Procedural timetables
This page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures.
Timetables are categorised according to the type of procedure (e.g. full applications, extensions and variations, as well as response timetables).
The dates for submission, start of the procedure and plenary meetings of the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT) are generally fixed, but the other dates may be subject to adjustment until the CHMP reaches the adoption of the final opinion for the individual application.
At the start of the procedure, the Agency will notify the applicant of the adopted final timetable in writing.
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Timetable: Initial (full) marketing authorisation application accelerated assessment timetables (XLSX/117.31 KB)
First published: 24/05/2016
Last updated: 04/07/2023
EMA/339594/2016 Rev. 12 -
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Timetable accelerated assessment request for initial marketing authorisation applications (XLSX/96.7 KB)
First published: 24/05/2016
Last updated: 04/07/2023
Legal effective date: 18/12/2020
EMA/347524/2016 Rev. 5 -
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Timetable: Initial (full) marketing authorisation application assessment (XLSX/121.46 KB)
First published: 22/12/2014
Last updated: 03/07/2023
Legal effective date: 18/12/2020
EMA/119185/2015 Rev.12 -
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Timetable: Extension application (XLSX/121.55 KB)
First published: 22/12/2020
Last updated: 03/07/2023
Legal effective date: 18/12/2020
EMA/412809/2015 Rev. 9 -
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Timetable: Informed consent and multiple application (XLSX/120.98 KB)
First published: 28/07/2015
Last updated: 27/07/2023
Legal effective date: 18/12/2020
EMA/488671/2015 Rev.6
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Choice of timetable for type II variations and worksharing applications (PDF/231.17 KB)
First published: 28/02/2017
Last updated: 22/01/2020
Legal effective date: 28/02/2017
EMA/103586/2017 Rev. 1 -
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Timetable: Type II variation and worksharing application monthly assessment (PDF/340.88 KB)
First published: 19/12/2016
Last updated: 10/02/2023
EMA/577385/2016 Rev. 7 -
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Timetable: Type II variation and worksharing application weekly assessment (XLSX/154.04 KB)
First published: 19/12/2016
Last updated: 11/08/2023
EMA/577386/2016 Rev. 7 -
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Timetable: Type II variation and worksharing application alternative monthly assessment (PDF/279.9 KB)
First published: 19/12/2016
Last updated: 15/02/2022
EMA/577387/2016 Rev.5 -
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Timetable: Type IB variation requiring linguistic review (PDF/135.06 KB)
First published: 08/10/2015
Last updated: 09/02/2021
Legal effective date: 08/10/2015
EMA/99646/2015 Rev. 2
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Timetable: Marketing authorisation renewal application (XLSX/114.25 KB) (updated)
First published: 28/07/2015
Last updated: 18/09/2023
Legal effective date: 28/07/2015
EMA/461220/2015 Rev. 3 -
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Timetable: Annual reassessment (XLSX/114.49 KB) (updated)
First published: 15/12/2015
Last updated: 18/09/2023
Legal effective date: 15/12/2015
EMA/823130/2015 Rev. 3 -
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Timetable: Annual renewal application of conditional marketing authorisation (XLSX/107.9 KB) (updated)
First published: 15/12/2015
Last updated: 18/09/2023
Legal effective date: 15/12/2015
EMA/823131/2015 Rev. 5
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Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) (XLSX/99.1 KB)
First published: 30/04/2015
Last updated: 25/07/2023
Legal effective date: 31/10/2017
EMA/251636/2015 Rev. 9 -
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Timetable: Post-authorisation safety study (PASS) protocols and final results (PDF/164.96 KB)
First published: 02/07/2015
Last updated: 11/01/2023
Legal effective date: 02/07/2015
EMA/404060/2015 Rev. 5 -
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Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) (PDF/195.24 KB)
First published: 02/07/2015
Last updated: 25/02/2021
EMA/403963/2015 Rev.4
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Timetable: Non-safety referrals (PDF/213.09 KB) (updated)
First published: 13/07/2021
Last updated: 08/09/2023
EMA/30819/2021 rev.1 -
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Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance) (PDF/212.62 KB) (updated)
