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 deadline Start of procedure - day 1 COMP meeting
day 60
(1st discussion)
COMP meeting
day 90
(2nd discussion)
21 May 2021 14 June 2021 13-15 July 2021 7-9 September 2021
25 June 2021 12 July 2021 7-9 September 2021 5-7 October 2021
16 July 2021 12 August 2021 5-7 October 2021 3-5 November 2021
31 August 2021 14 September 2021 3-5 November 2021 7-9 December 2021
28 September 2021 26 October 2021 7-9 December 2021 18-20 January 2022
26 October 2021 23 November 2021 18-20 January 2022 15-17 February 2022
23 November 2021 4 January 2022 15-17 February 2022 15-17 March 2022
07 December 2021 25 January 2022 15-17 March 2022 11-13 April 2022
24 January 2022 14 February 2022 11-13 April 2022 10-12 May 2022
25 February 2022 25 March 2022 10-12 May 2022 14-16 June 2022
24 March 2022 19 April 2022 14-16 June 2022 12-14 July 2022
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

*Dates updated in April 2021

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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