[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-161906-105":53,"doc-detail-161906-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","responses-to-questions-of-rms-and-cms-joint-response-template","Responses to Questions of RMS and CMS - joint response template","","This document provides procedural instructions and a structured joint response template for applicants handling questions raised in RMS and CMS contexts during decentralised and mutual recognition marketing authorisation procedures. It specifies how to load and use the template, prefill RMS/CMS questions verbatim, and ensure each question is clearly identified and answered in order without combining questions. It also defines section replication across topics and modules, covers requirements for identical Word and PDF versions, and sets expectations for annex usage and module-level documentation.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/responses-to-questions-of-rms-and-cms-joint-response-template/161906/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/responses-to-questions-of-rms-and-cms-joint-response-template/161906.png","ImageObject",442,249,{"name":88,"@type":89},"Noah","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-21","2026-08-30",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of this RMS and CMS joint response template?","Question",{"text":108,"@type":109},"It standardizes how applicants prepare answers to questions raised by the RMS and CMS during the procedure, ensuring consistent structure, ordering, and completeness.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should applicants handle the questions when filling the template?",{"text":113,"@type":109},"Applicants must prefill the questions verbatim, follow the same order as in the overview LoQ, clearly identify which Member State raised each question, and avoid combining questions.",{"name":115,"@type":106,"acceptedAnswer":116},"What document format requirements apply to the prepared responses?",{"text":117,"@type":109},"Responses must be provided in both PDF format in Module 1 and current Word format in the working document folder, with confirmation on the cover page that both versions are identical.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},161906,1788112654,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":76},8796095462418,"https://ap-avatar.wpscdn.com/avatar/80000253c1241d02b47?x-image-process=image/resize,m_fixed,w_180,h_180&k=1778826106357471780","Decentralised Procedure\u0013 FORMTEXT _\u0014\u0015\nThe applicant’s \u0013 FORMTEXT \u0014\u003Cjoint>\u0015/\u0013 FORMTEXT \u0014\u003CQuality>\u0015/\u0013 FORMTEXT \u0014\u003CNon-Clinical>\u0015/\u0013 FORMTEXT \u0014\u003CClinical>\u0015/\u0013 FORMTEXT \u0014\u003CModule 1>\u0015response\nResponses to the questions raised by RMS and CMSs\n\u0013 FORMTEXT \u0014\u003CInvented Name>\u0015\u0013 FORMTEXT _\u0014\u0015\n\u0013 FORMTEXT \u0014\u003C(Active Substance)>\u0015\n\u0013 FORMTEXT _\u0014\u0015\nAB/H/\u0013 FORMTEXT \u0014{nnnn}\u0015 /\u0013 FORMTEXT \u0014{nnn}\u0015/DC\nApplicant:\u0013 FORMTEXT _\u0014\u0015\nTick boxes:\n\u0003☐\u0004 This is a draft D106 joint response document\n\u0003☐\u0004 This is a D106 joint response document\n\u0003☐\u0004 This is a D160 joint response document\n\u0003☐\u0004 This is a D196 to 209 joint response document\n\u0003☐\u0004 Confirmation that all questions from the RMS and from the CMSs comments have been transferred into this template without any amendments\n\u0003☐\u0004 Confirmation that word document and pdf document are identical\n\u0003☐\u0004 Confirmation that module 1.2 (eAF) is up to date and data of the eAF are synchronized with module 3 and the rest of the relevant documentation\nResponses to Questions of RMS and CMS\nThe applicant loads the joint response template from \u0013 HYPERLINK \"https://www.hma.eu/127.html\" \u0014https://www.hma.eu/127.html\u0015.\nThe applicant prepares the responses to RMS’s D70 and CMSs’ D100 questions as they have been introduced, by compiling them verbatim into the joint response template by D106. Similarly, the responses in further steps of the procedure are filled in.\nAll sections (i.e. question, the applicant’s response, assessment of the applicant’s response, and overall summary and conclusion) should be replicated as many times as questions under each relevant topic (i.e. DP, DS; pharmacology, PK, toxicology; PK, PD, efficacy, safety, PhV; module 1). ASMF related questions are answered separately from joint response template. The applicant may choose whether one joint response document or several separate response documents are prepared. Adequate title on the front page is picked up.\nThe questions should follow the same order as included in the overview LoQ. Each question should be clearly identified and responded, identifying whether they were raised by RMS or CMS. Questions are not allowed to be combined.\nIn case the RMS requests the draft D106 responses, the (joint) response document is to be sent according to the RMS requirements.\nApplicant’s responses to clinical, nonclinical, quality and Module 1 issues should be provided in one joint document or as separate documents per Module. The response document(s) should be provided both in pdf format in Module 1 and in current Word format in the working doc folder, with a confirmation on the cover page that both versions are identical. This document will not be used for supporting technical documentation which will be included in the relevant Modules. Moreover, the applicant should provide PI documents (SmPC, PL, labelling text) in a tabulated format according to the CMDh guideline “Applicant’s response document in Mutual Recognition and Decentralised procedures for Marketing Authorisation Applications”.\nThe applicant should use this template for each response prepared throughout the procedure.\nQuality aspects\nNB: This document should only address responses to questions not related to the ASMF.\nResponses to questions on the Applicant’s Part and Restricted Part of the ASMF can be found in a separate document\nMajor Objections (RMS) / Potential Serious Risks to Public Health (CMS)\nDrug substance (related to additional data provided by applicant only)\nQuestion\nThe applicant prefills the RMS and CMSs questions (D70/100; D120/145; D180/195) as they have been introduced, i.e. verbatim. Numbering of the questions must be according to the overview. Each question should be followed by the initials of the Member State who raised the question.\nThe applicant’s response:\nThe applicant prefills their complete responses concerning each question. It is not acceptable to just refer to annexes. However, annexes may be used and referred to if large data packages, new data, space consuming tables or pictures need to be included","cbCaitUXwZlI11jq","https://ap.wps.com/l/cbCaitUXwZlI11jq","docx",37206,8,"English","# Applicant’s joint response process\n## Template use and loading\n## Response preparation and replication of sections\n## Ordering and identification of questions\n# Document submission and formats\n## Draft and final response handling\n## Word/PDF identity and module distribution\n# Template structure by scientific area\n## Quality aspects\n## Drug substance\n## Drug product\n## Non-clinical aspects\n## Clinical aspects","[{\"question\":\"What is the purpose of this RMS and CMS joint response template?\",\"answer\":\"It standardizes how applicants prepare answers to questions raised by the RMS and CMS during the procedure, ensuring consistent structure, ordering, and completeness.\"},{\"question\":\"How should applicants handle the questions when filling the template?\",\"answer\":\"Applicants must prefill the questions verbatim, follow the same order as in the overview LoQ, clearly identify which Member State raised each question, and avoid combining questions.\"},{\"question\":\"What document format requirements apply to the prepared responses?\",\"answer\":\"Responses must be provided in both PDF format in Module 1 and current Word format in the working document folder, with confirmation on the cover page that both versions are identical.\"}]","Responses to Questions of RMS and CMS - joint response template | DOCX"]