Amendment of regulation 58 (consideration of application)
62.—(1) Regulation 58 is amended as follows.
(2) After paragraph (4), insert—
“(4A) When considering an application for a UK marketing authorisation, the licensing authority may, if it considers it appropriate, have regard to—
(a)an opinion of the Committee for Medicinal Products for Human Use; or
(b)the results of an assessment of an application for a marketing authorisation by the appropriate authority for the licensing of medicinal products of a country other than the United Kingdom ,
in respect of the medicinal product to which the application relates.
(4B) The licensing authority may under paragraph (4A)—
(a)decide to have regard to the opinions and assessments described in sub-paragraphs (a) and (b) in relation to certain types of medicinal products only; and
(b)determine and publish a list of the countries other than the United Kingdom whose assessments of applications for a marketing authorisation are relevant for the purposes of paragraph (4A)(b).”.
(3) Omit paragraphs (6) and (7).