cmd(h) contribution to hma task force on resources in dcp/mrp · resources in dcp/mrp ......
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CMD(h) contribution to CMD(h) contribution to HMA HMA Task force on Task force on
resourcesresources in DCP/MRPin DCP/MRP
Christer Backman, SESabina Zalar, SI
Started 2008Chaired by Head: first SE and now SIReports to HMADiscussion in Strategic Day II in Paris 5 September
In queueAnswers were received from all agencies with booking
systems (17). Number of procedures in queue range from just one to 725. Totally (all agencies together) almost 1800 procedures are in queue. The booking time limits reported range from 6 months to no time limit, most agencies have a time limit of 18-24 months.
HMA Paris6-7 November
Proposals from Task Force
Overall supportComments 30 NovemberDecision of HMA 31 December
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DE DK UK NL SE FI AT CZ HU FR IE NO PL EE ES BE PT IT SK IS SI MT LV LU LT LI EL CY RO BL
RMS-ships Jan-Sep 2007
DCP and MRP
CMD(h) CMD(h) Ad hoc Working Group Ad hoc Working Group on on validation validation issues/issues/national requirementsnational requirements
Reduction of additional national requirements◦ CMD(h) document on data requested for new applications in the MRP/DCP (July 2008) http://www.hma.eu/cmdh.html
Validation issues
RReduction of national eduction of national rrequirementsequirements
Validation issuesValidation issues
Objectives:◦ to minimise delays in validation, ◦ to avoid invalidation of submissions, ◦ to reduce questions from Member States (both RMS and
CMS), and ◦ to enhance the efficiency of the regulatory process.
Validation issuesValidation issues
Time to act on higher levelTime to act on higher level
Need HMA action
HowHow
Propose concrete actionIdentify remaining hurdlesEven change national legislationRole of Task Force on resources in DCP