ࡱ> y ƭbjbj >{{7//2=2=>>>>>>8?Tf?>iJALA 0;2=2=r$$<ÍL6E,qoÍÍÍ`ÍÍÍiSÍÍÍÍÍÍÍÍÍ/ ;:  CREATEDATE \@ "d MMMM yyyy" \* MERGEFORMAT 8 November 2012  IF  DOCPROPERTY "DM_emea_doc_ref_id" \* MERGEFORMAT EMA/709671/2012 <> "Error*" DOCPROPERTY "DM_emea_doc_ref_id" \* MERGEFORMAT EMA/709671/2012 \* MERGEFORMAT EMA/709671/2012 Patient Health Protection Guidance on format of the risk management plan (RMP) in the EU part I: Product(s) Overview Active substance(s) (INN or common name): Pharmaco-therapeutic group (ATC Code):  Name of Marketing Authorisation Holder or Applicant: Number of medicinal products to which this RMP refers: Choose one of the following: 1 2 3 4 5 6Product(s) concerned (brand name(s)): Data lock point for this RMP Version number Date of final sign off Administrative information on the RMP PartModule/annexDate last updated for submission (sign off date)*Version number of RMP when last submitted/ or Not Applicable PART II Safety SpecificationSI Epidemiology of the indication and target population(s)SII Non-clinical part of the safety specificationSIII Clinical trial exposureSIV Populations not studied in clinical trialsSV Post-authorisation experienceSVI Additional EU requirements for the safety specificationSVII Identified and potential risksSVIII Summary of the safety concernsPART III Pharmacovigilance PlanPART IV Plan for post-authorisation efficacy studies PART V Risk Minimisation MeasuresPART VI Summary of RMPPART VII AnnexesANNEX 2 Current or proposed SmPC/PIL ANNEX 3 Worldwide marketing status by countryANNEX 4 Synopsis of clinical trial programmeANNEX 5 Synopsis of pharmacoepidemiological study programmeANNEX 6 Protocols for proposed and on-going studies in Part IIIANNEX 7 Specific adverse event follow-up formsANNEX 8 Protocols for studies in Part IVANNEX 9 Synopsis of newly available study reports in Parts III-IVANNEX 10 Details of proposed additional risk minimisation activitiesANNEX 11 Mock up examplesANNEX 12 Other supporting data* A new RMP version number should be assigned each time any Parts/modules are updated Some modules of the RMP may be omitted (for eligible types of products see GVP V table V.2) if the RMP relates only to products falling into these categories. In these circumstances leave the date field blank and write Not applicable or NA in the version field QPPV name QPPV signature Contact person for this RMP E-mail address or telephone number of contact person There can only ever by ONE agreed RMP for a product or products. Wherever possible there should only be one additional submitted RMP version under evaluation. To facilitate this, MAHs are reminded that where possible routine updates of a RMP should NOT be submitted when there is already a version of a RMP being evaluated as part of an on-going procedure. A cover letter should be submitted instead stating that there is no change to the RMP version xx dated yy submitted as part of procedure. Where a procedure would normally require the submission of an updated RMP as part of the dossier, but there is already another version under evaluation because of another procedure, it is also possible to submit a letter as stated above. In some circumstances there may be a need to submit a third RMP which is a different version from both the agreed RMP and a second RMP version currently undergoing evaluation e.g. if new safety concerns have been recently identified or if a new indication requires different risk minimisation measures. In this case different versions of a RMP will be simultaneously under evaluation. The purpose of this section is to provide oversight. Overview of versions: Version number of last agreed RMP: Version number Agreed within Current RMP versions under evaluation: RMP Version numberSubmitted onSubmitted within  etc. For each product in the RMP Invented name(s) in the European Economic Area (EEA)Authorisation procedureBrief description of the product including: chemical class summary of mode of action important information about its composition (e.g. origin of active substance of biological, relevant adjuvants or residues for vaccinesIndication(s) in the EEA Current (if applicable) Proposed (if applicable)Posology and route of administration in the EEA Current (if applicable) Proposed (if applicable)Pharmaceutical form(s) and strengths Current (if applicable) Proposed (if applicable) Country and date of first authorisation worldwide  Country and date of first launch worldwide  Country and date of first authorisation in the EEA Is the product subject to additional monitoring in the EU? 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Oh+'0@Ld     0Guidance on format of the RMP in the EU part IEuropean Medicines Agency0Guidance on format of the RMP in the EU part IBLANK REPORTPalepsaitiene Jolanta3Microsoft Office Word@F#@|P@^Q츽@ʣI՜.+,D՜.+,@ px  European Medicines Agency$0 ~ /Guidance on format of the RMP in the EU part I Title <Xx     `xDM_emea_filing_code DM_VersionDM_NameDM_Creation_DateDM_Modify_DateDM_Creator_NameDM_Modifier_Name DM_Type DM_DocRefId DM_Category DM_Path DM_emea_doc_ref_idDM_Modifer_NameDM_Modified_Date  CURRENT,1.10Guidance on format of the RMP in the EU part I08/11/2012 13:56:5508/11/2012 13:56:55Palepsaitiene JolantaPalepsaitiene Jolantaemea_documentEMA/709671/2012General/13. 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