Informed consent and multiple application*
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- Gwendolyn Casey
- 5 years ago
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1 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union 31 October 2017 EMA/488671/2015 Rev.2 Human Medicines Evaluation The timetables in this document may be subject to revision Informed consent and multiple application* Assessment of initial submission (60-day timetable) Assessment of responses to Questions (LOQ) Assessment of responses to Outstanding Issues (30-day timetable after clock-stop for responses) Assessment of responses to Outstanding Issues (30-day timetable after immediate responses) This timetable only applies to multiples of identical products with existing marketing authorisations. If the product of the multiple application is not identical to an existing product (authorised or under assessment), then an independent timetable for a full marketing authorisation application will apply to the multiple application. On the other hand, a multiple of an identical product with an ongoing marketing authorisation application will follow the same timetable as the ongoing application. However, there should be adequate time for validation of the multiple application. Therefore, the initial submission deadline of this timetable still applies in these cases (i.e. the application should be submitted following the deadline of the initial submission above and e.g. well ahead of any planned responses to the Questions for the parent product application). European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 1 / 11
2 Assessment of initial submission (60-day timetable) Deadline for Start (^) (~) Questions (LoQ) or A1 06/01/ /01/ /02/ /03/ /03/ /03/ /03/ /03/ /03/2017 A2 04/02/ /02/ /03/ /03/ /04/ /04/ /04/ /04/ /04/2017 A3 03/03/ /03/ /04/ /04/ /05/ /05/ /05/ /05/ /05/2017 A4 04/04/ /04/ /05/ /06/ /06/ /06/ /06/ /06/ /06/2017 A5 04/05/ /05/ /06/ /06/ /07/ /07/ /07/ /07/ /07/2017 A6 A7 30/06/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2017 A8 28/07/ /08/ /09/ /09/ /09/ /09/ /10/ /10/ /10/2017 A9 24/08/ /09/ /10/ /10/ /10/ /10/ /10/ /11/ /11/2017 A10 30/09/ /10/ /11/ /11/ /11/ /11/ /12/ /12/ /12/2017 A11 10/11/ /11/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2018 A12 28/11/ /12/ /01/ /02/ /02/ /02/ /02/ /02/ /02/2018 A13 02/01/ /01/ /02/ /03/ /03/ /03/ /03/ /03/ /03/2018 A14 06/02/ /02/ /04/ /04/ /04/ /04/ /04/ /04/ /04/2018 A15 08/03/ /04/ /05/ /05/ /05/ /05/ /05/ /05/ /05/2018 A16 10/04/ /04/ /06/ /06/ /06/ /06/ /06/ /06/ /06/2018 A17 07/05/ /05/ /07/ /07/ /07/ /07/ /07/ /07/ /07/2018 A18 A19 03/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2018 A20 31/07/ /08/ /09/ /09/ /10/ /10/ /10/ /10/ /10/2018 A21 28/08/ /09/ /10/ /10/ /10/ /10/ /11/ /11/ /11/2018 A22 25/09/ /10/ /11/ /11/ /11/ /11/ /12/ /12/ /12/2018 A23 13/11/ /12/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2019 A24 27/11/ /12/ /02/ /02/ /02/ /02/ /02/ /02/ /02/2019 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 2 / 11
