The Human Medicines Regulations 2012

[F1 Temporary exemption as to packaging requirements: change of place of establishment U.K.

27.— (1) Subject to sub-paragraph (2), a person to whom paragraph 26 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

(i) the name and address of the holder of the UK marketing authorisation, or, where applicable, the name of that holder's representative,

(ii) the number of the UK marketing authorisation, or

(iii) the name and address of the manufacturer of the product; and

(b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i) the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and

(ii) the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b) the UK marketing authorisation holder, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph “the transitional period” means the period of 36 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)