1.

The scientific data and other information in the application required under Article 15(2) may not be used for the benefit of a subsequent applicant for a period of seven 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: the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-08 · Text as adopted (Official Journal); later amendments are not incorporated in this text.