Compliance Communication Strategy

Compliance Communication Strategy

<p>0807487047c42cd18837c2c43bc9d3b8.doc</p><p>PROTECTING PUBLIC HEALTH TOGETHER</p><p>CMC WORK ITEM</p><p>PART A: TO BE FILLED IN BY THE APPLICANT</p><p>Title Proposed work item (Max 5 keywords)</p><p>CMC-Board History (list of references of all relevant communication to/from CMC-Board concerning this work item)</p><p>Applicant</p><p> Applicant member of CMC</p><p>AT BE BG CH CY CZ DE DK EE</p><p>ES FI FR GR HR HU IE IS IT</p><p>LI LT LU LV MT NL NO PL PT</p><p>RO SE SI SK TR UK EC</p><p> Applicant not within CMC-members</p><p>Working Group Name WG: </p><p>Other: Name Organisation: </p><p>Address: FORMTEXT </p><p>Contact person: </p><p>Telephone No: Fax No: </p><p>E-mail: </p><p>Date: </p><p>CMC_doc_1 version 09/01/2012 Page 1 of 6 0807487047c42cd18837c2c43bc9d3b8.doc</p><p>CMC WORK ITEM</p><p>Proposed work item</p><p>Rationale for application</p><p>Arguments pro and against NWI Supporting information (Working Groups, CAMD, etc.) Is there a consensus among Member States? What are the main reasons of lack of consensus?</p><p>Action/Decision proposed by applicant</p><p>Proposal for the lead official: </p><p>Supporting information (Working Groups, CAMD, etc.) + History of discussion: provide here the list of hyperlinks to relevant documents (eg. CIRCA)</p><p>Page 2 of 6 0807487047c42cd18837c2c43bc9d3b8.doc</p><p>CMC WORK ITEM</p><p>PART B: TO BE FILLED IN BY THE CMC-BOARD</p><p>Proposed work item Within scope of CMC? Yes No</p><p>Is Proposal mature for CMC ? Yes No</p><p>Recommendations: </p><p>Rationale for application Description complete? Yes No</p><p>Recommendations: </p><p>Arguments pro and against NWI Description complete? Yes No Supporting information (Working Groups, CAMD, etc.) Recommendations: Is there a consensus among MS? What are the main reasons of lack of consensus?</p><p>Proposal for the lead official Accepted? Yes No</p><p>Proposed alternative candidate: </p><p>Supporting information Documentation complete? Yes No (Working Groups, CAMD, etc.) + History: provide here the list of Recommendations: links to relevant documents (eg. CIRCA) </p><p>Page 3 of 6 0807487047c42cd18837c2c43bc9d3b8.doc</p><p>CMC WORK ITEM</p><p>PART C: RECOMMENDATION FROM CMC-BOARD TO CMC</p><p>CMC meeting date </p><p>CMC meeting agenda item </p><p>Transfer to CMC meeting For consideration</p><p>For appointment of the lead official</p><p>For allocation of work</p><p>For decision</p><p>Action/Decision proposed</p><p>Proposal for the lead official: </p><p>Proposal for the allocation of potentially necessary additional preparatory work:</p><p>Proposed work planning and timing to output:</p><p>Conclusion of the CMC-Board </p><p>Date: </p><p>Page 4 of 6 0807487047c42cd18837c2c43bc9d3b8.doc</p><p>CMC WORK ITEM</p><p>PART D: OUTCOME OF THE CMC MEETING</p><p>Agreed next steps (if applicable)</p><p>Date: </p><p>Voting by the CMC</p><p>Voting system simple majority</p><p> qualified majority</p><p>Vote taken on proposed copy in this box the full wording of the proposed decision decision:</p><p>Outcome of the voting: cast votes: </p><p> minimum number of cast votes required: 18</p><p> voting results: YES</p><p>ABSTENTION</p><p>NO</p><p> proposed decision accepted YES</p><p>NO</p><p>Action to implement the decision</p><p> a) public consultation needed ?</p><p>YES </p><p> public consultation timeframe (specify date) </p><p>NO b) other </p><p>Date: </p><p>Page 5 of 6 0807487047c42cd18837c2c43bc9d3b8.doc</p><p>CMC WORK ITEM</p><p>PART E: FOLLOW-UP OF THE CMC DECISION</p><p>Status of the action of the implementation</p><p>Date: </p><p>Page 6 of 6</p>

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