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It covers handling follow-up information on cessation of placing a product on the market when public health may be affected, including requests for exemption by the European Commission, and managing the end of the 3-year non-marketing period with required notifications. 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It also covers subsequent cessation information, exemption handling, and notification of the end of the 3-year period without marketing.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Which products and activities fall under the SOP’s scope?",{"text":68,"@type":64},"The SOP applies to Human Pre-and Post-authorisation Evaluation of Medicines for Human Use Units and covers medicinal products for human use authorised before or after 20 November 2005.",{"name":70,"@type":61,"acceptedAnswer":71},"How is the sunset timer defined and when is it considered ON or OFF?",{"text":72,"@type":64},"The sunset timer monitors a three-year period without marketing leading to invalidity of the Marketing Authorisation. It is ON when the 3-year counting is running and none of the presentations are available in any EEA country; it is OFF when at least one presentation is available in at least one EEA country.","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},253787,1791298273,{"code":4,"msg":82,"data":83},"success",[84,87,92,97,102,107,112,117,122],{"id":55,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":85,"slug":86},90,"presentations",{"id":88,"doc_module":22,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},12,"Resumes",80,"resumes",{"id":93,"doc_module":22,"doc_module_name":25,"category_name":94,"show_sort_weight":95,"slug":96},14,"Invoices",70,"invoices",{"id":98,"doc_module":22,"doc_module_name":25,"category_name":99,"show_sort_weight":100,"slug":101},15,"Posters",60,"posters",{"id":103,"doc_module":22,"doc_module_name":25,"category_name":104,"show_sort_weight":105,"slug":106},16,"Social Media",50,"social-media",{"id":108,"doc_module":22,"doc_module_name":25,"category_name":109,"show_sort_weight":110,"slug":111},17,"Forms",40,"forms",{"id":113,"doc_module":22,"doc_module_name":25,"category_name":114,"show_sort_weight":115,"slug":116},18,"Letters",30,"letters",{"id":118,"doc_module":22,"doc_module_name":25,"category_name":119,"show_sort_weight":120,"slug":121},21,"Paper Templates",5,"papers-templates",{"id":123,"doc_module":22,"doc_module_name":25,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158",{"code":4,"msg":82,"data":127},{"doc_id":79,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":55,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":135,"language":136,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":12,"update_tm":140,"read_time":120,"preview_page_count":4},8796095461564,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","European Medicines Agency Standard Operating Procedure  \n\n| Title: Marketing status reporting and sunset clause monitoring |  |  |\n| --- | --- | --- |\n| PUBLIC |  | Document no.: SOP/H/3128 |\n| Lead Author | Approver | Effective Date: 25-APR-08 |\n| Name: Christelle Bouygues | Name: Noel Wathion | Review Date: 25-APR-11 |\n| Signature: ON FILE | Signature: ON FILE | Supersedes:\u003Cbr>SOP/H/3128 (15-NOV-07) |\n| Date: 11-APR-08 | Date: 24-APR-08 | TrackWise record no.: 1710 |\n\n1. Purpose  \nTo describe:  \n- the handling of the marketing status reporting provided by Marketing Authorisation Holders (MAHs) and the monitoring of the sunset clause period/timer by the EMEA based on the marketing data, for medicinal products for human use whether authorised before or after 20 November 2005.  \n- the handling of subsequent information received on cessation of placing the product on the market which may be of public health concern, whether temporary or permanent, and the granting of an exemption to the application of the sunset clause by the European Commission.  \n- the procedure for managing the end of the 3-year period without marketing and notifying this situation to the European Commission.  \n2. Scope  \nThis SOP applies to the Human Pre-and Post-authorisation Evaluation of Medicines for Human Use Units.  \n3. Responsibilities  \nIt is the responsibility of each Head of Unit and Head of Sector to ensure that this procedure is adhered to within their own unit and sector. It is the responsibility of the PTL to monitor the overall sunset time. The responsibility for the execution of a particular part of this procedure is identified in the righthand column of 9. Procedure.  \n4. Changes since last revision  \nRevised number of the marketing of the product subfolder in EDMS and update of the links provided in section 6.  \n5. Documents needed for this SOP  \nThe following templates can be found in (X:\\Templates\\Others\\Sunset clause) and can be generated from SIAMED:  \n- Template letter to the MAH for confirmation of the expiry of the 3-year period without marketing  \n- Template notification to the Commission of the expiry of the 3-year period without marketing  \n6. Related documents  \n- Letter addressed to all MAHs for initiating marketing status reporting (dated February 2006)  \n- Questions and Answers on the notification to the EMEA of actual marketing and cessation of placing on the market for centrally authorised medicinal products (EMEA/180078/2005) -  \n[http://www.emea.europa.eu/htms/human/postguidance/q95.htm](http://www.emea.europa.eu/htms/human/postguidance/q95.htm)  \n[http://www.emea.europa.eu/htms/human/postguidance/q96.htm](http://www.emea.europa.eu/htms/human/postguidance/q96.htm)  \n- Questions and Answers on the application of the so-called “sunset clause” to centrally authorised medicinal products (EMEA/180079/2005) -[http://www.emea.europa.eu/htms/human/postguidance/q105.htm](http://www.emea.europa.eu/htms/human/postguidance/q105.htm)  \n[- Template table of Marketing Status reporting](- Template table of Marketing Status reporting)  \n[http://www.emea.europa.eu/htms/human/postguidance/q100.htm](http://www.emea.europa.eu/htms/human/postguidance/q100.htm)  \n- EMEA Post-Authorisation Guidance (sections “Marketing & Cessation notification” and “Sunset clause monitoring”)  \n[http://www.emea.europa.eu/htms/human/postguidance/list.htm](http://www.emea.europa.eu/htms/human/postguidance/list.htm)  \n[7. Definitions](7. Definitions)  \nMarketing Status reporting:  \nAn overview at one time point of the various presentations/pack-sizes of a specific product marketed or not in each country of the European Economic Area (EEA) . Marketing and cessation are indicated with a date.  \nSunset clause:  \nA three-year period without marketing of the medicinal product leads to the invalidity of the Marketing Authorisation (MA) . This period starts counting from the granting of the MA or from the last cessation of placing the product on the market.  \nSunset timer:","cbCaiodpnufAyC1o","https://ap.wps.com/l/cbCaiodpnufAyC1o","pdf",310603,13,"English","# Purpose\n## Scope\n## Responsibilities\n## Changes since last revision\n## Documents needed for this SOP\n## Related documents\n## Definitions","[{\"question\":\"What does this SOP cover for marketing status reporting and sunset clause monitoring?\",\"answer\":\"It describes handling of marketing status reporting from Marketing Authorisation Holders and EMEA monitoring of the sunset clause period using marketing data. It also covers subsequent cessation information, exemption handling, and notification of the end of the 3-year period without marketing.\"},{\"question\":\"Which products and activities fall under the SOP’s scope?\",\"answer\":\"The SOP applies to Human Pre-and Post-authorisation Evaluation of Medicines for Human Use Units and covers medicinal products for human use authorised before or after 20 November 2005.\"},{\"question\":\"How is the sunset timer defined and when is it considered ON or OFF?\",\"answer\":\"The sunset timer monitors a three-year period without marketing leading to invalidity of the Marketing Authorisation. It is ON when the 3-year counting is running and none of the presentations are available in any EEA country; it is OFF when at least one presentation is available in at least one EEA country.\"}]","European Medicines Agency Standard Operating Procedure - Marketing status reporting and sunset clause monitoring | PDF",1789270142]