What's new (last 6 Month)

This is the 'What's new' page for the Human Medicines section

Added in February 2012

1 February 2012

• UPDATE - RMS Day 70 Preliminary Assessment Report - Overview and List of Questions
  
  

Added in January 2012

30 January 2012

• UPDATE - Information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC, as amended
  CMDh: document updated

• UPDATE - Implementation of Commission Decisions after Article 30 referral procedures
  CMDh: document updated

• UPDATE - Update on monitoring of medicinal products originating from Japan for the possibility of radioactivity
  CMDh: document updated

• UPDATE - Revision of the cover letter template for submission of application dossier for marketing authorisation
  CMDh: document updated

• NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Minoxidil
  CMDh: document added

• NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Fenofibrate
  CMDh: document added

• NEW - Art. 45 Paediatric Regulation - Public Assessment Report for Phenoxymethylpenicillin
  CMDh: document added

• NEW - Ketoprofen and ketorolac and risk of gastrointestinal toxicity
  CMDh: document added

• NEW - Escitalopram and risk of QT prolongation
  CMDh: document added

• NEW - Oral methotrexate - Review on potential fatal overdose due to medication errors
  CMDh: document added

• NEW - HMG-CoA reductase inhibitors and the risk of new onset diabetes/impaired glucose metabolism
  CMDh: document added

• NEW - Rosuvastatin and risk of gynaecomastia
  CMDh: document added

• NEW - Topiramate and risk of congenital malformations
  CMDh: document added

27 January 2012

• NEW - Report from meeting held on 16 - 19 January 2012
  CMDh: document added

25 January 2012

• UPDATE - Information on national timeslot booking systems and recommendations for requests to act as RMS (January 2012)
  CMDh: document updated

• NEW - Meeting with Interested Parties - 14 November 2011
  CMDh: document added

 05 January 2012

• UPDATE - List of the active substances included in the worksharing procedure
  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

• UPDATE - Information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC, as amended
  CMDh: document updated

• UPDATE - Templates used by Reference Member State for DCP Day 70-preliminary assessment reports and preliminary assessment report for generics
  CMDh: documents updated

• UPDATE - CMDh procedural advice on changing the RMS
  CMDh: document updated

• NEW - Effect of Strattera (atomoxetine) on blood pressure and heart rate from review of MAH clinical trial database
  CMDh: document added

• NEW - Tibolone (Livial) and risk of venous thromboembolism (VTE) and other risks
  CMDh: document added

• UPDATE - PSUR Work Sharing list, alphabetic order (PDF & MS Excel versions)
  HMAh: document updated

• UPDATE - PSUR Synchronisation List, alphabetic order (PDF & MS Excel versions)
  HMAh: document updated

 

Added in December 2011

19 December 2011

• NEW - Guidance on the submission-updating of Risk Management Plans to reflect ‘atypical femoral fractures’ 
  CMDh: document added 

• NEW - Abbreviated core bisphosphonate RMP for atypical femoral fracture
  CMDh: document added

• NEW - Report from the meeting held on 12 - 14 December 2011
  CMDh: document added

12 December 2011

• UPDATE - Core SmPC for trivalent influenza vaccines (December 2011)
  CMDh: document updated

• UPDATE - Core Package Leaflet for trivalent influenza vaccines (December 2011)
  CMDh: document updated

5 December 2011

• NEW- Presentation on the status of the ASMF-project as at November 2011
  CMDh: Link added

Added in November 2011

30 November 2011

• NEW - Bio-analytical studies conducted at Cetero Research Houston, Texas (former BA Research)
  CMDh: document added

28 November 2011

• UPDATE - Revision of the Best Practice Guide on the use of the e-CTD in MRP and DCP
  CMDh: document updated

25 November 2011

• UPDATE - Information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC, as amended
  CMDh: document updated

• NEW - CMDh meeting with representatives of Interested Parties - 14 November 2011
  CMDh: documents added

