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2.

may submit the medicinal product for testing by a State laboratory or a laboratory designated for this purpose, in order to ensure that the control testing methods employed by the manufacturer and described in the application documents, in accordance with point 9 of the second paragraph of Article 5, are satisfactory;

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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.