Paragraph 32 Substitution of Article 31I1

For Article 31 (coordination of TABs), substitute—

“Article 31

Coordination of TABs

1

The TABs must make such arrangements as they consider appropriate to ensure the coordination of TABs and, if necessary, cooperation and consultation with other stakeholders.

2

If the TABs decide to establish a separate body having legal personality and established in the United Kingdom to facilitate the coordination of TABs, a responsible TAB may delegate its functions under the specified provisions in relation to developing and adopting UK Assessment Documents to that body.

3

The “specified provisions” are—

(a)

Article 19(1);

(b)

Article 22(1);

(c)

Article 23;

(d)

Article 24;

(e)

Article 27;

(f)

sections 2, 4, 5, 7, 8 (excluding the duty to communicate the draft UK Assessment Document to the manufacturer) and 9 of Annex 2.”.