This is the 'Recently Published' page for the Human Medicines section

Added in August 2024

2 August

• 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

Added in July 2024

31 July 

• NEW - Report from the meeting held on 23-24 July 2024
• NEW - Minutes of the CMDh meeting with Interested Parties on 27 June 2024
• NEW - 2024 - January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
• UPDATE - EU ASMF number request form
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
• 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

26 July

• NEW - 25-26 June 2024 CMDh minutes 

22 July

• NEW - 23-24 July CMDh agenda

11 July

• NEW - 27 June 2024 Agenda of CMDh meeting with Interested Parties
• NEW - Presentations from the 27 June 2024 meeting with Interested Parties
• UPDATE - CMDh Best Practice Guidae on Multilingual Packaging
• UPDATE - Cover letter for new applications submitted thourgh MRP/DCP
• UPDATE -  Template for Art. 61.3 notifications
• UPDATE - Request for MRP/RUP / Update assessment report
• UPDATE - 'Blue-box' requirements

5 July

• NEW - Report from the meeting held on 25-26 June 2024

2 July

• NEW - 28-29 May 2024 CMDh minutes

Added in June 2024

24 June 

• NEW - 25-27 June CMDh agenda

20 June

• UPDATE - Questions & Answers on Variations

7 June

• UPDATE - Mock-ups, Specimens and Samples for variations

5 June

• NEW - 23-25 April 2024 CMDh minutes
• NEW - Report from the meeting held on 28-29 May 2024
• UPDATE - The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF)
• 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 

Added in May 2024

27 May

• NEW - 28-29 May CMDh agenda

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 May 2024

2 May

• NEW - Report from the meeting held on 23-25 April 2024

Added in April 2024

30 April

• NEW - 19-20 March 2024 CMDh minutes

22 April

• NEW - 23-25 April CMDh agenda

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