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1.

Without prejudice to Articles 62 and 63, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where: the subsequent applicant submits a letter of access; or the relevant time limit for data protection has expired.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.