Submission deadlines for orphan designations

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)

20 May 2022

14 June 2022

12-14 July 2022

6-8 September 2022

24 June 2022

12 July 2022

6-8 September 2022

4-6 October 2022

15 July 2022

15 August 2022

4-6 October 2022

8-10 November 2022

31 August 2022

14 September 2022

8-10 November 2022

6-8 December 2022

28 September 2022

26 October 2022

6-8 December 2022

17-19 January 2023

26 October 2022

23 November 2022

17-19 January 2023

14-16 February 2023

24 November 2022

4 January 2023

14-16 February 2023

21-23 March 2023

6 December 2022

25 January 2023

21-23 March 2023

18-20 April 2023

26 January 2023

20 February 2023

18-20 April 2023

15-17 May 2023

27 February 2023

22 March 2023

15-17 May 2023

13-15 June 2023

27 March 2023

19 April 2023

13-15 June 2023

11-13 July 2023

22 May 2023

13 June 2023

11-13 July 2023

5-7 September 2023

23 June 2023

11 July 2023

5-7 September 2023

3-5 October 2023

14 July 2023

15 August 2023

3-5 October 2023

7-9 November 2023

29 August 2023

14 September 2023

7-9 November 2023

5-7 December 2023

*Dates updated in April 2022

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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