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 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 |
| 30 September 2026 | 28 October 2026 | 1-3 December 2026 | 19-21 January 2027 |
| 29 October 2026 | 24 November 2026 | 19-21 January 2027 | 16-18 February 2027 |
| 24 November 2026 | 5 January 2027 | 16-18 February 2027 | 22-24 March 2027 |
| 11 December 2026 | 28 January 2027 | 22-24 March 2027 | 20-22 April 2027 |
| 29 January 2027 | 26 February 2027 | 20-22 April 2027 | 18-20 May 2027 |
| 26 February 2027 | 23 March 2027 | 18-20 May 2027 | 15-17 June 2027 |
| 31 March 2027 | 26 April 2027 | 15-17 June 2027 | 13-15 July 2027 |
| 27 May 2027 | 18 June 2027 | 13-15 July 2027 | 7-9 September 2027 |
| 28 June 2027 | 16 July 2027 | 7-9 September 2027 | 5-7 October 2027 |
| 14 July 2027 | 13 August 2027 | 5-7 October 2027 | 3-5 November 2027 |
| 31 August 2027 | 15 September 2027 | 3-5 November 2027 | 7-9 December 2027 |
*Dates updated in January 2026
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.