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Provides placeholders to fill in specific obligations, follow-up measures, and PSUR/RMP requirements, and includes submission wording for EMEA SIAMED and related 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does the MAH undertake in this letter?","Question",{"text":63,"@type":64},"The MAH agrees to undertake Post-Authorisation Commitments (PACs) requested by the CHMP and to submit the listed data within the specified timeframe.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What should be done if a PAC results in a variation?",{"text":68,"@type":64},"A variation application should be submitted instead, and in any case before the due date of the PAC, including any variation applications arising from the CHMP assessment.",{"name":70,"@type":61,"acceptedAnswer":71},"How are stability program deviations reported?",{"text":72,"@type":64},"Confirmed out-of-specification results or significant negative trends are reported to the Rapporteur and the EMEA, consistent with EU GMP guidance.",{"name":74,"@type":61,"acceptedAnswer":75},"Which sections and requirements must be completed in the template?",{"text":76,"@type":64},"The table(s) should be completed or deleted as needed, including specific obligations, follow-up measures, and PSUR/RMP requirements if they differ from the normal PSUR cycle.","https://schema.org",{"og:url":32,"og:type":79,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":81,"canonical":32},"index,follow",{"doc_id":83,"site_id":7},170737,1788274749,{"code":4,"msg":86,"data":87},"success",[88,92,97,102,107,112,117,121,126],{"id":55,"doc_module":22,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Presentations",90,"presentations",{"id":93,"doc_module":22,"doc_module_name":25,"category_name":94,"show_sort_weight":95,"slug":96},12,"Resumes",80,"resumes",{"id":98,"doc_module":22,"doc_module_name":25,"category_name":99,"show_sort_weight":100,"slug":101},14,"Invoices",70,"invoices",{"id":103,"doc_module":22,"doc_module_name":25,"category_name":104,"show_sort_weight":105,"slug":106},15,"Posters",60,"posters",{"id":108,"doc_module":22,"doc_module_name":25,"category_name":109,"show_sort_weight":110,"slug":111},16,"Social 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\u0014\u003CDate>\u0015\n\u0013 FORMTEXT \u0014\u003CCHMP Chairman>\u0015\nEuropean Medicines Agency\n7 Westferry Circus\nCanary Wharf\nLondon\nE14 4HB\nUnited Kingdom\nDear \u0013 FORMTEXT \u0014\u003CChairman>\u0015,\nRE: \tEMEA/H/C/\u0013 FORMTEXT \u0014\u003Cproduct No./procedure No.>\u0015\n\u0013 FORMTEXT \u0014\u003CProduct Name>\u0015, \u0013 FORMTEXT \u0014\u003CINN>\u0015, \u0013 FORMTEXT \u0014\u003CMAH>\u0015\n\u0013 FORMTEXT \u0014\u003CMAH>\u0015 agrees to undertake the following Post-Authorisation Commitments (PACs) requested by the CHMP and commits to submit the data listed below within the specified timeframe.\nWe understand that when a Commitment results in a variation, an application for a variation should be submitted instead and in any case before the due date of the PAC. We also agree to submit any variation application resulting from the CHMP assessment of the below mentioned data.\nWith respect to on-going stability programs, we also undertake that, in accordance with EU GMP guidelines (6.32 of Vol. 4 Part I of the Rules Governing Medicinal Products in the European Union), any confirmed out of specification result, or significant negative trend, will be reported to the Rapporteur and the EMEA.\n[Please complete or delete the table(s) below as necessary.]\n[The EMEA procedure (i.e. EMEA/H/C/product No./procedure No.) from which the PAC originates should be stated for each commitment, e.g. EMEA/H/C/132/II/0032.]\n[Please give a clear and concise description of each PAC, with sufficient level of detail. This description will be entered into EMEA’s SIAMED database. Please note that the text of the description for Specific Obligations will be copied in Annex II.C to the Community Marketing Authorisation. The exact same description should be used in the template cover letter when submitting the PAC data.]\n[An updated Letter of Undertaking including only quality FUMs, is required at the time of the annual submission of Quality FUMs  A consolidated Letter of Undertaking including all PACs (quality, non-clinical, clinical and pharmacovigilance) is required at the time of renewal or annual reassessment, if applicable.]\n\u003CSpecific Obligations:>\n\u003CFollow-up Measures:>\n\u003CPeriodic Safety Update Reports and Risk Management Plan:>\n[Please specify PSUR and RMP requirements if different from the normal PSUR cycle, as requested by CHMP]\nYours sincerely,\n\u003CName and signature of authorised contact person>\n\u0013 FORMTEXT \u0014\u003CMAH>\u0015","cbCaiqouFkKSjoLD","https://ap.wps.com/l/cbCaiqouFkKSjoLD","doc",45568,"English","# Post-Authorisation commitments confirmation\n## Variation and due-date handling\n## Ongoing stability program reporting\n## Specific obligations and follow-up measures\n## Periodic Safety Update Reports and Risk Management Plan","[{\"question\":\"What does the MAH undertake in this letter?\",\"answer\":\"The MAH agrees to undertake Post-Authorisation Commitments (PACs) requested by the CHMP and to submit the listed data within the specified timeframe.\"},{\"question\":\"What should be done if a PAC results in a variation?\",\"answer\":\"A variation application should be submitted instead, and in any case before the due date of the PAC, including any variation applications arising from the CHMP assessment.\"},{\"question\":\"How are stability program deviations reported?\",\"answer\":\"Confirmed out-of-specification results or significant negative trends are reported to the Rapporteur and the EMEA, consistent with EU GMP guidance.\"},{\"question\":\"Which sections and requirements must be completed in the template?\",\"answer\":\"The table(s) should be completed or deleted as needed, including specific obligations, follow-up measures, and PSUR/RMP requirements if they differ from the normal PSUR cycle.\"}]","Letter of Undertaking - MAH Undertakes Post-Authorisation Commitments | DOC"]