The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

87.  In regulation 116 (amendment of regulation 130 (consideration of application))—

(a) in paragraph (3) for “for “Article” to the end substitute—

“for “is subject to” to the end substitute—

“—

(a) where the application is for a THR(NI) or THR(UK), is subject to Article 16c(4) of the 2001 Directive (procedure where product has been used in the European Union for less than 15 years);

(b) where the application is for a THR(GB), is subject to regulation 130A.”.”;

(b) in paragraph (4) for “for “list referred to” to the end substitute—

“after “of the 2001 Directive” insert “where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)”.”;

(c) for paragraph (5) substitute—

“(5) In paragraph (9), after “Where” insert “, in relation to an application for a THR(NI) or THR(UK),”.”;

(d) in paragraph (6) for “for “Article 16h(3)” to the end substitute—

“for “in Article 16h(3)” to the end substitute—

“—

(i) in Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK);

(ii) in regulation 143A, where the application is for a THR(GB),

that the authority thinks relevant to the application; or”.”;

(e) for paragraph (7) substitute—

“(7) In paragraph (12), after “This regulation does not apply where” insert “, in relation to an application for a THR(NI) or THR(UK),”.”;

(f) after paragraph (7) insert—

“(8) After paragraph (13) insert—

“(14) In the case of an application under the unfettered access route, the licensing authority may grant a THR(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 127(1A) will continue to be met.

(15) 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.”.”.