Revision of the EU Variations Regulations

GMP News
29 August 2007
 

Revision of the EU Variations Regulations

 
On 31 July 2007 the EU Commission published a summary record of the 62nd meeting which was held on 21 May 2007. Different legislatives issues were presented at this meeting, among others the next steps of the Variations Regulations. The following text is taken from the summary record:

"The Commission presented results of a stakeholder consultation on a concept paper, which ended on 20 December 2006. In total 28 written responses were submitted, which expressed a broad support for all five key items of the proposal, although some concerns were also expressed:

  • Harmonisation to national authorisation: outcome of the revision should be a simple
    Procedure
  • The incorporation of new concepts established or in development at ICH level (Q8, Q9 and Q10): voluntary character should be maintained and a transitional period should be introduced
  • "Do and tell" procedure as regards certain minor changes: the scope of the annual report, any changes should not increase workload
  • Work sharing between Member States; some delegations considered that the previous pilot projects were not fully successful
  • Introduction of the Type IB procedure as the default procedure: comments focused on practical details
  • In the discussion it was stressed by certain Member States' delegations, that the revision of the Variations Regulations should be mirrored in the corresponding national legislation governing pricing and reimbursement procedures. In conclusion, the Commission representatives outlined the next steps, in particular the objective to have a round of open public consultation on the basis of a draft Regulation in the course of 2007. An impact assessment of proposed revisions is currently ongoing."
     

    Conference Tip:
     
    Nicolas Rossignol, European Commission, DG Enterprise& Industry, Belgium will give a presentation at the European API Conference in Warsaw on 24 - 26 October. He will cover the following topics:
     
    Revision of the EU Variations Regulations
    - Backgrounds, reasons and objectives regarding the new revision
    - The revision process from 2006 to the present
    - Current status
    - Next steps
    - What are the most important changes in the new Variations Regulations vs. the previous
      Regulations?
     
    To read more about the Conference please visit: www.api-conference.org

     
    Prepared by:
    Oliver Schmidt
    On behalf of the European Compliance Academy (ECA)
     
    Source:
    http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_07/pharm555_summary-record_2007-05-21.pdf

     

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