This is the 'Recently Published' page for the Human Medicines section
Recently Published (last 6 Months)
Added in March
18 March
11 March
Added in February
29 February
28 February
- NEW - Art 46 PAR on Infarix-IPV+Hib
- NEW - CMDh Summary of activities 2023
- NEW - Presentations from the meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates
- UPDATE - D70 Preliminary AR Quality template
- UPDATE - CMDh Best Practice Guide on Multilingual Packaging
- NEW - Report from the meeting held on 20-22 February 2024
26 February
20 February
Added in January
31 January
- NEW - 12-14 December 2023 CMDh minutes
- NEW - 15 November 2023 CMDh meeting with representatives of Interested Parties minutes
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
- UPDATE - Template CMS comments in MRP
- UPDATE - Overview AR Template (including instructions)
- NEW - Art. 45 PAR on Diphtheria, Tetanus, Inactivated Poliomyelitis vaccine
- NEW - Art. 46 PAR on Wilate (Human von Willebrand factor, human coagulation factor VIII)
- NEW - Report from the meeting held on 23-24 January 2024
22 January
Added in December
20 December
- UPDATE - Chapter 6 - CMDh BPG for the processing of grouped applications in the Mutual Recognition Procedure
- UPDATE - Chapter 7 - CMDh BPG on Variation Worksharing
- UPDATE - Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008
- NEW - SmAR on Ramipril/bisoprolol
- NEW - SmAR on Human normal immunoglobulin IV
- NEW - Report from the meeting held on 12-14 December 2023
19 December
12 December
11 December
Added in November
23 November
- NEW - Agenda for the meeting with Interested Parties on 15 November 2023
- NEW - Presentations from the meeting with Interested Parties on 15 November 2023
22 November
- UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers
- NEW - PSUR Follow-Up assessment report on Montelukast
- NEW - Art. 46 PAR on Trileptal (Oxcarbazepine)
16 November
14 November
6 November
Added in October
18 October
- NEW - HaRP Assessment Report on Vancomycin hydrochloride
- NEW - HaRP Assessment Report on Paricalcitol
- NEW - HaRP Assessment Report on Oxcarbazepin
- NEW - HaRP Assessment Report on Mometasone
- NEW - HaRP Assessment Report on Metoprolol tartrate
- NEW - HaRP Assessment Report on Metoclopramide
- NEW - HaRP Assessment Report on Lamotrigine
- NEW - HaRP Assessment Report on Ipratropium bromide
- NEW - HaRP Assessment Report on Ephedrine
- NEW - HaRP Assessment Report on Enalapril lercanidipine
- NEW - HaRP Assessment Report on Dorzolamide hydrochloride
- NEW - HaRP Assessment Report on Domperidone
- NEW - HaRP Assessment Report on Diclofenac
- NEW - HaRP Assessment Report on Clobetasol propionate
- NEW - HaRP Assessment Report on Cefazolin
- NEW - HaRP Assessment Report on Carbecotin
- NEW - HaRP Assessment Report on Bupropion hydrochloride
- NEW - HaRP Assessment Report on Benzydamine/Cetylpyridinium chloride
- NEW - HaRP Assessment Report on Benzydamine
- NEW - HaRP Assessment Report on Azelastin
- NEW - HaRP Assessment Report on Amoxicillin/amoxivcillin trihydrate
- NEW - Recommendations on submission dates in 2024 for Applications of the DCP
- NEW - Recommendations on submission dates in 2024 for Applications of the MRP
- NEW - Report from the meeting held on 10-11 October 2023
- NEW - 12-13 September 2023 CMDh minutes
9 October
4 October
Added in September 2023
27 September
- NEW - Art. 45 assessment report for Oxycodone
- NEW - SmAR on Bilastine
- UPDATE - Applicant's response template
- UPDATE - Questions & Answers on Variations
- UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
26 September
- UPDATE - User Guide for the electronic Application Form for a Marketing Authorisation
- UPDATE - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications
- NEW - Overview of timetables 2024 - CMDh 60-day procedures for MRP/DCP applications
- NEW - 18-20 July 2023 CMDh minutes
20 September
11 September
Added in July 2023
28 July
- NEW - Report from the meeting held on 18-20 July 2023
- UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines
- UPDATE - Step 2 - Nitrosamine detected response template (docx)
- UPDATE - Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure
- UPDATE - Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure
- UPDATE - Chapter 7: CMDh BPG on Worksharing
- UPDATE - Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines
- NEW - Outcome of PSUSA follow-up via variation - Lisdexamfetamine
- NEW - SmAR on Ramipril/bisoprolol
- NEW - Art 45 assessment report for Ginkgo folium
- NEW - Art 46 assessment report for Fragmin (dalteparin sodium)
- NEW - Art 46 assessment report for Imovax polio
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- NEW - 2023 - January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
- UPDATE - Hormone Replacement Therapy - Core Package Leaflet
27 July
25 July
20 July
- NEW - Minutes of the meeting with IPs on variations held on 16 May 2023
- NEW - Minutes of the meeting with IPs held on 31 May 2023
17 July