This is the 'Recently Published' page for the Human Medicines section
Recently Published (last 6 Months)
Added in May 2024
2 May
- NEW - Report from the meeting held on 23-25 April 2024
- UPDATE - Request for MRP/RUP / Update assessment report
- NEW - Art 45 PAR on Alphanate (human von Willebrand factor, human coagulation factor VIII)
- NEW - Art 46 PAR on Riamet (artemether / lumefantrine)
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
Added in April 2024
30 April
22 April
3 April
- UPDATE - Q&A on Pharmacovigilance Legislation
- NEW - Procedural advice on Zero Day MR Procedures
- NEW - Minutes of the Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates
- NEW - Art. 46 PAR on Verorab (Rabies virus, inactivated)
- NEW - Art. 46 PAR on Triptorelin (Decapeptyl, Diphereline, Arvekap)
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
Added in March 2024
27 March
21 March
19 March
18 March
11 March
Added in February 2024
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 2024
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 2023
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 2023
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