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31 October 2017 EMA/412809/2015 Rev.2 Human Medicines Evaluation
The timetables in this document may be subject to revision
Extension application* assessment timetables Assessment 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) *These are also known as Annex I (of Regulation EC No 1234/2008) applications.
(*) 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 generally seventeen calendar 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 Co-Rapporteur is involved only in case the extension application is submitted in support of an extension of indication. (~) Step applicable only if RMP is submitted. (**) Comments from CHMP and PRAC members and the draft List of Questions are not made available to MAHs.
CHMP CHMP Rapporteur(s Rapporteur(s Joint) AR (^) Joint) AR (~) (#) (#)
Updated List of CHMP Outstanding Rapporteur(s Issues (LoOI) Joint) AR or Opinion (#)
PRAC Rapporteur AR (~)
Comments from PRAC (**) (~)
Updated PRAC Rapporteur AR (~)
PRAC outcome (~)
Comments from CHMP (**)
25/05/2021
28/05/2021
02/06/2021
03/06/2021
10/06/2021
14/06/2021
17/06/2021
24/06/2021
28/06/2021
22/06/2021
25/06/2021
30/06/2021
01/07/2021
08/07/2021
12/07/2021
15/07/2021
22/07/2021
19/07/2021
23/08/2021
17/08/2021
20/08/2021
25/08/2021
26/08/2021
03/09/2021
06/09/2021
09/09/2021
16/09/2021
16/08/2021
20/09/2021
14/09/2021
17/09/2021
22/09/2021
23/09/2021
30/09/2021
04/10/2021
07/10/2021
14/10/2021
Deadline for Submission (*)
Restart
B52
23/04/2021
26/04/2021
31/05/2021
B53
21/05/2021
24/05/2021
B55
16/07/2021
B56
13/08/2021
B54
B57
10/09/2021
13/09/2021
18/10/2021
12/10/2021
15/10/2021
20/10/2021
21/10/2021
28/10/2021
29/10/2021
04/11/2021
11/11/2021
B58
15/10/2021
18/10/2021
22/11/2021
16/11/2021
19/11/2021
24/11/2021
25/11/2021
02/12/2021
06/12/2021
09/12/2021
16/12/2021
B59
15/10/2021
18/10/2021
22/11/2021
16/11/2021
19/11/2021
24/11/2021
25/11/2021
02/12/2021
06/12/2021
09/12/2021
16/12/2021
(*) 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. (^) Step applicable if no RMP is submitted (no PRAC involvement). (#) A Joint assessment report is circulated by the CHMP Rapporteur and Co-Rapporteur in case both are involved in the assessment (extension application in support of extension of indication). (~) Step applicable only if RMP is submitted. (**) Comments from CHMP and PRAC members are not made available to MAHs.
(*) 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 Joint assessment report is circulated by the CHMP Rapporteur and Co-Rapporteur in case both are involved in the assessment (extension application in support of extension of indication). (~) Step applicable only if RMP is submitted. (**) Comments from CHMP and PRAC members are not made available to MAHs.
(¬) This timetable is only used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time. (*) 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 Joint assessment report is circulated by the CHMP Rapporteur and Co-Rapporteur in case both are involved in the assessment (extension application in support of extension of indication). (~) Step applicable only if RMP is submitted. (##) A PRAC discussion is not foreseen in this timetable; PRAC member comments are reflected in the updated PRAC Rapporteur assessment report. (**) Comments from CHMP and PRAC members are not made available to Applicants.
Timetable: Extension application - European Medicines Agency
Oct 31, 2017 - 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 generally seventeen calendar days. For further information about the dates on which the Agency will ...
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