Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us

Send us a question Go to www.ema.europa.eu/contact
Telephone +31 (0)88 781 6000

An agency of the European Union

30 June 2023
EMA/339594/2016 Rev.12
Human Medicines Division The timetables in this document may be subject to revision

Initial (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)

(¬) 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 ATMPs.

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 1 / 10
Assessment of initial submission (90-day timetable)
Comments
from PRAC Early draft
List of
Deadline for CHMP (Co) PRAC and CHMP Comments LOQ (for Peer review
Start date PRAC Questions
Submission Rapporteur Rapporteur Co- from CHMP Peer review telecon- Draft LoQ Opinion (#)
(^) outcome (LoQ) (~)
(*) ARs (***) AR Rapporteur (**) tele- ference (TC)
(#)
assessment conference)
(**)(***)

A1 10/10/2022 10/27/2022 12/20/2022 1/3/2023 1/6/2023 1/12/2023 1/12/2023 1/13/2023 1/16/2023 1/19/2023 1/24/2023 1/26/2023
A2 11/7/2022 11/24/2022 1/24/2023 1/31/2023 2/3/2023 2/9/2023 2/9/2023 2/10/2023 2/13/2023 2/16/2023 2/21/2023 2/23/2023
A3
A4 1/9/2023 1/25/2023 3/28/2023 4/3/2023 4/5/2023 4/14/2023 4/14/2023 4/14/2023 4/14/2023 4/19/2023 4/24/2023 4/26/2023
A5 2/6/2023 2/23/2023 4/25/2023 5/2/2023 5/5/2023 5/12/2023 5/12/2023 5/12/2023 5/15/2023 5/17/2023 5/23/2023 5/25/2023
A6 3/6/2023 3/23/2023 5/23/2023 5/30/2023 6/2/2023 6/8/2023 6/8/2023 6/9/2023 6/12/2023 6/15/2023 6/20/2023 6/22/2023
A7 4/3/2023 4/20/2023 6/20/2023 6/27/2023 6/30/2023 7/6/2023 7/6/2023 7/7/2023 7/10/2023 7/13/2023 7/18/2023 7/20/2023
A8
A9 5/30/2023 6/15/2023 8/16/2023 8/22/2023 8/25/2023 8/31/2023 8/31/2023 9/1/2023 9/4/2023 9/7/2023 9/12/2023 9/14/2023
A10 6/26/2023 7/13/2023 9/12/2023 9/19/2023 9/22/2023 9/28/2023 9/28/2023 9/29/2023 10/2/2023 10/5/2023 10/10/2023 10/12/2023
A11 7/24/2023 8/10/2023 10/10/2023 10/17/2023 10/20/2023 10/26/2023 10/26/2023 10/27/2023 10/30/2023 10/31/2023 11/7/2023 11/9/2023
A12 8/28/2023 9/14/2023 11/14/2023 11/21/2023 11/24/2023 11/30/2023 11/30/2023 12/1/2023 12/4/2023 12/7/2023 12/12/2023 12/14/2023
A13 10/9/2023 10/26/2023 12/19/2023 1/3/2024 1/5/2024 1/11/2024 1/11/2024 1/12/2024 1/15/2024 1/18/2024 1/23/2024 1/25/2024
A14 11/6/2023 11/23/2023 1/23/2024 1/30/2024 2/2/2024 2/8/2024 2/8/2024 2/9/2024 2/12/2024 2/15/2024 2/20/2024 2/22/2024
A15
A16 1/8/2024 1/25/2024 3/26/2024 4/2/2024 4/5/2024 4/11/2024 4/11/2024 4/12/2024 4/15/2024 4/18/2024 4/23/2024 4/25/2024
A17 2/12/2024 2/29/2024 4/30/2024 5/6/2024 5/8/2024 5/16/2024 5/16/2024 5/17/2024 5/21/2024 5/23/2024 5/28/2024 5/30/2024
A18 3/11/2024 3/28/2024 5/28/2024 6/4/2024 6/7/2024 6/7/2024 6/13/2024 6/14/2024 6/17/2024 6/20/2024 6/25/2024 6/27/2024
A19 4/8/2024 4/25/2024 6/25/2024 7/2/2024 7/5/2024 7/11/2024 7/11/2024 7/12/2024 7/15/2024 7/18/2024 7/23/2024 7/25/2024
A20
A21 6/3/2024 6/20/2024 8/20/2024 8/27/2024 8/30/2024 9/5/2024 9/5/2024 9/6/2024 9/9/2024 9/12/2024 9/17/2024 9/19/2024
A22 7/1/2024 7/18/2024 9/17/2024 9/24/2024 9/27/2024 10/3/2024 10/3/2024 10/4/2024 10/7/2024 10/10/2024 10/15/2024 10/17/2024
A23 7/29/2024 8/15/2024 10/15/2024 10/22/2024 10/25/2024 10/31/2024 10/31/2024 10/31/2024 11/4/2024 11/7/2024 11/12/2024 11/14/2024
A24 8/26/2024 9/12/2024 11/12/2024 11/19/2024 11/22/2024 11/28/2024 11/28/2024 11/29/2024 12/2/2024 12/5/2024 12/10/2024 12/12/2024
A25 10/14/2024 10/31/2024 1/2/2025 1/7/2025 1/10/2025 1/16/2025 1/16/2025 1/17/2025 1/20/2025 1/23/2025 1/28/2025 1/28/2025