3 Start (^) (~) Questions (LoQ) or A25 08/01/ /01/ /03/ /03/ /03/ /03/ /03/ /03/ /03/2019 A26 06/02/ /02/ /04/ /04/ /04/ /04/ /04/ /04/ /04/2019 A27 11/03/ /03/ /05/ /05/ /05/ /05/ /05/ /05/ /05/2019 A28 04/04/ /04/ /06/ /06/ /06/ /06/ /06/ /06/ /06/2019 A29 06/05/ /05/ /07/ /07/ /07/ /07/ /07/ /07/ /07/2019 A30 A31 02/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2019 A32 30/07/ /08/ /09/ /09/ /10/ /10/ /10/ /10/ /10/2019 A33 27/08/ /09/ /10/ /10/ /10/ /10/ /11/ /11/ /11/2019 A34 24/09/ /10/ /11/ /11/ /11/ /11/ /12/ /12/ /12/2019 A35 12/11/ /12/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2020 A36 26/11/ /12/ /02/ /02/ /02/ /02/ /02/ /02/ /02/2020 A37 07/01/ /01/ /03/ /03/ /03/ /03/ /03/ /03/ /03/2020 A38 11/02/ /03/ /04/ /04/ /04/ /04/ /04/ /04/ /04/2020 A39 10/03/ /03/ /05/ /05/ /05/ /05/ /05/ /05/ /05/2020 A40 02/04/ /04/ /06/ /06/ /06/ /06/ /06/ /06/ /06/2020 A41 30/04/ /05/ /06/ /07/ /07/ /07/ /07/ /07/ /07/2020 A42 A43 30/06/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2020 A44 28/07/ /08/ /09/ /09/ /10/ /10/ /10/ /10/ /10/2020 A45 24/08/ /09/ /10/ /10/ /10/ /10/ /11/ /11/ /11/2020 A46 22/09/ /10/ /11/ /11/ /11/ /11/ /11/ /12/ /12/2020 A47 10/11/ /11/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2021 A48 01/12/ /12/ /02/ /02/ /02/ /02/ /02/ /02/ /02/2021 A49 05/01/ /01/ /03/ /03/ /03/ /03/ /03/ /03/ /03/2021 A50 02/02/ /02/ /03/ /04/ /04/ /04/ /04/ /04/ /04/2021 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 3 / 11
4 Start (^) (~) Questions (LoQ) or A51 02/03/ /03/ /04/ /04/ /05/ /05/ /05/ /05/ /05/2021 A52 06/04/ /04/ /05/ /06/ /06/ /06/ /06/ /06/ /06/2021 A53 29/04/ /05/ /06/ /07/ /07/ /07/ /07/ /07/ /07/2021 A54 A55 29/06/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2021 A56 27/07/ /08/ /09/ /09/ /09/ /09/ /10/ /10/ /10/2021 A57 23/08/ /09/ /10/ /10/ /10/ /10/ /10/ /11/ /11/2021 A58 28/09/ /10/ /11/ /11/ /12/ /12/ /12/ /12/ /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. (^) 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. (~) PRAC steps are applicable only if RMP is submitted. and PRAC members are not made available to Applicants. (#) The is captured in the subsequent PRAC Rapporteur updated assessment report. An updated AR is optional and dependent on the comments received from committee (PRAC, CHMP) members which create the need for the update. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 4 / 11
5 Assessment of responses to Questions (LOQ) 60-day timetable after clock-stop for responses Deadline for (~) Outstanding Issues (LoOI) or B1 20/01/ /01/ /02/ /03/ /03/ /03/ /03/ /03/ /03/2017 B2 17/02/ /02/ /03/ /03/ /04/ /04/ /04/ /04/ /04/2017 B3 17/03/ /03/ /04/ /04/ /05/ /05/ /05/ /05/ /05/2017 B4 21/04/ /04/ /05/ /06/ /06/ /06/ /06/ /06/ /06/2017 B5 19/05/ /05/ /06/ /06/ /07/ /07/ /07/ /07/ /07/2017 B6 B7 14/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2017 B8 11/08/ /08/ /09/ /09/ /09/ /09/ /10/ /10/ /10/2017 B9 08/09/ /09/ /10/ /10/ /10/ /10/ /10/ /11/ /11/2017 B10 13/10/ /10/ /11/ /11/ /11/ /11/ /12/ /12/ /12/2017 B11 24/11/ /11/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2018 B12 22/12/ /12/ /01/ /02/ /02/ /02/ /02/ /02/ /02/2018 B13 19/01/ /01/ /02/ /03/ /03/ /03/ /03/ /03/ /03/2018 B14 23/02/ /02/ /04/ /04/ /04/ /04/ /04/ /04/ /04/2018 B15 28/03/ /04/ /05/ /05/ /05/ /05/ /05/ /05/ /05/2018 B16 27/04/ /04/ /06/ /06/ /06/ /06/ /06/ /06/ /06/2018 B17 25/05/ /05/ /07/ /07/ /07/ /07/ /07/ /07/ /07/2018 B18 B19 20/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2018 B20 17/08/ /08/ /09/ /09/ /10/ /10/ /10/ /10/ /10/2018 B21 14/09/ /09/ /10/ /10/ /10/ /10/ /11/ /11/ /11/2018 B22 12/10/ /10/ /11/ /11/ /11/ /11/ /12/ /12/ /12/2018 B23 30/11/ /12/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2019 B24 21/12/ /12/ /02/ /02/ /02/ /02/ /02/ /02/ /02/2019 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 5 / 11
6 (~) Outstanding Issues (LoOI) or B25 25/01/ /01/ /03/ /03/ /03/ /03/ /03/ /03/ /03/2019 B26 22/02/ /02/ /04/ /04/ /04/ /04/ /04/ /04/ /04/2019 B27 29/03/ /03/ /05/ /05/ /05/ /05/ /05/ /05/ /05/2019 B28 26/04/ /04/ /06/ /06/ /06/ /06/ /06/ /06/ /06/2019 B29 24/05/ /05/ /07/ /07/ /07/ /07/ /07/ /07/ /07/2019 B30 B31 19/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2019 B32 16/08/ /08/ /09/ /09/ /10/ /10/ /10/ /10/ /10/2019 B33 13/09/ /09/ /10/ /10/ /10/ /10/ /11/ /11/ /11/2019 B34 11/10/ /10/ /11/ /11/ /11/ /11/ /12/ /12/ /12/2019 B35 29/11/ /12/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2020 B36 23/12/ /12/ /02/ /02/ /02/ /02/ /02/ /02/ /02/2020 B37 24/01/ /01/ /03/ /03/ /03/ /03/ /03/ /03/ /03/2020 B38 28/02/ /03/ /04/ /04/ /04/ /04/ /04/ /04/ /04/2020 B39 27/03/ /03/ /05/ /05/ /05/ /05/ /05/ /05/ /05/2020 B40 24/04/ /04/ /06/ /06/ /06/ /06/ /06/ /06/ /06/2020 B41 22/05/ /05/ /06/ /07/ /07/ /07/ /07/ /07/ /07/2020 B42 B43 17/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2020 B44 14/08/ /08/ /09/ /09/ /10/ /10/ /10/ /10/ /10/2020 B45 11/09/ /09/ /10/ /10/ /10/ /10/ /11/ /11/ /11/2020 B46 09/10/ /10/ /11/ /11/ /11/ /11/ /11/ /12/ /12/2020 B47 27/11/ /11/ /01/ /01/ /01/ /01/ /01/ /01/ /01/2021 B48 23/12/ /12/ /02/ /02/ /02/ /02/ /02/ /02/ /02/2021 B49 22/01/ /01/ /03/ /03/ /03/ /03/ /03/ /03/ /03/2021 B50 19/02/ /02/ /03/ /04/ /04/ /04/ /04/ /04/ /04/2021 B51 19/03/ /03/ /04/ /04/ /05/ /05/ /05/ /05/ /05/2021 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 6 / 11
7 (~) Outstanding Issues (LoOI) or B52 23/04/ /04/ /05/ /06/ /06/ /06/ /06/ /06/ /06/2021 B53 21/05/ /05/ /06/ /07/ /07/ /07/ /07/ /07/ /07/2021 B54 B55 16/07/ /07/ /08/ /08/ /09/ /09/ /09/ /09/ /09/2021 B56 13/08/ /08/ /09/ /09/ /09/ /09/ /10/ /10/ /10/2021 B57 10/09/ /09/ /10/ /10/ /10/ /10/ /10/ /11/ /11/2021 B58 15/10/ /10/ /11/ /11/ /12/ /12/ /12/ /12/ /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. (~) PRAC steps are applicable only if RMP is submitted. and PRAC members are not made available to Applicants. (#) The is captured in the subsequent PRAC Rapporteur updated assessment report. An updated AR is optional and dependent on the comments received from committee (PRAC, CHMP) members which create the need for the update. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 7 / 11