• UPDATE - Recommendation on submission dates for Applicants of the Decentralised Procedure (DCP)
  CMDh: document updated

• UPDATE - Recommendation on submission dates for Applicants of the Mutual Recognition Procedure (MRP)
  CMDh: document updated

• NEW - Question & Answer on the implementation of QRD templates for package leaflets
  CMDh: document added

• UPDATE - Revision of the Member States’ recommendation on extension application in MRP/DCP
  CMDh: document updated

• UPDATE - Revision of the flow chart for mutual recognition procedure
  CMDh: document updated

• UPDATE - Revision of the Best Practice Guide on variations for the submission and processing of variations in mutual recognition procedures
  CMDh: document updated

• UPDATE - Revision of the Best Practice Guide for exchange of information regarding orphan medicinal products between EMA and National Competent Authorities
  CMDh: document updated

• NEW - List of MRP/DCP finalised in 2006-2010 with new active substances
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for Acarbose
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for Thiamazole
  CMDh: document added

• NEW - Domperidone and risk of QTc prolongation, serious ventricular arrhythmias and sudden cardiac death
  CMDh: document added

24 November 2011

• NEW - Report from the meeting held on 14-16 November 2011
  CMDh: document added

4 November 2011

• UPDATE - Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended
  CMDh: document updated

• UPDATE - Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended
  CMDh: document updated

Added in October 2011

28 October 2011

• NEW - Compilation of CMDh Contact Points
  CMDh: document added

• LINK - EMA Question & Answers on the Paediatric Regulation
  CMDh: link added

• UPDATE - Templates for Active Substance Mater File assessment report, Day 70 Preliminary assessment report on Quality and Day 120/180 Quality assessment reports
  CMDh: documents updated

• UPDATE - Standard Operating Procedure for Article 61(3) changes to patient information
  CMDh: document updated

• NEW - Member state agreement upon conditions under which the RMS can start MRP/DCP
  CMDh: document added

• UPDATE - Questions & Answers on naming of generics
  CMDh: Q&A updated

• NEW - Question & Answer on which reference product to use for the bioequivalence study in case the relevant strength of the originator is not marketed anymore
  CMDh: Q&A added

• UPDATE - CMDh recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
  CMDh: document updated

• UPDATE - Information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC
  CMDh: document updated

• NEW - Key elements for SmPC and PL regarding Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) for 14 “high risk” substance
  CMDh: document added

• NEW - Powder formulations of Plantago ovata seeds and allergic reactions after prolonged occupational exposure
  CMDh: document added

• NEW - Antipsychotics (conventional and atypical) and use during the third trimester of pregnancy and risk of abnormal muscle movements and/or withdrawal symptoms in newborns
  CMDh: document added

27 October 2011

• NEW - Citalopram and the risk of QT prolongation
  CMDh: document added

26 October 2011

• NEW - Report from the meeting held on 17-19 October 2011
  CMDh: document added

11 October 2011

• PUBLIC CONSULTATION - Procedural advice: Automatic validation of MR/Repeat-use/DC Procedures (October 2011) 
  CMDh: document added

7 October 2011

• UPDATE - CMDh recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
  CMDh: document updated

• UPDATE - Information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC
  CMDh: document updated

• NEW - Summary assessment report on Paracetamol use at therapeutic doses in severe hepatic impairment or severe haemolytic anaemia
  CMDh: document added

 5 October 2011

• NEW - Minutes of Meeting with Interested Parties - 20 June 2011
  CMDh: document added 

• UPDATE - PSUR Work Sharing list, alphabetic order (PDF & MS Excel versions)
  HMAh: document updated

• UPDATE - PSUR Synchronisation List, alphabetic order (PDF & MS Excel versions)
  HMAh: document updated

Added in September 2011

30 September 2011

• UPDATE: Core SmPC for trivalent influenza vaccines (September 2011)
  CMDh: document updated

• UPDATE: Core Package Leaflet for trivalent influenza vaccines (September 2011)
  CMDh: document updated

