Timetable Type II Variation Worksharing Application ...

1 The timetables in this document may be subject to revisionType II Variation and Worksharing Application monthly * assessment timetablesInitial submission assessment timetableResponses to Request for Supplementary Information (RSI) assessment Timetable * monthly timetables have an outcome during the week of the CHMP meeting30-day after clockstop30-day after immediate responses9 December 202190-day60-day60-day after clockstop30-dayEMA/577385/2016 Medicines DivisionOfficial addressDomenico Scarlattilaan 6 1083 HS Amsterdam The NetherlandsAddress for visits and deliveriesRefer to us a question Go to +31 (0)88 781 6000An agency of the European Union Page 1 / 19 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines Agency90-day initial submission assessment Timetable Submission deadline (*)Start date (^)CHMP (Co-) Rapporteur AR (**)PRAC Rapporteur AR (~)Comments from PRAC and Co-Rapporteur critique (**) (~) (**)Updated PRAC Rapporteur AR (**) (~)PRAC outcome (~) Comments from CHMP (**)Updated CHMP Rapporteur AR (**)Request for Supplementary Information (RSI)

2 Or OpinionA115/01/202001/02/202027/03/20200 2/04/202006/04/202007/04/202017/04/20202 0/04/202023/04/202030/04/2020A212/02/202 029/02/202024/04/202030/04/202006/05/202 007/05/202014/05/202018/05/202020/05/202 028/05/2020A311/03/202028/03/202020/05/2 02029/05/202003/06/202004/06/202011/06/2 02015/06/202018/06/202025/06/2020A408/04 /202025/04/202019/06/202026/06/202001/07 /202002/07/202009/07/202013/07/202016/07 /202023/07/2020A5A603/06/202020/06/20201 4/08/202021/08/202026/08/202027/08/20200 4/09/202007/09/202010/09/202017/09/2020A 701/07/202018/07/202011/09/202018/09/202 023/09/202024/09/202001/10/202005/10/202 008/10/202015/10/2020A829/07/202015/08/2 02009/10/202016/10/202021/10/202022/10/2 02029/10/202003/11/202005/11/202012/11/2 020A926/08/202012/09/202006/11/202013/11 /202018/11/202019/11/202026/11/202030/11 /202003/12/202010/12/2020A1014/10/202031 /10/202022/12/202004/01/202106/01/202107 /01/202114/01/202118/01/202121/01/202128 /01/2021A1111/11/202028/11/202022/01/202 129/01/202103/02/202104/02/202111/02/202 115/02/202118/02/202125/02/2021A1225/11/ 202026/12/202019/02/202126/02/202103/03/ 202104/03/202111/03/202115/03/202118/03/ 202125/03/2021A1306/01/202123/01/202119/ 03/202125/03/202129/03/202130/03/202109/ 04/202112/04/202115/04/202122/04/2021A14 03/02/202120/02/202116/04/202123/04/2021 28/04/202129/04/202106/05/202110/05/2021 12/05/202120/05/2021A1510/03/202127/03/2 02121/05/202128/05/202102/06/202103/06/2 02110/06/202114/06/202117/06/202124/06/2 021A1607/04/202124/04/202118/06/202125/0 6/202130/06/202101/07/202108/07/202112/0 7/202115/07/202122/07/2021A17A1802/06/20 2119/06/202113/08/202120/08/202125/08/20 2126/08/202102/09/202106/09/202109/09/20 2116/09/2021A1930/06/202117/07/202110/09 /202117/09/202122/09/202123/09/202130/09 /202104/10/202107/10/202114/10/2021A2028 /07/202114/08/202108/10/202115/10/202120 /10/202121/10/202128/10/202129/10/202104 /11/202111/11/2021A2101/09/202118/09/202 112/11/202119/11/202124/11/202125/11/202 102/12/202106/12/202109/12/202116/12/202 1A2213/10/202130/10/202121/12/202103/01/ 202205/01/202206/01/202213/01/202217/01/ 202220/01/202227/01/2022A2310/11/202127/ 11/202121/01/202228/01/202202/02/202203/ 02/202210/02/202214/02/202217/02/202224/ 02/2022 Page 2 / 19 European Medicines Agency, 2021.

