Article 7

In order to prepare its opinion, the Committee: shall verify that the particulars and documents submitted in accordance with Article 6 comply with the requirements of Directives 65/65/EEC, 75/318/EEC and 75/319/EEC, and examine whether the conditions specified in this Regulation for issuing a marketing authorization for the medicinal product are satisfied; may ask for a State laboratory or a laboratory designated for this purpose to test the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory; may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit. Where the Committee avails itself of this opinion, the time limit laid down in Article 6 shall be suspended until such time as the supplementary information requested has been provided. Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.

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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.