Due to the delays in the finalisation of the review programme, the end date of 31 December 2025 for the protection of data set out in Article 95(5) of Regulation (EU) No 528/2012 should be adapted to strike a balance between the interests of review programme participants on the one hand, and the interests of alternative suppliers of active substances and applicants for product authorisation, on the other hand. Such a balance between the various interests needs to be considered when deciding which active substances and data are concerned by the extension of protection, as well as on the extended duration of protection.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
