Article 4

In order to examine the application submitted in accordance with Article 4 of Directive 65/65/EEC, the competent authorities of the Member States: (a) must verify whether the particulars submitted in support of the application comply with the said Article 4 and examine whether the conditions for issuing an authorization to place proprietary medicinal products on the market (marketing authorization) are complied with; 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; may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed in the second paragraph of Article 4 of Directive 65/65/EEC. Where the competent authorities avail themselves of this option, the time limits laid down in Article 7 of the said Directive shall be suspended until such time as the supplementary information required has been provided. Likewise, these time limits shall be suspended for the time allowed the applicant, where appropriate, for giving oral or written explanation.

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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.