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)
23 May 2019 17 June 2019 16-18 July 2019 10-12 September 2019
27 June 2019 15 July 2019 10-12 September 2019 8-10 October 2019
17 July 2019 12 August 2019 8-10 October 2019 5-7 November 2019
28 August 2019 13 September 2019 5-7 November 2019 3-5 December 2019
27 September 29 October 2019 3-5 December 2019 21-23 January 2020
25 October 2019 26 November 2019 21-23 January 2020 18-20 February 2020
22 November 2019 3 January 2020 18-20 February 2020 17-19 March 2020
5 December 2019 27 January 2020 17-19 March 2020 21-23 April 2020
24 January 2020 25 February 2020 21-23 April 2020 18-20 May 2020
28 February 2020 25 March 2020 18-20 May 2020 16-18 June 2020
20 March 2020 23 April 2020 16-18 June 2020 14-16 July 2020
22 May 2020 17 June 2020 14-16 July 2020 8-9 September 2020
26 June 2020 15 July 2020 8-9 September 2020 6-8 October 2020
16 July 2020 12 August 2020 6-8 October 2020 3-5 November 2020
31 August 2020 14 September 2020 3-5 November 2020 1-3 December 2020

*Dates updated in May 2019

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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