(b)
may submit the proprietary medicinal product for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with point 7 of Article 4, second paragraph, of Directive 65/65/EEC are satisfactory;
← art_4__para · All articles · (c) →
Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.