(38)The generation of information by alternative means offering equivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activity models or from structurally related substances. To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance. It should also be possible not to submit certain information if appropriate justification can be provided. Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification.
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New version applies from 21/06/2016.
59 provisions change.
Later versions: 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 38 is deleted from 21/06/2016.