The Human Medicines Regulations 2012

Consideration of application U.K.

58.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation before the end of 210 days beginning immediately after the day on which the application for the authorisation is submitted in accordance with regulations 49 to 55.

(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—

(a) beginning with the date on which the request is made; and

(b) ending with the date on which the information or material is provided.

(3) If the licensing authority requests the applicant to give an oral or written explanation of the application, the period referred to in paragraph (1) is suspended for the period—

(a) beginning with the date on which the request is made; and

(b) ending with the date on which the explanation is provided.

(4) The licensing authority may grant the application only if, having considered the application and the accompanying material, the authority thinks that—

(a) the applicant has established the therapeutic efficacy of the product to which the application relates;

(b) the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product;

(c) the application and the accompanying material complies with regulations 49 to 55; and

(d) the product's qualitative and quantitative composition is as described in the application and the accompanying material.

[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.]

(5) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a UK marketing authorisation.

F2 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3 (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F4 (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

F1 Regs. 58(4A)-(4C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 58(6) omitted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(3)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Reg. 58(7) omitted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(3)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Reg. 58(8)(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(b)); 2020 c. 1, Sch. 5 para. 1(1)