The Human Medicines Regulations 2012

[F1 Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications) U.K.

32.— (1) Subject to sub-paragraph (2), a person—

(a) who applied to the EMA for an EU marketing authorisation before IP completion day;

(b) to whom the licensing authority grants a UK marketing authorisation on or after IP completion day in response to that application in accordance with paragraph 31; and

(c) who 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), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) Sub-paragraph (1) applies to a person only if, when submitting a copy of the application for the EU marketing authorisation to the licensing authority in accordance with paragraph 31, the person notifies the licensing authority in writing of—

(a) a named individual who resides and operates in the United Kingdom whom the licensing authority may contact in respect of any matter relating to the UK marketing authorisation during the transitional period; and

(b) that individual's address, telephone number and email address.

(3) In this paragraph, “the transitional period” means the period which beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 24 months after IP completion day.]

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)