What's new (last 6 Months)
This is the 'What's new' page for the Human Medicines section
Added in July 2017
11 July 2017
5 July 2017
- NEW - Art. 46 Public Assessment Report for Symbicort pMDI (budesonide, formoterol fumarate dihydrate)
- NEW - Art. 45 Public Assessment Report for Boostrix Polio dTpa-IPV vaccine
- NEW - Art. 45 Public Assessment Report for Valette (dienogest/ethinylestradiol)
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - List of active substances included in the work-sharing procedures
- UPDATE - Template for Active Substance Master File (ASMF) Assessment Report (Applicant's Part)
- NEW - Template for Active Substance Master File (ASMF) Assessment Report (Restricted Part)
- UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
- UPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCP
Added in June 2017
27 June 2017
21 June 2017
20 June 2017
- NEW - June 2017 CMDh Agenda
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - Article 30 Tracking table
19 June 2017
- NEW - Art. 46 Public Assessment Report for Nexium (esomeprazole magnesium)
- NEW - Art. 45 Public Assessment Report for Penciclovir 1% cream
- UPDATE - Criteria for selection of products for SmPC Harmonisation
- UPDATE - Pharmacovigilance Legislation
- UPDATE -Requirements on submissions (number and format) for New MA Applications within MRP,DCP or National procedures
- UPDATE -Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures
8 June 2017
Added in May 2017
31 May 2017
30 May
24 May 2017
15 May 2017
12 May 2017
4 May 2017
- UPDATE - Position paper on the use of the Quick Response (QR) codes to provide information about the medicinal product
- UPDATE - "Blue-box requirements"
3 May 2017
- UPDATE -Template CMS comments in MRP
- NEW - Art. 45 Public Assessment Report for Disflatyl (Simeticone)
- UPDATE - Q&A on Active Substance Master File
- UPDATE - Q&A on Applications for MA
- UPDATE - Q&A on Generics
- UPDATE - Q&A on QP Declaration
- UPDATE - CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity
2 May 2017
Added in April 2017
27 April 2017
26 April 2017
18 April 2017
4 April 2017
3 April 2017
- NEW - 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
- NEW - Template for PSUR Assessment Report
- NEW - PSUR assessment for varicella vaccine (live)
- NEW - Art. 46 Public Assessment Reports for Asmanex Twisthaler (mometasone furoate) and Riamet (artemether/lumefantrine)
- NEW - Art. 45 Public Assessment Report for sulfamethoxazole and trimethoprim
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - Templates for Day100, Day145 and Day205 CMS comments
- UPDATE - CMDh Best Practice Guidance on collaboration between Member States in relation to serious GMP non-compliance issues
- UPDATE - List of active substances included in the work-sharing procedures
- UPDATE - Statistics on Member States acting as Rapporteur in Paediatric worksharing procedure - Art.45 and Art.46
- UPDATE - Information on applications referred in accordance with Article 30 of Directive 2001/83/EC
- UPDATE - Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines
- UPDATE - Q&As on Pharmacovigilance Legislation
- UPDATE - Q&As on Post referral phase
Added in March 2017
29 March 2017
- NEW - CMDh procedural advice on changing the RMS
- NEW - Report from the meeting held on 20-22 March 2017
22 March 2017
13 March 2017
- NEW - Summary of CMDh Activities in 2016
- NEW - MRP/DCP statistics in 2016
- UPDATE - EU ASMF number request form
9 March 2017
- UPDATE - Recommendations on submission dates for Applicants of the MRP
- NEW - Art.46 public assessment report for Tobi/Tobi Podhaler (tobramycin)
- NEW - Art.46 public assessment report for Poliorix (inactivated poliovirus (IPV) types 1,2 and 3)
- UPDATE - Best Practice Guide on the submission on high quality national translations
- UPDATE - Q&As on QP declaration
- UPDATE - Core SmPC and Package Leaflet for Hormonal Replacement Therapy (HRT)products
- UPDATE - Urgent Safety Restriction Members States' Standard Operating Procedure
- NEW - CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive
- UPDATE - CMDh Recommendation for classification of unforeseen variations
- NEW- PSUR assessment report 17-alpha-oestradieol (topical)
1 March 2017
Added in February 2017
28 February 2017
23 February 2017
22 February 2017
- UPDATE Assessment Report templates for MRP and DCP procedures
- UPDATE Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures
14 February 2017
- UPDATE - PAR for refused marketing authorisation application
- UPDATE - Assessment Report templates for MRP and DCP procedures
- UPDATE - Guidance on the work sharing procedure for the assessment of Active Substance Master File (ASMF)
- NEW - Combined hormonal contraceptives (CHCs) containing ethinylestradiol
- NEW - Labelling for multi-language packages
13 February 2017
8 February 2017
- NEW - Minutes - Meeting with Interested Parties - 8 November 2016
- NEW - Minutes - Meeting with Interested Parties on MRP/DCP Improvements - 7 November 2016
1 February 2017
Added in January 2017
27 January 2017
- NEW- CMS Validation Checklist for human medicinal products in DCP
- NEW- RMS Validation Checklist for human medicinal products in DCP
- UPDATE - Procedural advice: Automatic validation of MR/Repeat-use/DC Procedures
- UPDATE - List of active substances included in the work-sharing procedures
13 January 2017
- UPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
12 January 2017
- UPDATE - Consultation with Target Patient Groups: meeting the requirements of Article 59(3) without the need for a full test - Recommendations for bridging
- UPDATE - Position paper on user testing of package leaflets
- UPDATE - Procedural advice on Repeat Use
- UPDATE - Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006
- UPDATE - Template for AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- UPDATE - Q&As on Variations
- UPDATE - Chapter 8: CMDh BPG on CMDh Recommendations on Unforeseen Variations
- NEW - Art.45 public assessment report for Zydol (Tramadol Hydrochloride)
- NEW - Art.46 public assessment report for Kreon 25 000 (Pancreatin)
- NEW - PSUR assessment reports for Chlorpromazine and Buprenorphine
- NEW- Mandate for the Non-Prescription Medicinal Products Task Force