What's new (last 6 Months)
This is the 'What's new' page for the Human Medicines section
Added in June 2013
17 June 2013
- NEW - Art.45 Paediatric Regulation - Public assessment report for Spironolactone
CMDh: document added
- UPDATED - Q&A on Pharmacovigilance Legislation
CMDh: document updated
14 June 2013
- UPDATED - Q&A on Variations
CMDh: document updated
- UPDATED - Information on applications referred to CMDh in accordance with Article 29(1) of Directive 2001/83/EC and Article 13 of Regulation (EC)
CMDh: document updated
- UPDATED - Information on applications referred in accordance with Article 30(2) of Directive 2001/83/EC
CMDh: document updated
12 June 2013
- NEW - Information and documents related to the PSUR Worksharing
CMDh: information and documents added
- NEW - Art.45 Paediatric Regulation - Public assessment Report for Pentamidine
CMDh: document added
- NEW - Art.45 Paediatric Regulation - Public assessment Report for Vinorelbine
CMDh: document added
- NEW - Art.46 Paediatric Regulation - Public assessment Report for Fluarix
CMDh: document added
- NEW - Art.46 Paediatric Regulation - Public assessment Reports for Priorix-Tetra
CMDh: documents added
- NEW - Presentations from Meeting with Interested Parties
CMDh: documents added
- NEW - Presentations from Meeting with Interested Parties on DCP/MRP improvement
CMDh: documents added
- UPDATED - List of Active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
CMDh: document updated
- UPDATED - CMDh recommendation for classification of unforseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
CMDh: document updated
7 June 2013
- NEW - Pharmacovigilance part of the May 2013 CMDh Agenda
CMDh: document added
- NEW - Pharmacovigilance part of the March 2013 CMDh Minutes
CMDh: document added
4 June 2013
Report from the meeting held on 27-29 May 2013
CMDh: document added
3 June 2013
- Updated: CMDh Best Practise Guide on the processing of renewals in the MRP/DCP
CMDh: document updated
Added in May 2013
14 May 2013
- Updated - Previous worksharing project - Public Assessment Report for Zantac
CMDh: document updated
9 May 2013
- NEW - Art.45 Paediatric Regulation - Public Assessment Report for Atracurium besilate
CMDh: document added
- NEW - Art.45 Paediatric Regulation - Public Assessment Report for Aztreonam
CMDh: document added
- NEW - Art.45 Paediatric Regulation - Public Assessment Report for Gonadorelin
CMDh: document added
- UPDATED - Role of the Vice-Chairpersons of the CMDh
CMDh: document updated
- UPDATED - Chapter 3 CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure
CMDh: document updated
- UPDATED - Chapter 7 CMDh BPG on Worksharing
CMDh: document updated
- UPDATED - Q&As on Variation
CMDh: document updated
- UPDATED - Examples for acceptable and not acceptable groupings for MRP/DCP products
CMDh: document updated
- UPDATED - Template for a Request form for Recommendation - Article 5 CMDh: document updated
- UPDATED - CMDh BPG for MRP/DCP
CMDh: document updated
Added in April 2013
30 April 2013
- UPDATED - Chapter 9 CMDh BPG on fast track procedure for the annual update of Human Influenza Vaccines
CMDh: document updated
- NEW - Report from the meeting held on 22-24 April 2013
CMDh: document added
25 April 2013
- NEW - Pharmacovigilance part of the April 2013 CMDh Agenda
CMDh: document added
18 April 2013
- NEW - Pharmacovigilance part of the January 2013 CMDh Minutes
CMDh: document added
- NEW - Pharmacovigilance part of the February 2013 CMDh Minutes
CMDh: document added
11 April 2013
- UPDATED - CMDh QRD annotated template for MRP/DCP
CMDh: document updated
9 April 2013
- UPDATED - Best Practice Guide for the Decentralised and Mutual Recognition Procedures
CMDh: document updated
- UPDATED - Decentralised Procedure Member States' Standard Operating Procedure
CMDh: document updated
- UPDATED - Flow chart of the Decentralised Procedure
CMDh: document updated
- UPDATED - CMDh Recommendation for classification of unforseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
CMDh: document updated
2 April 2013
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Alfentanil
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Captopril
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Daunorubicin
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Haloperidol
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Lovastatin
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Phytomenadione
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Testosterone
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Trazodone
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Ursodeoxycholic acid
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Verapamil
CMDh: document added
- NEW - Art. 46 Paediatric Regulation - Public Assessment Report for Daivobet (calcipotriol/betamethasone)
CMDh: document added
- UPDATED - CMDh Q&As on PSURs (Transitional arrangements for nationally authorised products)
CMDh: document updated
- UPDATED - CMDh Q&As on Variations
CMDh: document updated
- NEW - Member States agreement upon conditions under which the RMS can start renewal procedures
CMDh: document added
- UPDATED - Technical validation of e-CTD submissions for new MAAs in DCP - start of pilot phase
CMDh: document updated
- UPDATED - Requirements on eSubmissions (NeeS and eCTD) and paper documentation for Variations and Renewals within MRP or National procedures
CMDh: document updated
- UPDATED - Blue box requirements
CMDh: document updated
- UPDATED - Best Practice Guide on break-out sessions for MRP/DCP
CMDh: document updated
- UPDATED - Template for the assessment report MRP overview
CMDh: document updated
- UPDATED - Template for notifications of referrals to CMDh
CMDh: document updated
- UPDATED - Information on applications referred to CMDh in accordance with Article 29(1) of Directive 2001/83/EC and Article 13 of Regulation (EC)
CMDh: document updated
Added in March 2013
27 March 2013
