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New version applies from 16/06/2014. 122 provisions change. Later versions: 16/07/2021, 17/11/2024, 08/01/2026, 29/05/2026. Article 20 changes in this version: compare with the current text.

Article 20 - Principles for the development and adoption of European Assessment Documents

Article 20
Principles for the development and adoption of European Assessment Documents

1. The procedure for developing and adopting European Assessment Documents shall:

((a))

be transparent to the manufacturer concerned;

((b))

define appropriate mandatory time limits in order to avoid unjustified delay;

((c))

take appropriately into account the protection of commercial secrecy and confidentiality;

((d))

allow for adequate participation by the Commission;

((e))

be cost-effective for the manufacturer; and

((f))

ensure sufficient collegiality and coordination amongst TABs designated for the product in question.

2. The TABs shall, together with the organisation of TABs, bear the full costs of the development and adoption of European Assessment Documents.

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