Submission deadlines for orphan designations

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This page lists the submission deadlines for applications for orphan designation.

In accordance with Article 5.5 of Regulation (EC) No 141/2000, the Committee for Orphan Medicinal Products (COMP) will reach an opinion on a valid application for orphan designation within 90 days.

The dates below correspond to the COMP meetings falling on or just prior to day 90. Opinions may be reached earlier than day 90 if no questions are raised by COMP.

For further information on the procedure for designation, see how to apply for orphan designation.

Submission deadlineStart of procedure - day 1COMP meeting
day 60
(1st discussion)
COMP meeting
day 90
(2nd discussion)

23 March 2018

23 April 2018

19-21 June 2018

17-19 July 2018

24 May 2018

18 June 2018

17-19 July 2018

11-13 September 2018

29 June 2018

16 July 2018

11-13 September 2018

9-11 October 2018

17 July 2018

13 August 2018

9-11 October 2018

6-8 November 2018

30 August 2018

12 September 2018

6-8 November 2018

4-6 December 2018

27 September 2018

29 October 2018

4-6 December 2018

22-24 January 2019

25 October 2018

26 November 2018

22-24 January 2019

19-21 February 2019

22 November 2018

3 January 2019

19-21 February 2019

19-21 March 2019

6 December 2018

18 January 2019

19-21 March 2019

15-17 April 2019

24 January 2019

25 February 2019

15-17 April 2019

21-23 May 2019

28 February 2019

25 March 2019

21-23 May 2019

18-20 June 2019

21 March 2019

23 April 2019

18-20 June 2019

16-18 July 2019

23 May 2019

17 June 2019

16-18 July 2019

10-12 September 2019

27 June 2019

15 July 2019

10-12 September 2019

8-10 October 2019

17 July 2019

12 August 2019

8-10 October 2019

5-7 November 2019

28 August 2019

13 September 2019

5-7 November 2019

3-5 December 2019

*Dates updated in July 2018

Note: In accordance with Article 5.5 of Regulation (EC) No 141/2000, the COMP will reach an opinion on a valid application for orphan designation within 90 days. Opinions may be reached earlier than day 90 if no questions are raised by COMP. In preparing an application for orphan designation, sponsors are requested to follow the Commission guideline (ENTR/6283/00) for the format and content of applications for designation as orphan medicinal products.

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