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
Classified as public by the European Medicines Agency
#
Page 2 / 10
 Comments
from PRAC Early draft
List of
Deadline for CHMP (Co) PRAC and CHMP Comments LOQ (for Peer review
Start date PRAC Questions
Submission Rapporteur Rapporteur Co- from CHMP Peer review telecon- Draft LoQ Opinion (#)
(^) outcome (LoQ) (~)
(*) ARs (***) AR Rapporteur (**) tele- ference (TC)
(#)
assessment conference)
(**)(***)

A26 11/11/2024 11/28/2024 1/28/2025 2/4/2025 2/7/2025 2/13/2025 2/13/2025 2/14/2025 2/17/2025 2/20/2025 2/25/2025 2/25/2025
A27
A28 1/7/2025 1/24/2025 3/25/2025 4/1/2025 4/4/2025 4/10/2025 4/10/2025 4/11/2025 4/14/2025 4/16/2025 4/23/2025 4/23/2025
A29 2/3/2025 2/20/2025 4/22/2025 4/29/2025 5/2/2025 5/8/2025 5/8/2025 5/8/2025 5/12/2025 5/15/2025 5/20/2025 5/20/2025
A30 3/3/2025 3/20/2025 5/20/2025 5/26/2025 5/28/2025 6/5/2025 6/5/2025 6/6/2025 6/10/2025 6/12/2025 6/17/2025 6/17/2025
A31 4/4/2025 4/24/2025 6/24/2025 7/1/2025 7/4/2025 7/10/2025 7/10/2025 7/11/2025 7/14/2025 7/17/2025 7/22/2025 7/22/2025
A32
A33 6/2/2025 6/19/2025 8/19/2025 8/26/2025 8/29/2025 9/4/2025 9/4/2025 9/5/2025 9/8/2025 9/11/2025 9/16/2025 9/16/2025
A34 6/30/2025 7/17/2025 9/16/2025 9/23/2025 9/26/2025 10/2/2025 10/2/2025 10/3/2025 10/6/2025 10/9/2025 10/14/2025 10/14/2025
A35 7/28/2025 8/14/2025 10/14/2025 10/21/2025 10/24/2025 10/30/2025 10/30/2025 10/30/2025 11/3/2025 11/6/2025 11/11/2025 11/11/2025
A36 8/25/2025 9/11/2025 11/11/2025 11/18/2025 11/21/2025 11/27/2025 11/27/2025 11/28/2025 12/1/2025 12/4/2025 12/9/2025 12/9/2025
A37 10/13/2025 10/30/2025 12/23/2025 1/6/2026 1/9/2026 1/15/2026 1/15/2026 1/16/2026 1/19/2026 1/22/2026 1/27/2026 1/27/2026
A38 11/10/2025 11/27/2025 1/27/2026 2/3/2026 2/6/2026 2/12/2026 2/12/2026 2/13/2026 2/16/2026 2/19/2026 2/24/2026 2/24/2026
A39
A40 1/5/2026 1/22/2026 3/24/2026 3/31/2026 4/1/2026 4/9/2026 4/10/2026 4/10/2026 4/13/2026 4/16/2026 4/21/2026 4/21/2026
A41 2/2/2026 2/19/2026 4/21/2026 4/28/2026 4/30/2026 5/7/2026 5/7/2026 5/8/2026 5/11/2026 5/13/2026 5/19/2026 5/19/2026
A42 3/9/2026 3/26/2026 5/26/2026 6/2/2026 6/5/2026 6/11/2026 6/11/2026 6/12/2026 6/15/2026 6/18/2026 6/23/2026 6/23/2026
A43 3/30/2026 4/23/2026 6/23/2026 6/30/2026 7/3/2026 7/9/2026 7/9/2026 7/10/2026 7/13/2026 7/16/2026 7/21/2026 7/21/2026
A44
A45 6/1/2026 6/18/2026 8/18/2026 8/25/2026 8/28/2026 9/3/2026 9/3/2026 9/4/2026 9/7/2026 9/10/2026 9/15/2026 9/15/2026
A46 6/29/2026 7/16/2026 9/15/2026 9/22/2026 9/25/2026 10/1/2026 10/1/2026 10/2/2026 10/5/2026 10/8/2026 10/13/2026 10/13/2026
A47 7/27/2026 8/13/2026 10/13/2026 10/20/2026 10/23/2026 10/29/2026 10/29/2026 10/29/2026 11/3/2026 11/5/2026 11/10/2026 11/10/2026
A48 8/24/2026 9/10/2026 11/10/2026 11/17/2026 11/20/2026 11/26/2026 11/26/2026 11/27/2026 11/30/2026 12/3/2026 12/8/2026 12/8/2026
(*) 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.
(^) 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 on the website.
(~) The accelerated assessment timetable could be reverted to a regular one at the time of the List of Questions and at the judgement of the CHMP. In such a case, the assessment

