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31 October 2017 EMA/119185/2015 Rev.5 Human Medicines Evaluation
The timetables in this document may be subject to revision
Initial (Full) Marketing Authorisation 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) Assessment of Outstanding Issues following Oral Explanation (30-day timetable)
Early draft Updated Peer review Comments LOQ (for Peer PRAC PRAC teleconfrom CHMP review teleoutcome (~) Rapporteur ference (TC) conference) (**) AR (#)
Draft LoQ
List of Questions (LoQ) or Opinion
30/04/2021
20/05/2021
09/08/2021
23/08/2021
27/08/2021
27/08/2021
02/09/2021
03/09/2021
03/09/2021
06/09/2021
09/09/2021
16/09/2021
A56
31/05/2021
17/06/2021
06/09/2021
20/09/2021
24/09/2021
24/09/2021
30/09/2021
30/09/2021
30/09/2021
04/10/2021
07/10/2021
14/10/2021
A57
28/06/2021
15/07/2021
04/10/2021
18/10/2021
22/10/2021
22/10/2021
27/10/2021
28/10/2021
28/10/2021
29/10/2021
04/11/2021
11/11/2021
A58
02/08/2021
19/08/2021
08/11/2021
22/11/2021
26/11/2021
26/11/2021
02/12/2021
02/12/2021
02/12/2021
06/12/2021
09/12/2021
16/12/2021
Deadline for Submission (*) A55
(*) 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 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. (**) Comments from CHMP and PRAC members are not made available to Applicants. (#) Peer review is a process by which other members of the CHMP review the (Co) Rapporteurs’ scientific evaluation, as well as the validity of the scientific/regulatory conclusions reached. It applies during the initial phase of the assessment of a new Marketing Authorisation Application (MAA). (~) PRAC discussion (and outcome) during the 1st assessment phase is only envisaged for a minority of 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. (**) Comments from CHMP and PRAC members are not made available to Applicants. (#) The PRAC outcome is captured in the subsequent PRAC Rapporteur updated assessment report. (~) This assessment report incorporates the PRAC Rapporteur updated assessment report circulated earlier at the conclusion of the PRAC meeting.
Assessment of responses to List of Outstanding Issues (LoOI) 30-day timetable after clock-stop for responses CHMP and PRAC Comments Rapporteurs from PRAC and CHMP (**) Joint AR (JAR)
CHMP and PRAC Comments Rapporteurs from PRAC and CHMP (**) Joint AR (JAR)
Updated CHMP and PRAC Rapporteurs JAR (~)
Deadline for Submission (*)
Restart
C40
28/04/2020
29/04/2020
13/05/2020
18/05/2020
20/05/2020
28/05/2020
C41
26/05/2020
27/05/2020
10/06/2020
15/06/2020
18/06/2020
25/06/2020
C42
23/06/2020
24/06/2020
08/07/2020
13/07/2020
16/07/2020
23/07/2020
C44
18/08/2020
19/08/2020
02/09/2020
07/09/2020
10/09/2020
17/09/2020
C45
15/09/2020
16/09/2020
30/09/2020
05/10/2020
08/10/2020
15/10/2020
C46
13/10/2020
14/10/2020
28/10/2020
03/11/2020
05/11/2020
12/11/2020
C47
10/11/2020
11/11/2020
25/11/2020
30/11/2020
03/12/2020
10/12/2020
C48
23/12/2020
30/12/2020
13/01/2021
18/01/2021
21/01/2021
28/01/2021
C49
26/01/2021
27/01/2021
10/02/2021
15/02/2021
18/02/2021
25/02/2021
C50
23/02/2021
24/02/2021
10/03/2021
15/03/2021
18/03/2021
25/03/2021
C51
23/03/2021
24/03/2021
07/04/2021
12/04/2021
15/04/2021
22/04/2021
C52
20/04/2021
21/04/2021
05/05/2021
10/05/2021
12/05/2021
20/05/2021
C53
25/05/2021
26/05/2021
09/06/2021
14/06/2021
17/06/2021
24/06/2021
C54
22/06/2021
23/06/2021
07/07/2021
12/07/2021
15/07/2021
22/07/2021
C56
17/08/2021
18/08/2021
01/09/2021
06/09/2021
09/09/2021
16/09/2021
C57
14/09/2021
15/09/2021
29/09/2021
04/10/2021
07/10/2021
14/10/2021
C58
12/10/2021
13/10/2021
27/10/2021
03/11/2021
05/11/2021
11/11/2021
C59
16/11/2021
17/11/2021
01/12/2021
06/12/2021
09/12/2021
16/12/2021
Opinion
(*) 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 PRAC Rapporteur AR.
