Following the expiry of the protection periods on 31 December 2025, the data concerned were unprotected in the period from 1 January 2026 to 15 June 2026. Article 60(1), second subparagraph, of Regulation (EU) No 528/2012 lays down a rule according to which data for which the protection period has expired are not to be protected again. As the proposed extension of protection for the data concerned would result in that data being protected again, that provision should be amended to provide for a derogation from that rule for such data. During the period in which the data concerned were unprotected, alternative substance suppliers and product suppliers have been included in the list referred to in Article 95 of Regulation (EU) No 528/2012. Since those suppliers could have benefitted from the costs incurred by the review programme participants to generate such data, Article 95(5) should be amended to allow data owners to claim compensation from those substance suppliers and product suppliers, if they find it appropriate.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