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
Classified as public by the European Medicines Agency
#
Page 3 / 10
 Comments
from PRAC Early draft
List of
Deadline for CHMP (Co) PRAC and CHMP Comments LOQ (for Peer review
Start date PRAC Questions
Submission Rapporteur Rapporteur Co- from CHMP Peer review telecon- Draft LoQ Opinion (#)
(^) outcome (LoQ) (~)
(*) ARs (***) AR Rapporteur (**) tele- ference (TC)
(#)
assessment conference)
(**)(***)

of the responses to the List of Questions will follow the regular 60-day timetable foreseen for initial Marketing authorisation applications, to which the applicant should refer, and the
remainder of this timetable will no longer apply.
(#) A List of Question or an Opinion will be adopted at the end of the first assessment phase. An Opinion is adopted on the last day of the CHMP and concludes the assessment
procedure. Alternatively, a List of Questions is adopted on the second day of the CHMP meeting.
(**) Comments from CHMP and PRAC members are not made available to Applicants.
(***) The CHMP Co-Rapporteur introduces their assessment into the Rapporteur Day 80 Overview assessment report for non-COVID 19 related applications.
The Rapporteur AR and Co-Rapporteur assessment will be both made available to the applicant.

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
Classified as public by the European Medicines Agency
#
Page 4 / 10
Assessment of responses to List of Questions (LOQ)¬
30-day timetable after clock-stop for submission of responses

CHMP and Updated CHMP List of

Deadline for Comments
PRAC and PRAC Outstanding
Submission Restart from PRAC Opinion (#)
Rapporteurs Rapporteurs JAR Issues (LoOI)
(*) and CHMP
Joint AR (JAR) (~) (^) (#)

