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Details eligibility factors such as education and knowledge, practical experience range, trustworthiness and independence, language capability, and supervision arrangements including domicile and part-time RPs.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/responsible-person-requirements-document-valid-from-01072017/261702/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/responsible-person-requirements-document-valid-from-01072017/261702.png","ImageObject",442,249,{"name":42,"@type":43},"Liam","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-30","2026-09-14",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",6,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the document’s purpose and scope regarding the RP?","Question",{"text":63,"@type":64},"It describes how inspectorates interpret specific articles of the Medicinal Products Licensing Ordinance and provides a basis for companies to assess RP eligibility for applying to Swissmedic.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Which criteria are used to qualify a person to be a Responsible Person (RP)?",{"text":68,"@type":64},"Qualification is assessed based on education, knowledge, experience, trustworthiness, and independence, and also on language and direct supervision arrangements.",{"name":70,"@type":61,"acceptedAnswer":71},"How is direct supervision and participation handled for a Responsible Person?",{"text":72,"@type":64},"The RP must guarantee direct supervision to ensure regulatory compliance. The document addresses supervision including domicile requirements and the conditions for part-time RPs, along with the possibility of deputies and delegation.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},261702,1792219024,{"code":4,"msg":82,"data":83},"success",[84,89,94,99,104,109,113,118,123],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":92,"slug":93},12,"Resumes",80,"resumes",{"id":95,"doc_module":22,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},14,"Invoices",70,"invoices",{"id":100,"doc_module":22,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},15,"Posters",60,"posters",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},16,"Social Media",50,"social-media",{"id":110,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":111,"slug":112},17,40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":125,"show_sort_weight":4,"slug":126},158,"General","general-158",{"code":4,"msg":82,"data":128},{"doc_id":79,"user_id":129,"nickname":42,"user_avatar":130,"doc_module":22,"category_id":110,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":136,"language":137,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":12,"update_tm":141,"read_time":30},8796095461564,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Responsible Person: requirements  \nDocument valid from: 01.07.2017  \nDocument number: I-SMI.TI.17 Version No. 03E  \nClassification: Public  \nReplaced document: I-SMI.TI.17_02 dated: 23.06.2015  \nRoot QMI documents: -  \nReferenced QMI documents: -  \nApproval  \nDate: Signature:  \nAuthor:  10.03.2017   Roel op den Camp   \nTechnical verification:  19.04.2017   Georges Meseguer   \nVS-QMI:  \n(formal verification and release)  23.05.2017   Michelle Scheidegger   \nIndex  \n1. Purpose and scope ......................................................................................................... 3  \n2. Basics ............................................................................................................................. 3  \n3. Definitions and abbreviations .......................................................................................... 3  \n4. Responsibilities of a RP .................................................................................................. 3  \n5. Qualification to be a RP .................................................................................................. 3  \n5.1 Education and knowledge ............................................................................................... 3  \n5.2 Experience ...................................................................................................................... 3  \n5.3 Trustworthiness............................................................................................................... 4  \n5.4 Independence ................................................................................................................. 4  \n5.5 Language ........................................................................................................................ 4  \n5.6 Direct supervision ........................................................................................................... 5  \n5.6.1 Domicile .......................................................................................................................... 5  \n5.6.2 Part-time RP ................................................................................................................... 5  \n6. Deputies.......................................................................................................................... 6  \n7. Possibilities regarding delegation .................................................................................... 6  \n8. Changes to the previous version ..................................................................................... 6  \n9. Appendixes ..................................................................................................................... 7  \n1. Purpose and scope  \nThe requirements for a Responsible Person (RP) are described in art. 5 , art. 10, art. 14 and art. 15 of the Medicinal Products Licensing Ordinance. This Technical Interpretation describes the interpretation of these articles by the Swiss inspectorates. It can also be used by companies as a basis for assessing whether an individual fulfils the requirements for applying to Swissmedic to act as a Responsible Person.  \n2. Basics  \n􀁸 Therapeutic Products Act (SR 812 .21)  \n􀁸 Medicinal Products Licensing Ordinance (SR 812 .212. 1) , art. 5, art. 10, art. 14 and art. 15  \n3. Definitions and abbreviations  \nRP Responsible Person (German: ”fachtechnisch verantwortliche Person”; French:  \n“Responsable technique”; Italian: “Responsabile tecnico”) . The RP is a natural person and cannot be a juridical person  \nMPLO Medicinal Products Licensing Ordinance (SR 812 .212. 1)  \n4. Responsibilities of a RP  \nThe holder or applicant of an establishment licence is responsible to have a suitable RP available. The responsibilities of a RP are described in art. 5 , art. 10 , art. 14 and art. 15 of the MPLO. The RP must be able to execute his/her responsibility, understand the Swiss GMP/GDP requirements and meet regulatory compliance. ","cbCaiu3mhED3ye7z","https://ap.wps.com/l/cbCaiu3mhED3ye7z","pdf",335104,7,"English","# Index\n## 1. Purpose and scope\n## 2. Basics\n## 3. Definitions and abbreviations\n## 4. Responsibilities of a RP\n## 5. Qualification to be a RP\n## 5.1 Education and knowledge\n## 5.2 Experience\n## 5.3 Trustworthiness\n## 5.4 Independence\n## 5.5 Language\n## 5.6 Direct supervision\n## 5.6.1 Domicile\n## 5.6.2 Part-time RP\n## 6. Deputies\n## 7. Possibilities regarding delegation\n## 8. Changes to the previous version\n## 9. Appendixes","[{\"question\":\"What is the document’s purpose and scope regarding the RP?\",\"answer\":\"It describes how inspectorates interpret specific articles of the Medicinal Products Licensing Ordinance and provides a basis for companies to assess RP eligibility for applying to Swissmedic.\"},{\"question\":\"Which criteria are used to qualify a person to be a Responsible Person (RP)?\",\"answer\":\"Qualification is assessed based on education, knowledge, experience, trustworthiness, and independence, and also on language and direct supervision arrangements.\"},{\"question\":\"How is direct supervision and participation handled for a Responsible Person?\",\"answer\":\"The RP must guarantee direct supervision to ensure regulatory compliance. The document addresses supervision including domicile requirements and the conditions for part-time RPs, along with the possibility of deputies and delegation.\"}]","Responsible Person Requirements - Document valid from 01.07.2017 | PDF",1789356460]