1. The scientific data and other information in the application required under Article 15(3) may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
(c) the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.
2 . Until the end of the five-year period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the [F1appropriate authority] takes a decision on whether a claim could be or could have been [F2authorised under] Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant. ]
Textual Amendments
F1Words in Art. 21(2) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 17(22)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 21(2) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 17(22)(b); 2020 c. 1, Sch. 5 para. 1(1)