CHMP and PRAC Comments from Updated CHMP and Rapporteurs PRAC and CHMP PRAC Rapporteurs (**) JAR (~) Joint AR (JAR)
D40
05/05/2020
06/05/2020
13/05/2020
18/05/2020
20/05/2020
28/05/2020
D41
02/06/2020
03/06/2020
10/06/2020
15/06/2020
18/06/2020
25/06/2020
D42
30/06/2020
01/07/2020
08/07/2020
13/07/2020
16/07/2020
23/07/2020
D45
22/09/2020
23/09/2020
30/09/2020
05/10/2020
08/10/2020
15/10/2020
D46
20/10/2020
21/10/2020
28/10/2020
03/11/2020
05/11/2020
12/11/2020
D47
17/11/2020
18/11/2020
25/11/2020
30/11/2020
03/12/2020
10/12/2020
D48
05/01/2021
06/01/2021
13/01/2021
18/01/2021
21/01/2021
28/01/2021
D49
02/02/2021
03/02/2021
10/02/2021
15/02/2021
18/02/2021
25/02/2021
D50
02/03/2021
03/03/2021
10/03/2021
15/03/2021
18/03/2021
25/03/2021
D51
30/03/2021
31/03/2021
07/04/2021
12/04/2021
15/04/2021
22/04/2021
D52
27/04/2021
28/04/2021
05/05/2021
10/05/2021
12/05/2021
20/05/2021
D53
01/06/2021
02/06/2021
09/06/2021
14/06/2021
17/06/2021
24/06/2021
D54
29/06/2021
30/06/2021
07/07/2021
12/07/2021
15/07/2021
22/07/2021
D57
21/09/2021
22/09/2021
29/09/2021
04/10/2021
07/10/2021
14/10/2021
D58
19/10/2021
20/10/2021
27/10/2021
03/11/2021
05/11/2021
11/11/2021
D59
23/11/2021
24/11/2021
01/12/2021
06/12/2021
09/12/2021
16/12/2021
Opinion
D43 D44
D55 D56
(#) 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. (**) 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 PRAC Rapporteur AR.
(#) This timetable is used when minor issues, most commonly but not exclusively related to the Product Information and the Risk Management Plan, remain after an Oral Explanation. (*) The involvement of CHMP and PRAC Rapporteurs in this assessment phase depends on the nature of the remaining issues and it could be optional for the PRAC Rapporteur. (**) Comments from CHMP (and PRAC, if applicable) members are not made available to Applicants.
The validation period between submission date and start date is usually sixteen calendar days. (**) Comments from PRAC and CHMP members are not made available to Marketing Authorisation Holders. (***) An updated AR is optional and dependent on the co
The EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co-. ) Rapporteur. Pre-submission meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) ar
Reproduction is authorised provided the source is acknowledged. Page 1 / 7. EMA/825017/2015 Rev.1. Human Medicines Evaluation. The timetables in this document may be subject to revision. Marketing authorisation renewal application - ATMP. Assessment
letter should contain the template table to facilitate submission and registration. ..... contact us using the following email address: [email protected].
Jun 19, 2012 - QRD Product Information Template with explanatory notes ...... An automated 'acknowledgement' e-mail is sent from the system confirming ...
May 4, 2018 - and whose bioequivalence with the reference medicinal product ...... preferably be given on the line of text directly below the complete name.
Pharmacovigilance System Master File be physically located and administered outside EU if it ..... stability studies to support a Type IAIN variation before making an immediate notification1 because the change will not ...... product protected either
Dec 9, 2013 - 6564. 3.21. Can a new indication based on less comprehensive data be added to an already ...... variation complies fully with the data and documentation requirements as specified in the Variations ...... continuously at its disposal the
30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ...... should implement accordingly when the adopted changes are applicable to their MA. ...... 180. 13.11. When ...... Access to unpublished clinical data ca
How is a marketing authorisation application pre-submission meeting conducted at. EMA? Rev. ...... a new technology or a new application of technology is used for the development or the manufacture of the ..... applicable fee, see question "What fee
13.11. When should I register my studies in the EU PAS Register? ...... The Agency aims to respond to your query within 5 working days. ...... the MA or since the last renewal, making reference to relevant new information in the public domain.
To whom should I submit follow-up data requested after the conclusion of a PSUSA ...... contact us using the following email address: [email protected] ...... An automated acknowledgement email is sent from the system confirming ...
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 da
and to notify the Agency and (Co-)Rapporteurs of a 'real' submission date. The HMA-EMA ...... However, the fact that the mock-up has to be a real example of the sales presentation implies that the mock-up ...... The purpose of specifying study milest
Jun 19, 2012 - Human Medicines Research and Development Support ... EMA staff closely involved with the application as it proceeds. Note: ..... procedure has 'automatic' access to the centralised procedure under Article 3(3). 1.1.4.
Data exclusivity and market protection period for reference medicinal products ...... 21. 1.8.2. One year period of protection for new indications of well-established substances .... 22. 1.8.3. One-year period of protection for data supporting a chan
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...