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)
27 March 202422 April 202418-20 June 202416-18 July 2024
22 May 202417 June 202416-18 July 202410-12 September 2024
24 June 202415 July 202410-12 September 20248-10 October 2024
15 July 202415 August 20248-10 October 20245-7 November 2024
30 August 202413 September 20245-7 November 20243-5 December 2024
30 September 202426 October 20243-5 December 202421-23 January 2025
28 October 202423 November 202421-23 January 202518-20 February 2025
25 November 20244 January 202518-20 February 202518-20 March 2025
16 December 202426 January 202518-20 March 202514-16 April 2025
27 January 202526 February 202514-16 April 202513-15 May 2025
27 February 202525 March 202513-15 May 202510-12 June 2025
27 March 202522 April 202510-12 June 202515-17 July 2025
26 May 202517 June 202515-17 July 20259-11 September 2025
26 June 202515 July 20259-11 September 20257-9 October 2025
15 July 202515 August 20257-9 October 20254-6 November 2025
29 August 202513 September 20254-6 November 20252-4 December 2025

*Dates updated in February 2023

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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