Timetable: Initial (full) marketing authorisation …

1 European Medicines Agency, 2017. Reproduction is authorised provided the source is 1 / 13 EMA/119185/2015 Medicines Evaluation The timetables in this document may be subject to revisionInitial ( full ) marketing authorisation application assessment timetablesAssessment of Initial submission (120-day timetable)Assessment of responses to List of Questions (60-day timetable after clock-stop for submission of responses)Assessment of responses to List of Outstanding Issues (30-day timetable after clock-stop for responses)Assessment of responses to List of Outstanding Issues (30-day timetable after immediate responses)Assessment of Outstanding Issues following Oral Explanation (30-day timetable)31 October 201730 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website An agency of the European Union European Medicines Agency, 2017. Reproduction is authorised provided the source is 2 / 13 Assessment of Initial submission (120-day timetable)Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARsPRAC Rapporteur ARComments from PRAC (**)Comments from CHMP (**)Early draft LOQ (for Peer review tele-conference) (#)PRAC outcome (~)Updated PRAC Rapporteur ARPeer review telecon-ference (TC)Draft LoQ List of Questions (LoQ)

2 Or OpinionA102/01/201719/01/201708/04/20172 1/04/201728/04/201728/04/201705/05/20170 5/05/201705/05/201708/05/201711/05/20171 8/05/2017A206/02/201723/02/201713/05/201 729/05/201702/06/201702/06/201709/06/201 709/06/201709/06/201712/06/201715/06/201 722/06/2017A306/03/201723/03/201710/06/2 01723/06/201730/06/201730/06/201706/07/2 01706/07/201706/07/201710/07/201713/07/2 01720/07/2017A4A527/04/201718/05/201705/ 08/201718/08/201725/08/201725/08/201701/ 09/201701/09/201701/09/201704/09/201707/ 09/201714/09/2017A624/05/201715/06/20170 2/09/201715/09/201722/09/201722/09/20172 8/09/201728/09/201728/09/201702/10/20170 5/10/201712/10/2017A726/06/201713/07/201 730/09/201713/10/201720/10/201720/10/201 726/10/201726/10/201726/10/201730/10/201 703/11/201709/11/2017A831/07/201717/08/2 01704/11/201717/11/201724/11/201724/11/2 01730/11/201730/11/201730/11/201704/12/2 01707/12/201714/12/2017A911/09/201728/09 /201716/12/201703/01/201805/01/201805/01 /201811/01/201811/01/201811/01/201815/01 /201818/01/201825/01/2018A1009/10/201726 /10/201715/01/201826/01/201802/02/201802 /02/201808/02/201808/02/201808/02/201812 /02/201815/02/201822/02/2018A1106/11/201 723/11/201712/02/201826/02/201802/03/201 802/03/201808/03/201808/03/201808/03/201 812/03/201815/03/201822/03/2018A1227/11/ 201728/12/201719/03/201803/04/201806/04/ 201806/04/201812/04/201812/04/201812/04/ 201816/04/201819/04/201826/04/2018A1315/ 01/201801/02/201823/04/201807/05/201811/ 05/201811/05/201817/05/201817/05/201817/ 05/201822/05/201824/05/201831/05/2018A14 12/02/201801/03/201822/05/201804/06/2018 08/06/201808/06/201814/06/201814/06/2018 14/06/201818/06/201821/06/201828/06/2018 A1508/03/201829/03/201818/06/201802/07/2 01806/07/201806/07/201812/07/201812/07/2 01812/07/201816/07/201819/07/201826/07/2 018A16A1730/04/201824/05/201813/08/20182 8/08/201831/08/201831/08/201806/09/20180 6/09/201806/09/201810/09/201813/09/20182 0/09/2018A1804/06/201821/06/201810/09/20 1824/09/201828/09/201828/09/201804/10/20 1804/10/201804/10/201808/10/201811/10/20 1818/10/2018A1902/07/201819/07/201808/10 /201822/10/201826/10/201826/10/201831/10 /201831/10/201831/10/201805/11/201808/11 /201815/11/2018A2030/07/201816/08/201805 /11/201819/11/201823/11/201823/11/201829 /11/201829/11/201829/11/201803/12/201806 /12/201813/12/2018A2117/09/201804/10/201 820/12/201807/01/201911/01/201911/01/201 917/01/201917/01/201917/01/201921/01/201 924/01/201931/01/2019A2215/10/201801/11/ 201821/01/201904/02/201908/02/201908/02/ 201914/02/201914/02/201914/02/201918/02/ 201921/02/201928/02/2019A2312/11/201829/ 11/201818/02/201904/03/201908/03/201908/ 03/201914/03/201914/03/201914/03/201918/ 03/201921/03/201928/03/2019A2426/11/2018 28/12/201818/03/201901/04/201905/04/2019 05/04/201911/04/201911/04/201911/04/2019 15/04/201917/04/201926/04/2019A2514/01/2 01930/01/201923/04/201902/05/201910/05/2 01910/05/201916/05/201916/05/201916/05/2 01920/05/201923/05/201929/05/2019 European Medicines Agency, 2017.

