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.
Initial marketing authorisation and extension applications
Timetable: Initial (full) marketing authorisation application accelerated assessment timetables
English (EN) (122.98 KB - XLSX)
Timetable accelerated assessment request for initial marketing authorisation applications
English (EN) (97.8 KB - XLSX)
Timetable: Initial (full) marketing authorisation application assessment
English (EN) (128.14 KB - XLSX)
Timetable: Extension application
English (EN) (120.42 KB - XLSX)
Timetable: Informed consent and multiple application
English (EN) (120.42 KB - XLSX)
Variations
Choice of timetable for type II variations and worksharing applications
English (EN) (231.17 KB - PDF)
Timetable: Type II variation and worksharing application monthly assessment
Procedural timetable
English (EN) (247.93 KB - PDF)
Timetable: Type II variation and worksharing application weekly assessment
English (EN) (145.81 KB - XLSX)
Timetable: Type II variation and worksharing application alternative monthly assessment
Procedural timetable
English (EN) (131.42 KB - XLSX)
Timetable: Type IB variation requiring linguistic review
English (EN) (97.31 KB - XLSX)
Renewals and annual reassessments
Timetable: Marketing authorisation renewal application
English (EN) (114.25 KB - XLSX)
Timetable: Annual reassessment
Initial 90-day assessment
English (EN) (114.49 KB - XLSX)
Timetable: Annual renewal application of conditional marketing authorisation
Initial 60-day assessment
English (EN) (108.44 KB - XLSX)
Pharmacovigilance procedures
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
English (EN) (132.63 KB - PDF)
Timetable: Post-authorisation safety study (PASS) protocols and final results
Timetable: Post-authorisation safety study (PASS) protocols and final results
English (EN) (100.07 KB - XLSX)
Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)
English (EN) (112.72 KB - XLSX)
Referrals
Timetable: Non-safety referrals
English (EN) (213.09 KB - PDF)
Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)
English (EN) (212.62 KB - PDF)
Timetable: Safety referral (Article 107i, urgent Union procedure)
English (EN) (118.5 KB - PDF)
Post-authorisation measures
Timetable: Post-authorisation measure (PAM) assessed by CHMP
English (EN) (97.26 KB - XLSX)
Timetable: Post-authorisation measure (PAM) assessed by PRAC
English (EN) (97.61 KB - XLSX)
Timetable: Post-authorisation measure (PAM) assessed by CAT
Post-authorisation measure (PAM) assessed by CAT
English (EN) (97.2 KB - XLSX)
Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission
English (EN) (110.88 KB - XLSX)
Advanced therapy medicinal products (ATMPs) procedural timetables
Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)
English (EN) (109.9 KB - XLSX)
Timetable: Accelerated assessment request for initial marketing authorisations - ATMP
Timetable: Accelerated assessment request for initial marketing authorisations - ATMP
English (EN) (98.62 KB - XLSX)
Timetable: Type II variation and worksharing application assessment - ATMP
English (EN) (132.13 KB - XLSX)
Timetable: Initial (Full) marketing authorisation application - ATMP
English (EN) (128.43 KB - XLSX)
Timetable: Extension application - ATMP
English (EN) (125.07 KB - XLSX)
Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)
English (EN) (133.61 KB - PDF)
Timetable: Marketing authorisation renewal application - ATMP
Initial 60-day assessment
English (EN) (111.33 KB - XLSX)
Timetable: Annual reassessment - ATMP
Initial 90-day assessment
English (EN) (111.31 KB - XLSX)
Timetable: Annual renewal application of conditional marketing authorisation - ATMP
Annual renewal application of conditional marketing authorisation - ATMP - Initial 60-day assessment
English (EN) (106.04 KB - XLSX)
Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMP
English (EN) (111.71 KB - XLSX)
Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP
Post-authorisation measure (PAM) assessed by PRAC - ATMP
English (EN) (94.1 KB - PDF)
Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP
English (EN) (126.96 KB - PDF)
Companion diagnostic consultation
Timetable: Companion diagnostic initial consultation
English (EN) (121.46 KB - XLSX)
Timetable: Companion diagnostic initial consultation - ATMP
English (EN) (123.05 KB - XLSX)
Timetable: Companion diagnostic follow-up consultation
English (EN) (101.99 KB - XLSX)
Timetable: Companion diagnostic follow-up consultation - ATMP
English (EN) (102.03 KB - XLSX)