3 Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines AgencySubmission deadline (*)Start date (^)CHMP (Co-) Rapporteur AR (**)PRAC Rapporteur AR (~)Comments from PRAC and Co-Rapporteur critique (**) (~) (**)Updated PRAC Rapporteur AR (**) (~)PRAC outcome (~) Comments from CHMP (**)Updated CHMP Rapporteur AR (**)Request for Supplementary Information (RSI) or OpinionA2401/12/202125/12/202118/02/2022 25/02/202202/03/202203/03/202210/03/2022 14/03/202217/03/202224/03/2022A2506/01/2 02223/01/202218/03/202225/03/202230/03/2 02231/03/202207/04/202211/04/202213/04/2 02222/04/2022A2602/02/202219/02/202213/0 4/202222/04/202226/04/202228/04/202205/0 5/202206/05/202212/05/202219/05/2022A270 9/03/202226/03/202220/05/202225/05/20220 1/06/202202/06/202210/06/202213/06/20221 6/06/202223/06/2022A2806/04/202223/04/20 2217/06/202224/06/202229/06/202230/06/20 2207/07/202211/07/202214/07/202221/07/20 22A29A3001/06/202218/06/202212/08/202219 /08/202224/08/202225/08/202201/09/202205 /09/202208/09/202215/09/2022A3129/06/202 216/07/202209/09/202216/09/202221/09/202 222/09/202229/09/202203/10/202206/10/202 213/10/2022A3227/07/202213/08/202207/10/ 202214/10/202219/10/202220/10/202227/10/ 202228/10/202203/11/202210/11/2022A3331/ 08/202217/09/202211/11/202218/11/202223/ 11/202224/11/202201/12/202205/12/202208/ 12/202215/12/2022A3412/10/202229/10/2022 22/12/202203/01/202304/01/202305/01/2023 12/01/202316/01/202319/01/202326/01/2023 A3509/11/202226/11/202220/01/202327/01/2 02301/02/202302/02/202309/02/202313/02/2 02316/02/202323/02/2023A3630/11/202231/1 2/202224/02/202303/03/202308/03/202309/0 3/202316/03/202320/03/202323/03/202330/0 3/2023A3710/01/202327/01/202324/03/20233 1/03/202304/04/202305/04/202314/04/20231 7/04/202320/04/202326/04/2023A3808/02/20 2325/02/202321/04/202328/04/202303/05/20 2304/05/202312/05/202315/05/202317/05/20 2325/05/2023A3908/03/202325/03/202317/05 /202326/05/202331/05/202301/06/202308/06 /202312/06/202315/06/202322/06/2023A4005 /04/202322/04/202316/06/202323/06/202328 /06/202329/06/202306/07/202310/07/202313 /07/202320/07/2023A41A4231/05/202317/06/ 202311/08/202318/08/202323/08/202324/08/ 202331/08/202304/09/202307/09/202314/09/ 2023A4328/06/202315/07/202308/09/202315/ 09/202320/09/202321/09/202328/09/202302/ 10/202305/10/202312/10/2023A4426/07/2023 12/08/202306/10/202313/10/202318/10/2023 19/10/202326/10/202330/10/202331/10/2023 09/11/2023A4530/08/202316/09/202310/11/2 02317/11/202322/11/202323/11/202330/11/2 02304/12/202307/12/202314/12/2023A4611/1 0/202328/10/202321/12/202303/01/202404/0 1/202405/01/202411/01/202415/01/202418/0 1/202425/01/2024A4708/11/202325/11/20231 9/01/202426/01/202431/01/202401/02/20240 8/02/202412/02/202415/02/202422/02/2024A 4829/11/202323/12/202316/02/202423/02/20 2428/02/202429/02/202407/03/202411/03/20 2414/03/202421/03/2024 Page 3 / 19 European Medicines Agency, 2021.

4 Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines AgencySubmission deadline (*)Start date (^)CHMP (Co-) Rapporteur AR (**)PRAC Rapporteur AR (~)Comments from PRAC and Co-Rapporteur critique (**) (~) (**)Updated PRAC Rapporteur AR (**) (~)PRAC outcome (~) Comments from CHMP (**)Updated CHMP Rapporteur AR (**)Request for Supplementary Information (RSI) or OpinionA4910/01/202427/01/202422/03/2024 27/03/202403/04/202404/04/202411/04/2024 15/04/202418/04/202425/04/2024A5014/02/2 02402/03/202426/04/202403/05/202407/05/2 02408/05/202416/05/202421/05/202423/05/2 02430/05/2024A5113/03/202430/03/202424/0 5/202431/05/202405/06/202406/06/202413/0 6/202417/06/202420/06/202427/06/2024A521 0/04/202427/04/202421/06/202428/06/20240 3/07/202404/07/202411/07/202415/07/20241 8/07/202425/07/2024A53A5405/06/202422/06 /202416/08/202423/08/202428/08/202429/08 /202405/09/202409/09/202412/09/202419/09 /2024A5503/07/202420/07/202413/09/202420 /09/202425/09/202426/09/202403/10/202407 /10/202410/10/202417/10/2024A5631/07/202 417/08/202411/10/202418/10/202423/10/202 424/10/202431/10/202404/11/202407/11/202 414/11/2024A5728/08/202414/09/202408/11/ 202415/11/202420/11/202421/11/202428/11/ 202402/12/202405/12/202412/12/2024( ) This Timetable is only applicable to the initial assessment of variations concerning a change to or addition of therapeutic indications and occasionally ofgrouped variations agreed by the Agency.

