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What's new (last 6 Month)

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

Added in August 2010

25 August 2010 

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

20 August 2010 

  • UPDATE - Isotretinoin and the risk of erythema multiforme HERE
    CMDh: document added

05 August 2010

  • UPDATE - Public AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006, as amended HERE
    CMDh: document updated
  • UPDATE - Public AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended HERE
    CMDh: document updated
  • NEW - Template on Validation for Application on Marketing Authorisation HERE
    CMDh: document added
  • UPDATE - Tracking table for information on applications referred to the CMDh in accordance with Article 29 (1) of Directive 2001/83, as amended HERE
    CMDh: document updated
  • NEW - 1st Semester 2010 - Statistics for New Applications (MRP/DCP) & Art.29 CMDh Referrals HERE
    CMDh: document added
  • NEW - Camphor containing ointments and risk of unintented oral ingestion HERE
    CMDh: document added
  • UPDATE - Recommendations for implementing Commission Decisions following an Art. 29 Application under the Paediatric Regulation HERE
    CMDh: document updated
  • UPDATE - Best Practice Guide Article 45 - EU Worksharing procedure HERE
    CMDh: document updated
  • NEW - Art.46 Paediatric Regulation - Public Assessment Report for Famciclovir HERE
    CMDh: document added
  • NEW - Art.46 Paediatric Regulation - Public Assessment Report for Lansoprazole HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Phleum pratense HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Canis familiaris / Felis domesticus HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Mirtazapine HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Amoxicillin / Clavulanic Acid HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Amoxicillin / Amimox HERE
    CMDh: document added
  • UPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 HERE
    CMDh: document updated
  • UPDATE - Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 HERE
    CMDh: documet updated
  • UPDATE - Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure HERE
    CMDh: document updated

Added in July 2010

 

27 July 2010

  •  NEW - Draft List of Products for SPC Harmonisation - 2010 HERE
    CMDh: document added
  • NEW - Report from the meeting held on 19-21 July 2010 HERE
    CMDh: document added

15 July 2010

  • UPDATE - CMDh Standard Operating Procedure for Article 61(3) changes to patient information and the notification for product information amendment under Article 61(3) HERE
    CMDh: document updated

13 July 2010

  • UPDATE - Contact e-mail addresses for submission of electronic version of the Responses to the List of Questions for Applications referred to the CMDh HERE
    CMDh: document updated
  • UPDATE - Compiled list of contact points for Advice on MRP/DCP HERE
    CMDh: document updated

07 July 2010

  • UPDATE - Best Practice Guide Article 46 - EU Worksharing procedure HERE
    CMDh: document updated
  • UPDATE - Art.45 Paediatric Regulation - Public Assessment Report for Bisacodyl HERE
    CMDh: document updated

06 July 2010

  • UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation HERE
    CMDh: document updated
  • UPDATE - List of the active substances included in the work-sharing procedure HERE
    CMDh: document updated
  • UPDATE - Tracking table for information on applications referred in accordance with Artilce 30(2) of Directive 2001/83 HERE
    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 HERE
    CMDh: document updated
  • UPDATE - Requirements on electronic submissions for New Applications within MRP, DCP or National procedures HERE
    CMDh: document updated
  • UPDATE - Templates - DCP (AR/Comments) D100 - D145 - D205 HERE
    CMDh: document updated
  • UPDATE - Information to be submitted by the Member State of the European Reference Medicinal Product HERE
    CMDh: document updated
  • UPDATE - Tracking table for information on CMDh Recommendation for classification of unforseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 HERE
    CMDh: document updated
  • UPDATE - Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 HERE
    CMDh: document updated

02 July 2010

  • NEW - Presentations of the meeting with Interested Parties which took place on the 21st June 2010 HERE
    CMDh: document added

01 July 2010

  • UPDATE - Questions & Answers on the SOP Disagreement in Procedures, Referral to CMDh HERE
    CMDh: document updated
  • UPDATE - CMDh Standard Operating Procedure - Disagreement in procedures referred to CMDh (incl. Annex: Guidance on OE to CMDh) HERE
    CMDh: document updated
  • UPDATE - CMDh Recommendations on implementation of Article 30 Decisions cf. Directive 2001/83/EC, as amended for Generic/Hybrid/Biosimilar Medicinal Products approved through MRP/DCP HERE
    CMDh: document updated
  • NEW - Best Practice Guide on communication and implementation of safety information HERE
    CMDh: document added
  • NEW - Art.46 Paediatric Regulation - Public Assessment Report for tacrolimus HERE
    CMDh: document added
  • NEW - Art.46 Paediatric Regulation - Public Assessment Report for granisetron HERE
    CMDh: document added
  •  NEW - Art.45 Paediatric Regulation - Public Assessment Report for mianserin HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for filgrastim HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for ciclosporin HERE
    CMDh: document added
  • NEW- Rosuvastatin and higher incidence of diabetes mellitus and glucose metabolism disorders in healthy individuals without hyperlipidaemia HERE
    CMDh: document added
  • UPDATE - Fluoxetine and risk of congenital malformations HERE
    CMDh: document updated
  • NEW - Report from the meeting held on 21-23 June 2010 HERE
    CMDh: document added

Added in June 2010

15 June 2010

  • UPDATE - Compiled list of contact points for Advice on MRP/DCP HERE
    CMDh: document updated
  • UPDATE - CMDh Best Practice Guide on the use of eCTD in the MRP/DCP HERE
    CMDh: document updated

