lexiara

2.

Applications for authorisation shall be made by, or on behalf of, the prospective authorisation holder. Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State (‘the receiving competent authority’). Applications for Union authorisation shall be submitted to the Agency.

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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.