Submission deadlines for orphan designations

This page lists the submission deadlines for applications for orphan designation.
Human Regulatory and procedural guidance Rare diseases

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 deadline Start of procedure - day 1 COMP meeting
day 60
(1st discussion)
COMP meeting
day 90
(2nd discussion)
27 January 2025 26 February 2025 14-16 April 2025 13-15 May 2025
27 February 2025 25 March 2025 13-15 May 2025 10-12 June 2025
27 March 2025 22 April 2025 10-12 June 2025 15-17 July 2025
26 May 2025 17 June 2025 15-17 July 2025 9-11 September 2025
26 June 2025 15 July 2025 9-11 September 2025 7-9 October 2025
15 July 2025 15 August 2025 7-9 October 2025 4-6 November 2025
29 August 2025 15 September 2025 4-6 November 2025 2-4 December 2025
30 September 2025 28 October 2025 2-4 December 2025 20-22 January 2026
28 October 2025 24 November 2025 20-22 January 2026 17-19 February 2026
25 November 2025 5 January 2026 17-19 February 2026 17-19 March 2026
12 December 2025 26 January 2026 17-19 March 2026 14-16 April 2026
27 January 2026 26 February 2026 14-16 April 2026 11-13 May 2026
27 February 2026 25 March 2026 11-13 May 2026 16-18 June 2026
27 March 2026 22 April 2026 16-18 June 2026 14-16 July 2026
26 May 2026 17 June 2026 14-16 July 2026 8-10 September 2026
26 June 2026 15 July 2026 8-10 September 2026 6-8 October 2026
14 July 2026 14 August 2026 6-8 October 2026 3-5 November 2026
28 August 2026 14 September 2026 3-5 November 2026 1-3 December 2026

*Dates updated in February 2025

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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