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.