Paragraph 44 Place of establishment for holders of certificates of registration established in EEA before IP completion dayF1

(1)

Subject to sub-paragraph (2), any person—

(a)

who—

(i)

holds a certificate of registration immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii)

has made an application for, or to renew, a certificate of registration before IP completion day, which has not been determined by the licensing authority before that date, or

(iii)

makes such an application on or after IP completion day but before the end of the transitional period; and

(b)

who was, immediately before IP completion day, established in an EEA State and who remains there on and after that day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 103(4) or 108(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2)

But sub-paragraph (1) continues to apply to a person, in relation to a certificate of registration in force in Great Britain, only if the person has notified the licensing authority in writing of—

(a)

a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the certificate of registration, or application for a certificate of registration, during the transitional period; and

(b)

that individual's address, telephone number and email address.

(3)

A person must notify the licensing authority under sub-paragraph (2)—

(a)

where sub-paragraph (1)(a)(i) or (ii) applies, within the period of 4 weeks beginning with IP completion day; or

(b)

where sub-paragraph (1)(a)(iii) applies, at the time of making the application.

(4)

In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Annotations

Textual amendments

F1: Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)