art_32__para_2

2. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall: be transparent to Member States, the manufacturer concerned and to other manufacturers or stakeholders that request to be informed; disclose confidential information to the Commission only when necessary to assess the compliance of a European assessment document with regulatory provisions and protect commercial secrecy and confidentiality; specify appropriate mandatory time limits in order to avoid unjustified delay; allow for adequate participation by the Member States and the Commission; be cost-effective for the manufacturer; and ensure sufficient collegiality and coordination amongst TABs designated for the product in question. The balancing of requirements laid down in points (a) and (b) of the first subparagraph shall allow at least for the disclosure of the name of the product at the stage of the approval and the communication of the work programme, as set out in point 3 of Annex VI, and for the disclosure of the detailed contents of the draft European assessment document set out in point 8 of Annex VI.

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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.