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Regulatory Affairs - Romania

Tuesday, 21 April 2009

Important notice to the attention of Marketing Authorisation Holders

The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 16th 17th February 2009 (http://www.hma.eu/186.html)

1.  Common request form for reference member state in a decentralised procedure
The Heads of Medicines Agencies have, in cooperation with the CMD(h), developed a common request form to be used by Applicants when requesting National Competent Authorities to act as Reference Member State in a decentralised procedure.
The common request form is published on the CMD(h) website, http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/MA_Application/CMDh_036_2009_Rev0_Request_Form.doc, together with the link
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_020_2009_Rev0_NCAs_Links.pdf)
to National Competent Authorities Webpages where recommendations for requests to act as RMS are published.
2.  CMD(h)/EMEA Sub-Group on Paediatric Regulation
a)As requested in the CMD(h) meeting with representatives of Interested Parties, the CMD(h) has agreed an early publication of the list of active substances to be included in the third wave of the Article 45 work sharing procedure of the Paediatric Regulation.
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/PaediatricData/Worksharing/CMDh_014_2008_Rev3_AS_WS_Paed.pd
Marketing Authorisation Holders will be requested in April 2009 to submit the paediatric studies for the active substances in the third wave to the appointed Rapporteur within one month of the request, with a view to starting the work-sharing procedure as of May 2009.
b)The CMD(h) has agreed a document with Recommendations for implementing Commission decisions following an Article 29 application under the Paediatric Regulation. The document will be published on the CMD(h) website.
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/PaediatricData/Responsibilities/Art_29/CMDh_019_2009_Rev0_Art29_Paed.pdf
3.  CMD(h) Best Practice Guide on the use of eCTD in the mutual recognition and decentralised procedures
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/eSubmissions/BPG_eCTD_MRP_DCP_Rev0.pdf
The CMD(h) has agreed to extend the period for consultation on the above mentioned document until the end of June 2009.
Any comments should be sent to the attention of the CMD(h) Secretariat (HCMDhSecretariat@ emea.europa.eu) until the end of June 2009.
The aim of the BPG is to facilitate and encourage the use of eCTD as the submission format in MRP and DCP and is available for immediate use by Applicants.

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