Safety Signal - Assessment of responses to Request for Supplementary Information (RSI)
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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 6 July 2018 EMA/403963/2015 Rev.3 Human Medicines Evaluation The timetables in this document may be subject to revision Safety Signal - Assessment of responses to Request for Supplementary Information (RSI) 30-day 60-day 90-day European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 1 / 7
2 30-day assessment timetable AR Comments from /MAH Updated AR (#) adoption (^) A1 08/06/ /06/ /06/ /07/ /07/ /07/ /07/2018 A2 A3 03/08/ /08/ /08/ /08/ /08/ /09/ /09/2018 A4 31/08/ /09/ /09/ /09/ /09/ /10/ /10/2018 A5 28/09/ /10/ /10/ /10/ /10/ /10/ /11/2018 A6 26/10/ /10/ /11/ /11/ /11/ /11/ /12/2018 A7 07/12/ /12/ /01/ /01/ /01/ /01/ /01/2019 A8 11/01/ /01/ /01/ /02/ /02/ /02/ /02/2019 A9 08/02/ /02/ /02/ /03/ /03/ /03/ /03/2019 A10 08/03/ /03/ /03/ /04/ /04/ /04/ /04/2019 A11 05/04/ /04/ /04/ /05/ /05/ /05/ /05/2019 A12 06/05/ /05/ /05/ /05/ /06/ /06/ /06/2019 A13 07/06/ /06/ /06/ /07/ /07/ /07/ /07/2019 A14 A15 02/08/ /08/ /08/ /08/ /08/ /09/ /09/2019 A16 30/08/ /09/ /09/ /09/ /09/ /10/ /10/2019 A17 27/09/ /10/ /10/ /10/ /10/ /10/ /11/2019 A18 25/10/ /10/ /11/ /11/ /11/ /11/ /12/2019 A19 06/12/ /12/ /01/ /01/ /01/ /01/ /01/2020 A20 10/01/ /01/ /01/ /02/ /02/ /02/ /02/2020 A21 07/02/ /02/ /02/ /03/ /03/ /03/ /03/2020 A22 16/03/ /03/ /04/ /04/ /04/ /04/ /04/2020 A23 08/04/ /04/ /04/ /05/ /05/ /05/ /05/2020 A24 08/05/ /05/ /05/ /06/ /06/ /06/ /06/2020 A25 05/06/ /06/ /06/ /06/ /07/ /07/ /07/2020 A26 A27 03/08/ /08/ /08/ /08/ /08/ /09/ /09/2020 A28 28/08/ /09/ /09/ /09/ /09/ /10/ /10/2020 A29 25/09/ /09/ /10/ /10/ /10/ /10/ /11/2020 A30 23/10/ /10/ /11/ /11/ /11/ /11/ /12/2020 A31 04/12/ /12/ /01/ /01/ /01/ /01/ /01/2021 A32 08/01/ /01/ /01/ /02/ /02/ /02/ /02/2021 A33 05/02/ /02/ /02/ /03/ /03/ /03/ /03/2021 A34 08/03/ /03/ /03/ /03/ /03/ /04/ /04/2021 A35 30/03/ /04/ /04/ /04/ /04/ /05/ /05/2021 A36 07/05/ /05/ /05/ /05/ /06/ /06/ /06/2021 A37 04/06/ /06/ /06/ /06/ /07/ /07/ /07/2021 A38 A39 02/08/ /08/ /08/ /08/ /08/ /09/ /09/2021 A40 27/08/ /09/ /09/ /09/ /09/ /09/ /10/2021 A41 24/09/ /09/ /10/ /10/ /10/ /10/ /11/2021 A42 27/10/ /11/ /11/ /11/ /11/ /12/ /12/2021 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 2 / 7
3 ( ) The applicability of a 90-, 60- or 30-day timetable will be specified at the time of the preceding RSI. 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. (#) An updated AR is optional and dependent on the comments received from members and Marketing authorisation Holders (MAHs) which create the need for the update. (^) A adoption step applies only in case of recommendation for variation to the terms of marketing authorisations of centrally authorised products. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 3 / 7
