Textual Amendments
F1Reg. 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
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(b)Article 40 (products recalled, withdrawn or stolen);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
F2Reg. 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)
F3Reg. 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)