8 Assessment of responses to Outstanding Issues (LoOI) 30-day timetable after clock-stop for responses Deadline for (~) from (PRAC and) CHMP Updated (PRAC and) CHMP C1 24/01/ /01/ /02/ /02/ /02/ /02/2017 C2 21/02/ /02/ /03/ /03/ /03/ /03/2017 C3 22/03/ /03/ /04/ /04/ /04/ /04/2017 C4 18/04/ /04/ /05/ /05/ /05/ /05/2017 C5 23/05/ /05/ /06/ /06/ /06/ /06/2017 C6 20/06/ /06/ /07/ /07/ /07/ /07/2017 C7 C8 15/08/ /08/ /08/ /09/ /09/ /09/2017 C9 12/09/ /09/ /09/ /10/ /10/ /10/2017 C10 10/10/ /10/ /10/ /10/ /11/ /11/2017 C11 14/11/ /11/ /11/ /12/ /12/ /12/2017 C12 22/12/ /12/ /01/ /01/ /01/ /01/2018 C13 23/01/ /01/ /02/ /02/ /02/ /02/2018 C14 20/02/ /02/ /03/ /03/ /03/ /03/2018 C15 27/03/ /03/ /04/ /04/ /04/ /04/2018 C16 30/04/ /05/ /05/ /05/ /05/ /05/2018 C17 29/05/ /05/ /06/ /06/ /06/ /06/2018 C18 26/06/ /06/ /07/ /07/ /07/ /07/2018 C19 C20 21/08/ /08/ /09/ /09/ /09/ /09/2018 C21 18/09/ /09/ /10/ /10/ /10/ /10/2018 C22 16/10/ /10/ /10/ /11/ /11/ /11/2018 C23 13/11/ /11/ /11/ /12/ /12/ /12/2018 C24 21/12/ /01/ /01/ /01/ /01/ /01/2019 C25 29/01/ /01/ /02/ /02/ /02/ /02/2019 C26 26/02/ /02/ /03/ /03/ /03/ /03/2019 C27 27/03/ /03/ /04/ /04/ /04/ /04/2019 C28 29/04/ /04/ /05/ /05/ /05/ /05/2019 C29 28/05/ /05/ /06/ /06/ /06/ /06/2019 C30 25/06/ /06/ /07/ /07/ /07/ /07/2019 C31 C32 20/08/ /08/ /09/ /09/ /09/ /09/2019 C33 17/09/ /09/ /10/ /10/ /10/ /10/2019 C34 15/10/ /10/ /10/ /11/ /11/ /11/2019 C35 12/11/ /11/ /11/ /12/ /12/ /12/2019 C36 23/12/ /01/ /01/ /01/ /01/ /01/2020 C37 28/01/ /01/ /02/ /02/ /02/ /02/2020 C38 25/02/ /02/ /03/ /03/ /03/ /03/2020 C39 31/03/ /04/ /04/ /04/ /04/ /04/2020 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 8 / 11
9 (~) from (PRAC and) CHMP Updated (PRAC and) CHMP C40 28/04/ /04/ /05/ /05/ /05/ /05/2020 C41 26/05/ /05/ /06/ /06/ /06/ /06/2020 C42 23/06/ /06/ /07/ /07/ /07/ /07/2020 C43 C44 18/08/ /08/ /09/ /09/ /09/ /09/2020 C45 15/09/ /09/ /09/ /10/ /10/ /10/2020 C46 13/10/ /10/ /10/ /11/ /11/ /11/2020 C47 10/11/ /11/ /11/ /11/ /12/ /12/2020 C48 23/12/ /12/ /01/ /01/ /01/ /01/2021 C49 26/01/ /01/ /02/ /02/ /02/ /02/2021 C50 23/02/ /02/ /03/ /03/ /03/ /03/2021 C51 23/03/ /03/ /04/ /04/ /04/ /04/2021 C52 20/04/ /04/ /05/ /05/ /05/ /05/2021 C53 25/05/ /05/ /06/ /06/ /06/ /06/2021 C54 22/06/ /06/ /07/ /07/ /07/ /07/2021 C55 C56 17/08/ /08/ /09/ /09/ /09/ /09/2021 C57 14/09/ /09/ /09/ /10/ /10/ /10/2021 C58 12/10/ /10/ /10/ /11/ /11/ /11/2021 C59 16/11/ /11/ /12/ /12/ /12/ /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. (~) PRAC steps are applicable only if RMP is submitted. (#) A PRAC discussion is not foreseen for a 30-day timetable; PRAC member comments are reflected in the subsequent updated PRAC Rapporteur's AR. and PRAC members are not made available to Applicants. An updated AR is optional and dependent on the comments received from committee (PRAC, CHMP) members which create the need for the update. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 9 / 11
