16 October 2017 EMA/675761/2017 Human Medicines Evaluation Division

PRIME eligibility requests 2018 Deadlines for submission and timetable for assessment

Deadline for

Start of procedure

SAWP

CAT

CHMP

submission

(SAWP meeting)

recommendation

recommendation(*)

adoption

03/01/2018

8 – 11 January 2018

08/02/2018

16/02/2018

22/02/2018

31/01/2018

5 – 8 February 2018

08/03/2018

16/03/2018

22/03/2018

28/02/2018

5 – 8 March 2018

12/04/2018

20/04/2018

26/04/2018

04/04/2018

9 – 12 April 2018

17/05/2018

25/05/2018

31/05/2018

06/05/2018

14 – 17 May 2018

14/06/2018

22/06/2018

28/06/2018

06/06/2018

11 – 14 June 2018

12/07/2018

20/07/2018

26/07/2018

04/07/2018

9 – 12 July 2018

06/09/2018

14/09/2018

20/09/2018

29/08/2018

3 – 6 September 2018

04/10/2018

12/10/2018

18/10/2018

26/09/2018

1 – 4 October 2018

31/10/2018

09/11/2018

15/11/2018

24/10/2018

29 – 31 October 2018

29/11/2018

07/12/2018

13/12/2018

21/11/2018

26 – 29 November

17/01/2019

25/01/2019

31/01/2019

2018 * In case of advanced therapy medicinal products 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5510 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

2018 PRIME eligibility requests - European Medicines Agency

Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 16 October 2017. EMA/675761/2017. Human Medicines Evaluation Division. PRIME eligibility requests. 2018 Deadlines for submission and timetable for ...

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