Post-Authorisation Measure (PAM) - European Medicines Agency

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6 July 2018 EMA/403033/2015 Rev.1 Human Medicines Evaluation The timetables in this document may be subject to revision

Post-Authorisation Measure (PAM) assessed by CHMP Deadline for Submission (*)

Start date

CHMP Rapporteur AR

Comments from CHMP (~)

Updated CHMP Rapporteur AR (#)

CHMP conclusion

A1

12/06/2018

25/06/2018

30/07/2018

13/08/2018

16/08/2018

23/08/2018

A2

10/07/2018

23/07/2018

28/08/2018

10/09/2018

13/09/2018

20/09/2018

A3

07/08/2018

20/08/2018

24/09/2018

08/10/2018

11/10/2018

18/10/2018

A4

04/09/2018

17/09/2018

22/10/2018

05/11/2018

08/11/2018

15/11/2018

A5

02/10/2018

15/10/2018

19/11/2018

03/12/2018

06/12/2018

13/12/2018

A6

20/11/2018

03/12/2018

07/01/2019

21/01/2019

24/01/2019

31/01/2019

A7

07/12/2018

31/12/2018

04/02/2019

18/02/2019

21/02/2019

28/02/2019

A8

15/01/2019

28/01/2019

04/03/2019

18/03/2019

21/03/2019

28/03/2019

A9

13/02/2019

26/02/2019

01/04/2019

15/04/2019

17/04/2019

26/04/2019

A10

18/03/2019

31/03/2019

06/05/2019

20/05/2019

23/05/2019

29/05/2019

A11

16/04/2019

29/04/2019

03/06/2019

17/06/2019

20/06/2019

27/06/2019

A12

14/05/2019

27/05/2019

01/07/2019

15/07/2019

18/07/2019

25/07/2019

A13

11/06/2019

24/06/2019

29/07/2019

12/08/2019

15/08/2019

22/08/2019

A14

09/07/2019

22/07/2019

27/08/2019

09/09/2019

12/09/2019

19/09/2019

A15

06/08/2019

19/08/2019

23/09/2019

07/10/2019

10/10/2019

17/10/2019

A16

03/09/2019

16/09/2019

21/10/2019

04/11/2019

07/11/2019

14/11/2019

A17

01/10/2019

14/10/2019

18/11/2019

02/12/2019

05/12/2019

12/12/2019

A18

19/11/2019

02/12/2019

06/01/2020

20/01/2020

23/01/2020

30/01/2020

A19

06/12/2019

30/12/2019

03/02/2020

17/02/2020

20/02/2020

27/02/2020

A20

14/01/2020

27/01/2020

02/03/2020

16/03/2020

19/03/2020

26/03/2020

A21

18/02/2020

02/03/2020

06/04/2020

20/04/2020

23/04/2020

30/04/2020

A22

17/03/2020

30/03/2020

04/05/2020

18/05/2020

20/05/2020

28/05/2020

A23

14/04/2020

27/04/2020

02/06/2020

15/06/2020

18/06/2020

25/06/2020

A24

12/05/2020

25/05/2020

29/06/2020

13/07/2020

16/07/2020

23/07/2020

A25

09/06/2020

22/06/2020

27/07/2020

10/08/2020

13/08/2020

20/08/2020

A26

07/07/2020

20/07/2020

24/08/2020

07/09/2020

10/09/2020

17/09/2020

A27

04/08/2020

17/08/2020

21/09/2020

05/10/2020

08/10/2020

15/10/2020

A28

01/09/2020

14/09/2020

19/10/2020

03/11/2020

05/11/2020

12/11/2020

A29

29/09/2020

12/10/2020

16/11/2020

30/11/2020

03/12/2020

10/12/2020

A30

17/11/2020

30/11/2020

04/01/2021

18/01/2021

21/01/2021

28/01/2021

A31

10/12/2020

28/12/2020

01/02/2021

15/02/2021

18/02/2021

25/02/2021

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

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Deadline for Submission (*)

Start date

CHMP Rapporteur AR

Comments from CHMP (~)

Updated CHMP Rapporteur AR (#)

CHMP conclusion

A32

12/01/2021

25/01/2021

01/03/2021

15/03/2021

18/03/2021

25/03/2021

A33

09/02/2021

22/02/2021

29/03/2021

12/04/2021

15/04/2021

22/04/2021

A34

09/03/2021

22/03/2021

26/04/2021

10/05/2021

12/05/2021

20/05/2021

A35

13/04/2021

26/04/2021

31/05/2021

14/06/2021

17/06/2021

24/06/2021

A36

11/05/2021

24/05/2021

28/06/2021

12/07/2021

15/07/2021

22/07/2021

A37

08/06/2021

21/06/2021

26/07/2021

09/08/2021

12/08/2021

19/08/2021

A38

06/07/2021

19/07/2021

23/08/2021

06/09/2021

09/09/2021

16/09/2021

A39

03/08/2021

16/08/2021

20/09/2021

04/10/2021

07/10/2021

14/10/2021

A40

31/08/2021

13/09/2021

18/10/2021

29/10/2021

04/11/2021

11/11/2021

A41

05/10/2021

18/10/2021

22/11/2021

06/12/2021

09/12/2021

16/12/2021

(*) 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 (MAHs). (#) An updated AR is optional and dependent on the comments received from CHMP members which create the need for the update.

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

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