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art_8__para_4__text_1

When a patient affected, or suspected of being affected, by a rare disease applies for prior authorisation, a clinical evaluation may be carried out by experts in that field. If no experts can be found within the Member State of affiliation or if the expert’s opinion is inconclusive, the Member State of affiliation may request scientific advice.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-11 · Text as adopted (Official Journal); later amendments are not incorporated in this text.