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 deadlineStart of procedure - day 1COMP meeting
day 60
(1st discussion)
COMP meeting
day 90
(2nd discussion)
22 May 202017 June 202014-16 July 20208-9 September 2020
26 June 202015 July 20208-9 September 20206-8 October 2020
16 July 202012 August 20206-8 October 20203-5 November 2020
31 August 202014 September 20203-5 November 20201-3 December 2020
28 September 202026 October 20201-3 December 202019-21 January 2021
26 October 202023 November 202019-21 January 202116-18 February 2021
23 November 20204 January 202116-18 February 202116-18 March 2021
07 December 202025 January 202116-18 March 202113-15 April 2021
21 January 202112 February 202113-15 April 202110-12 May 2021
26 February 202125 March 202110-12 May 202115-17 June 2021
22 March 202119 April 202115-17 June 202113-15 July 2021
21 May 202114 June 202113-15 July 20217-9 September 2021
25 June 202112 July 20217-9 September 20215-7 October 2021
16 July 202112 August 20215-7 October 20213-5 November 2021
31 August 202114 September 20213-5 November 20217-9 December 2021

*Dates updated in April 2020

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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