Regulation 161 Written representations procedure

(1)

If a recipient makes written representations in accordance with regulation 160(2)(a) the licensing authority must appoint a panel of at least two persons (“the reviewers”) to advise on the provisional determination.

(2)

The licensing authority must provide the reviewers with—

(a)

the recipient's written representations; and

(b)

any written representations of the licensing authority.

(3)

The reviewers must advise the licensing authority on the authority's provisional determination taking account of—

(a)

the written representations; and

(b)

any other evidence submitted to them.

(4)

The licensing authority must take into account the reviewers' advice and make a final determination as to whether the product is a medicinal product.

(5)

The licensing authority must—

(a)

inform the recipient in writing of its final determination and of the reasons for it; and

(b)

if the licensing authority disagrees with the reviewers' advice, inform the recipient in writing of the reasons for that disagreement.