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for timolol
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for cyclophosphamide
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for isradipine
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for quinapril
  CMDh: document added

• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Fibrogammin P (human coagulation factor XIII)
  CMDh: document added

• UPDATE - List of the active substances included in the worksharing procedure
  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

• UPDATE - Beta-blocking agents for ophthalmic use and systemic adverse drug reactions after ophthalmic administration
  CMDh: document updated

• UPDATE - EMA/CMDh explanatory notes on variation application form
  CMDh: document updated

• UPDATE - Timetable for request to CMDh for a recommendation on the classification of an unforeseen variation - Article 5 (September 2011)
  CMDh: document updated

• UPDATE - Timetable for MRP/DCP applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC (September 2011)
  CMDh: document updated

• UPDATE - SOP on Disagreement in procedures and referral to CMDh (September 2011)
  CMDh: document updated

• UPDATE - SOP on decentralised procedures (September 2011)
  CMDh: document updated

• UPDATE - Implementation of Commission Decisions after Article 30 referral procedures
  CMDh: document updated

27 September 2011

•  NEW - Report from the meeting held on 19-21 September 2011
  CMDh: document added

07 September 2011

• NEW - 2011 - 1st Semester Statistics for New Applications (MRP/DCP), Art.29 CMDh Referrals and Art.5 Variation
  CMDh: document added

02 September 2011

• UPDATE - Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures (September 2011)
  CMDh: document updated

01 September 2011

• NEW - Mandate for the Joint CMDh/GCP Inspectors Subgroup
  CMDh: document added

Added in August 2011

30 August 2011

• UPDATE - CMDh QRD annotated template for MRP/DCP
  CMDh: document updated

• UPDATE - Recommendation on contacts with representative organisations
  CMDh: document updated

26 August 2011

• NEW - Monitoring of medicines originating from Japan (August 2011)
  CMDh: document added

• UPDATE - Information on national timeslot booking systems and recommendations for requests to act as RMS
  CMDh: document updated

9 August 2011

• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Neurontin
  CMDh: document added

• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Strattera
  CMDh: document added

• UPDATE - Procedural Advice on Repeat Use
  CMDh: document updated

• UPDATE - CMDh Recommendation for Marketing Authorisation Holders on the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures
  CMDh: document updated

• UPDATE - Best Practice Guide on Assessment Report in the Mutual Recognition and Decentralised Procedures
  CMDh: document updated

• UPDATE - Question & Answer on how to change the name of a medicinal product prior to granting a marketing authorisation
  CMDh: document updated

• UPDATE - Templates used by Concerned and Reference Member State to request and initiate a referral to the CMDh
  CMDh: documents updated

• UPDATE - List of the active substances included in the worksharing procedure
  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

• UPDATE - Information on national timeslot booking systems and recommendations for requests to act as RMS
  CMDh: document updated

• UPDATE - Requirements on electronic submissions for New Applications within MRP, DCP or National procedures
  CMDh: document updated

• UPDATE - Compiled list of contact points for Advice on MRP and DCP
  CMDh: document updated

• UPDATE - Contact e-mail addresses for submission of Paediatric information in Member States (Articles 45 and 46 of the Regulation of the European Parliament and of the Council (EC) No 1901/2006)
  CMDh: document updated

• UPDATE - Contact e-mail addresses for submission of electronic response documents during MRP and DCP
  CMDh: document udpated

• UPDATE - Contact addresses for submission of translations in MRP and DCP
  CMDh: document updated

• UPDATE - Notification for product information amendment under article 61(3) - (not accompanying a variation change)
  CMDh: document updated

5 August 2011

• NEW - Beta-blocking agents for ophthalmic use and systemic adverse drug reactions after ophthalmic administration
  CMDh: document added

• NEW - Hydrochlorothiazide (HCTZ) and use in lactation + consolidated wording for the SmPC and PL of ACE-inhibitors alone or in combination with HCTZ in pregnancy and lactation
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for aciclovir
  CMDh: document added