3 Reproduction is authorised provided the source is 3 / 13 Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARsPRAC Rapporteur ARComments from PRAC (**)Comments from CHMP (**)Early draft LOQ (for Peer review tele-conference) (#)PRAC outcome (~)Updated PRAC Rapporteur ARPeer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) or OpinionA2611/02/201928/02/201920/05/2019 03/06/201907/06/201907/06/201913/06/2019 14/06/201914/06/201917/06/201920/06/2019 27/06/2019A2711/03/201928/03/201917/06/2 01901/07/201905/07/201905/07/201911/07/2 01911/07/201911/07/201915/07/201918/07/2 01925/07/2019A28A2906/05/201923/05/20191 2/08/201927/08/201930/08/201930/08/20190 5/09/201905/09/201905/09/201909/09/20191 2/09/201919/09/2019A3003/06/201920/06/20 1909/09/201923/09/201927/09/201927/09/20 1903/10/201903/10/201903/10/201907/10/20 1910/10/201917/10/2019A3101/07/201918/07 /201907/10/201921/10/201925/10/201925/10 /201931/10/201931/10/201931/10/201904/11 /201907/11/201914/11/2019A3329/07/201915 /08/201904/11/201918/11/201922/11/201922 /11/201928/11/201928/11/201928/11/201902 /12/201905/12/201912/12/2019A3416/09/201 903/10/201919/12/201906/01/202010/01/202 010/01/202016/01/202016/01/202016/01/202 020/01/202023/01/202030/01/2020A3514/10/ 201931/10/201920/01/202003/02/202007/02/ 202007/02/202013/02/202013/02/202013/02/ 202017/02/202020/02/202027/02/2020A3611/ 11/201928/11/201917/02/202002/03/202006/ 03/202006/03/202012/03/202012/03/202012/ 03/202016/03/202019/03/202026/03/2020A37 25/11/201902/01/202023/03/202006/04/2020 08/04/202008/04/202016/04/202017/04/2020 17/04/202020/04/202023/04/202030/04/2020 A3813/01/202030/01/202020/04/202004/05/2 02008/05/202008/05/202014/05/202014/05/2 02014/05/202018/05/202020/05/202028/05/2 020A3910/02/202027/02/202018/05/202001/0 6/202005/06/202005/06/202011/06/202011/0 6/202011/06/202015/06/202018/06/202025/0 6/2020A4009/03/202026/03/202015/06/20202 9/06/202003/07/202003/07/202009/07/20200 9/07/202009/07/202013/07/202016/07/20202 3/07/2020A41A4204/05/202021/05/202010/08 /202024/08/202028/08/202028/08/202003/09 /202004/09/202004/09/202007/09/202010/09 /202017/09/2020A4301/06/202018/06/202007 /09/202021/09/202025/09/202025/09/202001 /10/202001/10/202001/10/202005/10/202008 /10/202015/10/2020A4529/06/202016/07/202 005/10/202019/10/202023/10/202023/10/202 029/10/202029/10/202029/10/202003/11/202 005/11/202012/11/2020A4627/07/202013/08/ 202003/11/202016/11/202020/11/202020/11/ 202026/11/202026/11/202026/11/202030/11/ 202003/12/202010/12/2020A4714/09/202001/ 10/202021/12/202004/01/202108/01/202108/ 01/202114/01/202114/01/202114/01/202118/ 01/202121/01/202128/01/2021A4812/10/2020 29/10/202018/01/202101/02/202105/02/2021 05/02/202111/02/202111/02/202111/02/2021 15/02/202118/02/202125/02/2021A4909/11/2 02026/11/202015/02/202101/03/202105/03/2 02105/03/202111/03/202111/03/202111/03/2 02115/03/202118/03/202125/03/2021A5023/1 1/202024/12/202015/03/202129/03/202131/0 3/202131/03/202108/04/202109/04/202109/0 4/202112/04/202115/04/202122/04/2021A510 4/01/202121/01/202112/04/202126/04/20213 0/04/202130/04/202106/05/202106/05/20210 6/05/202110/05/202112/05/202120/05/2021A 5208/02/202125/02/202117/05/202131/05/20 2104/06/202104/06/202110/06/202110/06/20 2110/06/202114/06/202117/06/202124/06/20 21A5308/03/202125/03/202114/06/202128/06 /202102/07/202102/07/202108/07/202108/07 /202108/07/202112/07/202115/07/202122/07 /2021A54 European Medicines Agency, 2017.