B1 12/22/2022 12/26/2022 1/12/2023 1/17/2023 1/19/2023 1/24/2023 1/26/2023

B2 1/20/2023 1/23/2023 2/9/2023 2/14/2023 2/16/2023 2/21/2023 2/23/2023
B3 2/24/2023 2/27/2023 3/16/2023 3/21/2023 3/23/2023 3/28/2023 3/30/2023
B4 3/23/2023 3/26/2023 4/13/2023 4/18/2023 4/20/2023 4/24/2023 4/26/2023
B5 4/21/2023 4/24/2023 5/11/2023 5/16/2023 5/17/2023 5/23/2023 5/25/2023
B6 5/17/2023 5/22/2023 6/8/2023 6/13/2023 6/15/2023 6/20/2023 6/22/2023
B7 6/16/2023 6/19/2023 7/6/2023 7/11/2023 7/13/2023 7/18/2023 7/20/2023
B8
B9 8/11/2023 8/14/2023 8/31/2023 9/5/2023 9/7/2023 9/12/2023 9/14/2023
B10 9/8/2023 9/11/2023 9/28/2023 10/3/2023 10/5/2023 10/10/2023 10/12/2023
B11 10/6/2023 10/9/2023 10/26/2023 10/30/2023 10/31/2023 11/7/2023 11/9/2023
B12 11/10/2023 11/13/2023 11/30/2023 12/5/2023 12/7/2023 12/12/2023 12/14/2023
B13 12/21/2023 12/25/2023 1/11/2024 1/16/2024 1/18/2024 1/23/2024 1/25/2024
B14 1/19/2024 1/22/2024 2/8/2024 2/13/2024 2/15/2024 2/20/2024 2/22/2024
B15 2/16/2024 2/19/2024 3/7/2024 3/12/2024 3/14/2024 3/19/2024 3/21/2024
B16 3/22/2024 3/25/2024 4/11/2024 4/16/2024 4/18/2024 4/23/2024 4/25/2024
B17 4/26/2024 4/29/2024 5/16/2024 5/21/2024 5/23/2024 5/28/2024 5/30/2024
B18 5/24/2024 5/27/2024 6/13/2024 6/18/2024 6/20/2024 6/25/2024 6/27/2024
B19 6/21/2024 6/24/2024 7/11/2024 7/16/2024 7/18/2024 7/23/2024 7/25/2024
B20
B21 8/16/2024 8/19/2024 9/5/2024 9/10/2024 9/12/2024 9/17/2024 9/19/2024
B22 9/13/2024 9/16/2024 10/3/2024 10/8/2024 10/10/2024 10/15/2024 10/17/2024
B23 10/11/2024 10/14/2024 10/31/2024 11/5/2024 11/7/2024 11/12/2024 11/14/2024
B24 11/8/2024 11/11/2024 11/28/2024 12/3/2024 12/5/2024 12/10/2024 12/12/2024
B25 12/20/2024 12/30/2024 1/16/2025 1/21/2025 1/23/2025 1/28/2025 1/30/2025
B26 1/24/2025 1/27/2025 2/13/2025 2/18/2025 2/20/2025 2/25/2025 2/27/2025
B27 2/21/2025 2/24/2025 3/13/2025 3/18/2025 3/20/2025 3/25/2025 3/27/2025
B28 3/24/2025 3/25/2025 4/10/2025 4/15/2025 4/16/2025 4/23/2025 4/25/2025
B29 4/16/2025 4/21/2025 5/8/2025 5/13/2025 5/15/2025 5/20/2025 5/22/2025

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 5 / 10
 CHMP and Updated CHMP List of
Deadline for Comments
PRAC and PRAC Outstanding
Submission Restart from PRAC Opinion (#)
Rapporteurs Rapporteurs JAR Issues (LoOI)
(*) and CHMP
Joint AR (JAR) (~) (^) (#)

