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Article 10b(1)(c) and Article 10(1), (3) and (4) 8. Clinical Investigation (see fields under 5. Clinical Investigation, (a) to (f)): (a) Decisions taken by Competent Authority pursuant to Article 10(3), date of decision and grounds; (b) Early termination on safety grounds pursuant to Article 10(4), date of decision and grounds.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.