4 60-day assessment timetable AR Comments from /MAH Updated AR (#) adoption (^) B1 08/05/ /05/ /06/ /07/ /07/ /07/ /07/2018 B2 B3 04/07/ /07/ /08/ /08/ /08/ /09/ /09/2018 B4 01/08/ /08/ /09/ /09/ /09/ /10/ /10/2018 B5 29/08/ /09/ /10/ /10/ /10/ /10/ /11/2018 B6 26/09/ /10/ /11/ /11/ /11/ /11/ /12/2018 B7 07/11/ /11/ /12/ /01/ /01/ /01/ /01/2019 B8 12/12/ /12/ /01/ /02/ /02/ /02/ /02/2019 B9 09/01/ /01/ /02/ /03/ /03/ /03/ /03/2019 B10 06/02/ /02/ /03/ /04/ /04/ /04/ /04/2019 B11 06/03/ /03/ /04/ /04/ /05/ /05/ /05/2019 B12 11/04/ /04/ /05/ /06/ /06/ /06/ /06/2019 B13 07/05/ /05/ /06/ /07/ /07/ /07/ /07/2019 B14 B15 03/07/ /07/ /08/ /08/ /08/ /09/ /09/2019 B16 31/07/ /08/ /09/ /09/ /09/ /10/ /10/2019 B17 28/08/ /09/ /10/ /10/ /10/ /10/ /11/2019 B18 25/09/ /09/ /11/ /11/ /11/ /11/ /12/2019 B19 06/11/ /11/ /12/ /01/ /01/ /01/ /01/2020 B20 11/12/ /12/ /01/ /02/ /02/ /02/ /02/2020 B21 08/01/ /01/ /02/ /03/ /03/ /03/ /03/2020 B22 10/02/ /02/ /03/ /04/ /04/ /04/ /04/2020 B23 11/03/ /03/ /04/ /05/ /05/ /05/ /05/2020 B24 06/04/ /04/ /05/ /05/ /06/ /06/ /06/2020 B25 06/05/ /05/ /06/ /06/ /07/ /07/ /07/2020 B26 B27 02/07/ /07/ /08/ /08/ /08/ /09/ /09/2020 B28 29/07/ /08/ /09/ /09/ /09/ /10/ /10/2020 B29 26/08/ /08/ /10/ /10/ /10/ /10/ /11/2020 B30 23/09/ /09/ /11/ /11/ /11/ /11/ /12/2020 B31 11/11/ /11/ /12/ /01/ /01/ /01/ /01/2021 B32 09/12/ /12/ /01/ /02/ /02/ /02/ /02/2021 B33 06/01/ /01/ /02/ /03/ /03/ /03/ /03/2021 B34 04/02/ /02/ /03/ /03/ /03/ /04/ /04/2021 B35 03/03/ /03/ /04/ /04/ /04/ /05/ /05/2021 B36 07/04/ /04/ /05/ /05/ /06/ /06/ /06/2021 B37 05/05/ /05/ /06/ /06/ /07/ /07/ /07/2021 B38 B39 01/07/ /07/ /08/ /08/ /08/ /09/ /09/2021 B40 28/07/ /08/ /09/ /09/ /09/ /09/ /10/2021 B41 25/08/ /08/ /10/ /10/ /10/ /10/ /11/2021 B42 29/09/ /10/ /11/ /11/ /11/ /12/ /12/2021 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 4 / 7
5 ( ) The applicability of a 90-, 60- or 30-day timetable will be specified at the time of the preceding RSI. 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. (#) An updated AR is optional and dependent on the comments received from members and Marketing authorisation Holders (MAHs) which create the need for the update. (^) A adoption step applies only in case of recommendation for variation to the terms of marketing authorisations of centrally authorised products. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 5 / 7
6 90-day assessment timetable Individual s/ Lead MSs AR (~) Preliminary (Joint) AR Comments from /MAH Updated Joint AR (#) adoption (^) C1 11/04/ /04/ /05/ /06/ /06/ /07/ /07/ /07/2018 C2 C3 06/06/ /06/ /07/ /08/ /08/ /08/ /09/ /09/2018 C4 04/07/ /07/ /08/ /09/ /09/ /09/ /10/ /10/2018 C5 31/07/ /08/ /09/ /10/ /10/ /10/ /10/ /11/2018 C6 29/08/ /09/ /10/ /10/ /11/ /11/ /11/ /12/2018 C7 08/10/ /10/ /11/ /12/ /01/ /01/ /01/ /01/2019 