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7. Amendments and adoption of a European Assessment Document

The responsible TAB shall communicate the draft European Assessment Document to the manufacturer, who shall have 15 working days to react thereto. Thereafter, the organisation of TABs shall: if applicable, inform the manufacturer as to how his reactions have been taken into account; adopt the draft European Assessment Document; and send a copy to the Commission. If, within 15 working days of receipt, the Commission communicates to the organisation of TABs its observations on the draft European Assessment Document, the organisation of TABs, after having been given the opportunity to comment, shall amend the draft accordingly and shall send a copy of the adopted European Assessment Document to the manufacturer and to the Commission.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-12 · Text as adopted (Official Journal); later amendments are not incorporated in this text.