B30 5/16/2025 5/19/2025 6/5/2025 6/10/2025 6/12/2025 6/17/2025 6/19/2025

B31 6/20/2025 6/23/2025 7/10/2025 7/15/2025 7/17/2025 7/22/2025 7/24/2025
B32
B33 8/14/2025 8/18/2025 9/4/2025 9/9/2025 9/11/2025 9/16/2025 9/18/2025
B34 9/12/2025 9/15/2025 10/2/2025 10/7/2025 10/9/2025 10/14/2025 10/16/2025
B35 10/10/2025 10/13/2025 10/30/2025 11/4/2025 11/6/2025 11/11/2025 11/13/2025
B36 11/7/2025 11/10/2025 11/27/2025 12/2/2025 12/4/2025 12/9/2025 12/11/2025
B37 12/23/2025 12/29/2025 1/15/2026 1/20/2026 1/22/2026 1/27/2026 1/29/2026
B38 1/23/2026 1/26/2026 2/12/2026 2/17/2026 2/19/2026 2/24/2026 2/26/2026
B39 2/20/2026 2/23/2026 3/12/2026 3/17/2026 3/19/2026 3/24/2026 3/26/2026
B40 3/20/2026 3/23/2026 4/9/2026 4/14/2026 4/16/2026 4/21/2026 4/23/2026
B41 4/17/2026 4/20/2026 5/7/2026 5/12/2026 5/13/2026 5/19/2026 5/21/2026
B42 5/22/2026 5/25/2026 6/11/2026 6/16/2026 6/18/2026 6/23/2026 6/25/2026
B43 6/19/2026 6/22/2026 7/9/2026 7/14/2026 7/16/2026 7/21/2026 7/23/2026
B44
B45 8/14/2026 8/17/2026 9/3/2026 9/8/2026 9/10/2026 9/15/2026 9/17/2026
B46 9/11/2026 9/14/2026 10/1/2026 10/6/2026 10/8/2026 10/13/2026 10/15/2026
B47 10/9/2026 10/12/2026 10/29/2026 11/3/2026 11/5/2026 11/10/2026 11/12/2026
B48 11/6/2026 11/9/2026 11/26/2026 12/1/2026 12/3/2026 12/8/2026 12/10/2026
(¬) For the assessment of responses to a List of Questions a 30-day timetable with or without clockstop (immediate responses)
could apply depending on the applicant's ability to provide responses within 5 days and the CHMP and PRAC Rapporteur's
capacity to assess them with a timeframe shorter than 30 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.
(~) A PRAC discussion is not foreseen for a 30-day timetable; PRAC member comments are reflected in the updated
CHMP and PRAC Rapporteur joint assessment report.
(^) The accelerated assessment tmetable could still be reverted to a regular one at the time of the List of Outstanding
Issues (LoOI) and at the judgement of the CHMP. In such a case, the assessment of the responses to the LoOI will follow
the 60-day timetable foreseen for the responses to the List of Questions for initial Marketing authorisation applications,
to which the applicant should refer, and the remainder of this timetable will no longer apply.
(#) List of Questions and Opinion are alternative outcomes adopted on the second or last day of the CHMP meeting,
respectively.

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 6 / 10
Assessment of responses to List of Questions (LOQ)¬
30-day timetable after immediate responses

CHMP and Updated CHMP List of

Deadline for Comments
PRAC and PRAC Outstanding
Submission Restart from PRAC Opinion (#)
Rapporteurs Rapporteurs JAR Issues (LoOI)
(*) and CHMP (**)
Joint AR (JAR) (~) (^) (#)

