Paragraph 22 Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion dayF1

(1)

Subject to sub-paragraph (2), a person who—

(a)

holds a converted EU marketing authorisation on IP completion day (whether or not it is suspended); and

(b)

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

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3) or 66(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 after the end of the specified period only if the person has, before the end of that period, 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 converted EU marketing authorisation during the transitional period; and

(b)

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

(3)

In this paragraph—

“the specified period” means 4 weeks beginning with IP completion day; and
“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)