# The Human Medicines Regulations 2012, 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/161 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-161
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.