(c)

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products · European Union

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.