4 Reproduction is authorised provided the source is 4 / 13 Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARsPRAC Rapporteur ARComments from PRAC (**)Comments from CHMP (**)Early draft LOQ (for Peer review tele-conference) (#)PRAC outcome (~)Updated PRAC Rapporteur ARPeer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) or OpinionA5530/04/202120/05/202109/08/2021 23/08/202127/08/202127/08/202102/09/2021 03/09/202103/09/202106/09/202109/09/2021 16/09/2021A5631/05/202117/06/202106/09/2 02120/09/202124/09/202124/09/202130/09/2 02130/09/202130/09/202104/10/202107/10/2 02114/10/2021A5728/06/202115/07/202104/1 0/202118/10/202122/10/202122/10/202127/1 0/202128/10/202128/10/202129/10/202104/1 1/202111/11/2021A5802/08/202119/08/20210 8/11/202122/11/202126/11/202126/11/20210 2/12/202102/12/202102/12/202106/12/20210 9/12/202116/12/2021(*) The Agency strongly recommends submitting the application before the published submission deadline. This is to avoid missing the target start date as a result of a technically invalid eCTD submission, in which case the submission is considered void and it needs to be re-despatched.

5 (^) The validation period between submission date and start date is generally thirteen EMA working days. For further information about the dates on which the Agency will be closedduring the current year, please refer to the business hours and holidays page on the website.(**) Comments from CHMP and PRAC members are not made available to Applicants.(#) Peer review is a process by which other members of the CHMP review the (Co) Rapporteurs scientific evaluation, as well as the validity of the scientific/regulatory conclusions reached. It applies during the Initial phase of the assessment of a new marketing authorisation Application (MAA).(~) PRAC discussion (and outcome) during the 1st assessment phase is only envisaged for a minority of applications . European Medicines Agency, 2017. Reproduction is authorised provided the source is 5 / 13 Assessment of responses to List of Questions (LOQ)60-day timetable after clock-stop for submission of responsesDeadline for Submission (*)RestartCHMP and PRAC Rapporteurs Joint AR (JAR)Comments from PRAC (**)PRAC outcome (#)Updated PRAC Rapporteur AR Comments from CHMP (**)Updated CHMP (and PRAC) Rapporteurs JAR (~) List of Outstanding Issues (LoOI)

6 Or OpinionB120/01/201723/01/201727/02/20170 3/03/201709/03/201709/03/201713/03/20171 6/03/201723/03/2017B217/02/201721/02/201 727/03/201731/03/201706/04/201706/04/201 710/04/201712/04/201721/04/2017B317/03/2 01720/03/201724/04/201728/04/201705/05/2 01705/05/201708/05/201711/05/201718/05/2 017B421/04/201724/04/201729/05/201702/06 /201709/06/201709/06/201712/06/201715/06 /201722/06/2017B519/05/201722/05/201726/ 06/201730/06/201706/07/201706/07/201710/ 07/201713/07/201720/07/2017B6B714/07/201 717/07/201721/08/201725/08/201701/09/201 701/09/201704/09/201707/09/201714/09/201 7B811/08/201714/08/201718/09/201722/09/2 01728/09/201728/09/201702/10/201705/10/2 01712/10/2017B908/09/201711/09/201716/10 /201720/10/201726/10/201726/10/201730/10 /201703/11/201709/11/2017B1013/10/201716 /10/201720/11/201724/11/201730/11/201730 /11/201704/12/201707/12/201714/12/2017B1 124/11/201727/11/201703/01/201805/01/201 811/01/201811/01/201815/01/201818/01/201 825/01/2018B1222/12/201725/12/201729/01/ 201802/02/201808/02/201808/02/201812/02/ 201815/02/201822/02/2018B1319/01/201822/ 01/201826/02/201802/03/201808/03/201808/ 03/201812/03/201815/03/201822/03/2018B14 23/02/201826/02/201803/04/201806/04/2018 12/04/201812/04/201816/04/201819/04/2018 26/04/2018B1528/03/201802/04/201804/05/2 01808/05/201817/05/201817/05/201822/05/2 01824/05/201831/05/2018B1627/04/201830/0 4/201804/06/201808/06/201814/06/201814/0 6/201818/06/201821/06/201828/06/2018B172 5/05/201828/05/201802/07/201806/07/20181 2/07/201812/07/201816/07/201819/07/20182 6/07/2018B18B1920/07/201823/07/201828/08 /201831/08/201806/09/201806/09/201810/09 /201813/09/201820/09/2018B2017/08/201820 /08/201824/09/201828/09/201804/10/201804 /10/201808/10/201811/10/201818/10/2018B2 114/09/201817/09/201822/10/201826/10/201 831/10/201831/10/201805/11/201808/11/201 815/11/2018B2212/10/201815/10/201819/11/ 201823/11/201829/11/201829/11/201803/12/ 201806/12/201813/12/2018B2330/11/201803/ 12/201807/01/201911/01/201917/01/201917/ 01/201921/01/201924/01/201931/01/2019 European Medicines Agency, 2017.

