The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6, shall inform the applicant if the documentation submitted in support of the application is insufficient. The competent authority or the Agency, as applicable, shall request the applicant to provide additional information within a given time limit. In such a case the time limits laid down in Articles 44, 47, 49, 52 and 53 shall be suspended until the additional information has been provided.
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Chapter II · MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS › Section 7 · Examination of applications and basis for granting marketing authorisations › Article 31
Additional information from the applicant
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