Added in July 2011

28 July 2011

• UPDATE - CMDh Best Practice Guide for the submission and processing of variations in the mutual recognition procedure
  CMDh: document updated

•  NEW - Report from the meeting held on 18-20 July 2011
  CMDh: document added

18 July 2011

• NEW - Mandate of the Working Group on Active Substance Master File Procedures
  CMDh: document linked
13 July 2011

• UPDATE - Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008
  CMDh: document updated

• UPDATE - CMDh Rules of Procedure
  CMDh: document updated

12 July 2011

• NEW - Hormone Replacement Therapy - Core Package Leaflet (July 2011)
  CMDh: document added

6 July 2011

• UPDATE - Declaration form for submission of DDPS already approved by a competent authority
  CMDh: document updated

• UPDATE - CMDh guidance for Declaration form submission DDPS already approved by a competent authority
  CMDh: document updated

• UPDATE - List of the active substances included in the worsharing procedure
  CMDh: document updated
 
• UPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
  CMDh: document updated
 
•  UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
  CMDh: document updated
 
• NEW - Art.45 Paediatric Regulation - Public Assessment Report for alendronate sodium
  CMDh: document added
 
• NEW - Art.45 Paediatric Regulation - Public Assessment Report for milrinone
  CMDh: document added
 
• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Famvir and associated names (famciclovir)
  CMDh: document added
 
• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Xatral (alfuzosin)
  CMDh: document added
 
• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Afluria/Enzira (influenza vaccine)
  CMDh: document added
 
• UPDATE - Best Practice Guide for the Reference Member State in the MRP/DCP
  CMDh: document updated
 
• NEW - Meeting with Interested Parties - 20 June 2011
  CMDh: document added
 
• NEW - Meeting with Interested Parties on the Self-Medication Project - 20 June 2011
  CMDh: document added

• UPDATE - Information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC
  CMDh: document updated
 
• UPDATE - Information on applications referred in accordance with Article 30(2) of Directive 2001/83/EC
  CMDh: document updated

Added in June 2011

29 June 2011

• UPDATE - PSUR Work Sharing list, alphabetic order (PDF & MS Excel versions)
  HMAh: document updated

• UPDATE - PSUR Synchronisation List, alphabetic order (PDF & MS Excel versions)
  HMAh: document updated

• NEW - Report from the meeting held on 20-22 June 2011
  CMDh: document added

10 June 2011

• UPDATE - Information on national timeslot booking systems and recommendations for requests to act as RMS
  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

7 June 2011

• UPDATE - Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended
  CMDh: document updated

• UPDATE - Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended
  CMDh: document updated

• UPDATE - Art.45 Paediatric Regulation - Public Assessment Report for Topiramate
  CMDh: document updated 

6 June 2011

• UPDATE - Art.45 Paediatric Regulation - Public Assessment Report for Fentanyl
  CMDh: document updated

• UPDATE - Tracking table for information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83, as amended
  CMDh: document updated

•  UPDATE - Criteria for selection of products for SmPC harmonisation
  CMDh: document updated

• UPDATE - Recommendation on contacts with representative organisations
  CMDh: document updated

• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Singulair (montelukast)
  CMDh: document added

• NEW - Art.46 Paediatric Regulation - Public Assessment Report for Elidel (pimecrolimus)
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for Ipratropium bromide and salbutamol
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for Ipratropium bromide
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for Flumazenil
  CMDh: document added

• NEW - Art.45 Paediatric Regulation - Public Assessment Report for Clindamycin
  CMDh: document added

• UPDATE - CMDh recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
  CMDh: document updated

Added in May 2011

25 May 2011

• NEW - Report from the meeting held on 16-18 May 2011
  CMDh: document added

06 May 2011

• UPDATE - CMDh Work plan for 2011
  CMDh: document updated

05 May 2011

• UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
  CMDh: document updated

02 May 2011

• UPDATE - Compiled list of contact points for Advice on MRP and DCP
  CMDh: document updated