CHAPTER IVHARMONISED TECHNICAL SPECIFICATIONS

Article 20Principles for the development and adoption of F1UK Assessment Documents

1.

The procedure for developing and adopting F2UK 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 F3Secretary of State;

(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 F4... bear the full costs of the development and adoption of F5UK Assessment Documents.