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4.

Upon request from any interested person, the Agency shall make available the assessment report of the medicinal product by the Committee for Proprietary Medicinal Products and the reasons for its opinion in favour of granting authorization, after deletion of any information of a commercially confidential nature.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.