held on 20-21 May 2025UPDATE – 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 formNEW – 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 2025UPDATE – AR template for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006UPDATE – AR template for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006UPDATE – 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 9NEW – 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 ReportUPDATE – 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 reportUPDATE – AR template – PSUR Assessment ReportUPDATE – List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric RegulationUPDATE – 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 ReportUPDATE – AR template CMS comments in Mutual Recognition ProcedureUPDATE – AR template Mutual Recognition ProcedureUPDATE – AR template CMS Comments to be sent at Day 205 at the latestUPDATE – AR template CMS Day 120 Draft Assessment Report to be sent at Day 145 at the latestUPDATE – AR template CMS Comments Day 70 Preliminary Assessment Report to be sent at Day 100 at the latestUPDATE – AR template RMS Day 70 Preliminary Assessment ReportUPDATE – AR template Preliminary Renewal Assessment ReportUPDATE – 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 & ephedrineNEW – CMDh statistics 2024NEW – Summary of CMDh activities 2024UPDATE – Examples for acceptable and not acceptable groupings for MRP/DCP productsUPDATE – BPG for the Submission and Processing of Variations in the MRP, chapter 6UPDATE – BPG Article 45 and 46 EU Worksharing ProcedureUPDATE – Cover letter for Submission of information about paediatric studiesUPDATE – Questions and Answers on Paediatric RegulationUPDATE – End of procedure AR templateNEW – 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 DCPUPDATE – Procedural Advice on Repeat UseUPDATE – 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/followedUPDATE – BPGs for the Submission and Processing of Variations in the MRP, chapters 3 and 6UPDATE – SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivityNEW – 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
