Procedural timetables

  • Email
  • Help

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

Back to top

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

Post-authorisation procedures

Back to top

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

Pharmacovigilance procedures

Back to top

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

Referrals

Back to top

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

Post-authorisation measures

Back to top

Advanced therapy medicinal products (ATMPs) procedural timetables

Back to top

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