The Human Medicines Regulations 2012 No. 1916

PART 5 U.K. Marketing authorisations

[F1 Offences relating to the safety features appearing on the packaging of medicinal products U.K.

Textual Amendments

F1 Reg. 94A and cross-heading inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 8 and reg. 94A and cross-heading inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 8

Offences relating to Commission Regulation 2016/161 U.K.

94A.— [F2 (1) A person who is—

(a) the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or

(b) a parallel distributor,

is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).]

(2) The provisions mentioned in paragraph (1) are—

(a) Article 33 (uploading of information in the repositories system);

(b) Article 40 (products recalled, withdrawn or stolen);

(c) Article 41 (products to be supplied as free samples); and

(d) Article 42 (removal of unique identifiers from the repositories system).

[F3 (3) In this regulation “parallel distributor” means a person who imports into Northern Ireland from an EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of a UKMA(NI), UKMA(UK), Article 126a authorisation, COR(NI), COR(UK), THR(NI) or THR(UK).]]

Textual Amendments

F2 Reg. 94A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 91(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 68)

F3 Reg. 94A(3) substituted (31.12.2020) by S.I. 2019/775, reg. 91(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 68)