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