C1 12/22/2022 12/26/2022 1/12/2023 1/17/2023 1/19/2023 1/24/2023 1/26/2023

C2 1/30/2023 1/31/2023 2/9/2023 2/14/2023 2/16/2023 2/21/2023 2/23/2023
C3 2/28/2023 3/1/2023 3/16/2023 3/21/2023 3/23/2023 3/28/2023 3/30/2023
C4 3/31/2023 4/3/2023 4/13/2023 4/18/2023 4/20/2023 4/24/2023 4/26/2023
C5 4/28/2023 5/2/2023 5/11/2023 5/16/2023 5/17/2023 5/23/2023 5/25/2023
C6 5/26/2023 5/30/2023 6/8/2023 6/13/2023 6/15/2023 6/20/2023 6/22/2023
C7 6/26/2023 6/27/2023 7/6/2023 7/11/2023 7/13/2023 7/18/2023 7/20/2023
C8
C9 8/21/2023 8/22/2023 8/31/2023 9/5/2023 9/7/2023 9/12/2023 9/14/2023
C10 9/18/2023 9/19/2023 9/28/2023 10/3/2023 10/5/2023 10/10/2023 10/12/2023
C11 10/16/2023 10/17/2023 10/26/2023 10/30/2023 10/31/2023 11/7/2023 11/9/2023
C12 11/14/2023 11/15/2023 11/30/2023 12/5/2023 12/7/2023 12/12/2023 12/14/2023
C13 12/21/2023 12/25/2023 1/11/2024 1/16/2024 1/18/2024 1/23/2024 1/25/2024
C14 1/29/2024 1/30/2024 2/8/2024 2/13/2024 2/15/2024 2/20/2024 2/22/2024
C15 2/26/2024 2/27/2024 3/7/2024 3/12/2024 3/14/2024 3/19/2024 3/21/2024
C16 3/26/2024 3/27/2024 4/11/2024 4/16/2024 4/18/2024 4/23/2024 4/25/2024
C17 4/30/2024 5/1/2024 5/16/2024 5/21/2024 5/23/2024 5/28/2024 5/30/2024
C18 6/3/2024 6/4/2024 6/13/2024 6/18/2024 6/20/2024 6/25/2024 6/27/2024
C19 7/1/2024 7/2/2024 7/11/2024 7/16/2024 7/18/2024 7/23/2024 7/25/2024
C20
C21 8/26/2024 8/27/2024 9/5/2024 9/10/2024 9/12/2024 9/17/2024 9/19/2024
C22 9/23/2024 9/24/2024 10/3/2024 10/8/2024 10/10/2024 10/15/2024 10/17/2024
C23 10/21/2024 10/22/2024 10/31/2024 11/5/2024 11/7/2024 11/12/2024 11/14/2024
C24 11/18/2024 11/19/2024 11/28/2024 12/3/2024 12/5/2024 12/10/2024 12/12/2024
C25 12/20/2024 1/2/2025 1/16/2025 1/21/2025 1/23/2025 1/28/2025 1/30/2025
C26 2/3/2025 2/4/2025 2/13/2025 2/18/2025 2/20/2025 2/25/2025 2/27/2025
C27 3/3/2025 3/4/2025 3/13/2025 3/18/2025 3/20/2025 3/25/2025 3/27/2025
C28 4/1/2025 4/2/2025 4/10/2025 4/15/2025 4/16/2025 4/23/2025 4/25/2025
C29 4/28/2025 4/29/2025 5/8/2025 5/13/2025 5/15/2025 5/20/2025 5/22/2025
C30 5/26/2025 5/27/2025 6/5/2025 6/10/2025 6/12/2025 6/17/2025 6/19/2025
C31 6/25/2025 6/26/2025 7/10/2025 7/15/2025 7/17/2025 7/22/2025 7/24/2025
C32
C33 8/25/2025 8/26/2025 9/4/2025 9/9/2025 9/11/2025 9/16/2025 9/18/2025
C34 9/22/2025 9/23/2025 10/2/2025 10/7/2025 10/9/2025 10/14/2025 10/16/2025
C35 10/20/2025 10/21/2025 10/30/2025 11/4/2025 11/6/2025 11/11/2025 11/13/2025
C36 11/17/2025 11/18/2025 11/27/2025 12/2/2025 12/4/2025 12/9/2025 12/11/2025
C37 12/23/2025 1/1/2026 1/15/2026 1/20/2026 1/22/2026 1/27/2026 1/29/2026
C38 2/2/2026 2/3/2026 2/12/2026 2/17/2026 2/19/2026 2/24/2026 2/26/2026
C39 3/2/2026 3/3/2026 3/12/2026 3/17/2026 3/19/2026 3/24/2026 3/26/2026
C40 3/30/2026 3/31/2026 4/9/2026 4/14/2026 4/16/2026 4/21/2026 4/23/2026
C41 4/28/2026 4/29/2026 5/7/2026 5/12/2026 5/13/2026 5/19/2026 5/21/2026
C42 5/27/2026 5/28/2026 6/11/2026 6/16/2026 6/18/2026 6/23/2026 6/25/2026
C43 6/29/2026 6/30/2026 7/9/2026 7/14/2026 7/16/2026 7/21/2026 7/23/2026
C44
C45 8/24/2026 8/25/2026 9/3/2026 9/8/2026 9/10/2026 9/15/2026 9/17/2026
C46 9/21/2026 9/22/2026 10/1/2026 10/6/2026 10/8/2026 10/13/2026 10/15/2026
C47 10/19/2026 10/20/2026 10/29/2026 11/3/2026 11/5/2026 11/10/2026 11/12/2026
C48 11/16/2026 11/17/2026 11/26/2026 12/1/2026 12/3/2026 12/8/2026 12/10/2026

