(c)

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

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.