5 Changes of existing indications (and rarely additions of new indications) may exceptionally follow a 60-day Timetable ,if supported by limited additional data. A 90-day initial Timetable for a grouped Variation or a 60-day initial Timetable for an indication change (rarely,for new indication) should be agreed with the Agency at the time of validation of the Application . (^) The validation period between initial submission and start date is usually sixteen calendar days. (*) 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.(~) Step applicable only if the submission partially falls under the remit of the PRAC (typically, when a RMP is submitted).

6 (**) Comments from CHMP and PRAC members are not made available to Applicants.(**) An updated AR is optional and dependent on the comments received from committee (PRAC, CHMP) members which create the need for the update.(**) When involved, the CHMP Co-Rapporteur produces a critique on the CHMP AR for non-COVID 19 related applications . The Rapporteur AR and Co-Rapporteur critique will be both made available to the 4 / 19 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines Agency60-day initial submission assessment Timetable CHMP Rapporteur ARPRAC Rapporteur ARComments from PRAC (**)Updated PRAC Rapporteur AR (**)PRAC outcomeB110/01/202027/01/202002/03/20202 5/02/202028/02/202004/03/202005/03/20201 2/03/202016/03/202019/03/202026/03/2020B 214/02/202002/03/202006/04/202031/03/202 003/04/202007/04/202008/04/202017/04/202 020/04/202023/04/202030/04/2020B313/03/2 02030/03/202004/05/202028/04/202030/04/2 02006/05/202007/05/202014/05/202018/05/2 02020/05/202028/05/2020B408/04/202027/04 /202002/06/202026/05/202029/05/202003/06 /202004/06/202011/06/202015/06/202018/06 /202025/06/2020B508/05/202025/05/202029/ 06/202023/06/202026/06/202001/07/202002/ 07/202009/07/202013/07/202016/07/202023/ 07/2020B6B703/07/202020/07/202024/08/202 018/08/202021/08/202026/08/202027/08/202 004/09/202007/09/202010/09/202017/09/202 0B831/07/202017/08/202021/09/202015/09/2 02018/09/202023/09/202024/09/202001/10/2 02005/10/202008/10/202015/10/2020B928/08 /202014/09/202019/10/202013/10/202016/10 /202021/10/202022/10/202029/10/202003/11 /202005/11/202012/11/2020B1025/09/202012 /10/202016/11/202010/11/202013/11/202018 /11/202019/11/202026/11/202030/11/202003 /12/202010/12/2020B1113/11/202030/11/202 004/01/202122/12/202004/01/202106/01/202 107/01/202114/01/202118/01/202121/01/202 128/01/2021B1227/11/202028/12/202001/02/ 202126/01/202129/01/202103/02/202104/02/ 202111/02/202115/02/202118/02/202125/02/ 2021B1308/01/202125/01/202101/03/202123/ 02/202126/02/202103/03/202104/03/202111/ 03/202115/03/202118/03/202125/03/2021B14 05/02/202122/02/202129/03/202123/03/2021 26/03/202130/03/202131/03/202109/04/2021 12/04/202115/04/202122/04/2021B1505/03/2 02122/03/202126/04/202120/04/202123/04/2 02128/04/202129/04/202106/05/202110/05/2 02112/05/202120/05/2021B1609/04/202126/0 4/202131/05/202125/05/202128/05/202102/0 6/202103/06/202110/06/202114/06/202117/0 6/202124/06/2021B1707/05/202124/05/20212 8/06/202122/06/202125/06/202130/06/20210 1/07/202108/07/202112/07/202115/07/20212 2/07/2021B18B1902/07/202119/07/202123/08 /202117/08/202120/08/202125/08/202126/08 /202103/09/202106/09/202109/09/202116/09 /2021B2030/07/202116/08/202120/09/202114 /09/202117/09/202122/09/202123/09/202130 /09/202104/10/202107/10/202114/10/2021B2 127/08/202113/09/202118/10/202112/10/202 115/10/202120/10/202121/10/202128/10/202 129/10/202104/11/202111/11/2021B2201/10/ 202118/10/202122/11/202116/11/202119/11/ 202124/11/202125/11/202102/12/202106/12/ 202109/12/202116/12/2021B2312/11/202129/ 11/202103/01/202222/12/202103/01/202205/ 01/202206/01/202213/01/202217/01/202220/ 01/202227/