Procedural timetables

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This page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures.

Timetables are categorised according to the type of procedure (e.g. full applications, extensions and variations, as well as response timetables).

The dates for submission, start of the procedure and plenary meetings of the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT) are generally fixed, but the other dates may be subject to adjustment until the CHMP reaches the adoption of the final opinion for the individual application. 

At the start of the procedure, the Agency will notify the applicant of the adopted final timetable in writing. 

Table of contents


Initial marketing authorisation and extension applications

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Document(s) Language Status First published Last updated Effective Date
Timetable initial (full) marketing authorisation application - Accelerated assessment (English only)   24/05/2016    
Timetable accelerated assessment request for initial marketing authorisation applications (English only)   24/05/2016    
Timetable: Initial (full) marketing authorisation application (submitted until April 2015) (English only)   08/07/2011 26/11/2015 31/08/2012
Timetable: Initial (full) marketing authorisation application (submitted after April 2015) (English only)   22/12/2014 26/11/2015 22/12/2014
Timetable: Extension application (English only)   02/07/2015 26/11/2015 02/07/2015
Timetable: Informed consent and multiple application (English only)   28/07/2015 26/11/2015 28/07/2015

Post-authorisation procedures

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Document(s) Language Status First published Last updated Effective Date
Type II variation and worksharing application: 30-day assessment timetable (English only)   20/02/2015 26/11/2015 20/02/2015
Type II variation and worksharing application: 60-day monthly-start timetable (English only)   20/02/2015 26/11/2015 20/02/2015
Type II variation and worksharing application: 90-day assessment timetable (English only)   20/02/2015 26/11/2015 20/02/2015
Type II variation and worksharing application: 60-day weekly-start timetable (English only)   20/02/2015 02/07/2015 20/02/2015
Timetable: Marketing authorisation renewal application (English only)   28/07/2015 15/12/2015  
Timetable: Type IB variation requiring linguistic review (English only)   08/10/2015   08/10/2015
Timetable: Annual reassessment (English only)   15/12/2015   15/12/2015
Timetable: Annual renewal application of conditional marketing authorisation (English only)   15/12/2015   15/12/2015

Pharmacovigilance procedures

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Document(s) Language Status First published Last updated Effective Date
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) (English only)   30/04/2015 26/11/2015 30/04/2015
Timetable: Post-authorisation safety study (PASS) protocols (English only)   02/07/2015 26/11/2015 02/07/2015
Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) (English only)   02/07/2015 28/07/2015 02/07/2015

Referrals

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Document(s) Language Status First published Last updated Effective Date
Timetable: Non-safety referrals (English only)   12/12/2012 06/10/2015 01/10/2015
Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance) (English only)   08/04/2015 06/10/2015 01/10/2015
Timetable: Safety referral (Article 107i, urgent Union procedure) (English only)   21/09/2012 06/10/2015 01/10/2015

Post-authorisation measures

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Advanced therapy medicinal products (ATMPs) procedural timetables

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Document(s) Language Status First published Last updated Effective Date
Timetable: Initial (Full) marketing authorisation application - ATMP (English only)   15/12/2015   15/12/2015
Timetable: Extension application - ATMP (English only)   15/12/2015   15/12/2015
Type II variation and worksharing application: 30-day assessment timetable - ATMP (English only)   15/12/2015   15/12/2015
Type II variation and worksharing application: 60-day assessment timetable - ATMP (English only)   15/12/2015   15/12/2015
Type II variation and worksharing application: 90-day assessment timetable - ATMP (English only)   15/12/2015   15/12/2015
Timetable: Periodic safety update report (PSUR) and PSUR single sssessment (PSUSA) - Advanced therapy medicinal products (ATMPs) (English only)   30/04/2015 02/07/2015 30/04/2015
Timetable: Marketing authorisation renewal application - ATMP (English only)   15/12/2015   15/12/2015
Timetable: Annual reassessment - ATMP (English only)   15/12/2015   15/12/2015
Timetable: Annual renewal application of conditional marketing authorisation - ATMP (English only)   15/12/2015   15/12/2015
Timetable: Paediatric art. 46 submission - ATMP (English only)   25/04/2016    
Timetable: Post-authorisation measure (PAM) assessed by CAT (English only)   25/04/2016    
Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP (English only)   25/04/2016    
Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP (English only)   25/04/2016