62.—(1) Regulation 58 is amended as follows.
(2) After paragraph (4), insert—
[F1“(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 that paragraph in relation to certain types of medicinal products only;
(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); and
(c)decide to have regard to the assessments described in paragraph (4A)(b) in relation to medicinal products that have been authorised by way of certain procedures only.
(4C) When considering an application for a UK marketing authorisation (other than an application under the unfettered access route), the licensing authority may, if it considers it appropriate and without undertaking further consideration, rely on a decision by the European Commission to authorise the medicinal product to which the application relates to establish that any or all of the conditions in paragraph (4)(a), (b) or (d) have been met.”].
(3) Omit paragraphs (6) and (7).
[F2(4) After paragraph (7) insert—
“(8) In the case of an application under the unfettered access route, the licensing authority may grant a UKMA(GB) (notwithstanding paragraph (4)) where the licensing authority—
(a)has considered the application under the unfettered access route and the accompanying material,
(b)is satisfied that the applicant has complied with the application requirements, and
(c)is satisfied that the conditions in regulation 50 will continue to be met.
(9) The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.”.]
Textual Amendments
F1Words in reg. 62(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 45(a)
F2Reg. 62(4) substituted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 45(b)
Commencement Information
I1Reg. 62 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1