Regulation 74 Amendment of regulation 66 (application for renewal of authorisation)I1
United Kingdom
In regulation F166, for paragraph (2) substitute—
“(2)The applicant, where it is applying for renewal of—
(a)a UKMA(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 UKMA(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 UKMA(UK), must be established in the United Kingdom.”
Annotations
Textual amendments
- F1
Words in reg. 74 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. 55
Commencement
- I1
Reg. 74 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1