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3: Human Medicines (ALT-U)
- 3.1: Heads of Agencies (ALT-E)
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- 3.3: MRI Product Index (ALT-R)
- 3.4: Directory (ALT-I)
4: Veterinary Medicines (ALT-V)

You are here: Human Medicines > CMD(h) > What's new history

3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
3.2.5: CMDh-Referrals
3.2.6: Product Information (ALT-T)
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-G)
3.2.10: Paediatric Regulation (ALT-N)
3.2.11: Questions & Answers (ALT-Q)
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-W)

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