Procedural timetables

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.

Initial marketing authorisation and extension applications

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables

Reference Number: EMA/339594/2016 Rev. 13

Timetable accelerated assessment request for initial marketing authorisation applications

Legal effective date: 18/12/2020Reference Number: EMA/347524/2016 Rev. 6

Timetable: Initial (full) marketing authorisation application assessment

Legal effective date: 18/12/2020Reference Number: EMA/119185/2015 Rev.13

Timetable: Extension application

Legal effective date: 18/12/2020Reference Number: EMA/412809/2015 Rev. 11

Timetable: Informed consent and multiple application

Legal effective date: 18/12/2020Reference Number: EMA/488671/2015 Rev.7

Variations

Choice of timetable for type II variations and worksharing applications

Legal effective date: 28/02/2017Reference Number: EMA/103586/2017 Rev. 1

Timetable: Type II variation and worksharing application monthly assessment

Reference Number: EMA/577385/2016 Rev. 8Summary:

Procedural timetable

Timetable: Type II variation and worksharing application weekly assessment

Reference Number: EMA/577386/2016 Rev.8

Timetable: Type II variation and worksharing application alternative monthly assessment

Reference Number: EMA/577387/2016 Rev.6Summary:

Procedural timetable

Timetable: Type IB variation requiring linguistic review

Legal effective date: 08/10/2015Reference Number: EMA/99646/2015 Rev. 3

Renewals and annual reassessments

Timetable: Marketing authorisation renewal application

Legal effective date: 28/07/2015Reference Number: EMA/461220/2015 Rev. 3

Timetable: Annual reassessment

Legal effective date: 15/12/2015Reference Number: EMA/823130/2015 Rev. 3Summary:

Initial 90-day assessment

Timetable: Annual renewal application of conditional marketing authorisation

Legal effective date: 15/12/2015Reference Number: EMA/823131/2015 Rev. 6Summary:

Initial 60-day assessment

Pharmacovigilance procedures

Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)

Legal effective date: 31/10/2017Reference Number: EMA/251636/2015 Rev. 9

Timetable: Post-authorisation safety study (PASS) protocols and final results

Legal effective date: 02/07/2015Reference Number: EMA/404060/2015 Rev. 5Summary:

Timetable: Post-authorisation safety study (PASS) protocols and final results

Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)

Reference Number: EMA/403963/2015 Rev.5

Referrals

Timetable: Non-safety referrals

Reference Number: EMA/30819/2021 rev.1

Timetable: Safety referral (Article-20 and Article-31 pharmacovigilance)

Reference Number: EMA/29545/2021 rev.1

Timetable: Safety referral (Article 107i, urgent Union procedure)

Reference Number: EMA/273042/2023

Post-authorisation measures

Timetable: Post-authorisation measure (PAM) assessed by CHMP

Legal effective date: 02/07/2015Reference Number: EMA/403033/2015 Rev.3

Timetable: Post-authorisation measure (PAM) assessed by PRAC

Reference Number: EMA/403287/2015 Rev.8

Timetable: Post-authorisation measure (PAM) assessed by CAT

Legal effective date: 25/04/2016Reference Number: EMA/267768/2016 Rev.3Summary:

Post-authorisation measure (PAM) assessed by CAT

Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission

Legal effective date: 02/07/2015Reference Number: EMA/403143/2015 Rev.3

Advanced therapy medicinal products (ATMPs) procedural timetables

Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)

Reference Number: EMA/51610/2021

Timetable: Accelerated assessment request for initial marketing authorisations - ATMP

Reference Number: EMA/69089/2021 Rev.3Summary:

Timetable: Accelerated assessment request for initial marketing authorisations - ATMP

Timetable: Type II variation and worksharing application assessment - ATMP

Reference Number: EMA/727192/2017 Rev. 3

Timetable: Initial (Full) marketing authorisation application - ATMP

Legal effective date: 18/12/2020Reference Number: EMA/824993/2015 Rev.5

Timetable: Extension application - ATMP

Legal effective date: 18/12/2020Reference Number: EMA/824995/2015 Rev.6

Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)

Legal effective date: 31/10/2017Reference Number: EMA/251635/2015 Rev. 6

Timetable: Marketing authorisation renewal application - ATMP

Legal effective date: 15/12/2015Reference Number: EMA/825017/2015 Rev. 3Summary:

Initial 60-day assessment

Timetable: Annual reassessment - ATMP

Legal effective date: 15/12/2015Reference Number: EMA/825019/2015 Rev.2Summary:

Initial 90-day assessment

Timetable: Annual renewal application of conditional marketing authorisation - ATMP

Legal effective date: 15/12/2015Reference Number: EMA/825018/2015 Rev.3Summary:

Annual renewal application of conditional marketing authorisation - ATMP - Initial 60-day assessment

Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMP

Legal effective date: 25/04/2016Reference Number: EMA/267769/2016 Rev.3

Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP

Reference Number: EMA/267767/2016 Rev. 5Summary:

Post-authorisation measure (PAM) assessed by PRAC - ATMP

Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMP

Reference Number: EMA/267915/2016 Rev.3

Companion diagnostic consultation

Timetable: Companion diagnostic initial consultation

Reference Number: EMA/3932/2022 Rev.2

Timetable: Companion diagnostic initial consultation - ATMP

Reference Number: EMA/3933/2022 Rev.3

Timetable: Companion diagnostic follow-up consultation

Reference Number: EMA/3932/2022 Rev.1

Timetable: Companion diagnostic follow-up consultation - ATMP

Reference Number: EMA/3933/2022 Rev.1