Article 9

In order to examine the application submitted pursuant to Article 4, the competent authorities of the Member States: 1. shall check that the documentation submitted in support of the application complies with Article 5 and, on the basis of the reports drawn up by the experts pursuant to Article 7, ascertain whether the conditions for the issue of the marketing authorization have been fulfilled; 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; 3. may, where appropriate, require the applicant to provide further information as regards the items listed in Article 5. Where the competent authorities take this course of action, the time limits specified in Article 8 shall be suspended until the further data required have been provided. Similarly, these time limits shall be suspended for any period which the applicant may be given to provide 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.