First published: 13/07/2021
Last updated: 08/09/2023
EMA/29545/2021 rev.1 -
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Timetable: Safety referral (Article 107i, urgent Union procedure) (PDF/118.5 KB) (updated)
First published: 13/07/2021
Last updated: 08/09/2023
EMA/273042/2023
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Timetable: Post-authorisation measure (PAM) assessed by CHMP (PDF/130.6 KB)
First published: 02/07/2015
Last updated: 16/02/2021
Legal effective date: 02/07/2015
EMA/403033/2015 Rev.2 -
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Timetable: Post-authorisation measure (PAM) assessed by PRAC (PDF/132.65 KB)
First published: 02/07/2015
Last updated: 28/01/2022
EMA/403287/2015 Rev.7 -
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Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission (PDF/185.38 KB)
First published: 02/07/2015
Last updated: 16/02/2021
Legal effective date: 02/07/2015
EMA/403143/2015 Rev.2
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Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP) (XLSX/110.06 KB)
First published: 02/02/2021
EMA/51610/2021 -
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Timetable: Accelerated assessment request for initial marketing authorisations - ATMP (XLSX/98.59 KB)
First published: 04/02/2021
Last updated: 26/07/2023
EMA/69089/2021 Rev.2 -
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Timetable: Type II variation and worksharing application assessment - ATMP (PDF/312.2 KB)
First published: 23/11/2017
Last updated: 13/12/2021
EMA/727192/2017 Rev. 2 -
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Timetable: Initial (Full) marketing authorisation application - ATMP (XLSX/128.76 KB)
First published: 15/12/2015
Last updated: 26/07/2023
Legal effective date: 18/12/2020
EMA/824993/2015 Rev.5 -
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Timetable: Extension application - ATMP (XLSX/125.57 KB)
First published: 15/12/2015
Last updated: 26/07/2023
Legal effective date: 18/12/2020
EMA/824995/2015 Rev.5 -
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Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs) (XLSX/99.04 KB)
First published: 30/04/2015
Last updated: 25/07/2023
Legal effective date: 31/10/2017
EMA/251635/2015 Rev. 6 -
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Timetable: Marketing authorisation renewal application - ATMP (PDF/206.33 KB)
First published: 15/12/2015
Last updated: 20/01/2021
Legal effective date: 15/12/2015
EMA/825017/2015 Rev. 2 -
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Timetable: Annual reassessment - ATMP (PDF/236.31 KB)
First published: 15/12/2015
Last updated: 20/01/2021
Legal effective date: 15/12/2015
EMA/825019/2015 Rev.1 -
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Timetable: Annual renewal application of conditional marketing authorisation - ATMP (PDF/172.93 KB)
First published: 15/12/2015
Last updated: 10/02/2022
Legal effective date: 15/12/2015
EMA/825018/2015 Rev.3 -
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Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMP (PDF/188.19 KB)
First published: 25/04/2016
Last updated: 16/02/2021
Legal effective date: 25/04/2016
EMA/267769/2016 Rev.2 -
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Timetable: Post-authorisation measure (PAM) assessed by CAT (PDF/132.58 KB)
First published: 25/04/2016
Last updated: 16/02/2021
Legal effective date: 25/04/2016
EMA/267768/2016 Rev.2 -
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Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP (PDF/133.91 KB)
First published: 25/04/2016
Last updated: 28/01/2022
EMA/267767/2016 Rev. 4 -
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Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP (PDF/196.8 KB)
First published: 25/04/2016
Last updated: 25/02/2021
EMA/267915/2016 Rev.2
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Timetable: Companion diagnostic initial consultation (PDF/232.82 KB)
First published: 21/01/2022
Last updated: 11/05/2022
EMA/3932/2022 Rev.1 -
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Timetable: Companion diagnostic initial consultation - ATMP (PDF/226.62 KB)
First published: 21/01/2022
Last updated: 28/04/2023
EMA/3933/2022 Rev.2 -
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Timetable: Companion diagnostic follow-up consultation (PDF/139.08 KB)
First published: 08/12/2022
EMA/3932/2022 -
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Timetable: Companion diagnostic follow-up consultation - ATMP (PDF/172.98 KB)
First published: 08/12/2022
EMA/3933/2022