Regulation 101 Amendment of regulation 108 (application for renewal of certificate)I1
United Kingdom
In regulation 108(2), F1for “must be established in the European Union” substitute—
“, where it is applying for renewal of—
(a)a COR(NI) and originally granted—
(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 COR(GB) and originally granted—
(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)in the whole United Kingdom, must be established in the United Kingdom.”
Annotations
Textual amendments
- F1
Words in reg. 101 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. 78
Commencement
- I1
Reg. 101 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1