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What's new (last 6 Month)

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

Added March 2010

09 March 2010

  • UPDATE - Q&As on the SOP Disagreement in procedures referred to CMD(h) HERE
    CMD(h): document updated

  • UPDATE - Guidance on oral explanations to CMD(h) - Annex to CMD(h) SOP on Disagreement in Procedures, Referral to CMD(h) HERE
    CMD(h): document updated

  • UPDATE - CMD(h) Standard Operating Procedure - Disagreement in procedures referred to CMD(h) (incl. Annex: Guidance on OE toCMDh) HERE
    CMD(h): document updated

08 March 2010

  • UPDATE - Draft Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure HERE
    CMD(h): document updated
  • UPDATE - Q&As for the submission of Variations according to the Commission Regulation (EC) 1234/2008 HERE
    CMD(h): document updated
  • UPDATE - Information on national timeslot booking systems and recommendations for requests to act as RMS HERE
    CMD(h): document updated

01 March 2010

  • NEW - Q&As on suspension of Marketing Authorisation following a referral according to Article 29(4) of Directive 2001/83/EC HERE
    CMD(h): document added

Added February 2010

25 February 2010

UPDATE - Information on national timeslot booking systems and recommendations for requests to act as RMS HERE
CMD(h): document updated

24 February 2010

  • UPDATE - Implementation of New Variation Regulation in each Member State for Medicinal Products Authorised by purely national procedures HERE
    CMD(h): document updated
  • UPDATE - European Medicines Agency/CMDh explanatory notes on Variation Application Form HERE
    CMD(h): document updated
  • UPDATE - Requirements on electronic submissions for New Applications within MRP, DCP or National procedures HERE
    CMD(h): document updated

23 February 2010

  • UPDATE - Compiled list of contact points for Advice on MRP and DCP HERE
    CMD(h): document updated
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Amikacin sulphate HERE
    CMD(h): document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Gentamicin sulphate HERE
    CMD(h): document added

22 February 2010

  • UPDATE - Tracking table for information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC HERE
    CMD(h): document updated
  • NEW - Report from the meeting held on 15-16 February 2010 HERE
    CMD(h): document added

11 February 2010

  • NEW - CMD(h) Summary of Activities 2009 HERE
    CMD(h): document added

09 February 2010

  • UPDATE - Compiled list of contact e-mail addresses for submission of electronic response documents during Mutual Recognition & Decentralised Procedures HERE
    CMD(h): document updated

  • UPDATE - Compiled list of contact addresses for submission of Paediatric information in Member States - Art. 45 & 46 HERE
    CMD(h): document updated

  • UPDATE - Compiled list of contact e-mail addresses for submission of electronic version of the responses to the List of Questions for applications referred to the CMD(h) HERE
    CMD(h): document updated

  • UPDATE - Compiled list of contact addresses for submission of translations in MRP and DCP HERE
    CMD(h): document updated 

  • UPDATE - Compiled list of contact points for Advice on MRP and DCP HERE
    CMD(h): document updated

  • NEW - CMDh Workplan 2010 HERE
    CMD(h): document added

08 February 2010

  • NEW - 2009 Statistics for New Applications (MRP/DCP) and Art.29 CMD(h) Referrals HERE
    CMD(h): document added

02 February 2010

  • UPDATE - Hormone Replacement Therapy - Core SPC HERE
    CMD(h): document updated

01 February 2010

  • NEW - Implementation of New Variation Regulation in each Member State for Medicinal Products Authorised by purely national procedures HERE
    CMD(h): document added
  • UPDATE - CMDh BPG on the use of eCTD in MRP/DCP HERE
    CMDh: document updated

Added January 2010

 

29 January 2010

  • NEW - Template of letter of intent for the submission of a worksharing procedure HERE
    CMDh: document added
  • UPDATE - Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 HERE
    CMDh: document updated
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Tranexamic acid HERE
    CMDh: document added
  • NEW - Propylthiouracil and the risk of serious liver injury (agreed wording in SPC and PL) HERE
    CMDh: document added
  • NEW - Valproic Acid and the risk of interaction with carbapenems (agreed wording in SPC and PL) HERE
    CMDh: document added
  • NEW - Workplan 2010 on Paediatric Regulation HERE
    CMDh: document added
  • NEW - Statistics on Member States acting as rapporteurs in Paediatric worksharing procedures HERE
    CMDh: document added
  • NEW - Minutes from the meeting held on 16 November 2009 HERE
    CMDh: document added
  • UPDATE - Template on assessment report feedback form HERE
    CMDh: document updated
  • UPDATE - Tracking table for information on applications referred in accordance with Article 30(2) of Directive 2001/83/EC 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/EC, as amended HERE
    CMDh: document updated

27 January 2010

  • NEW - Report from the meeting held on 18-19 January 2010 HERE
    CMDh: document added

11 January 2010

  • UPDATE - Tracking table for information on applications referred to the CMDh in accordance with Article 29(1) of Directive 2001/83/EC, as amended HERE
    CMDh: document updated
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Bisacodyl HERE
    CMDh: document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Colestyramine HERE
    CMDh: document added
  • NEW - Art. 45 Paediatric Regulation - List of active substances for which data has been submitted HERE
    CMDh: document added

08 January 2010

  • NEW - Recommendations on submission and assessment in paediatric worksharing HERE
    CMDh: document added
  • UPDATE - Public Assessment Report Template HERE
    CMDh: document updated
  • UPDATE - Decentralised Procedure Members States' SOP HERE
    CMDh: document updated