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 7 / 10
 CHMP and Updated CHMP List of
Deadline for Comments
PRAC and PRAC Outstanding
Submission Restart from PRAC Opinion (#)
Rapporteurs Rapporteurs JAR Issues (LoOI)
(*) and CHMP (**)
Joint AR (JAR) (~) (^) (#)

(¬) For the assessment of responses to a List of Questions a 30-day timetable with or without clockstop (immediate responses)
could apply depending on the applicant's ability to provide responses within 5 days and the CHMP and PRAC Rapporteur's
capacity to assess them with a timeframe shorter than 30 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.
(**) Comments from CHMP and PRAC members are not made available to Applicants.
(~) A PRAC discussion is not foreseen for a 30-day timetable; PRAC member comments are reflected in the updated
CHMP and PRAC Rapporteur joint assessment report.
(^) The accelerated assessment tmetable could still be reverted to a regular one at the time of the List of Outstanding
Issues (LoOI) and at the judgement of the CHMP. In such a case, the assessment of the responses to the LoOI will follow
the 60-day timetable foreseen for the responses to the List of Questions for initial Marketing authorisation applications,
to which the applicant should refer, and the remainder of this timetable will no longer apply.
(#) List of Questions and Opinion are alternative outcomes adopted on the second or last day of the CHMP meeting,
respectively.

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 8 / 10
Assessment of responses to List of Outstanding Issues (LoOI) ¬
30-day timetable after immediate responses

Updated CHMP
CHMP and PRAC
Deadline for Comments from and PRAC Opinion(^)
Restart Rapporteurs
Submission (*) PRAC and CHMP Rapporteurs JAR
Joint AR (JAR)
(~)