10 Assessment of responses to Outstanding Issues (LoOI) 30-day timetable after immediate responses Deadline for (~) from (PRAC and) CHMP Updated (PRAC and) CHMP D1 31/01/ /02/ /02/ /02/ /02/ /02/2017 D2 28/02/ /03/ /03/ /03/ /03/ /03/2017 D3 29/03/ /03/ /04/ /04/ /04/ /04/2017 D4 25/04/ /04/ /05/ /05/ /05/ /05/2017 D5 23/05/ /05/ /06/ /06/ /06/ /06/2017 D6 27/06/ /06/ /07/ /07/ /07/ /07/2017 D7 D8 15/08/ /08/ /08/ /09/ /09/ /09/2017 D9 19/09/ /09/ /09/ /10/ /10/ /10/2017 D10 17/10/ /10/ /10/ /10/ /11/ /11/2017 D11 14/11/ /11/ /11/ /12/ /12/ /12/2017 D12 19/12/ /01/ /01/ /01/ /01/ /01/2018 D13 30/01/ /01/ /02/ /02/ /02/ /02/2018 D14 27/02/ /02/ /03/ /03/ /03/ /03/2018 D15 27/03/ /04/ /04/ /04/ /04/ /04/2018 D16 30/04/ /05/ /05/ /05/ /05/ /05/2018 D17 05/06/ /06/ /06/ /06/ /06/ /06/2018 D18 03/07/ /07/ /07/ /07/ /07/ /07/2018 D19 D20 21/08/ /08/ /09/ /09/ /09/ /09/2018 D21 25/09/ /09/ /10/ /10/ /10/ /10/2018 D22 23/10/ /10/ /10/ /11/ /11/ /11/2018 D23 20/11/ /11/ /11/ /12/ /12/ /12/2018 D24 08/01/ /01/ /01/ /01/ /01/ /01/2019 D25 05/02/ /02/ /02/ /02/ /02/ /02/2019 D26 05/03/ /03/ /03/ /03/ /03/ /03/2019 D27 03/04/ /04/ /04/ /04/ /04/ /04/2019 D28 06/05/ /05/ /05/ /05/ /05/ /05/2019 D29 04/06/ /06/ /06/ /06/ /06/ /06/2019 D30 02/07/ /07/ /07/ /07/ /07/ /07/2019 D31 D32 27/08/ /08/ /09/ /09/ /09/ /09/2019 D33 24/09/ /09/ /10/ /10/ /10/ /10/2019 D34 22/10/ /10/ /10/ /11/ /11/ /11/2019 D35 19/11/ /11/ /11/ /12/ /12/ /12/2019 D36 07/01/ /01/ /01/ /01/ /01/ /01/2020 D37 04/02/ /02/ /02/ /02/ /02/ /02/2020 D38 03/03/ /03/ /03/ /03/ /03/ /03/2020 D39 07/04/ /04/ /04/ /04/ /04/ /04/2020 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 10 / 11
11 (~) from (PRAC and) CHMP Updated (PRAC and) CHMP D40 05/05/ /05/ /05/ /05/ /05/ /05/2020 D41 02/06/ /06/ /06/ /06/ /06/ /06/2020 D42 30/06/ /07/ /07/ /07/ /07/ /07/2020 D43 D44 25/08/ /08/ /09/ /09/ /09/ /09/2020 D45 22/09/ /09/ /09/ /10/ /10/ /10/2020 D46 20/10/ /10/ /10/ /11/ /11/ /11/2020 D47 17/11/ /11/ /11/ /11/ /12/ /12/2020 D48 05/01/ /01/ /01/ /01/ /01/ /01/2021 D49 02/02/ /02/ /02/ /02/ /02/ /02/2021 D50 02/03/ /03/ /03/ /03/ /03/ /03/2021 D51 30/03/ /03/ /04/ /04/ /04/ /04/2021 D52 27/04/ /04/ /05/ /05/ /05/ /05/2021 D53 01/06/ /06/ /06/ /06/ /06/ /06/2021 D54 29/06/ /06/ /07/ /07/ /07/ /07/2021 D55 24/08/ /08/ /09/ /09/ /09/ /09/2021 D56 21/09/ /09/ /09/ /10/ /10/ /10/2021 D57 19/10/ /10/ /10/ /11/ /11/ /11/2021 D58 23/11/ /11/ /12/ /12/ /12/ /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. (~) PRAC steps are applicable only if RMP is submitted. (#) A PRAC discussion is not foreseen for a 30-day timetable; PRAC member comments are reflected in the subsequent updated PRAC Rapporteur's AR. and PRAC members are not made available to Applicants. An updated AR is optional and dependent on the comments received from committee (PRAC, CHMP) members which create the need for the update. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 11 / 11
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