7 Reproduction is authorised provided the source is 6 / 13 Deadline for Submission (*)RestartCHMP and PRAC Rapporteurs Joint AR (JAR)Comments from PRAC (**)PRAC outcome (#)Updated PRAC Rapporteur AR Comments from CHMP (**)Updated CHMP (and PRAC) Rapporteurs JAR (~) List of Outstanding Issues (LoOI) or OpinionB2421/12/201831/12/201804/02/2019 08/02/201914/02/201914/02/201918/02/2019 21/02/201928/02/2019B2525/01/201928/01/2 01904/03/201908/03/201914/03/201914/03/2 01918/03/201921/03/201928/03/2019B2622/0 2/201926/02/201901/04/201905/04/201912/0 4/201912/04/201915/04/201917/04/201926/0 4/2019B2729/03/201931/03/201906/05/20191 0/05/201915/05/201915/05/201920/05/20192 3/05/201929/05/2019B2826/04/201929/04/20 1903/06/201907/06/201914/06/201914/06/20 1917/06/201920/06/201927/06/2019B2924/05 /201927/05/201901/07/201905/07/201911/07 /201911/07/201915/07/201918/07/201925/07 /2019B30B3119/07/201922/07/201926/08/201 930/08/201905/09/201905/09/201909/09/201 912/09/201919/09/2019B3216/08/201919/08/ 201923/09/201927/09/201903/10/201903/10/ 201907/10/201910/10/201917/10/2019B3313/ 09/201916/09/201921/10/201925/10/201931/ 10/201931/10/201904/11/201907/11/201914/ 11/2019B3411/10/201914/10/201918/11/2019 22/11/201928/11/201928/11/201902/12/2019 05/12/201912/12/2019B3529/11/201902/12/2 01906/01/202010/01/202016/01/202016/01/2 02020/01/202023/01/202030/01/2020B3623/1 2/201930/12/201903/02/202007/02/202013/0 2/202013/02/202017/02/202020/02/202027/0 2/2020B3724/01/202027/01/202002/03/20200 6/03/202012/03/202012/03/202016/03/20201 9/03/202026/03/2020B3828/02/202002/03/20 2006/04/202008/04/202017/04/202017/04/20 2020/04/202023/04/202030/04/2020B3927/03 /202030/03/202004/05/202008/05/202014/05 /202014/05/202018/05/202020/05/202028/05 /2020B4024/04/202027/04/202001/06/202005 /06/202011/06/202011/06/202015/06/202018 /06/202025/06/2020B4122/05/202025/05/202 029/06/202003/07/202009/07/202009/07/202 013/07/202016/07/202023/07/2020B42B4317/ 07/202020/07/202024/08/202028/08/202004/ 09/202004/09/202007/09/202010/09/202017/ 09/2020B4414/08/202017/08/202021/09/2020 25/09/202001/10/202001/10/202005/10/2020 08/10/202015/10/2020B4511/09/202014/09/2 02019/10/202023/10/202029/10/202029/10/2 02003/11/202005/11/202012/11/2020B4609/1 0/202012/10/202016/11/202020/11/202026/1 1/202026/11/202030/11/202003/12/202010/1 2/2020B4727/11/202030/11/202004/01/20210 8/01/202114/01/202114/01/202118/01/20212 1/01/202128/01/2021B4823/12/202028/12/20 2001/02/202105/02/202111/02/202111/02/20 2115/02/202118/02/202125/02/2021B4922/01 /202125/01/202101/03/202105/03/202111/03 /202111/03/202115/03/202118/03/202125/03 /2021 European Medicines Agency, 2017.

8 Reproduction is authorised provided the source is 7 / 13 Deadline for Submission (*)RestartCHMP and PRAC Rapporteurs Joint AR (JAR)Comments from PRAC (**)PRAC outcome (#)Updated PRAC Rapporteur AR Comments from CHMP (**)Updated CHMP (and PRAC) Rapporteurs JAR (~) List of Outstanding Issues (LoOI) or OpinionB5019/02/20212