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