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5 March 2018 EMA/461220/2015 Rev.2 Human Medicines Evaluation
The timetables in this document may be subject to revision
Marketing authorisation renewal application Assessment of initial submission (90-day timetable) Assessment of responses to Request for Supplementary Information (30-day timetable after clock-stop for responses) Assessment of responses to Request for Supplementary Information (30-day timetable after immediate responses)
Request for Supplementary Information (RSI) or Opinion
A39
10/03/2021
27/03/2021
25/05/2021
31/05/2021
03/06/2021
10/06/2021
24/06/2021
A40
07/04/2021
24/04/2021
22/06/2021
28/06/2021
01/07/2021
08/07/2021
22/07/2021
A42
02/06/2021
19/06/2021
17/08/2021
23/08/2021
26/08/2021
03/09/2021
16/09/2021
A43
30/06/2021
17/07/2021
14/09/2021
20/09/2021
23/09/2021
30/09/2021
14/10/2021
A44
28/07/2021
14/08/2021
12/10/2021
18/10/2021
21/10/2021
28/10/2021
11/11/2021
A45
01/09/2021
18/09/2021
16/11/2021
22/11/2021
25/11/2021
02/12/2021
16/12/2021
A41
(*) Renewal applications must be submitted at least nine months before the actual expiry date of the marketing authorisation, i.e. the 5-year anniversary of the Commission Decision granting or renewing the marketing authorisation and irrespective of whether the marketing authorisation may be suspended. The start of the evaluation process will be the next possible date in the table after submission and validation of the dossier. The MAHs should agree in advance the submission date of the renewal application with the Agency. 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 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 comments received from committee (PRAC, CHMP) members which create the need for the update.
(*) 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 PRAC and CHMP members are not made available to Marketing Authorisation Holders. (***) An updated AR is optional and dependent on the comments received from committee (PRAC, CHMP) members which create the need for the update.
(¹) This timetable is only applicable when minor issues remain. (*) 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 members are not made available to Marketing Authorisation Holders. (***) An updated AR is optional and dependent on the comments received from CHMP members which create the need for the update.
Marketing authorisation renewal application - European Medicines ...
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 comments received from committee (PRAC, CHMP) members ...
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
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
Jan 1, 2017 - Understand the access to EudraVigilance provided via the EudraVigilance Data Analysis. System (EVDAS). ⢠Be familiar with the EVDAS user ...
Oct 7, 2016 - Applications by marketing authorisation holders (MAHs). Guidance for ... Issues identified during validation will be notified to the MAH via email.
Jan 1, 2017 - Revised definition and process for emerging safety issues, previously addressed in GVP. Module VI. ⢠Streamlined information on scientific aspects of signal management. ⢠Clarifications on terminology, roles and responsibilities and
Jan 1, 2017 - download (*EVPM). ICSR creation. ICSR ... The following illustration shows the report's filters. EV-M5b - EVDAS .... Grouping is a manual activity performed by the Agency to facilitate such analysis. ...... The ICSR is provided in PDF f
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 ...
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