14 June 2010

  • UPDATE - PSUR Work Sharing list, alphabetic order HERE
    HMA(h): document updated
  • UPDATE - PSUR Work Sharing list, alphabetic order, xls version HERE
    HMA(h): document updated
  • UPDATE - Synchronisation List, alphabetic order, Status: (202.54 kb) HERE
    HMA(h): document updated

03 June 2010

  • UPDATE - EMA/CMDh explanatory notes on Variation Application Form HERE
    CMDh: document updated
  • UPDATE - CMDh annotated QRD template for MRP/DCP HERE
    CMDh: document updated

Added May 2010

26 May 2010

  • NEW - Mandate for CTS Working Group HERE
    CMDh: document added
  • UPDATE - Timetables for request to CMDh for a recommendation on the classification of an unforeseen variation - Article 5 HERE
    CMDh: document updated
  • UPDATE - CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure HERE
    CMDh: documemt updated
  • UPDATE - Tracking table for information on applications referred in accordance with Artilce 30(2) of Directive 2001/83 HERE
    CMDh: documet updated
  • UPDATE - Tracking table for information on applications referred to the CMDh in accordance with Article 29 (1) of Directive 2001/83, as amended HERE
    CMDh: document updated
  • NEW - Q&A on Data Exclusivity HERE
    CMDh: question added
  • NEW - Examples for acceptable and not acceptable groupings for MRP/DCP products HERE
    CMDh: document added

24 May 2010

  • UPDATE - Flow chart of the Decentralised Procedure HERE
    CMDh: document updated
  • NEW - Questions & Answers - The use of eCTD on MRP/DCP HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Dermatophagoides pteronyssinus/farinae HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Sevoflurane HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Beclometasone dipropionate HERE
    CMDh: document added
  • UPDATE - Tracking table for information on CMDh Recommendation for classification of unforseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 HERE
    CMDh: document updated
  • NEW - Report from the meeting held on 17-19 May 2010 HERE
    CMDh: document added

13 May 2010

  • UPDATE - Contact addresses for the submission of Paediatric information in Member States HERE
    CMDh: document updated
  • UPDATE - Contact e-mail addresses for submission of electronic version of the responses to the list of questions for applications referred to the CMDh HERE
    CMDh: document updated
  • UPDATE - Contact addresses for Submission of Translations in Mutual Recognition and Decentralised Procedures HERE
    CMDh: document updated
  • UPDATE - Contact e-mail addresses for submission of electronic  response documents during Mutual Recognition and Decentralised Procedures HERE
    CMDh: document updated
  • UPDATE - Compiled list of contact points for Advice on MRP/DCP HERE
    CMDh: document updated

Added April 2010

 

28 April 2010

  • UPDATE - Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 HERE
    CMDh: document added
  • UPDATE - EMA/CMDh explanatory notes on Variation Application Form HERE
    CMDh: document updated
  • NEW - Tracking table for information on CMDh Recommendation for classification of unforseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 HERE
    CMDh: document added
  • UPDATE - Tracking table for information on applications referred in accordance with Artilce 30(2) of Directive 2001/83 HERE
    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 HERE
    CMDh: document updated
  • UPDATE - List of active substances and agreed SPC wordings - EU work sharing procedure in the assessment of paediatric data HERE
    CMDh: document updated

27 April 2010

  • UPDATE - Art.45 Paediatric Regulation - Public Assessment Report for Levothyroxine HERE
    CMDh: document updated
  • NEW - Previous Worksharing Project - Public Assessment Report for Suprane HERE
    CMDh: document added
  • NEW - Art.46 Paediatric Regulation - Public Assessment Report for Strattera HERE
    CMDh: document added
  • NEW - Art.46 Paediatric Regulation - Public Assessment Report for Elidel HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Betula verrucosa HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Paclitaxel HERE
    CMDh: document added 

26 April 2010

  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Rifaximin HERE
    CMDh: document added
  •  NEW - Report from the meeting held on 19-20 April 2010 HERE
    CMDh: document added

19 April 2010

  • UPDATE - Contact addresses for the submission of Paediatric information in Member States HERE
    CMDh: document updated
  • UPDATE - Contact e-mail addresses for submission of electronic version of the responses to the list of questions for applications referred to the CMDh HERE
    CMDh: document updated
  • UPDATE - Contact addresses for Submission of Translations in Mutual Recognition and Decentralised Procedures HERE
    CMDh: document updated
  • UPDATE - Contact e-mail addresses for submission od electronic response documents during Mutual Recognition & Decentralised Procedures HERE
    CMDh: document updated
  • UPDATE - Compiled list of contact points for Advice on MRP/DCP HERE
    CMDh: document updated

12 April 2010

  • UPDATE - Final list of products for SPC Harmonisation – 2009 HERE
    CMDh: document updated
  • UPDATE - List of the active substances included in the work-sharing procedure HERE
    CMDh: document updated

08 April 2010

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

07 April 2010

  • UPDATE - Contact addresses for the submission of Paediatric information in Member States HERE
    CMDh: document updated
  • UPDATE - Contact e-mail addresses for submission of electronic version of the responses to the list of questions for applications referred to the CMDh HERE
    CMDh: document updated
  • UPDATE - Contact addresses for Submission of Translations in Mutual Recognition and Decentralised Procedures HERE
    CMDh: document updated
  • UPDATE - Contact e-mail addresses for submission od electronic response documents during Mutual Recognition & Decentralised Procedures HERE
    CMDh: document updated
  • UPDATE - Compiled list of contact points for Advice on MRP/DCP HERE
    CMDh: document updated

06 April 2010

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