The Human Medicines Regulations 2012

Oral representations procedure

162.—(1) If a recipient informs the licensing authority in accordance with regulation 160(2)(b) that the recipient wants to make oral representations, the licensing authority must—

(a) appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b) after consultation with the recipient set a date for the hearing.

(2) The licensing authority may alter the date of the hearing at the request of the recipient or of its own motion if it thinks that because of exceptional circumstances or the nature or complexity of the issues involved additional time is needed for preparation for the hearing.

(3) The licensing authority must inform the recipient in writing of any alteration under paragraph (2) and of the reasons for it.

(4) The recipient and the licensing authority may make oral representations at the hearing.

(5) The reviewers must advise the licensing authority on the authority’s provisional determination, taking account of—

(a) the oral representations made and any other evidence submitted by the recipient at the hearing;

(b) any oral representations made or other evidence submitted by the licensing authority at the hearing; and

(c) any other evidence heard by the review panel.

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

(7) 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.