Timetable: Initial (Full) Marketing Authorisation ...

1 The timetables in this document may be subject to revisionInitial (Full) Marketing Authorisation application accelerated assessment timetables Assessment of Initial submission (90-day timetable)Assessment of responses to List of Questions (30-day timetable after clock-stop for submission of responses)Assessment of responses to List of Questions (30-day timetable after immediate responses)Assessment of responses to List of Outstanding Issues (30-day timetable after immediate responses)10 February 2023 EMA/339594/2016 Medicines Division( ) This timetable is not applicable to Advanced Therapy Medicinal Products (ATMPs); for these the applicant should refer to the timetable for Initial Marketing Authorisation applications for 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 European Medicines Agency, 2023.

2 Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines AgencyPage 1 / 12 Assessment of Initial submission (90-day timetable)Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARs (**)PRAC Rapporteur ARComments from PRAC and CHMP Co-Rapporteur assessment (**)(**)Comments from CHMP (**)PRAC outcomeEarly draft LOQ (for Peer review tele-conference)Peer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) (~) (#)Opinion (#)A113/01/202030/01/202031/03/202007/04 /202008/04/202008/04/202017/04/202017/04 /202020/04/202023/04/202028/04/202030/04 /2020A210/02/202027/02/202028/04/202005/ 05/202008/05/202008/05/202014/05/202015/ 05/202018/05/202020/05/202026/05/202028/ 05/2020A309/03/202026/03/202026/05/20200 2/06/202005/06/202005/06/202011/06/20201 2/06/202015/06/202018/06/202023/06/20202 5/06/2020A401/04/202023/04/202023/06/202 030/06/202003/07/202003/07/202009/07/202 010/07/202013/07/202016/07/202021/07/202 023/07/2020A5A629/05/202018/06/202018/08 /202025/08/202028/08/202028/08/202004/09 /202004/09/202007/09/202010/09/202015/09 /202017/09/2020A729/06/202016/07/202015/ 09/202022/09/202025/09/202025/09/202001/ 10/202002/10/202005/10/202008/10/202013/ 10/202015/10/2020A827/07/202013/08/20201 3/10/202020/10/202023/10/202023/10/20202 9/10/202030/10/202003/11/202005/11/20201 0/11/202012/11/2020A924/08/202010/09/202 010/11/202017/11/202020/11/202020/11/202 026/11/202027/11/202030/11/202003/12/202 008/12/202010/12/2020A1012/10/202029/10/ 202004/01/202107/01/202108/01/202108/01/ 202114/01/202115/01/202118/01/202121/01/ 202126/01/202128/01/2021A1109/11/202026/ 11/202026/01/202102/02/202105/02/202105/ 02/202111/02/202112/02/202115/02/202118/ 02/202123/02/202125/02/2021A12A1304/01/2 02121/01/202123/03/202130/03/202131/03/2 02131/03/202109/04/202109/04/202112/04/2 02115/04/202120/04/202122/04/2021A1401/0 2/202118/02/202120/04/202127/04/202130/0 4/202130/04/202106/05/202107/05/202110/0 5/202112/05/202118/05/202120/05/2021A150 8/03/202125/03/202125/05/202101/06/20210 4/06/202110/06/202110/06/202111/06/20211 4/06/202117/06/202122/06/202124/06/2021A 1605/04/202122/04/202122/06/202129/06/20 2102/07/202108/07/202108/07/202109/07/20 2112/07/202115/07/202120/07/202122/07/20 21A17A1831/05/202117/06/202117/08/202124 /08/202127/08/202102/09/202102/09/202103 /09/202106/09/202109/09/202114/09/202116 /09/2021A1928/06/202115/07/202114/09/202 121/09/202124/09/202130/09/202130/09/202 101/10/202104/10/202107/10/202112/10/202 114/10/2021A2026/07/202112/08/202112/10/ 202119/10/202122/10/202128/10/202128/10/ 202129/10/202129/10/202104/11/202109/11/ 202111/11/2021A2127/08/202116/09/202116/ 11/202123/11/202126/11/202102/12/202102/ 12/202103/12/202106/12/202109/12/202114/ 12/202116/12/2021A2211/10/202128/10/2021 21/12/202104/01/202207/01/202213/01/2022 13/01/202214/01/202217/01/202220/01/2022 25/01/202227/01/2022A2308/11/202125/11/2 02125/01/202201/02/202204/02/202210/02/2 02210/02/202211/02/202214/02/202217/02/2 02222/02/202224/02/2022A24 European Medicines Agency, 2023.

