The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

68.  For regulation 91 (omission of regulation 94A (offences relating to Commission Regulation 2016/161)) substitute—

“Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)

91.   In regulation 94A—

(a) for paragraph (1) substitute—

“(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).”;

(b) for paragraph (3) substitute—

“(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).”.”.