04 January 2010

  • NEW - European Medicines Agency/CMDh explanatory notes on Variation Application Form (Human medicinal products only) HERE
    CMDh: document added

Added December 2009

18 December 2009

  • UPDATE - Best Practice Guide on Break-out Sessions HERE
    CMDh: document updated
  • NEW - Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 HERE
    CMDh: document added
  • UPDATE - Cover Letter for Variation Applications in the Mutual Recognition Procedure HERE
    CMDh: document updated
  • UPDATE - List of active substances included in the work-sharing procedure Article 45 HERE
    CMDh: document updated
  • NEW - Report from the meeting held on 14-16 December 2009 HERE
    CMDh: document added

12 December 2009

  • UPDATE - Guidance Document for Marketing Authorisation Holders on Submissions under the EU PSUR synchronisation scheme HERE
    HMAh: document updated

  • UPDATE - PhVWP and CMD(h) Best Practice Guide for Work Sharing oncerning the Assessment of PSURs of Products for which an EU harmonised virtual Birth Date and related harmonised Data Lock Point have been agreed HERE
    HMAh: document updated

  • NEW - Template for the P-RMS Assessment Report HERE
    HMAh: document added

8 December 2009

  • NEW - Minutes from the meeting with Interested Parties on Paediatric Regulation, held on 21st September 2009 HERE
    CMD(h): document added

4 December 2009

  • NEW - Recommendations on transparency: Requests for access to PSURs HERE
    HMAj: document added

3 December 2009

  • UPDATE - Q&A on the Paediatric Regulation HERE
    CMD(h): document added

Added November 2009

27 November 2009

  • NEW - Q&A on New Variation Regulation - Transition period HERE
    CMD(h): document added

26 November 2009

  • NEW - Cyproterone acetate and the risk of meningiomas (agreed wording in SPC and PL) HERE
    CMD(h): document added
  • NEW - Association of HMG-CoA Reductase Inhibitors with safety concerns (agreed wording in SPC and PL) HERE
    CMD(h): document added
  • NEW - Phenytoin-related Stevens-Johnson Syndrome (SJS) in association with HLA-B*1502 allele in individuals of Thai or Han Chinese origin (agreed wording in SPC and PL) HERE
    CMD(h): document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Amlodipine HERE
    CMD(h): document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Felodipine HERE
    CMD(h): document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Glucosamine HERE
    CMD(h): document added
  • NEW - Art.45 Paediatric Regulation - Public Assessment Report for Lisinopril HERE
    CMD(h): document added

25 November 2009

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

24 November 2009

  • NEW – Mandate of the Working Party on the Future of the CMDh HERE
    CMD(h): document added
  • NEW – Presentations from the CMDh Meeting with Interested Parties held on 16 November 2009 HERE
    CMD(h): document added
  • UPDATE - CMDh Position paper on processing of generic applications when the generic has more indications or fewer indications than the reference product in the CMS HERE
    CMD(h): document added

23 November 2009

  • UPDATE – Recommendations on submission dates for applicants of the Decentralised Procedure HERE
    CMD(h): document added
  • UPDATE – Recommendations on submission dates for applicants of the Mutual Recognition Procedure HERE
    CMD(h): document added
  • NEW - Report from the meeting held on 16-18 November 2009 HERE
    CMD(h): document added

20 November 2009

  • NEW - Stakeholder Information from the HMA meeting in Uppsala, Sweden on 28-29 October 2009 HERE 
    HMAj : document added
  • NEW - Special press release on e-submissions (Nov 2009) HERE
    HMAj : document added

11 November 2009

  • UPDATE - Contact points for advice on Mutual Recognition and Decentralised Procedures HERE
    CMD(h): document added

9 November 2009

  • UPDATE - Template Rapporteur's Preliminary/Final AR for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No 1901/2006, as amended HERE
    CMD(h): document added

4 November 2009

  • UPDATE - Questions and Answers on the Paediatric Regulation HERE
    CMD(h): document added
  • NEW - Short-acting beta agonists and risk of myocardial ischemia (agreed wording in SPC and PL) HERE
    CMD(h): document added

3 November 2009

  • UPDATE - CMD(h) BPG Article 45 - Paediatric Regulation HERE
    CMD(h): document added
  • UPDATE - CMD(h) BPG Article 46 - Paediatric Regulation HERE
    CMD(h): document added
  • UPDATE - Template Rapporteur's Preliminary/Final AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006, as amended HERE
    CMD(h): document added
  • NEW - Apomorphine containing products and risk of QT interval prolongation (agreed wording in SPC and PL) HERE
    CMD(h): document added
  • NEW - Vigabatrin and MRI abnormalities and movement disorders (agreed wording in SPC and PL) HERE
    CMD(h): document added
  • NEW- Antipsychotics and increased mortality (agreed wording in SPC and PL) HERE
    CMD(h): document added 
  • NEW - Antipsychotics and risk of venous thromboembolism (agreed wording in SPC and PL) HERE
    CMD(h): document added

Added October 2009

29 October 2009

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

26 October 2009

  • UPDATE - Draft CMD(h) BPG for the Submission and Processing of Variations in the Mutual Recognition Procedure HERE
    CMD(h): document added
  • NEW - Report from the meeting held on 19-21 October 2009 HERE
    CMD(h): document added

13 October 2009

  • UPDATE - Core Summary of Product Characteristics for Trivalent Influenza Vaccines HERE
    CMD(h): document added
  • UPDATE - Core Package Leaflet for Trivalent Influenza Vaccines HERE
    CMD(h): document added