anx_VI__table__4
| 8.1. | In the cases referred to in points 1.1 and 1.2, the responsible TAB shall communicate the draft European assessment document to the manufacturer or the Group, respectively, who shall have 20 working days to react thereto. Thereafter, the organisation of TABs shall: (a) if applicable, inform the manufacturer or the Group as to how their reactions have been taken into account; (b) adopt the draft European assessment document; (c) send a copy of it to the Commission.
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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.