D1 12/22/2022 12/28/2022 1/12/2023 1/17/2023 1/19/2023 1/26/2023

D2 1/31/2023 2/1/2023 2/9/2023 2/14/2023 2/16/2023 2/23/2023
D3 2/28/2023 3/1/2023 3/16/2023 3/21/2023 3/23/2023 3/30/2023
D4 4/3/2023 4/4/2023 4/13/2023 4/18/2023 4/20/2023 4/26/2023
D5 5/2/2023 5/3/2023 5/11/2023 5/16/2023 5/17/2023 5/25/2023
D6 5/30/2023 5/31/2023 6/8/2023 6/13/2023 6/15/2023 6/22/2023
D7 6/27/2023 6/28/2023 7/6/2023 7/11/2023 7/13/2023 7/20/2023
D8
D9 8/14/2023 8/16/2023 8/31/2023 9/5/2023 9/7/2023 9/14/2023
D10 9/19/2023 9/20/2023 9/28/2023 10/3/2023 10/5/2023 10/12/2023
D11 10/17/2023 10/18/2023 10/26/2023 10/30/2023 10/31/2023 11/9/2023
D12 11/16/2023 11/17/2023 11/30/2023 12/5/2023 12/7/2023 12/14/2023
D13 12/21/2023 12/27/2023 1/11/2024 1/16/2024 1/18/2024 1/25/2024
D14 1/30/2024 1/31/2024 2/8/2024 2/13/2024 2/15/2024 2/22/2024
D15 2/27/2024 2/28/2024 3/7/2024 3/12/2024 3/14/2024 3/21/2024
D16 3/27/2024 3/29/2024 4/11/2024 4/16/2024 4/18/2024 4/25/2024
D17 5/2/2024 5/3/2024 5/16/2024 5/21/2024 5/23/2024 5/30/2024
D18 6/4/2024 6/5/2024 6/13/2024 6/18/2024 6/20/2024 6/27/2024
D19 7/2/2024 7/3/2024 7/11/2024 7/16/2024 7/18/2024 7/25/2024
D20
D21 8/20/2024 8/21/2024 9/5/2024 9/10/2024 9/12/2024 9/19/2024
D22 9/24/2024 9/25/2024 10/3/2024 10/8/2024 10/10/2024 10/17/2024
D23 10/22/2024 10/23/2024 10/31/2024 11/5/2024 11/7/2024 11/14/2024
D24 11/19/2024 11/20/2024 11/28/2024 12/3/2024 12/5/2024 12/12/2024
D25 12/20/2024 1/1/2025 1/16/2025 1/21/2025 1/23/2025 1/30/2025
D26 2/4/2025 2/5/2025 2/13/2025 2/18/2025 2/20/2025 2/27/2025
D27 3/4/2025 3/5/2025 3/13/2025 3/18/2025 3/20/2025 3/27/2025
D28 4/2/2025 4/3/2025 4/10/2025 4/15/2025 4/16/2025 4/25/2025
D29 4/29/2025 4/30/2025 5/8/2025 5/13/2025 5/15/2025 5/22/2025
D30 5/27/2025 5/28/2025 6/5/2025 6/10/2025 6/12/2025 6/19/2025
D31 6/26/2025 6/27/2025 7/10/2025 7/15/2025 7/17/2025 7/24/2025
D32
D33 8/19/2025 8/20/2025 9/4/2025 9/9/2025 9/11/2025 9/18/2025
D34 9/23/2025 9/24/2025 10/2/2025 10/7/2025 10/9/2025 10/16/2025
D35 10/21/2025 10/22/2025 10/30/2025 11/4/2025 11/6/2025 11/13/2025
D36 11/18/2025 11/19/2025 11/27/2025 12/2/2025 12/4/2025 12/11/2025
D37 12/23/2025 12/31/2025 1/15/2026 1/20/2026 1/22/2026 1/29/2026
D38 2/3/2026 2/4/2026 2/12/2026 2/17/2026 2/19/2026 2/26/2026
D39 3/3/2026 3/4/2026 3/12/2026 3/17/2026 3/19/2026 3/26/2026
D40 3/31/2026 4/1/2026 4/9/2026 4/14/2026 4/16/2026 4/23/2026
D41 4/28/2026 4/29/2026 5/7/2026 5/12/2026 5/13/2026 5/21/2026

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 9 / 10
 Updated CHMP
CHMP and PRAC
Deadline for Comments from and PRAC Opinion(^)
Restart Rapporteurs
Submission (*) PRAC and CHMP Rapporteurs JAR
Joint AR (JAR)
(~)

D42 5/28/2026 5/29/2026 6/11/2026 6/16/2026 6/18/2026 6/25/2026

D43 6/30/2026 7/1/2026 7/9/2026 7/14/2026 7/16/2026 7/23/2026
D44
D45 8/18/2026 8/19/2026 9/3/2026 9/8/2026 9/10/2026 9/17/2026
D46 9/22/2026 9/23/2026 10/1/2026 10/6/2026 10/8/2026 10/15/2026
D47 10/20/2026 10/21/2026 10/29/2026 11/3/2026 11/5/2026 11/12/2026
D48 11/17/2026 11/18/2026 11/26/2026 12/1/2026 12/3/2026 12/10/2026
(¬) For the assessment of responses to a List of Outstanding Issues a 30-day timetable with or without clockstop
(immediate responses) could apply depending on the applicant's ability to provide responses within 5 days and the CHMP
and PRAC Rapporteur's capacity to assess them with the shorter timeframe.
(*) 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.
(~) A PRAC discussion is not foreseen for a 30-day timetable; PRAC member comments are reflected in the updated
PRAC Rapporteur AR.
(^) The accelerated assessment timetable could still be reverted to a regular one at this time through adoption of a
second List of Outstanding Issues (LoOI) and at the judgement of the CHMP. In such a case, the assessment of the
responses to the 2nd LoOI can only follow the 30-day timetable foreseen for the responses to the List of Outstanding
Issues for initial Marketing authorisation applications, to which the applicant should refer.

© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.
# Classified as public by the European Medicines Agency Page 10 / 10