OpenLegislation

Regulation 118 Amendment of regulation 133 (application for renewal of registration)I1

United Kingdom

In regulation 133(2), F1for “must be established in the European Union” substitute—

““, where it is applying for renewal of—

(a)

a THR(NI)—

(i)

in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii)

on any other basis, must be established in the United Kingdom;

(b)

a THR(GB)—

(i)

under the unfettered access route, must be established in Northern Ireland;

(ii)

other than under the unfettered access route, must be established in the United Kingdom;

(c)

a THR(UK), must be established in the United Kingdom.”.”

Annotations

Textual amendments

F1

Words in reg. 118 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. 89

Commencement

I1

Reg. 118 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1