- NEW - Report from meeting held on 18-20 March 2013
CMDh: document added
26 March 2013
- NEW - Pharmacovigilance part of the CMDh Agenda - March 2013
CMDh: document added
22 March 2013
- NEW - Chapter 9 CMDh Best Practise Guide on fast track procedure for the annual update of Human Influenza Vaccines - for public consultation
CMDh: document added
7 March 2013
- UPDATED - CMDh Q&As on traditional herbal medicinal products
CMDh: document updated
- UPDATED - Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure
CMDh: document updated
6 March 2013
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Dexamethasone combinations
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Dobutamine hydrochloride
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Ketoconazole
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Miconazole nitrate
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Setraline
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Zanamivir
CMDh: document added
- NEW - Art. 46 Paediatric Regulation - Public Assessment Report for Poliorix
CMDh: document added
- NEW - Paediatric Working Party work plan 2013
CMDh: document added
- NEW - Summary of CMDh Acitivities 2012
CMDh: document added
- NEW - MRP/DCP statistics in 2012
CMDh: document added
- UPDATED - Document on examples for acceptable and not-acceptable groupings
The CMDh: document updated
- UPDATED - CMDh Q&As on variation
The CMDh: document updated
- UPDATED - CMDh recommendation for MRP after finalization of a referral procedure with a positive decision by the EC
The CMDh: document updated
- UPDATED - Information on applications referred to the CMDh in accordance with Art. 29(1) of Directive 2001/83/EC
The CMDh: document updated
- UPDATED - List of active substances for which data has been submitted in accordance with Art. 45 of the Paediatric Regulation
The CMDh: document updated
- UPDATED - Statistics on MS acting as rapporteurs in Paediatric worksharing procedure
The CMDh: document updated
Added in February 2013
27 February 2013
- NEW - Report from meeting held 18-20 February 2013
CMDh: document added
18 February 2013
- NEW - Pharmacovigilance part of the February 2013 Agenda
CMDh: document added
12 February 2013
UPDATED - Statistics on Member States acting as rapporteurs in Paediatric worksharing procedure
CMDh: document updated
8 February 2013
NEW - Pharmacovigilance part of the December 2012 Minutes
CMDh: document added
Added in January 2013
31 January 2013
- NEW - Minutes from the meeting with Interested Parties on DCP/MRP Improvements - 12 November 2012
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Netilmicin sulphate
CMDh: document added
30 January 2013
- NEW - Minutes from the meeting with Interested Parties - 12 November 2012
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Budesonide/Formoterol
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Rabeprozole
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Risperidone
CMDh: document added
- UPDATED - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
CMDh: document updated
- UPDATED - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
CMDh: document updated
24 January 2013
- NEW - CMDh Q&As on traditional herbal medicinal products
CMDh: document added
- NEW - Art. 46 Paediatric Regulation - Public Assessment Report for Actonel (risedronate)
CMDh: document added
- NEW - Art. 46 Paediatric Regulation - Public Assessment Report for Genotropin (somatropin)
CMDh: document added
- UPDATED - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP
CMDh: document updated
- UPDATED - Best Practise Guide Article 46 - EU Worksharing procedure
CMDh: document updated
- UPDATED - Common ground seen for delaying day 0 of renewal procedures
CMDh: document updated
- UPDATED - CMDh Q&As on referrals
CMDh: document updated
- UPDATED - CMDh Q&As on applications for marketing authorisation
CMDh: document updated
23 January 2013
- NEW - Report from meeting held 14 - 16 January 2013
CMDh: document added
16 January 2013
- NEW - Pharmacovigilance part of the CMDh Agenda
CMDh: document added
Added in December 2012
21 December 2012
- NEW - CMDh Q&A on Pharmacovigilance legislation
CMDh: document updated
19 December 2012
- NEW - Report from the meeting held on 10-12 December 2012
CMDh: document added
- NEW - CMDh letter for all MAHs of combined oral contraceptives and broad spectrum antibiotics
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Esmolol hydrochloride
CMDh: document added
- NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Bupivacine hydrochloride
CMDh: document added
- NEW - Art. 46 Paediatric Regulation - Public Assessment Report for Voluven (Poly (O-2- hydroxethyl) starch)
CMDh: document added
- UPDATED - List of the active substances included in the worksharing procedure
CMDh: document updated
- UPDATED - Examples for acceptable and non-acceptable groupings for MRP/DCP products
CMDh: document updated
- UPDATED - Position paper on the transparency policy of CMDh
CMDh: document updated
- NEW: Template - Letter of access for informed consent applications
CMDh: document added
- UPDATED: CMDh Q&A on EU enlargment
CMDh: document updated
- NEW: Pharmacovigilance part of the November 2012 Minutes
CMDh: document added
- NEW: Template for ASMF Type IB Variation Assessment Report
CMDh: document added
- UPDATE: Template for ASMF Assessment Report
CMDh: document updated
- UPDATE: Template for Type II Variation Preliminary Assessment Report
CMDh: document updated
- UPDATE: Template for Type II Variation Final Assessment Report
CMDh: document updated
- UPDATE: CMDh Q&As on homeopathics
CMDh: document updated
- UPDATE: Information on applications referred to CMDh in accordance with Article 29(1) of Directive 2001/83/EC and Article 13 of Regulation (EC) 1234/2008
CMDh: document updated
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
CMDh: document updated
10 December 2012
- NEW - Pharmacovigilance part of the December CMDh Meeting agenda
CMDh: document added