[Template for the Letter of Undertaking (commitments undertaken by the Applicant/MAH) to be provided in MS Word format and as a signed PDF document] (< FROM MAH ON HEADED PAPER >) <Date> <CHMP Chairman> European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Dear <Chairman>, RE: EMEA/H/C/<product No./procedure No.> <Product Name>, <INN>, <MAH> <MAH> 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. We 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. With 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. [Please complete or delete the table(s) below as necessary.] [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.] [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.] [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, nonclinical, clinical and pharmacovigilance) is required at the time of renewal or annual reassessment, if applicable.] <Specific Obligations:> Area Description Due Date Quality <Description> <dd/mm/yyyy> Non-clinical Clinical <Description> <Description> [Please include the protocol / study number and title, and a brief description of the study / data to be submitted, if applicable. Please provide a submission timeframe / schedule when protocols, interim and final study reports are to be <dd/mm/yyyy> <dd/mm/yyyy> Pharmacovigilance submitted] <Description> <dd/mm/yyyy> <Follow-up Measures:> Area Quality Non-clinical Clinical Pharmacovigilance Description <Description> [Unless otherwise justified, all Quality FUMs should be grouped under a single entry with a single proposed due date for annual submission (ideally at the anniversary of the initial marketing authorisation) in order to minimise the number of submissions of Quality FUMs.] <Description> <Description> [Please include the protocol / study number and title, and a brief description of the study / data to be submitted, if applicable. Please provide a submission timeframe / schedule when protocols, interim and final study reports are to be submitted] <Description> Due Date <dd/mm/yyyy> <dd/mm/yyyy> <dd/mm/yyyy> <dd/mm/yyyy> <Periodic Safety Update Reports and Risk Management Plan:> [Please specify PSUR and RMP requirements if different from the normal PSUR cycle, as requested by CHMP] Yours sincerely, <Name and signature of authorised contact person> <MAH>