2.

Before issuing its opinion, the Agency shall provide the applicant and, where applicable, the authorisation holder with an opportunity to provide written comments within a specified time limit not exceeding 30 days. The Agency may suspend the time limit referred to in paragraph 1 to allow the applicant or the authorisation holder to prepare the comments.

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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.