(53)In order to allow a potential registrant of a phase-in substance to proceed with his registration, even if he cannot reach agreement with a previous registrant, the Agency, on request, should allow use of any summary or robust study summary of tests already submitted. The registrant who receives these data should be obliged to pay a contribution to the costs to the owner of the data. For non-phase-in substances, the Agency may ask for evidence that a potential registrant has paid the owner of a study before the Agency gives permission for the potential registrant to use that information in his registration.
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New version applies from 01/06/2012.
57 provisions change.
Later versions: 05/06/2012, 09/10/2012, 06/03/2013, 21/04/2013, 01/07/2013, 10/04/2014, 22/08/2014, 01/01/2015, 23/03/2015, 13/05/2015, 01/06/2015, 25/09/2015, 27/12/2015, 03/02/2016, 08/03/2016, 01/04/2016, 21/06/2016, 14/07/2016, 11/10/2016, 02/01/2017, 02/03/2017, 04/07/2017, 10/10/2017, 31/01/2018, 01/03/2018, 09/05/2018, 01/12/2018, 07/01/2019, 02/07/2019, 30/10/2019, 01/01/2020, 27/02/2020, 28/04/2020, 24/08/2020, 01/01/2021, 15/02/2021, 05/07/2021, 25/08/2021, 01/10/2021, 08/01/2022, 01/03/2022, 01/05/2022, 14/10/2022, 17/12/2022, 28/05/2023, 29/06/2023, 06/08/2023, 01/12/2023, 06/06/2024, 10/10/2024, 22/04/2025, 23/06/2025, 01/09/2025, 23/10/2025, 11/05/2026, 22/06/2026.
Recital 53 changes in this version: compare with the current text.