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EMEA/192632/2006  \nAnnex C: TEMPLATE FOR EU RISK MANAGEMENT PLAN (EU – RMP)  \nThis template provides advice on how the data requested in the Guideline, if ava able, hould be presented. It is anticipated that, particularly in section 1, all the informati will no be vailable or all drugs and that the type of product and where it is in its lifecycle will affec how mu h information can be provided.  \n\n| Overview of EU Risk Management Plan Template |  |\n| --- | --- |\n| Section |  |\n|  | Product information |\n| 1 | Safety Specification |\n| 2 | Pharmacovigilanc Plan |\n| 3 | Evaluation of the n ed f risk m nimisation activities |\n| 4 | Risk Minim ation Plan |\n| 5 | Summar o the EU-RMP |\n| 6 | Contact per n details |\n|  |  |\n| Annex 1 | Interfa between EU-RMP and Eudravigilance To b provided in electronic form only |\n| Annex 2 | C rrent (or roposed if initial EU-RMP) SPC, Package eaflet |\n| Annex 3 | Syn psis of ongoing and completed clinical trial programme |\n| Ann 4 | Synopsis of ongoing and completed pharmacoepidemiological study programme |\n| nnex 5 | Protocols for proposed and ongoing studies in pharmacovigilance plan |\n| Anne 6 | Newly available study reports |\n| Anne 7 | Other supporting data |\n| Ann x 8 | Details of proposed educational programme (if applicable) |\n\nTo be lid an EU-RMP MUST contain sections 1,2 & 3. With the exception of section 4 (which must e completed if additional risk minimisation activities are proposed) all sections should be p ovided. Annex 1 should be provided in electronic form only.  \nPlease ensure that the data provided in this document are coded in MedDRA terms where appropriate and are consistent with those submitted electronically in the template attached in Annex 1.  \n7 Westferry Circus, Canary Wharf, London, E14 4HB, UK  \nTel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 20  \nE-mail: mail@emea.europa.eu  [http://www.emea.europa.eu](http://www.emea.europa.eu)  \n©EMEA 2006 Reproduction and/or distribution of this document is au horised for non-commercial purposes only provided the EMEA is acknowledged  \nPRODUCT DETAILS  \n\n| Invented name of the medicinal product (product shortname): |  |\n| --- | --- |\n| Active substance(s) (INN or common name): |  |\n| Pharmaco-therapeutic group\u003Cbr>(ATC Code): |  |\n| Medicinal Product Code (From EudraVigilance) |  |\n| Authorisation procedure(s) (central, mutual recognition, decentralised, national) |  |\n| Name of Marketing Authorisation Holder or Applicant: |  |\n| Date and country of first authorisation worldwide |  |\n| Date and country of first launch worldwide |  |\n| Date and country of first authorisation in the EEA | If diffe nt from above |\n| Date and country of first launch in the EEA | If ferent from above |\n\nata loc  \npoint for EU – RMP  \ndd/mm/yyyy  \nVersion  \nEMEA/192632/2006 0. 11, CURRENT 19/10/2006 Page 2/21  \n©EMEA 2006  \n\n| Brief description of product\u003Cbr>(chemical class, mode of action etc) |  |\n| --- | --- |\n| Indication(s) | Current if applicable\u003Cbr>Proposed if applicable |\n| Dosage | Current or proposed for eac indic ion and duration of therapy |\n| Pharmaceutical form(s) and strength(s) |  |\n\nEMEA/192632/2006 0. 11, CURRENT 19/10/2006 Page 3/21  \n©EMEA 2006  \nPART I  \n1. SAFETY SPECIFICATION  \nNon-clinical  \n1.1.1. \u003COutline of safety concerns that have not been adequately addressed by clinica data or which are of unknown significance>; for example  \nToxicity (including repeat-dose toxicity, reproductive/developmental toxicity neph otoxicity, hepatotoxicity, genotoxicity, carcinogenicity etc.)  \nGeneral safety pharmacology (cardiovascular [including QT interval prol ngati ] nervous system, etc.)  \nMechanisms for drug interactions  \nOther toxicity-related information or data  \n\n| SAFETY CONCERN (from non clinical studies) | RELEVANCE TO HUMAN U AGE |\n| --- | --- |\n| \u003Crepeat dose toxicity> |  |\n| \u003Creproductive toxicity> a summary of impor","cbCaiglWkEiZmaa3","https://ap.wps.com/l/cbCaiglWkEiZmaa3","pdf",194622,"English","# Product information\n## Safety specification\n## Pharmacovigilance plan\n## Evaluation of the need for risk minimisation activities\n## Risk minimisation plan\n## Summary of the EU-RMP\n## Contact person details\n# Annexes","[{\"question\":\"Which sections must an EU RMP contain to be valid?\",\"answer\":\"A valid EU-RMP must contain sections 1, 2 and 3. Section 4 must be completed if additional risk minimisation activities are proposed, while other sections should be provided.\"},{\"question\":\"How should the provided data be coded in the template?\",\"answer\":\"Data should be coded in MedDRA terms where appropriate and must be consistent with the information submitted electronically in Annex 1.\"},{\"question\":\"What clinical exposure information does the template require?\",\"answer\":\"It requires exposure summaries separately for each indication, including table sets by duration, by dose, by age group and gender, and by ethnic origin, based on exposed persons in specified clinical trial populations.\"}]","European Union Risk Management Plan (EU - RMP) Template | PDF",7]