The Human Medicines Regulations 2012

[F1 Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day U.K.

26.— (1) Subject to sub-paragraphs (2) and (3), any person—

(a) who—

(i) holds a UK marketing authorisation immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii) holds a parallel import licence immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(iii) has made an application for, or to renew, a UK marketing authorisation or parallel import licence before IP completion day, which has not been determined before that date,

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

(v) is deemed to hold a parallel import licence under paragraph 28(2); and

(b) 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), 66(2) or 66A(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 where the UK marketing authorisation or parallel import licence authorises sale or supply of the medicinal product 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 UK marketing authorisation or parallel import licence, or application for a UK marketing authorisation or parallel import licence (as the case may be), 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) to (iii) applies, within the period of 4 weeks beginning with IP completion day; or

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

(4) This paragraph does not apply to a UK marketing authorisation that is a converted EU marketing authorisation within the meaning of paragraph 6.

(5) In this paragraph “the transitional period” means the period of 24 months beginning with 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)