C8 14/11/ /11/ /12/ /01/ /01/ /02/ /02/ /02/2019 C9 12/12/ /12/ /01/ /02/ /02/ /03/ /03/ /03/2019 C10 09/01/ /01/ /02/ /03/ /03/ /04/ /04/ /04/2019 C11 13/02/ /02/ /03/ /04/ /04/ /05/ /05/ /05/2019 C12 12/03/ /03/ /04/ /05/ /05/ /06/ /06/ /06/2019 C13 10/04/ /04/ /05/ /06/ /06/ /07/ /07/ /07/2019 C14 C15 05/06/ /06/ /07/ /08/ /08/ /08/ /09/ /09/2019 C16 03/07/ /07/ /08/ /09/ /09/ /09/ /10/ /10/2019 C17 31/07/ /08/ /09/ /10/ /10/ /10/ /10/ /11/2019 C18 28/08/ /08/ /09/ /10/ /11/ /11/ /11/ /12/2019 C19 09/10/ /10/ /11/ /12/ /01/ /01/ /01/ /01/2020 C20 13/11/ /11/ /12/ /01/ /01/ /02/ /02/ /02/2020 C21 11/12/ /12/ /01/ /02/ /02/ /03/ /03/ /03/2020 C22 10/01/ /01/ /02/ /03/ /03/ /04/ /04/ /04/2020 C23 12/02/ /02/ /03/ /04/ /04/ /05/ /05/ /05/2020 C24 06/03/ /03/ /04/ /05/ /05/ /06/ /06/ /06/2020 European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 6 / 7
7 Individual s/ Lead MSs AR (~) Preliminary (Joint) AR Comments from /MAH Updated Joint AR (#) adoption (^) C25 08/04/ /04/ /05/ /06/ /06/ /07/ /07/ /07/2020 C26 C27 04/06/ /06/ /07/ /08/ /08/ /08/ /09/ /09/2020 C28 01/07/ /07/ /08/ /09/ /09/ /09/ /10/ /10/2020 C29 29/07/ /08/ /09/ /09/ /10/ /10/ /10/ /11/2020 C30 26/08/ /08/ /09/ /10/ /11/ /11/ /11/ /12/2020 C31 14/10/ /10/ /11/ /12/ /01/ /01/ /01/ /01/2021 C32 11/11/ /11/ /12/ /01/ /01/ /02/ /02/ /02/2021 C33 09/12/ /12/ /01/ /02/ /02/ /03/ /03/ /03/2021 C34 07/01/ /01/ /02/ /03/ /03/ /03/ /04/ /04/2021 C35 03/02/ /02/ /03/ /04/ /04/ /04/ /05/ /05/2021 C36 10/03/ /03/ /04/ /05/ /05/ /06/ /06/ /06/2021 C37 07/04/ /04/ /05/ /06/ /06/ /07/ /07/ /07/2021 C38 C39 03/06/ /06/ /07/ /08/ /08/ /08/ /09/ /09/2021 C40 30/06/ /07/ /08/ /08/ /09/ /09/ /09/ /10/2021 C41 28/07/ /07/ /08/ /09/ /10/ /10/ /10/ /11/2021 C42 01/09/ /09/ /10/ /11/ /11/ /11/ /12/ /12/2021 ( ) The applicability of a 90-, 60- or 30-day timetable will be specified at the time of the preceding RSI. (~) This step may apply in case the signal involves several active substances/products (e.g. class issues). In such cases, individual assessments may be carried out by the relevant Lead Member State(s) according to the List of substances and products subject to worksharing for signal management (for nationally authorised products NAPs) and/or the relevant s (for centrally authorised products - CAPs), before a joint assessment report is prepared by the -appointed for the evaluation of the signal. 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. (#) An updated AR is optional and dependent on the comments received from members and Marketing authorisation Holders (MAHs) which create the need for the update. (^) A adoption step applies only in case of recommendation for variation to the terms of marketing authorisations of CAPs. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. Page 7 / 7
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