3 Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines AgencyPage 2 / 12 Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARs (**)PRAC Rapporteur ARComments from PRAC and CHMP Co-Rapporteur assessment (**)(**)Comments from CHMP (**)PRAC outcomeEarly draft LOQ (for Peer review tele-conference)Peer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) (~) (#)Opinion (#)A2504/01/202221/01/202222/03/202229/0 3/202201/04/202207/04/202207/04/202208/0 4/202211/04/202213/04/202220/04/202222/0 4/2022A2631/01/202217/02/202219/04/20222 6/04/202229/04/202205/05/202205/05/20220 6/05/202210/05/202212/05/202217/05/20221 9/05/2022A2707/03/202224/03/202224/05/20 2231/05/202203/06/202210/06/202210/06/20 2210/06/202213/06/202216/06/202221/06/20 2223/06/2022A2804/04/202221/04/202221/06 /202228/06/202201/07/202207/07/202207/07 /202208/07/202211/07/202214/07/202219/07 /202221/07/2022A29A3030/05/202216/06/202 216/08/202223/08/202226/08/202201/09/202 201/09/202202/09/202205/09/202208/09/202 213/09/202215/09/2022A3127/06/202214/07/ 202213/09/202220/09/202223/09/202229/09/ 202229/09/202230/09/202203/10/202206/10/ 202211/10/202213/10/2022A3225/07/202211/ 08/202211/10/202218/10/202221/10/202227/ 10/202227/10/202228/10/202228/10/202203/ 11/202208/11/202210/11/2022A3329/08/2022 15/09/202215/11/202222/11/202225/11/2022 01/12/202201/12/202202/12/202205/12/2022 08/12/202213/12/202215/12/2022A3410/10/2 02227/10/202220/12/202203/01/202306/01/2 02312/01/202312/01/202313/01/202316/01/2 02319/01/202324/01/202326/01/2023A3507/1 1/202224/11/202224/01/202331/01/202303/0 2/202309/02/202309/02/202310/02/202313/0 2/202316/02/202321/02/202323/02/2023A36A 3709/01/202325/01/202328/03/202303/04/20 2305/04/202314/04/202314/04/202314/04/20 2314/04/202319/04/202324/04/202326/04/20 23A3806/02/202323/02/202325/04/202302/05 /202305/05/202312/05/202312/05/202312/05 /202315/05/202317/05/202323/05/202325/05 /2023A3906/03/202323/03/202323/05/202330 /05/202302/06/202308/06/202308/06/202309 /06/202312/06/202315/06/202320/06/202322 /06/2023A4003/04/202320/04/202320/06/202 327/06/202330/06/202306/07/202306/07/202 307/07/202310/07/202313/07/202318/07/202 320/07/2023A41A4230/05/202315/06/202316/ 08/202322/08/202325/08/202331/08/202331/ 08/202301/09/202304/09/202307/09/202312/ 09/202314/09/2023A4326/06/202313/07/2023 12/09/202319/09/202322/09/202328/09/2023 28/09/202329/09/202302/10/202305/10/2023 10/10/202312/10/2023A4424/07/202310/08/2 02310/10/202317/10/202320/10/202326/10/2 02326/10/202327/10/202330/10/202331/10/2 02307/11/202309/11/2023A4528/08/202314/0 9/202314/11/202321/11/202324/11/202330/1 1/202330/11/202301/12/202304/12/202307/1 2/202312/12/202314/12/2023A4609/10/20232 6/10/202319/12/202303/01/202405/01/20241 1/01/202411/01/202412/01/202415/01/20241 8/01/202423/01/202425/01/2024A4706/11/20 2323/11/202323/01/202430/01/202402/02/20 2408/02/202408/02/202409/02/202412/02/20 2415/02/202420/02/202422/02/2024A48A4908 /01/202425/01/202426/03/202402/04/202405 /04/202411/04/202411/04/202412/04/202415 /04/202418/04/202423/04/202425/04/2024A5 012/02/202429/02/202430/04/202406/05/202 408/05/202416/05/202416/05/202417/05/202 421/05/202423/05/202428/05/202430/05/202 4 European Medicines Agency, 2023.

4 Reproduction is authorised provided the source is acknowledged.#Classified as public by the European Medicines AgencyPage 3 / 12 Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARs (**)PRAC Rapporteur ARComments from PRAC and CHMP Co-Rapporteur assessment (**)(**)Comments from CHMP (**)PRAC outcomeEarly draft LOQ (for Peer review tele-conference)Peer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) (~) (#)Opinion (#)A5111/03/202428/03/202428/05/202404/0 6/202407/06/202407/06/202413/06/202414/0 6/202417/06/202420/06/202425/06/202427/0 6/2024A5208/04/202425/04/202425/06/20240 2/07/202405/07/202411/07/202411/07/20241 2/07/202415/07/202418/07/202423/07/20242 5/07/2024A53A5403/06/202420/06/202420/08 /202427/08/202430/08/202405/09/202405/09 /202406/09/202409/09/202412/09/202417/09 /202419/09/2024A5501/07/202418/07/202417 /09/202424/09/202427/09/202403/10/202403 /10/202404/10/202407/10/202410/10/202415 /10/202417/10/2024A5629/07/202415/08/202 415/10/202422/10/202425/10/202431/10/202 431/10/202431/10/202404/11/202407/11/202 412/11/202414/11/2024A5726/08/202412/09/ 202412/11/202419/11/202422/11/202428/11/ 202428/11/202429/11/202402/12/202405/12/ 202410/12/202412/12/2024(*) The Agency strongly recommends submitting the application before the published submission deadline.

5 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.(^) The validation period between submission date and start date is thirteen EMA working days. For further information about the dates on which the Agency will be closed during the current year, please refer to the business hours and holidays page