art_44__para_2__text_1
Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly. The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received. However, the suspension shall not exceed 180 days in total other than in exceptional cases and where justified by the nature of the information requested.
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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.